1

CHAPTER 31

INTELLECTUAL PROPERTY, INNOVATION, AND TECHNOLOGY TRANSFER

IN HEALTH IN KENYA AND AFRICA: CASE OF COVID-19 AND MALARIA

This Chapter may be cited as Ben Sihanya (forthcoming 2020) “Intellectual Property, Innovation, and

Technology Transfer in Health in Kenya and Africa: Case of COVID-19 and Malaria,” in Ben Sihanya

(forthcoming 2020) Intellectual Property and Innovation Law in Kenya and Africa: Cases and Materials

(IPILKA 2), Sihanya Mentoring & Innovative Lawyering, Nairobi & Siaya

Sihanya Mentoring and Innovative Lawyering Working Paper

sihanyamentoring@gmail.com

Nairobi, 21/7/2020; 22/7/2020; 25/7/2020

2

TABLE OF CONTENTS

CHAPTER 31: INTELLECTUAL PROPERTY, INNOVATION, AND TECHNOLOGY

TRANSFER IN HEALTH IN KENYA AND AFRICA: CASE OF COVID-19 AND

MALARIA .................................................................................................................................3

31.1 Nomenclature and Conceptualising Intellectual Property, Innovation, and Technology

Transfer in Health in Kenya and Africa ...................................................................................4

31.2 Methodology on IP, Innovation and Technology Transfer on COVID-19 and Malaria ... 16

31.3 Contextualizing IP, Innovation, and Technology Transfer in Health in Kenya and Africa

.............................................................................................................................................. 17

31.3.1 Incidence and Burden of Key Diseases in Kenya and Africa ................................... 17

31.3.2 Pharmaceutical Researchers, Innovators, Manufacturers and Distributors in Kenya

and Africa ......................................................................................................................... 19

31.3.3 Patent in Pharmaceutical and Chemical Inventions in Kenya and Africa ................. 22

31.4 Health Invention and Innovation in Kenya and Africa .................................................... 30

31.5 The Bar and Bench’s Response to COVID-19 in Kenya................................................. 44

31.5A The Universities’ response to COVID-19 in Kenya ..................................................... 46

31.6 Promoting Health through Intellectual Property in Kenya and Africa ............................. 49

31.6.2 Pharmaceutical Patent under ARIPO and OAPI, EAC, COMESA, ECOWAS,

SADC, and AfCFTA ......................................................................................................... 52

31.6.3 Pharmaceutical Patent under Pan African Intellectual Property Organization PAIPO

.......................................................................................................................................... 53

31.6.4 Patent Protection under the Agreement of Trade Related Aspects of Intellectual

Property, Including Trade in Counterfeit Goods (TRIPs) 1994........................................... 54

31.6.5 Doha Declaration on the TRIPS Agreement and Public Health 2001 ....................... 57

31.7 Compulsory licensing in the Health Sector in Kenya and Africa .................................... 61

31.8 Parallel Importation in the Health Sector in Kenya and Africa ....................................... 65

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31.9 Scenarios and Reforms in the (Post-) COVID-19 Age: Constitutional, Legislative, Policy,

and Administrative Options on IP, Innovation and Technology Transfer in Health in Kenya

and Africa ............................................................................................................................. 69

31.10 Summary of Findings, Conclusions, and Proposed Reforms on Intellectual Property,

Innovation, Technology Transfer in Kenyan and African (Public) Health .............................. 72

BIBLIOGRAPHY ................................................................................................................... 74

Books and Monographs

Journal Articles

Book Chapters

Newspaper Articles

Kenyan Constitutions ............................................................................................................ 97

Kenyan Statutes..................................................................................................................... 97

Rules, Regulations, Bills and Policies .................................................................................... 98

Cases ..................................................................................................................................... 98

Agreements and Conventions ................................................................................................ 98

African Statutes ..................................................................................................................... 99

Foreign Non-African Statutes ................................................................................................ 99

Annex 1: COVID-19 status in Kenya and Africa ................................................................... 99

Annex 2: Daily or Regular Tracking of COVID-19 in Kenya and Africa ............................... 99

Annex 3: Potential COVID-19 Vaccines ............................................................................... 99

Annex 4: The Judiciary in Emergencies, War, Crises,and Revolutionary Situations in Kenya

and Africa ................................................................................................................................. 99

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5

CHAPTER 31

INTELLECTUAL PROPERTY, INNOVATION, AND TECHNOLOGY TRANSFER

IN HEALTH IN KENYA AND AFRICA: CASE OF COVID-19 AND MALARIA1

This Chapter may be cited as Ben Sihanya (forthcoming 2020) “Intellectual Property, Innovation, and

Technology Transfer in Health in Kenya and Africa: Case of COVID-19 and Malaria,” in Ben Sihanya

(forthcoming 2020) Intellectual Property and Innovation Law in Kenya and Africa: Cases and Materials

(IPILKA 2), Sihanya Mentoring & Innovative Lawyering, Nairobi & Siaya.

31.1 Nomenclature and Conceptualising Intellectual Property, Innovation, and Technology

Transfer in Health in Kenya and Africa

What is the meaning, scope, and significance of intellectual property, innovation, and technology

transfer in health in Kenya and Africa? How should intellectual property (IP) in health be

conceptualized, problematized and contextualized while using COVID-19 and malaria as a case

study?

My overarching argument is that intellectual property can play a facilitative, restrictive, or

neutral role in innovation, technology transfer and sustainable development in health services,

health research and development (R&D), and the health sector generally in Kenya and Africa. A

lot depends on the policy choices or options, political economy, regulatory regime, and

institutional design.2

What is health? Health relates to human health and is closely linked to environmental health or

sanitary and phytosanitary standards (SPS).3

What is the meaning and role of germs,4 bacteria,

5 viruses,

6 fungi,

7 protozoa,

8 vectors,

9

parasites,10

and antibodies11

in the causes, effect, and management of diseases.

1 This Chapter 31 is being restructured into at least two chapters. 2 Ben Sihanya (2016; reprinted 2020) Intellectual Property and Innovation Law in Kenya and Africa:

Transferring Technology for Sustainable Development, (IPILKA 1) and Ben Sihanya (forthcoming 2020)

Intellectual Property and Innovation Law in Kenya and Africa: Cases and Materials, (IPILKA 2), Sihanya

Mentoring & Innovative Lawyering, Nairobi & Siaya. 3 Cf. Health Act 2017; Public Health Act 2012; Sanitary and Phytosanitary Standards (SPS) under the WTO

Agreement 1994. See Sihanya, IPILKA 1 & 2, ibid. Also see National Health Act No. 61 of 2003 (South Africa),

National Health Act No. 8 of 2014 (Nigeria), Public Health Act 1935 (Cap 281) (Uganda), Public Health Act No.

851 of 2012 (Ghana), Public Health Act No.1 of 2009 (Tanzania). 4 The term “germs” refers to the microscopic bacteria, viruses, fungi, and protozoa that can cause disease.

See RCHSD website, at https://www.rchsd.org/health-articles/what-are-germs-2/ (accessed 2/6/2020).

6

Second, whether they are property and if so whose? It is more generally agreed that they are

property if out of the body. Some countries also allow cells and human tissue in the body to be

property and be traded.12

Law, culture, traditions, religion and ethics play a role on whether and to what extent human

tissues and body parts can be appropriated and even donated by the living and post humously.13

There is the related debate on whether there is property in a dead body, corpse or cadaver. This

concerns detention of patients or dead bodies for non-payment of hospital fees thus claiming a

lien on a body.14

Custody and burial of dead bodies sometimes raise property rights issues. For instance, the old

English case of William v. William ruled that there is no property in a dead body at common law

but that the trustee, administrator or personal representative had a duty (and not a right?) to bury

the deceased according to the deceased’s status and estate.15

In the SM Otieno case the Court of

Appeal problematically decided that custody and burial or other disposal of the body of a Luo

5 Bacteria are tiny, single-celled organisms that get nutrients from their environments. In some cases, that

environment is your child or some other living being. ibid. 6 A virus is a submicroscopic infectious agent that replicates only inside the living cells of an organism. See

NCBI website, at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7150099/ (accessed 15/6/2020). 7 Fungi are multi-celled, plant-like organisms. They get nutrition from plants, food, and animals in damp,

warm environments. See RCHSD website, at https://www.rchsd.org/health-articles/what-are-germs-2/ (accessed

2/6/2020). 8 Protozoa are, like bacteria, one-celled organisms and many are able to move on their own. Protozoa love

moisture, so intestinal infections and other diseases they cause are often spread through contaminated water. See

RCHSD website, at https://www.rchsd.org/health-articles/what-are-germs-2/ (accessed 2/6/2020). 9 Vectors are organisms, typically a biting insects or ticks, that transmit diseases or parasites from one animal

or plant to another. See RCHSD website, at https://www.rchsd.org/health-articles/what-are-germs-2/ (accessed

2/6/2020). 10 A parasite is an organism that lives on or in a host and gets its food from or at the expense of its host. See

CDC website, at https://www.cdc.gov/parasites/about.html (accessed 5/6/2020). 11 A blood protein produced in response to and counteracting a specific antigen. Antibodies combine

chemically with substances which the body recognizes as alien, such as bacteria, viruses, and foreign substances in

the blood. See RCHSD website, at https://www.rchsd.org/health-articles/what-are-germs-2/ (accessed 2/6/2020). 12 13 14 See Isaac Ngugi v. Nairobi Hospital & 3 Ors, Petition 407 of 2012; Mary Nyang’anyi Nyaigro & Anor v. Karen Hospital & Anor, Civil Suit No. 448 of 2015. There have been proposals that hospital fees be pursued as debt

recovery through legal means. See Health (Amendment) Bill 2019. The Bill was sponsored by Mr Jared Okelo,

Nyando MP (ODM, NASA); Samuel Owino (2019) “Patients bodies detention ban to cost tax payers KES 2.3

billion,” Business Daily, Nairobi, Tuesday, 24/9/2019… Mr Okelo stated that “a body has no value and detaining it

only ends up putting more pressure on the bereaved family.” 15 William v. William [1882] 20 ChD 659..

7

man is a clan matter: “Once a Luo always a Luo.”16

A High Court judge followed this in the

Kamau case: “once a Kikuyu always a Kikuyu.”17

Significantly, the COVID-19 pandemic has given rise to debates on how to dispose of dead

bodies in a manner that observes health standards while according the deceased and bereaved

human dignity. The stated High Court of Kenya at Siaya (R.E. Aburili, J) in case Joan Akoth

Ajuang & Another v. Michael Owuor Osodo:

“The protection of the dead and their dignity is just like the protection of the living and their dignity.”

18

Third is whether human tissues and body parts are IP and if so whose. In the US, it is possible to

get IP especially a patent for improved cells. There must be human scientific intervention.

Europe has been saying No. African states are ambivalent.19

16 See Virginia Edith Wamboi Otieno v. Joash Ochieng Ougo & Another, Civil Case No. 4873 of 1986;

Virginia Edith Wamboi Otieno v. Joash Ochieng Ougo & Another Civil Appeal No. 31 of 1987. 17 . Cf. Josinda Katumba Kamau v. Annah Ngendo, Civil Case No. 1790 of 1998. The husband of the parties

or disputants had died in the Nairobi bomblast of August 1997…. 18 Joan Akoth Ajuang and Anor v. Michael Owuor Osodo, Chief Ukwala Location & 3 Others [2020] eKLR

(Siaya High Court Constitutional Petition No. 1 of 2020) quoting Justice J Turkel in The Inspector-General of The

Israel Police v. Ramla Magistrate Court Judge Mr Baizer, HCJ 81/66 at 337, 353. Mr James Oyugi Onyango, a

former Kenya Ports Authority (KPA) official was buried in Kamalunga Vvllage, Ugenya, Siaya County, by

Ggvernment officials late at night “like a dog” without participation of the deceased’s family… in June 2020,

Abenny Jachiga, a leading Ohangla musician whose songs include the hit “Mano kasinde” (that’s her cousin) was

buried in Chiga, Kano, Kisumu Ccunty by police in a similar manner. Rushdie Oudia (2020) “Kisumu police

apologise for chaotic burial of Ohangla star Jachinga,” Sunday Nation, Nairobi, 21/6/2020, at 3. None of these died of COVID-19 even if that were to be the excuse… While cautioning Kenyans against recklessness in the COVID-19

age, the Nation recklessly listed Mr James Oyugi Onyango as one of the COVID-19 deaths. He and others had not

been tested, diagnosed, nor subjected to a conclusive postmortem or autopsy. See Chapter 31.9 below. The stories

are generally informative. See Nation Reporter (2020) “COVID: Lives and stories of the ones we have lost,” Daily

Nation, Nairobi, 14/7/2020, at 1; Allan Olingo (2020) “Not just a number: In honour of the Kenyans we’ve lost,”

Daily Nation, Nairobi, 14/7/2020, at 6; Nasibo Kabale (2020) “Kenya has highest rate of deaths in East Africa,”

Daily Nation, Nairobi, 14/7/2020, at 6; Elizabeth Merab (2020) “More young people dying of coronavirus,” Daily

Nation, Nairobi, 14/7/2020, at 6; Brian Ojamaa (2020) “Tributes flow as Dr Adisa is laid to rest in Bungoma,” Daily

Nation, Nairobi, 14/7/2020, at 7; Sarah Nanjala (2020) “What you need to know when burying a loved one after

COVID-19 death,” Daily Nation, Nairobi, 14/7/2020 at 7. 19 Robin Feldman (2011) “Whose body is it anyway? Human cells and the strange effects of property and intellectual property law,” Stanford Law Review, at https://pubmed.ncbi.nlm.nih.gov/21774193/ (accessed

8/6/2020). See the Moore deceased spleen case; The Hecht case on the property rights of sperm… See John Moore

v. the Regents of the University of California 793 P.2d 479 (Cal. 1990)… See Charles Jordan (2002) “First Moore

then Hecht: Isn’t it time we recognize a property interest in tissues, cells, and gametes,” National Library of

Medicine, at https://pubmed.ncbi.nlm.nih.gov/15212039/ (accessed 16/6/2020). See James Boyle (1997) Shamans,

Ssftware and Ssleens, Harvard University Press..

8

The right to health is governed by article 43 of the Constitution of Kenya 2010, statutes, rules,

regulations, and policy.20

Article 43 provides thus on the right to health.

“Every person has the right to the highest attainable standard of health, which includes the right

to health care services, including reproductive health care.”21

And IP, which is human creativity embodied in tangible form, innovation and technology

transfer are governed by the Constitution, statutes, rules and regulations, and scattered sectoral

policies. The link between the two is sometimes tenuous.

How has Kenya, South Africa, Nigeria, Uganda, Tanzania and other African states addressed IP

law and reform in health, including health and IP protection, audit, valuation, commercialization,

securitization, piracy, infringement, counterfeiting, administration and enforcement? What are

the opportunities for applying an Afro-Kenyanist theory on IP, innovation and technology

transfer in health?

At least six forms of IP are relevant to innovation and technology transfer in health in Kenya and

Africa namely; patent, utility model, trade secret, unfair competition, traditional knowledge (TK)

and traditional cultural knowledge (TCE),22

and trade mark. Domain name system (DNS) and

copyright are increasingly becoming important in the context of digitization of health R&D as

well as delivery, for instance e-medicine.23

Significantly, researchers in Kenya, South Africa, Nigeria, Ghana, Egypt, Uganda, Tanzania, and

other African states are already encountering IP challenges as they use biotechnology and

information and communication technology (ICT) or digital technology in health. These IP

challenges relate to research and development (R&D) of diagnostics, therapies, vaccines, caring

or coping mechanisms, and related innovations. These challenges and opportunities are in critical

20 Ben Sihanya (forthcoming 2020) Constitutional Democracy and Administrative Law in Kenya and Africa,

(CODRALKA) Vol 1 & 2, Sihanya Mentoring and Innovative Lawyering, Nairobi & Siaya. 21 Article 43(1)(a) Constitution of Kenya 2010. 22 Traditional Knowledge and Traditional Cultural Expressions Act 2016. TK and TCE are always linked to

the conservation, sustainable utilization, and access and benefit sharing (ABS) of genetic resources in the context of the following three issues. First, generic resources. Second material transfer agreement (MTA) based on the

foregoing as well as production, diffusion, access to environmentally sound technologies. And third, bio-piracy ….

See Ben Sihanya (1994) “Technology transfer, intellectual property rights and bio-safety: strategies for

implementing the Convention on Biodiversity,” in Vol. 6 No. 3, AgBiotech News and Information, Centre on

Agricultural Biotechnology (CAB), London, pp. 53N-60N; Sihanya, IPILKA 1 & 2. 23

9

areas like the novel Coronavirus disease (COVID-19), HIV/AIDS, malaria, tuberculosis (TB),

cholera, cancer,24

and Ebola.25

What is malaria? According to WHO:

“Malaria is an acute febrile illness caused by Plasmodium parasites. The parasites are spread to

people through the bites of infected female Anopheles mosquitoes, called ‘malaria vectors.’ In a non-immune individual, symptoms usually appear 10–15 days after the infective mosquito bite.

The first symptoms – fever, headache, and chills – may be mild and difficult to recognize as

malaria. If not treated within 24 hours, P. falciparum malaria can progress to severe illness, often

leading to death.”26

Malaria is a major killer in Kenya and Africa as discussed here and below. It is responsible for

approximately 1-3 million deaths per year. Of these deaths, the overwhelming majority are

children aged 5 years or younger and 80-90% of the deaths are in rural sub-Saharan Africa.27

What is cholera? According to the World Health Organisation (WHO):

“Cholera is an acute diarrhoeal infection caused by ingestion of food or water contaminated with

the bacterium Vibrio cholerae. It is an extremely virulent disease that can cause severe acute watery diarrhoea. It takes between 12 hours and 5 days for a person to show symptoms after

ingesting contaminated food or water.”28

Kenya and Africa have suffered the effects of cholera. Between 1970 and 2011, African

countries reported 3,221,050 suspected cholera cases to the World Health Organization,

24 Lynet Igadwah (2020) “How doctors are innovating to save cancer patients avoiding hospital,” Business

Daily, Nairobi, 5/6/2020. 25 See Ben Sihanya (2003) “Patent wars raging over Aids cure,” Opinion: Pandemic, Daily Nation (Nairobi), Wednesday, 17/12/2003, at 9; IPILKA 1. Cf. Ben Sihanya (2008) “How IMF policies constrain policy space in

Kenya’s health sector,” in Ben Sihanya (ed) The Impact of IMF Policies on Education, Health and Women’s Rights

in Kenya, Action Aid International Kenya, Nairobi, Part IV, pp. 65-95. .An example being the controversy between

scientists from Oxford University and the University of Nairobi. This was with respect to patenting and related IP

rights on the products of R&D on HIV/AIDS, including a proposed vaccine. 26 See World Health Organization website, at https://www.who.int/news-room/fact-sheets/detail/malaria

(accessed 4/6/2020). 27 See Thomas E. Herchline (2020) “What is the mortality rate of malaria?” at

https://www.medscape.com/answers/221134-40790/what-is-the-mortality-rate-of-malaria (accessed 16/6/2020).

That partly explains the race for a malaria vaccine for the under five and the clinical trials reportedly undertaken in

Kenya and the Malawi on COVID-19 tests and trial. See WHO (2019) “Malaria vaccine launched in Kenya: Kenya joins Ghana and Malawi to roll out landmark vaccine in pilot introduction,” WHO, at

https://www.afro.who.int/news/malaria-vaccine-launched-kenya-kenya-joins-ghana-and-malawi-roll-out-landmark-

vaccine-pilot (accessed 21/7/2020). 28 See World Health Organization website, at https://www.who.int/news-room/fact-sheets/detail/cholera

(accessed 15/6/2020). What have been the impact of cholera outbreaks, epidemics and pandemics in Kenya and

Africa?

10

representing 46 % of all cases reported globally.29

Excluding the Haitian epidemic, sub-Saharan

Africa accounted for 86 % of reported cases and 99% of deaths worldwide in 2011.30

Kenya has experienced a surge in cholera cases since 2017. According to WHO reports, there

was an outbreak from October 2016 which was controlled by April 2017.31

A second wave of

cholera outbreaks started in Garissa County on 2 April 2017 and was reported later in nine other

counties including Nairobi, Murang’a, Vihiga, Mombasa, Turkana, Kericho, Nakuru, Kiambu,

and Narok.32

What is COVID-19? According to the World Health Organisation (WHO):

“Coronaviruses are a large group of viruses that cause diseases in animals and humans. They

often circulate among camels, cats, and bats, and can sometimes evolve and infect people. They include Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome

(SERS). MERS was first reported in 2012 in Saudi Arabia and spread to more than 25 other

countries. MERS originated in camels and emerged to infect people. Symptoms usually include

fever, cough, and shortness of breath, and often progress to pneumonia.” 33

WHO continues:

“SARS originated in small mammal and emerged to infect people. SARS was first reported in

Southern China in 2002 and the illness spread to more than two dozen countries in North America, South America, Europe, and Asia. Symptoms include fever, chills, and body aches, and

may progress to pneumonia.”34

What are the symptoms of the novel corona virus 2019 (COVID-19) diseases?35

Remarkably

some of the patients are said to be asymptomatic meaning that they do not show any signs or

symptoms of infection.36

One of the consequences is that Health CS Mutahi Kagwe announced

29 See Martin Mengel (2014) “Cholera outbreaks in Africa,” Research Gate, at

https://www.researchgate.net/publication/262339340_Cholera_Outbreaks_in_Africa (accessed 20/7/2020. 30 ibid. 31 See World Health Organization website, at https://www.who.int/csr/don/21-july-2017-cholera-kenya/en/

(accessed 20/7/2020). 32 ibid. 33 See World Health Organization website, at https://www.who.int/health-topics/coronavirus#tab=tab_1 (accessed 22/5/2020). 34 ibid. See Standard Reporter (2020) “China to run human coronavirus vaccine trial in UAE,” Standard,

Nairobi, 23/6/2020, at https://www.standardmedia.co.ke/article/2001376229/china-to-run-human-coronavirus-

vaccine-trial-in-uae (accessed 23/6/2020). 35 Graham Kajilwa (2020) “COVID-19 risky to your heart,” Standard, Nairobi, Wednesday, 3/6/2020, at 10. 36

11

on June 4, 2020 that such patients would be released from crowded facilities to be managed or to

recuperate from home.37

What is tuberculosis (TB)? According to WHO, TB is a bacterial infection that mostly affects the

lungs. TB is spread from person to person through the air. When people with lung TB cough,

sneeze or spit, they propel the TB germs into the air. A person needs to inhale only a few of these

germs to become infected.38

What is cancer? According to WHO, Cancer is a large group of diseases that can start in almost

any organ or tissue of the body when abnormal cells grow uncontrollably, go beyond their usual

boundaries to invade adjoining parts of the body and/or spread to other organs. The latter process

is called metastasizing and is a major cause of death from cancer. A neoplasm and malignant

tumour are other common names for cancer.39

The most common types of cancer in Kenya are breast, oesophagus and cervical cancers in

women and oesophagus and prostate cancer and Kaposi sarcoma in men.40

Some of these diseases have been referred to as public health emergencies, epidemics or

pandemics. What is a public health emergency under WHO and WTO TRIPs rules? An epidemic

is a widespread occurrence of an infectious disease in a community at a particular time.41

37 Graham Kajilwa (2020) “Kenya to stop testing asymptomatic patients after WHO report,” Standard,

Nairobi, 17/6/2020, at https://www.standardmedia.co.ke/article/2001375447/covid-19-kenya-to-stop-testing-asymptomatic-patients-after-who-report (accessed 19/6/2020); Bernadine Mutanu (2020) “Government rolls out

home care plan for COVID-19 patients,” Daily Nation, Nairobi, 10/6/2020, at

https://www.nation.co.ke/kenya/news/govt-rolls-out-home-care-plan-for-covid-19-patients-652940 (accessed

19/6/2020); Saada Hassan (2020) “Nairobi, Mombasa, Kajiado hotspots for Covid-19 asymptomatic cases,”

Standard, Nairobi, 22/6/2020, at https://www.standardmedia.co.ke/article/2001376045/nairobi-mombasa-kajiado-

hotspots-for-covid-19-asymptomatic-cases (accessed 23/6/2020); Annie Njanja (2020) “Nyumba Kumi to police

Covid patients in State homecare plan,” Business Daily, Nairobi, 23/6/2020, at

https://www.businessdailyafrica.com/news/Nyumba-Kumi-to-police-Covid-patients/539546-5581076-

8937v7/index.html (accessed 24/6/2020). . 38 See World Health Organization website, at https://www.who.int/news-room/fact-sheets/detail/tuberculosis

(accessed 4/6/2020). 39 See World Health Organization website, at https://www.who.int/health-topics/cancer#tab=tab_1 (accessed

7/6/2020). Cf. Ministry of Health (2017) “National cancer control strategy 2017-2022,” Government Press, Nairobi. 40 Ministry of Public Health and Sanitation (2016) “National Cancer Control Strategy,” Government Printer,

Nairobi, at https://www.youtube.com/watch?v=MI-tNMoowMk (accessed 15/6/20202). 41 Heath Kelly (2011) “The elusive definition of a pandemic is not elusive,” World Health Organization

Bulletin, at http://www9.who.int/bulletin/volumes/89/7/11-088815/en/ (accessed 3/6/2020).

12

A pandemic is a disease outbreak that spreads across countries or continents.42

It affects more

people and takes more lives than an epidemic.43

The science,44

origin45

and impact of COVID-19 is complex, contradictory, and needs further

research.

There are at least three different but related scientific questions on COVID-19. First, the natural,

physical (or biological) and medical science. Second, the social science including statistics and

political economy. Third, the legal scientific or jurisprudential questions and affective issues of

values, and cultural aspects of COVID-19.

First, the physical, biological, chemical, and medical science questions include the cause,

diagnosis, or tests, treatment or therapy and vaccination for the novel coronavirus 2019 (COVID-

19). What are the appropriate dietary or nutritional responses? What are the symptoms? What

does it mean to be asymptomatic? Why is there uncertainty on whether asymptomatic people or

patients can infect others?46

Some of the scientific questions relate to the challenges regarding

HIV/AIDS in the 1980s and 1990s.47

Given the novelty of COVID-19 there is uncertainty and

speculation or conspiracy theories, some of which are similar to those in the early of HIV/AIDS

and in the year 2000 (Y2K) compare problem.48

42 ibid. “Health (care) workers” has been problematized by some as demeaning on the Kenyan debate on the

Health Act 2017… 43 WHO (2020) “Global epidemics and impact of cholera,” at https://www.who.int/topics/cholera/impact/en/ (accessed 19/6/2020). 44 Some of the questions being asked are; where did the first case of Corona virus originate? What are the

(first) symptoms of COVID-19? How is COVID-19 transmitted? (is it by physical contact? airborne? Through body

fluids?) What does an asymptomatic COVID-19 patient mean? 45 Correspondent (2020) “Origin of COVID-19 and China’s role under….” …. Reggie Aqui & Ken Miguel

(2020) “Corona virus origin: COVID 19 was discovered in China but where did it come from?” ABC News, USA, at

https://abc7news.com/where-did-coronavirus-come-from-originally-what-is-the-cause-of-really-covid/6175783/

(accessed 2/6/2020). 46 47 See Ben Sihanya, “Patent wars raging over Aids cure,” (2003) Daily Nation (Nairobi), Wednesday,

17/12/2003, at 9. 48 Joanne Miller (2020) “COVID-19 conspiracy theories: Expert discusses the psychology and danger,”

University of Delaware, at https://www.newswise.com/coronavirus/covid-19-conspiracy-theories-pose-extreme-

danger/?article_id=730187 (accessed 21/7/2020); Peter Daszak (2020) “Ignore the conspiracy theories: Scientists

know COVID-19 wasn’t created in a lab,” The Guardian, at

https://www.theguardian.com/commentisfree/2020/jun/09/conspiracies-covid-19-lab-false-pandemic (accessed

21/7/2020).

13

Remarkably, US President Donald Trump called it the “Chinese flu” or “Kung flu” … That is a

pun or parody, caricature, satire or pastiche of the name of the martial artist Kung Fu… Trump

claimed COVID-19 came from a Chinese lab (in Wuhan Province?).49

Tanzania President John Pombe Maghufuli has denied the existence or incidence(?) of COVID-

19.50

In Burundi, President Pierre Nkumnziza relatedly succumbed to COVID-19 after mass

presidential campaign rallies and meeting with other leaders….51

And some citizens in Kenya, Africa and the US have behaved in a manner that defies the

protocol.52

The impact, management, politics, political economy and governance is varied, convoluted and

controversial in Kenya and Africa53

and has demonstrated how unprepared Kenya and African

states are to address health and related emergencies, including epidemics and pandemics.54

49 Cf. AFP (2020) “Bill Gates conspiracy theories echo through Africa,” Standard, Nairobi, 29/5/2020, at https://www.standardmedia.co.ke/article/2001373117/bill-gates-conspiracy-theories-echo-through-africa (accessed

2/6/2020). “Allegations, rumours about American philanthropist’s prediction” …; Adam Taylor (2020) “What

caused the coronavirus? A scientist’s take on the theories about the outbreak’s Chinese origin,” Washington Post,

16/4/2020; Nation Reporter (2020) “Trump says border wall has ‘stopped everything’ including Covid-19,” Daily

Nation, Nairobi, 24/6/2020, at https://www.nation.co.ke/kenya/news/world/trump-says-border-wall-has-stopped-

everything-including-covid-19-887062 (accessed 24/6/2020) . 50 BBC Reporter (2020) “Coronavirus: John Magufuli declares Tanzania free of COVID-19,” BBC News, at

https://www.bbc.com/news/world-africa-52966016 (accessed 25/7/2020). 51 Allan Olingo (2020) “In self-isolation, Nkurunziza turned to Kenya for embrace,” Daily Nation, Nairobi,

11/6/2020, at https://www.nation.co.ke/kenya/news/in-self-isolation-nkurunziza-turned-to-kenya-for-embrace-

653154 (accessed 25/7/2020). 52 For instance in the demonstration to the police against the killing of George Flyod. What science explains

the less experimental infection? What about some large gatherings in some funerals or meetings in Kenya and

Africa? 53 Cf. Macharia Munene (2020) “Perhaps it is time to ease corona virus restrictions,” Standard, Nairobi,

25/5/2020, at https://www.standardmedia.co.ke/article/2001372640/perhaps-it-s-time-to-ease-coronavirus-

restrictions (accessed 29/5/2020). 54 Kabale, Nasibo (2020) “Corona testing curbed by lack of test materials,” Business Daily, Nairobi, 2/6/2020,

at https://www.businessdailyafrica.com/news/Corona-testing-curbed-by-lack-of-test-materials/539546-5569022-

wok6bh/index.html (accessed 3/6/2020); Annie Njanja (2020) “Health ministry admits corona test kits shortages,”

Business Daily, Nairobi, Wednesday, 3/6/2020, at 2; N Iraki (2020) “How many COVID-19 stimulus packages does

a country need?” [curfew and the restriction have stifled activities and reduced tax income][stimulus; economic

recovery; Kenya, Africa, the world have wallowed in a recession].

14

Indeed in Kenya COVID-19 has been preceded and attended by misplaced economic,

technological and health priorities including procuring irrelevant but expensive equipment under

the management equipment service (MES)55

and misuse, misappropriation or looting of COVID-

19 funds.56

What is the meaning of and role of epidemiology in the cause, effect, and management of a

disease? Epidemiology is the study of the origin and causes of diseases in a community.57

It is

the scientific method of investigation and problem-solving used by disease detectives,

epidemiologists, laboratory scientists, technicians, physicians, and other health care workers, and

public health professionals to address health problems and outbreaks.58

What risks do disease detectives, epidemiologists, laboratory scientists, technicians, physicians,

and other health care workers or providers, and public health professionals face in the course of

duty? They have a markedly higher risk of becoming infected with COVID-19, especially if they

are exposed to a high volume of sick patients (such as in the emergency room) or respiratory

secretions (such as intensive care unit healthcare providers).59

How has Kenya and other African states prepared its frontline human resource, especially health

care workers and other health professionals in the fight against COVID-19?60

What was the risk

and welfare benefits promised by the Government and payment plan? KES 3 billion? How much

has been paid? For what period?61

How many health workers have been paid the risk

55 At least KES 63 billion. Cf. Renson Mnyamwezi (2020) “COVID-19 at stake because of funds, says

health boss,” Sunday Standard, Nairobi, at 11…. 56 See Nasibo Kabale and Bernard Mwinzi (2020) “Kagwe transfers 30 officers in battle against cartels,”

Daily Nation, Nairobi, Wednesday, 13/5/2020; Samuel Owino (2020) “Mutahi Kagwe pledges to destroy Afya

House cartels,” Daily Nation, Nairobi, Wednesday, 18/3/2020; George Munene (2020) “Waiguru rejects changes to

COVID-19 budget,” Daily Nation, Nairobi, Thursday, 4/6/2020, at 21; Onyango, Jonah (2020) “Good governance in

the wake of COVID-19,” Standard, Nairobi, 2/6/2020. 57 See CDC website, at https://www.cdc.gov/csels/dsepd/ss1978/lesson1/section11.html (accessed 23/6/2020). 58 ibid. 59 Malcom Sim (2020) “The COVID-19 pandemic: major risks to healthcare and other workers on the front

line,” Vol. 77 Issue 5, BMJ Occupational & Environmental Medicine Journal, at https://oem.bmj.com/content/77/5/281 (accessed 23/6/2020). 60 Human Rights Watch (2020) “Covid-19 exposes healthcare shortfalls,” Human Rights Watch, at

https://www.hrw.org/news/2020/06/08/africa-covid-19-exposes-healthcare-shortfalls (accessed 23/6/2020). 61 Samuel Too (2020) “KMPDU says doctors have not received risk allowances as promised,” Standard,

Nairobi, 8/6/2020, at https://www.standardmedia.co.ke/article/2001374435/kmpdu-says-doctors-have-not-received-

risk-allowances-as-promised (accessed 20/7/2020).

15

allowance?62

How many health workers have succumbed?63

Been infected? As at July 14, 2020

about 292 health workers had tested positive for the corona virus in Kenya.64

Recovered?65

The Kenya Government relatedly spent about KES 4 million of COVID-19 funds on tea and

samosas.66

How much was spent on therapy? IP and innovation? Licensing? research? CS

Mutahi Kagwe’s promised to end cartels in the Ministry of Health’s Afya house.67

These misplaced economic, technological and health priorities and limited cushioning of

economic actors and the population have also led to the loss of jobs and closure of businesses.68

The food service, hotel, transport, horticulture, and tourism industries have especially been hit

hard.69

Ng’ang’a Kamau, a Business Daily reporter noted:

“As a result of the massive loss of revenue, top hotels have, since march, drastically downsized

their operations, with some like the Sarova Stanley, Hotel Intercontinental, and Fairmount the

Norfolk, closing their doors altogether. Most of them have had to send their staff on unpaid leave

62 Capital Reporter (2020) “Frontline health workers COVID-19 risk allowances ready for disbursement say

MOH,” Capital News, Nairobi, 12/7/2020, at https://www.capitalfm.co.ke/news/2020/07/frontline-health-workers-

covid-19-risk-allowances-ready-for-disbursement-moh/ (accessed 20/)7/2020. 63 Bernadine Mutanu (2020) “Honor our nurses,” Daily Nation, Nairobi, 14/7/2020 at 8; Allan Odingo (2020)

“Not just a number: In honour of the Kenyans we’ve lost,” Daily Nation, Nairobi, 14/7/2020 at 6. 64 Elizabeth Merab (2020) “No easy day in the life of a health worker,” Daily Nation, Nairobi, 14/7/2020 at 8;

Felix Tih (2020) “Kenya: 257 health workers infected with COVID-19,” Anadolu Agency, at

https://www.aa.com.tr/en/africa/kenya-257-health-workers-infected-with-covid-19/1903926 (accessed 20/7/2020). 65 66 BBC Reporter (2020) “Corona virus in Kenya: Fearing ‘money heists’ amid pandemic,” BBC News,

7/5/2020, at https://www.bbc.com/news/world-africa-52540076 (accessed 15/6/2020). 67 Nasibo Kabale and Bernard Mwinzi (2020) “Kagwe transfers 30 officers in battle against cartels,” Daily

Nation, Nairobi, Wednesday, 13/5/2020; Samuel Owino (2020) “Mutahi Kagwe pledges to destroy Afya House

cartels,” Daily Nation, Nairobi, Wednesday, 18/3/2020. 68 Macharia Kamau (2020) “Virus leaves 300,000 Kenyans without jobs in three months,” Standard, Nairobi,

2/6/2020, at https://www.standardmedia.co.ke/article/2001373583/virus-leaves-300-000-kenyans-without-jobs-in-

three-months (accessed 3/6/2020); Constant Munda (2020) “Over 770,000 youths lose their jobs in three months,”

Business Daily, Nairobi, 2/6/2020, at https://www.businessdailyafrica.com/news/Over-770-000-youths-lose-their-

jobs-in-three-months/539546-5569020-135h0ts/index.html (accessed 3/6/2020).

69 Adonijah Ochieng (2020) “Norfolk closes indefinitely, fires all employees,” Daily Nation, Nairobi,

29/5//2020, at https://mobile.nation.co.ke/business/Norfolk-closes-indefinitely--fires-employees/1950106-5566372-t9nnvu/index.html (accessed 30/5/2020); Moses Michira (2020) “116 year old hotel closes as corona virus pummels

iconic brands,” Standard, Nairobi, 2/6/2020, at https://www.standardmedia.co.ke/article/2001373597/brands-that-

covid-19-ate (accessed 3/6/2020); Kamau Muthoni (2020) “Negotiate with your employer, court orders staff sent on

unpaid leave due to Covid-19,” Standard, Nairobi, 21/6/2020, at

https://www.standardmedia.co.ke/article/2001375877/capital-club-staff-sent-on-unpaid-leave-due-to-covid-19-

directed-to-negotiate-with-employer (accessed 21/6/2020). .

16

while some have shed jobs, and this has led to yet another challenge that is likely to haunt the

hospitality industry in the medium term – the loss of IP,”70

Mbugua continues,

“One of the unintended consequences of top hotels is the loss of skilled manpower [sic human

resources], trained at a great cost to become the best in the hospitality industry. Their knowledge

or know-how to create a world class consumer experience is ranked in the industry as IP.”71

Another sector that has been hit hard by the COVID-19 is education and learning or education,

training, research, innovation, and mentoring (ETRIM). The COVID-19 has led to the closure of

all learning institutions meaning that students, pupils, teachers, lecturers, administrative and

other staff are forced to stay at home.72

Closure of these learning institutions has had diverse consequences. These include educational,

or academic, nutritional and social impact for instance for students who rely on school feeding

programs as their main source of nutrition.73

Similar scientific, administrative, political, and economic challenges are recorded in the

increasing cases of obesity,74

cancer, cholera, diabetes, and hypertension.75

70 Ng’ang’a Mbugua (2020) “Skills threat that high-end hotels face on closures tied to COVID-19,” Business

Daily, Nairobi, 5-7/6/2020 at 12-13; Awal Mohammed (2020) “More SMEs on the brink as virus takes a toll on

economy,” Standard, Nairobi, 2/6/2020, at https://www.standardmedia.co.ke/article/2001373596/smes-position-to-

opening-the-country (accessed 3/6/2020). 71 ibid. 72 See Nancy Agutu & Musembi Nzengu (2020) “Each class to have 15-20 students once schools reopen-

Magoha,” Star, Nairobi, 24/6/2020, at https://www/the-star.co.ke/news/2020-06-24-each-class-to-have-15-20-

students-once-schools-reopen-magoha/ (accessed 24/6/2020); Kitavi Mutua (2020) “Magoha: School social

distancing a big challenge,” Daily Nation, Nairobi, 24/6/2020, at https://www.nation.co.ke/kenya/news/magoha-

school-social-distancing-a-big-challenge-962140?view=htmlamp (accessed 24/6/2020). See also Chapter 31.5A

(below) on The Universities response to COVID-19 in Kenya.... Cf. Chapter 31.5 below on The Bar and Bench’s

response to COVID-19 in Kenya.. 73 Damaris Seleina and Evelyn Jepkemei (2020) “How school closures during COVID-19 further marginalize

vulnerable children in Kenya,” Brookings Blog, at https://www.brookings.edu/blog/education-plus-

development/2020/05/06/how-school-closures-during-covid-19-further-marginalize-vulnerable-children-in-kenya/

(accessed 25/6/2020). 74 See patent wars regarding bio-piracy including of the hoodia plant by a US patent applicant after

hoodiaihad been biopirated…. from the San of the Kalahari Desert… See Ben Sihanya (2016; reprinted 2020;

forthcoming 2020) Intellectual Property and Innovation Law in Kenya and Africa ( IPILKA) 1 & 2, Sihanya

Mentoring & Innovative Lawyering, Nairobi & Siaya. 75 Standard (2020) “Health ministry targets alcohol and junk food,” Standard, Nairobi, Monday, May 25,

2020.

17

COVID-19 and the foregoing diseases are no longer regarded as just health challenges, but as

challenges in health, social and political economy as well as constitutional democracy in Kenya

and Africa.76

The opportunities available through IP, innovation and technology transfer are yet to be

optimally utilized to address these health challenges.

The pharmaceutical and related industries, patent, trade mark, plant breeders rights, utility

model, trade secret, unfair competition and related IP are considered a crucial precondition for

investment in the research and development (R&D) necessary for new health innovations.77

For

instance, patent is highly valued. This is partly due to the high sunk costs, as well as the ease

with which new diagnostic kits, chemical compounds, vaccines, and drugs can be copied or

imitated.78

Thus IP is crucial to innovation and technology transfer in health.

How do IP, innovation and technology transfer help in disease prevention, treatment,

vaccination, and general disease control?

What are the key disease prevention techniques, innovations and technologies with regard to

malaria, TB, HIV/AIDs, cholera, obesity, hypertension and COVID-19?

In the case of COVID-19 some of the WHO79

and Ministry of Health (MOH)80

protocols or

measures include hand washing with soap and running water, wearing ordinary and medical or

surgical face masks, and the personal protective equipment (PPE),81

applying sanitizers, social

76 Sihanya (forthcoming 2020) Constitutional Democracy and Administrative Law in Kenya and Africa, (CODRALKA) Vols. 1 & 2, op. cit. 77 Elizabeth Merab (2020) “Vaccine tested in Wuhan found safe and induces rapid immune response,” Daily

Nation, May 26, 2020, Nairobi, Kenya. 78

Carsten Fink(2005) “Patent protection, transnational corporations and market structure: a simulation study

of the Indian pharmaceutical industry,” in Keith Maskus and Carsten Fink (eds) Intellectual Property and

Development; Lessons from Recent Economic Research, op. cit. 79 AFT (2020) “China failed to release virus data on time for WHO to act,” Standard, Nairobi, 3/6/2020, at 25. 80 Annie Njanja (2020) “Health ministry admits corona test kits shortages,” Business Daily, Nairobi,

Wednesday, 3/6/2020, at 2… 81 Stanley Ngotho (2020) “Covid Fund takes protective equipment to 54 facilities,” Business Daily, Nairobi,

25/6/2020, at https://www.businessdailyafrica.com/news/Covid-Fund-takes-protective-equipment-to-54-

facilities/539546-5582440-epv01gz/index.html (accessed 25/6/2020).

18

distancing, (self) isolation,82

staying at home, generally keeping safe, testing, tracking, (self and

forced) quarantine,83

curfew,84

containment,85

and lockdown…

What are the main challenges and opportunities regarding COVID-19 therapy or treatment?

What are the key challenges and opportunities regarding a COVID-19 vaccine?86

Most of these protocols apply public domain techniques or processes. Some are based on

(emerging) innovations and IP protected technologies…87

31.2 Methodology on IP, Innovation and Technology Transfer on COVID-19 and Malaria

This study on IP, innovation and technology transfer on COVID-19 and malaria in Kenya and

Africa is guided by a three pronged methodology. First, the research questions, conceptualization

and problematization are based on an Afro-Kenyan perspective on IP, innovation and technology

transfer in health.

Second, the study is mainly based on the review of the literature, constitutions, agreements,

National laws, regulations, policy and administrative procedures on IP and health. Third, the

study utilizes content analysis of the scientific, professional, and popular print, electronic and

82 Ruth Mbula (2020) “County readies itself with a new isolation centres as COVID lists neighbours” Daily

Nation, Nairobi, 5/6/2020, at 22. 83 Daily Nation (2020) “Overwhelmed: Soon you’ll nurse coronavirus at home,” Daily Nation, Nairobi, Friday, 5/6/2020, at 18; Angala Oketch (2020) “Home care floated asymptomatic patients,” Daily Nation, … ,

5/6/2020 at 8 [“Health ministry to issue guidelines based on WHO protocols. Says CS Kagwe … packed facilities

and lack of test kits…; Anne Njanja (2020) “State plans home care for COVID-19 patients as cases rise to 2340,”

Business Daily, Nairobi, 5/6/2020, at 2. 84 X.N. Iraki (2020) “How many COVID-19 stimulus packages does a country need?” [curfew and the

restriction have stifled activities and reduced tax income][stimulus; economic recovery; Kenya, Africa, the world

have wallowed in a recession]; Standard (2020) “Mindless killings by police over curfew must come to an end,”

Standard, Nairobi; Kamore Maina and Kirsten Kanji (2020) “Police put on spot over brutality during curfew,”

Standard, Nairobi, Wednesday, at 20 (impact: police kill more than COVID-19). See also Daily Nation cartoon of

5/6/2020… 85 Daily Nation (2020) “Overwhelmed: Soon you’ll nurse coronavirus at home,” Daily Nation, Nairobi, Friday, 5/6/2020, at 18. 86 Elizabeth Merab (2020) “Vaccine tested in Wuhan found safe and induces rapid immune response,” Daily

Nation, May 26, 2020, Nairobi, Kenya; BBC (2020) “Stalled vaccine programmes put children’s lives at risk,”

Business Daily, Nairobi, 5-7/6/2020, at 3; Dorothy Pamella (2020) “Integrate traditional, cultural medicine to

achieve UHC,” Sunday Standard, Nairobi, 31/5/2020, at 17. 87

19

social media as well as (participant) observation.88

This is partly because of the limited peer

reviewed literature on COVID-19 and the resurgent malaria.89

31.3 Contextualizing IP, Innovation, and Technology Transfer in Health in Kenya and

Africa

Two research questions are key in this section. First, what is the incidence and burden of the

main diseases in Kenya and Africa? Second, what is the role of IP, innovation and technology

transfer on many diseases and health challenges in Kenya and Africa.

31.3.1 Incidence and Burden of Key Diseases in Kenya and Africa

What are the main diseases in Kenya? What is their incidence? How many cases per day? Per

month? Per year? How many die? How many recover? What is the burden of these diseases?90

These questions are best addressed with a SEIR/SERS model meaning Susceptible – Exposed

Infections – Recovered – Susceptible…. According to medical experts, “A SEIR model assumes

people carry lifelong immunity to a disease upon recovery but for many diseases the immunity

infection wanes one time.”91

Remarkably, a May 2020 study shows that Africans are generally less likely to die from COVID-

19 compared with Europeans and not likely to die from the disease compared with Asians and

South Americans.” Relatedly, “the researchers, however, [cautioned that]… if the WHO

prediction comes to pass… Africa could still record increased cases and deaths.”92

Table 1 below is based on the case analysis and a SEIR/SERS model or methodology.

88 COVID-19 and malaria depict characteristics of a moving target and the author and the research population

experience the challenges and opportunities daily. Moreover, the author is finalizing a book on the issues and is a

member of the IP Committee of the African Scientific, Research and Innovation Council (ASRIC) Advisory Board

on STI Intervention for Covid-19. See Sihanya, IPILKA 2. 89 See also Sihanya, IPILKA 1 & 2, op. cit. Cf. Justin Cohen (2012) “Malaria resurgence: A systematic

review and assessment of its causes,” Malaria Journal, at https://malariajournal.biomedcentral.com/articles/10.1186/1475-2875-11-122 (accessed 19/6/2020). 90 See IDM docs (2020) “SEIR and SEARS models,” at https://www.idmod.org/docs/hiv/model-seir.html

(accessed 16/6/2020) 91 92 Bernadine Mutanu (2020) “Low number of corona virus cases in Africa baffles scientists,” Daily Nation,

Nairobi, Thursday, 4/6/2020, at 10.

20

Table 1: Incidence and Burden of Diseases and Health in Kenya93

Disease Cases

Approx; pa

Deaths

Approx; pa

Recovery

Approx; pa

Cost

Approx; pa

1. COVID-1994

13 353 234 5 122

2. Malaria 3.5 million 10 700 $63.2

million95

3. Tuberculosis

(TB)

93 28396

4. HIV/AIDS 1 493 400 28 200 US$1.75

billion97

93 See Annex 2 on the daily or regular tracking of COVID-19 in Kenya and Africa. To copy edit Table from

numerous …. Incidents from the earlier tables and one from the latest, including the first case … the outbreak;

emergency status? The spike? The peak? At what level and when did the flat curve, flatten in Kenya and Africa? 94 COVID-19 cases are on the rise in Kenya daily thus the data provided above is subject to change on a daily

basis. See also Annex … on… COVID-19 status in Africa, Standard, Thursday, 28/5/2020. See also Bernadine

Mutanu (2020) Kenya Covid-19 cases hit 5,206,” The East African, 24/6/2020, at

https://www.theeastafrican.co.ke/news/ea/Kenya-Covid-update/4552908-5582180-9dcbi9z/index.html (accessed

25/6/2020). Anita Chepkoech (2020) “Covid-19: 104 more test positive,” Daily Nation, Nairobi, 20/6/2020, at

https://www.nation.co.ke/kenya/news/covid-19-104-more-test-positive-733624 (accessed 21/6/2020); Kevin

Cheruiyot (2020) “Kenya records 104 new cases of Covid-19, totalling to 4, 478,” The Star, Nairobi, 20/6/2020, at

https://www.the-star.co.ke/news/2020-06-20-kenya-records-104-new-cases-of-covid-19-totaling-to-4478/ (accessed

21/6/2020); Tracy Mutinda (2020) “Kenya’s virus cases rise to 4,374, another 91 discharged,” Star, Nairobi, 19/6/2020, at https://www.the-star.co.ke/news/2020-06-19-kenyas-virus-cases-rise-to-4374-another-91-discharged/

(accessed 19/6/2020); Magdaline Saya (2020) “10 more deaths as Nairobi continues to be virus hotspot,” Star,

19/6/2020, at https://www.the-star.co.ke/news/2020-06-19-10-more-deaths-as-nairobi-continues-to-be-virus-hotspot/

(accessed 19/6/2020); James Mbaka and Gideon Keter (2020) “Governors, 66 others sought after Covid-19 hits

State House,” Star, Nairobi, at https://www.the-star-co.ke/news/2020--6-19-governor-66-others-sought-after-covid-

19-hits-state-hoouse/ (accessed 21/6/2020); Amina Wako (2020) “Kenya confirms 117 new Covid-19 cases,”

Nairobi News, 19/6/2020, at https://nairobinews.nation.co.ke/featured/june-19-kenya-confirms-117-new-covid-19-

cases (accessed 19/6/2020); Gilbert Koech & Magdalene Saiya (2020) “Two senior officials at Ardhi House test

positive for the virus,” Star, Nairobi, 23/6/2020, at https://www.the-star.co.ke/news/2020-06-23-two-senior-

officials-at-ardhi-house-test-positive/ (accessed 24/6/2020). 95 USAID (2019) “President’s Malaria Initiative Kenya: Malaria Operational Plan FY 2019,” at https://www.pmi.gov/docs/default-source/default-document-library/malaria-operational-plans/fy19/fy-2019-kenya-

malaria-operational-plan.pdf (accessed 9/6/2020). 96 USAID (2019) “Kenya tuberculosis accelerated response and care,” at

https://www.usaid.gov/sites/default/files/documents/1860/TB_ARC_II_factsheet_2019.pdf (accessed 9/6/2020). 97 Ministry of Health (2018) Kenya Aids Response Progress Report 2018, National AIDS Control Council, at

https://www.lvcthealth.org/wp-content/uploads/2018/11/KARPR-Report_2018.pdf (accessed 9/6/2020).

21

5. Cancer 47 000 32 987 KES 1.37

billion98

6. Diabetes 552 400 8 700

7. Obesity

8. Typhoid

9. Cholera

10. Hypertension

Source: Sihanya, IPILKA 1 & 2, and ongoing research at Sihanya Mentoring (SM) and

Innovative Lawyering (IL)…; MOH? WHO? KNBS? See other Tables and Annexes on COVID-

19 data.

31.3.2 Pharmaceutical Researchers, Innovators, Manufacturers and Distributors in Kenya

and Africa

Who are the main pharmaceutical researchers, innovators or inventors, technology transfer

agencies, manufacturers and distributors in Kenya (and Africa). What is the structure of the

industry? Competitive? Monopolistic? Oligopolistic? We study these under the following five

prongs.

First, research agencies including research institutes, universities, researchers, labs, and physical

facilities… These include Kenya Industrial Research and Development Institute (KIRDI);99

the

Kenya Agricultural and Livestock Research Organisation (KALRO);100

the Kenya Forest

98 Joshua Mutisya (2020) “New cancer cases almost doubled in a decade as deadly illness takes heavy toll,”

Daily Nation, Nairobi, 18/3/2020, at https://www.nation.co.ke/dailynation/newsplex/new-cancer-cases-almost-

doubled-in-a-decade-as-deadly-illness-takes-heavy-toll-223616 (accessed 9/6/2020). Cf. Kathini Makau (2020) “A

review of Kenya’s cancer policies to improve access to cancer testing and treatment in the country,” Health

Research Policy and Systems, at https://health-policy-systems.biomedcentral.com/articles/10.1186/s12961-019-

0506-2 (accessed 8/6/2020). 99 KIRDI is a state corporation under the Ministry of Industry, Trade and Cooperatives and is mandated to undertake multidisciplinary research and development (R&D) in industrial and allied technologies

including: mechanical, electrical & electronics, chemical, ceramics and building materials, food, leather, textile,

ICT, environment and energy. See Kenya Industrial Research and Development Institute website, at <

https://www.kirdi.go.ke/> (accessed 16/6/2020). 100 The Kenya Agricultural and Livestock Research Organisation (KALRO) emerged from the merger of the

Kenya Agriculture Research Institute (KARI) and other research institutions. It is a government organisation

22

Research Institute (KEFRI);101

Kenya Marine and Fisheries Research Institute (KMFRI);102

Kenya Medical Research Institute (KEMRI);103

the Kenya Trypanosomiasis Research Institute

(KETRI).104

The Kenya Trypanosomiasis Research Institute (KETRI) is a research institution established and

operationalized under the section 53 and Fourth Schedule of the Kenya Science Technology and

Innovation Act No. 28 of 2013. KETRI’s main mandate was to carry out research and develop

technologies for effective control of trypanosomiasis including collection and preservation of

trypanosomiasis stabilities.105

KEMRI’s main mandate is four pronged: first, to carry out research in human health. Second,

cooperate with other research organizations and institutions of higher learning on matters of

relevant research and training. Third, liaise with other relevant bodies within and outside Kenya

carrying out research and related activities.

Fourth, disseminate and translate research findings for evidence-based policy formulation and

implementation. Fifth, cooperate with the Ministry of Health, the National Commission for

mandated with the task and duty of conducting research into, among others, crop and livestock production and

marketing. See Maureen Kiruka, Julius Okello, Violet Kirigua & Festus Murithi (eds) (2012) “The role of the Kenya

Agricultural Research Institute (KARI) in the attainment of household food security in Kenya: A policy and

organizational review,” at <

https://www.researchgate.net/publication/257788782_The_role_of_the_Kenya_Agricultural_Research_Institute_KA

RI_in_the_attainment_of_household_food_security_in_Kenya_A_policy_and_organizational_review> (accessed

16/6/2020). 101 The Kenya Forest Research Institute (KEFRI) is a state corporation provided for under the Science Technology and Innovation Act, No. 28 of 2013. It is mandated to undertake research in forestry and allied natural

resources. KEFRI conducts research and development activities under five thematic areas namely: Forest

productivity and Improvement; biodiversity and environment management; forest products development; social-

economics, policy and governance and technical support services. See Kenya Forestry Research Institute website <

https://www.kefri.org/> (accessed 16/6/2020). 102 Kenya Marine and Fisheries Research Institute (KMFRI) is a State Corporation that was established by the

Science and Technology Act, Cap 250 that was repealed by the Science, Technology and Innovation (STI) Act No.

28 of 2013. KMFRl's mandate is to undertake research in marine and freshwater fisheries, aquaculture,

environmental and ecological studies, and marine research including chemical and physical oceanography. See

Kenya Marine and Fisheries Research Institute website < http://www.kmfri.co.ke/> (accessed 16/6/2020). 103 See Kenya Medical Research Institute website, at < https://www.kemri.org/index.php/features-intro/background> (accessed 16/6/2020). 104 See Grace Murilla, Joanna Auma, & Johnson Ouma (ed) (2014) “Kenya Trypanasomiasis Research

Institute Cyrobank for Human and Animal Trypanosome Isolates to Support Research: Opportunities and

Challenges,” PLOS Vol. 8, Issue 5, at <

http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.874.7019&rep=rep1&type=pdf> (accessed 16/6/2020). 105 ibid.

23

Science, Technology & Innovation (NACOSTI) and the Medical Sciences Advisory Research

Committee on matters pertaining to research policies and priorities.106

Second, innovators and inventors. These include the principal investigators regarding

epidemics,107

as well as numerous research scientists and scholars of science, technology and

innovation (STI) and IP law and policy108

…

Third, pharmaceutical manufacturers include manufacturers of equipment, diagnostic… kits or

devices, drugs and therapies, and vaccines.

Fourth, pharmaceutical distributors include distributors of the foregoing. Some of the main

manufacturers include GlaxoSmithKline,109

Bayer…110

….Astrazeneca, Moderna, Sinovac,

Novavax.111

Benmed Pharmaceuticals, Beta Healthcare International Ltd, Comet Healthcare Ltd

in Kenya.112

In Nigeria they include A&J Pharmaceutical Nig. Ltd, Abumec Pharmaceuticals

Ltd, Afrab Chem Ltd.113

In South Africa there is Adcock Ingram Holdings Ltd, Litha Healthcare

Group (Pty) Ltd, Glaxosmithkline South Africa (Pty) Ltd.114

The fifth category are Government Agencies that fund, regulate, or protect and promote

innovation, invention and commercialization including the National Commission for science,

technology and innovation (NACOSTI);115

the Kenya National Innovation Agency (KENIA).116

106 See Kenya Medical Research Institute website, at < https://www.kemri.org/index.php/features-

intro/background> (accessed 16/6/2020). 107 108 This paper is the present author’s contribution to the scientific literature on COVID-19, malaria and health

generally from the perspective and methodology of IP, innovation and technology transfer in Kenya and Africa. Part

of this study is published in the University of Nairobi Utafiti News (Research magazine) and under the AU Advisory Board Members on Science, technology and Innovation (STI) Intervention for COVID-19 (ASRIC). Remarkably,

the STI and IP research and scholarship has benefited from researchers and scholars of science, technology,

engineering and medicine (STEM). 109 GlaxoSmithKline plc is a “science led global healthcare company.” See GSK website, at

https://www.gsk.com/en-gb/about-us/ accessed 19/6/2020). See also GSK in Kenya. 110 111 112 See Kenyapharmtech website, at https://www.kenyapharmtech.com/kenya-pharmaceutical-manufacturers/

(accessed 20/7/2020). 113 See Pharmapproach (2020) “List of pharmaceutical companies in Nigeria,” at

https://www.pharmapproach.com/list-of-pharmaceutical-companies-nigeria/ (accessed 20/7/2020). 114 Laura Wood (2018) “South Africa pharmaceutical industry,” Business Wire, at

https://www.businesswire.com/news/home/20180719005331/en/South-African-Pharmaceutical-Industry-2017-

2018-88-Company (accessed 20/7/2020). 115 The National Commission for science, technology and innovation (NACOSTI) is established by section 3

of the Science, Technology and Innovation Act No. 28 of 2013, which repealed and replaced the Science and

Technology Act Cap 250, as a body corporate. See National Commission for Science, Technology, and Innovation

24

Some of the foregoing institutions have contributed to R&D, patenting and commercialization of

pharmaceutical products and processes.

31.3.3 Patent in Pharmaceutical and Chemical Inventions in Kenya and Africa

For a long time, there has been a two pronged argument on whether intellectual property (IP)

enhances or stifles innovation (creativity), technology transfer and development especially in the

public health industry. The dualism has been wrong. The argument should be three pronged….

My overarching argument is that intellectual property acts as a protective and reward mechanism

to inventors, innovators, investors, traders, professionals, and consumers of health products and

services.

Evidence from the pharmaceutical industry suggests that the (sunk) cost117

including investment

in research and development (R&D) would be seriously limited if patent protection were to be

removed.118

What is a patentable invention? How do sections 2, 21, 22, 26 of Kenya’s Industrial Property Act

2001 (2016) and Intellectual Property of Kenya Bill 2020 deal with invention, patentable and

non-patentable invention?119

What is the doctrine of technology-neutral or no arbitrary exclusion from patentability? What is

the state of debate on patenting pharmaceutical and chemical products as compared to processes

website, at < https://www.nacosti.go.ke/about-us/history> (accessed 16/6/2020). NACOSTI succeeded the National

Council for Science and Technology (NCST). 116 The Kenya National Innovation Agency (KENIA) is also body corporate established by section 28 of the

Science, Technology and Innovation Act, No. 28. of 2013, under the Ministry of Education.? Its core mandate is to

develop and manage Kenya’s National Innovation System as well as the co-ordination, promotion and regulation of

the national innovation ecosystem. See Kenya National Innovation Agency website, at <

http://www.innovationagency.go.ke/index.php/background/> (accessed 16/6/2020).

117 The cost can be on total R&D, prevention, diagnosis or testing treatment, and vaccination costs…. The

cost may also be in terms of opportunity costs (lost time, services foregone…). Already there are concerns regarding

opportunity costs arising from COVID-19… See Peter Sands (2020) “COVID-19 threatens to derail fight against

HIV, TB and malaria,” at https://www.theglobalfund.org/en/blog/2020-05-27-covid-19-threatens-to-derail-fight-

against-hiv-tb-and-malaria/ (accessed 29/5/2020). 118 Christopher Kalanje (2006) “Role of Intellectual Property in Innovation and New Product Development,”

World Intellectual Property Organisation at

http://www.wipo.int/export/sites/www/sme/en/documents/pdf/ip_innovation_development.pdf (accessed

17/10/2017). Cf. Sihanya (2016; reprinted 2020) Intellectual Property and Innovation Law in Kenya and Africa:

Transferring Technology for Sustainable Development, op. cit. 119 See Sihanya, IPILKA 1, ibid.

25

in Kenya and Africa? What about key jurisdictions like USA, UK, Switzerland, India,120

Brazil,121

and Thailand…?122

According to section 2 of the Industrial Property Act 2001 an invention

“means a new and useful art (whether producing a physical effect or not), process,

machine, manufacture or composition of matter which is not obvious, or any new and

useful improvement thereof which is not obvious, capable of being used or applied in

trade or industry and includes an alleged invention.”123

Moreover, under section 21 of the Industrial Property Act 2001, an invention “means a solution

to a specific problem in the field of technology.” And section 21(2) states “subject to sub section

three (3) an invention may be or may relate to a product124

or process…”125

Section 22 clarifies that an “invention is patentable if it is new [or novel],126

involves an

inventive step [or is not obvious…],127

and is industrially applicable [or useful].128

Sections 21(3) and 26 provide for “non-inventions” and “non-patentable inventions”

respectively. The first category is regarding as non-inventions in the first place or ab initio,

hence patentability does not arise because for any product or process to be patentable it must be

an invention in the first place.

The statutory basis of determining that something is not an invention varies. It may be because

there is no scientific intervention, no technical or physical effect just a broad policy fiat…

Section 21(3) thus states;

120 There has been a long debate on pharmaceutical process v. product patent debates between India and USA,

WTO (TRIPs). See Phillipe Cullet (2003) “Patents and Medicines: The Relationship between TRIPS and the Human

Right to Health,” International Affairs (Royal Institute of International Affairs 1944-) Vol. 79, No. 1 (Jan., 2003),

139-160. Cf. Paul Goldstein & Marketa Trimble (2019) International Intellectual Property Law, Cases and

Materials, Foundation Press, New York. 121 122 123 Section 2 Industrial Property Act 2001. This interpretation or definition clause is more comprehensive than

section 21 of the Industrial Property Act 2001. 124 125 126 Section 23 of the Industrial Property Act 2001 deals with novelty. It states that an invention is new if it is

not anticipated by prior art. 127 Section 24 of the Industrial Property Act 2001. 128 Section 25 of the Industrial Property Act 2001. It states that “an invention shall be considered industrially

applicable if, according to its nature, it can be made or used in any kind of industry, including agriculture, medicine,

fishery and other services.”

26

“The following shall not be regarded as inventions and shall be excluded from patent protection:

discoveries, scientific theories and mathematical methods; schemes, rules or methods for doing business, performing purely mental acts or playing games; methods for treatment of the human or

animal body by surgery or therapy, as well as diagnostic methods practised in relation thereto,

except products for use in any such methods (Also excluded from the category of inventions are;

“mere presentation of information; and Public Health related methods of use or uses of any molecule or other substances whatsoever used for the prevention or treatment of any disease

which the Minister responsible for matters relating to health may designate as a serious health

hazard or as a life threatening disease.”129

And section 26 of the Industrial Property Act 2001 stipulates;

“The following shall not be patentable: plant varieties as provided for in the Seeds and Plant

Varieties Act, but not parts thereof or products of biotechnological process; and inventions contrary to public order, morality, public health and safety, principles of humanity and

environmental conservation.”

In Diamond v. Chakrabarty,130

a scientist had developed a product from bacteria which was

useful for removing oil spills. The US Patent and Trade Mark Office (USPTO) refused to grant a

patent on the ground that the bacteria which he had used in the alleged invention were products

of nature and there was no scientific or technological intervention.

The Supreme Court delivered two major opinions in 1980. First, the court held that the

bacterium was not a product of nature because a human made it; it was a manufacture or

combination under the US patent law and thus patentable.131

Second, the Court held that no patent statute excluded living things from patentability at the

time. The Supreme Court thus halted a long line of cases that had rejected life-form patents on

129 Section 21(3) of the Industrial Property Act 2001. 130 477 US 303 (1980). See Paul Goldstein (1999) Copyright, Patent, Trademark and Related State Doctrines:

Cases and Materials on the Law of Intellectual Property, at 385-399, Foundation Press, New York (revised 4th ed.)

See also Goldstein & Reese (2010) Copyright, Patent, Trademark and Related State Doctrines, op. cit., at 405-414. 131 Ss. 1 et seq, Title 35 US Patent Act, 1930 (10/4/1790, 21/2/1793, 1836, 1870 Federal Courts Improvement Act 1982…). Patent law creates a distinction between (discovery of) a occurring substance like life forms (not

patentable) and (scientifically) modifying a naturally existing substance (like a new based drug). Cf. Art. 27(3)(b) of

the TRIPs Agreement. See Paul Goldstein & Marketa Trimble (2019) International Intellectual Property Law,

Cases and Materials, Foundation Press; Goldstein & Reese (2010) Copyright, Patent, Trademark and Related State

Doctrines: Case and Materials on the Law of Intellectual Property., op. cit. at 415-679 on Federal patent law; 1047-

1089 on state patent law, pp 1099-1112 on design patent law….

27

the basis of the “product of nature” doctrine.132

Significantly, it observed, obiter, that “anything

under the sun made by man133

is patentable.”134

Only inventions are patentable. Inventions are new solutions to specific technical problems. Such

solutions must, naturally, rely on the properties or laws of the material universe. There must be

scientific (and technological) human invention a “contribution.” … Otherwise they could not

have a technical, physical, or material effect or application which are required by patent law. But

those properties or laws need not be properties or laws “not hitherto recognised.”135

An invention puts to new technical use such properties or laws, whether they are recognised

(“discovered”) simultaneously with making the invention or whether they were already

recognised (“discovered”) before, and independently of, the invention. Mathematical methods,

theories and formulae as well as schemes, rules or methods of doing business are other common

statutory exceptions to patentability.136

Patentability is controversial to the extent that the

products or processes affect or relate to health, agriculture or food and nutrition, and the related

industrial chemicals….

Some of the questions relate to who owns your cells? are your cells intellectual property? Is

one’s biological property one’s by law or who owns it? There are at least three questions. The

first is whether the cells or bio materials are in the body or not. That is the regime of Kenya’s

Human Tissue Act 1966 (2012).137

What are the three contending arguments on IP in health?

132 Cf. Discovering an animal, plant or microorganism…. Under section 21(3) of the Industrial Property Act

2001 on “non-inventions,” and section 26 on non-patentable inventions in Kenya.; Ben Sihanya (2007) “Patent law

and practice in Kenya,” Vol. 38, 6/2007, International Review of Intellectual Property and Competition Law, pp.

648–658, Journal of the Max Planck Institute for Intellectual Property, Competition and Tax Law 133 This should now be rendered as “a human being”…. 134 This language is drawn from Congressional record on the debate on the Patent Act, 1952. Congress wished

to emphasise that any invention was prima facie patentable. This language and Diamond v. Chakarabarty were invoked by Court of Appeals for the Federal Circuit (CAFC) in recognising (or extending) protection to software

patents. This is discussed below. Cf. Chapter 10 (digital copyright in Kenya and Africa). 135 Cf. Goldstein & Reese (2010) Copyright, Patent, Trademark and Related State Doctrines: Case and

Materials on the Law of Intellectual Property., op. cit. 136 S. 21(3) IPA, 2001 (K); (s. 6 (3)(a) IPA, 1989, op. cit.. 137 See Human Tissue Act No. 34 of 1966 ; Anatomy Act 1968 (Cap 252).

28

First, IP facilitates innovation and technology transfer because there are usually heavy upfront or

sunk costs or investments before a drug can be developed. Thus IP supplies the incentive to

invent with the prospect of recouping returns on investment. The main cost of sunk costs include

initial research,138

to clinical and related trials,139

as well as approval and marketing as well as

initial development of the drug.140

These are related R&D costs can be as high as USD 1

billion….141

Second, it has also been argued that intellectual property stifles invention, innovation, research

and development (R&D), technology transfer and access to health processes, procedures, and

products. Some have argued that the Swiss and Indian pharmaceutical industries developed due

to the absence of pharmaceutical patent. Relatedly, it has been argued that intellectual property

and particularly patent increase the cost of medicines because royalties have to be paid to the

right holders of the patent, utility model, trade secret, unfair competition, or trade mark.142

Third, my analysis is that IP may have a neutral impact on innovation and technology transfer on

health in Kenya and Africa. A lot depends on the political economy, legal sociology, meaning or

rules, methods, and processes or the policy options adopted. It is best to optimize the benefits of

IP which minimizing and regulating adverse effects.143

Remarkably, drugs for Human Immuno Virus/Acquired Immune Deficiency Syndrome

(HIV/AIDS), tuberculosis (TB), malaria, Ebola (EVD), and Cholera have been very expensive144

partly because of patent, utility model, trade secret, unfair competition, and trade mark.

And R&D on COVID-19 personal protective equipment (PEP),145

therapies and vaccines146

is

partly derailed by the COVID-19 Patent race. In comparison and using painkillers as an example,

138 See Chapter 2.4.2 “Incentives and rewards in Kenya and Africa for IP and Innovation,” in Sihanya (2016;

reprinted 2020) Intellectual Property and Innovation Law in Kenya and Africa: Transferring Technology for

Sustainable Development, op. cit., at 52… 139 ibid. 140 Sihanya (2016; 2020) Intellectual Property and Innovation Law in Kenya and Africa: Transferring

Technology for Sustainable Development, at 40-42… 141 Sihanya (forthcoming 2020) Intellectual Property and Innovation Law in Kenya and Africa: Cases and materials, Sihanya Mentoring & Innovative Lawyering, Nairobi & Siaya; Sihanya (2016; reprinted 2020)

Intellectual Property and Innovation Law in Kenya and Africa: Transferring Technology for Sustainable

Development, ibid. 142 ibid. 143 See Sihanya, IPILKA 1 & 2. 144 Table 2 on a sample of drugs available for some of these diseases and costs or prices …in IP….

29

the active ingredient that matters most is paracetamol.147

Yet trade mark or branding forms the

basis for charging for the IP, effectively increasing the price of the painkillers.148

Table 2: Sample of Diseases, Drugs and Prices in Kenya and Africa

Disease Drug Manufacturer Price

1. Malaria Artemether–lumefantrine (AL)

(recommended as first-line

treatment for uncomplicated

malaria)

dihydroartemisinin-piperaquine

(second-line treatment for

uncomplicated malaria)

2. Cholera Doxycycline (recommended as

first-line treatment for adults)

Azithromycin (recommended

as first-line treatment for

children and pregnant women)

3. TB Isoniazid (H/Inh)

Rifampicin (R/Rif) (In the United States rifampicin is

called rifampin)

Pyrazinamide (Z/Pza)

Ethambutol (E/Emb)

4. HIV/AIDS Dolutegravir (DTG)

5. Diabetes Meglitinides (Prandin and

Starlix)

Repaglinide (Prandin)

Nateglinide (Starlix)

KES 500 per unit149

145 Angela Oketch (2020) “Kenya moves to make own PPE as imported ones fail quality tests,” Saturday

Nation, Nairobi, 23/5/2020 at 8… 146 See Gatonye Gathura (2020) “Vaccine test targets 400 Kenyan health workers,” Standard, Nairobi, Monday, May 25, 2020, at 2… 147 148 Kalanje (2006) “Role of Intellectual Property in Innovation and New Product Development,” op. cit. 149 Geordan Shannon (2019) “Innovating to increase access to diabetes care in Kenya: an evaluation of Novo

Nordisk’s base of the pyramid project,” Global Health Action Journal, at

https://www.tandfonline.com/doi/full/10.1080/16549716.2019.1605704 (accessed 9/6/2020).

30

Sulfonylureas

Metformin (Glucophage)

Canagliflozin (Invokana)

Dapagliflozin (Farxiga)

Isophane

6. Hypertension Amlodipine

Atenolol

Carvedilol

Enalapril

7. Obesity Orlistat (Xenical)

Lorcaserin (Belviq)

Phentermine and Topiramate

(Qsymia)

Buproprion and Naltrexone

(Contrave)

Liraglutide (Saxenda)

8. Cancer Larotrectinib

Trastuzumab, (also known as

Herceptin)

KES 150 000150

9. COVID-19151

Hydroxychloroquine152

Asprin153

DDT154

Dexamethasone 155

150 Magdaline Saya (2019) “Relief as WHO approves low-cost drug for breast cancer treatment,” Star,

Nairobi, 20/12/19, at https://www.the-star.co.ke/news/2019-12-20-relief-as-who-approves-low-cost-drug-for-breast-

cancer-treatment/ (accessed 8/6/2020). 151 What is the role of nutrition and supplements for vitamins A, C, D?.... 152 Standard Reporter (2020) “US halts Trump-touted hydroxychloroquine for Covid-19 patients,” Standard,

21/6/2020, at https://www.standardmedia.co.ke/health/article/2001375873/us-halts-trump-touted-hydroxychloroquine (accessed 21/6/2020). 153 154 155 Michelle Roberts (2020) “Dexamethasone proves first life-saving drug,” BBC News, at

https://www.bbc.com/news/health-53061281 (accessed 19/6/2020); BBC (2020) “Coronavirus: What is

dexamethane and how does it work?” Sunday Standard, Nairobi, 21/6/2020, at 10; Elizabeth Merab (2020) ‘WHO

31

Source: Sihanya, IPILKA 1 & 2, and ongoing research at Sihanya Mentoring (SM) and

Innovative Lawyering (IL)…; ….

The concern that intellectual property stifles invention, innovation, access, and development is

crucial in the wake of the novel Corona virus (COVID-19)156

pandemic in 2020. This is mainly

because Kenya and other African states have historically suffered challenges in accessing

diagnostics, cures, and vaccines, or relevant technologies, and equipment157

or facilities158

due to

the potentially restrictive nature of IP rights in the pharmaceutical industry.159

The Kenyan health system defines six levels of the hierarchy, as follows. First, level 1,

community services. Second, level 2, dispensaries and clinics. Third, level 3, health centres and

maternity and nursing homes. Fourth, level 4, sub-county hospitals and medium-sized private

hospitals. Fifth, level 5, county referral hospitals and large private hospitals; And sixth, level 6,

national referral hospitals and large private teaching hospitals.160

According to WHO, diagnostics can range from complex tests that need specialist skills and

equipment and that can only be carried out in a laboratory setting, to rapid tests (such as dipstick

tests) that can be performed in the patient’s own home or community. 161

hails ‘breakthrough’ for Covid-19 treatment,” The East African, 17/6/2020, at

https://www.theeastafrican.co.ke/scienceandhealth/WHO-hails-breakthrough-for-Covid-19-treatment/3073694-

5578368-t53cvmz/index.html (19/6/2020) …. 156 See World Health Organization website, at https://www.who.int/health-topics/coronavirus#tab=tab_1

(accessed 22/5/2020). 157 ibid. 158 Health facilities are places that provide health care. They include hospitals, clinics, outpatient care centers,

and specialized care centers, such as birthing centres and psychiatric care centres. 159 Ben Sihanya (2005) “Patents, parallel importation and compulsory licensing of HIV/AIDS drugs in

Kenya,”a Chapter in Peter Gallagher, Patrick Low, and Andrew L. Stoler (eds) Managing the Challenges of WTO

Participation, Cambridge University Press, London, A study and a Chapter under the auspices of the World Trade

Organisation (WTO) and Adelaide University. 160 See WHO (2017) “Primary health care systems: Case study from Kenya,” World Health Organisation,

WHO/HIS/HSR/17.6, at https://www.who.int/alliance-hpsr/projects/alliancehpsr_kenyaabridgedprimasys.pdf?ua=1#:~:text=The%20Kenyan%20health%20system%20defi

nes,referral%20hospitals%20and%20large%20private (accessed 19/6/2020); Geoffrey Mosoku (2017) “State moves

to reclassify hospitals,” Standard, Nairobi, at https://www.standardmedia.co.ke/health/article/2001231398/state-

moves-to-reclassify-hospitals (accessed 19/6/2020). 161 See World Health Organisation website, at https://www.who.int/tdr/diseases-topics/diagnostics/en/

(accessed 27/5/2020).

32

The term “cure” refers to a strategy or strategies that would eliminate a disease from a person’s

body, or permanently control a virus, bacteria or infection and render it unable to cause a

disease.162

According to WHO, vaccination is one of the most effective ways to prevent diseases. A vaccine

helps the body’s immune system to recognize and fight pathogens like viruses or bacteria, which

then keeps humans or animals safe from the diseases they cause. 163

Medical technology is a broad field where innovation plays a crucial role in sustaining health.

Areas like biotechnology, pharmaceuticals, information technology, the development

of medical devices and equipment, and more have all made significant contributions to

improving the health of people all around the world. 164

31.4 Health Invention and Innovation in Kenya and Africa

An invention is the generation of new ideas or knowledge aimed at solving a specific technical

problem.165

Thus an invention relates to both products and processes, characteristically protected by patent,

utility model, trade secret, and unfair competition and is covered by section 21 of Kenya’s

Industrial Property Act, 2001.166

Innovation means developing a new idea and putting it into practice. It is the process of

developing a valuable new process or product (a good, service or institution) and introducing it

into the market or society. This includes the idea or concept formulation stage and the successful

launch of the new or improved process or product in the market.167

162 See AIDSmap website, at http://www.aidsmap.com/news/mar-2011/what-about-vaccine (access

27/5/2020). 163 See World Health Organisation website, at https://www.who.int/topics/vaccines/en/ (27/5/2020). 164 See Health Care Tech website, at http://www.healthcarebusinesstech.com/medical-technology/ (accessed

27/5/2020). 165 See Sihanya (2016; reprinted 2020) Intellectual Property and Innovation Law in Kenya and Africa:

Transferring Technology for Sustainable Development, op. cit., at 10-14. See Chapter 31 above. 166 See Section 21 Industrial Property Act 2001 defines an invention for the purposes of “this part” (Part III-

Patent: Patentability:” invention means a solution a specific field of technology.” Under section 81 of the Industrial

Property Act 2001 that definition and Part III applies with necessary modifications to patents mutatis mutandis to

utility models. Section 103 on the revocation or invalidation of patents, utility models and industrial designs is

equally important in conceptualizing and contextualizing innovation.

Cf. Clause 47 Intellectual Property Bill 2020. 167

Kalanje (2017) “The role of intellectual property in innovation and new product development,” op. cit.;

Drucker (1985) Innovation and Entrepreneurship: Practice and Principles, op. cit.

33

Innovation can also be defined in the narrow sense to commercial, cultural and institutional

creativity, while innovation in the broader sense includes inventions as well as cultural,

institutional and commercial creativity.168

Service level innovation also fall under the broader

conceptualization.169

The typology or categories of health inventions or innovations in Kenya and Africa is at least

three pronged. First, a typology that focuses on the type of disease, for instance, COVID-19,

malaria, TB, HIV/AIDs, cholera, Ebola, diabetes, cancer, obesity, and hypertension….

Table 3: Research of Some Key Diseases in Kenya and Africa170

Disease Research Agency: Institutes, Universities,

Centre, Lab171

1. COVID-19172

Kenya Medical Research Institute (KEMRI)

University of Nairobi scientists, medics, IP law

scholar

Kenyatta University scientists, medics

2. Malaria Kenya Medical Research Institute (KEMRI)

Kenya Medical Supplies Agency (KEMSA)

3. Tuberculosis (TB) Kenya Medical Research Institute (KEMRI)

Centre for Respiratory

Diseases Research (CRDR)

168 Ben Sihanya (2007) “Patent law and practice in Kenya,” International Review of Intellectual Property and

Competition Law, Volume 38, 6/2007, pp. 648–658, Journal of the Max Planck Institute for Intellectual Property,

Competition and Tax Law, edited by Prof William Cornish, Prof Paul Goldstein et al. 169 170 This Table 3 does not assess the quality or competence of the research agency or lab. The assessment in

this essay is part of work in progress and Sihanya Mentoring. 171 To document some of the key principal investigators, researchers, and research collaborators like the

African Scientific, Research and Innovation Council (ASRIC) Advisory Board on STI Intervention for Covid-19.

The Author is a member of the ASRIC Intellectual Property Guidelines for the African Scientific, Research and

Innovation Council . Some of the Principal investigators, researchers and collaborators include Dr Loice Achieng

Ombajo, who heads the Infectious Disease Unit at Kenyatta National Hospital, among others. See Pamela Sittoni (2020) “Kenya all set to begin clinical trial for three possible COVID 19 Drugs,” Daily Nation, 13/5/2020, at

https://www.nation.co.ke/news/Kenya-set-to-begin-clinical-trial-for-three-possible-drugs/1056-5542798-

fgpsntz/index.html (accessed 29/5/2020).

172 See also Angela Oketch (2020) “Kenya moves to make own PPE as imported ones fail quality tests,”

Saturday Nation, Nairobi, 23/5/2020, at 8.

34

4. HIV/AIDS Kenya Medical Research Institute (KEMRI)

Kenya AIDS Vaccine Initiative-Institute for

Clinical Research (KAVI-ICR)

Desmond Tutu HIV Foundation (DTHF)

Center for Family Health Research (CFHR)

5. Cancer Kenya Medical Research Institute (KEMRI)

National Cancer Institute (NCI)

International Agency

for Research on Cancer (IARC)

6. Diabetes Kenya Medical Research Institute (KEMRI)

Centre for Public Health Research (CPHR)

7. Obesity Kenya Medical Research Institute (KEMRI)

Centre for Public Health Research (CPHR)

8. Cholera Kenya Medical Research Institute (KEMRI)

9. Hypertension Kenya Medical Research Institute (KEMRI)

Source: Sihanya, IPILKA 1 & 2, and ongoing research at Sihanya Mentoring (SM) and

Innovative Lawyering (IL)…173

Second, a typology that focuses on whether the invention or innovation is a product (or device)

or a process, and which one specifically? For instance, diagnostics, therapies, vaccines

(immunization? inoculation?)174

….

Moreover, it is important to note and analyze the individuals or organiations claiming credit for

the (alleged) innovations or inventions….

173 See also Angela Oketch (2020) “Kenya moves to make own PPE as imported ones fail quality tests,”

Saturday Nation, Nairobi, 23/5/2020 at 8. 174

35

Table 4: Sample of Diseases, Innovators and Status in Kenya and Africa175

Disease Invention or innovation innovator or inventor

1. COVID-19 (Surgical) face masks

Wooden pedal hand washing

machine

176

Ventilator177

KoviTrace178

Re-engineering a factory to

mass produce face masks,

sanitizers179

school boy innovates foot

hand washing machine

Kenyatta University

Students180

2. Malaria

3. Tuberculosis

4. HIV/AIDS Antiretroviral (ARV)181

Kemron182

Pearl Omega183

175 This Table 4 does not assess the quality or authenticity of the claimed (or alleged) innovation. That process

is analyzed in sections of this paper and is work in progress at Sihanya Mentoring. 176 BBC Reporter (2020) “Kenyan boy who made hand-washing machine awarded,” BBC News, at

https://www.bbc.com/news/world-africa-52898797 (accessed 17/6/2020)…. 177 There was a debate on whether these were inventions, high level innovations, or lower level fabrications.

See…. 178 Mary Wambui (2020) “Hope as three Kenyans develop app for contact tracing,” Daily Nation, Nairobi,

17/6/2020, at 10. 179 See Max Beerak (2020) “The Kenyan factory that transformed into a surgical mask assembly line

overnight,” Washington Post, at https://www.washingtonpost.com/world/africa/the-kenyan-factory-that-

transformed-into-a-surgical-mask-assembly-line-overnight/2020/04/08/fac04912-783e-11ea-a311-

adb1344719a9_story.html (accessed 17/6/2020). 180 See Star Reporter (2020) “KU develops Sh500,000 ventilator prototype in war on Covid-19,” Star, Nairobi,

11/4/2020, at https://www.the-star.co.ke/news/2020-04-11-ku-develops-sh500000-ventilator-prototype-in-war-on-

covid-19/ (accessed 17/6/2020). 181 Antiretroviral (ARV) drugs include Lamivine and zidovudine… See WHO “Antiretroviral therapy for HIV

infection in infants and children: Towards universal access,” https://www.who.int/hiv/pub/paediatric/paediatric_arv_dosing.pdf (accessed 20/7/2020). 182 Sihanya (2003) “Patent wars raging over Aids cure,” op. cit.; John Kamau 2020) “Kemron: The HIV/AIDS

cure that never was,” op. cit. 183 Mwangi Githahu (2020) “Hoax corona cures throwback to Pearl Omega and Ozone therapy,” Star, Nairobi,

2/5/2020, at https://www.the-star.co.ke/sasa/lifestyle/2020-05-02-hoax-corona-cures-throwback-to-pearl-omega-

and-ozone-therapy/ (accessed 22/6/2020).

36

Loliondo herbal medicine184

5. Cancer

6. Diabetes

7. Obesity

8. Cholera

9. Hypertension

Source: Sihanya, IPILKA 1 & 2, and ongoing research at Sihanya Mentoring (SM) and

Innovative Lawyering (IL)…; ….

As discussed earlier malaria is a major cause of morbidity and mortality in Kenya and Africa.

There have been numerous diagnostic drugs and (…) vaccines…

Table 5: Malaria Vaccines in Kenya and Africa

Platform Antigens Salient features

1. Pre-erythrocytic Irradiated sporooites, Circum

Sporozoite Protein (CSP) or

peptides, Liver stage Antigens

– 1 ((LSA-1)

Stage/species specific;

antibody blocks infection of

liver; large immunising dose

required; can abort an

infection

2. Merozoite and

Erythrocytes

Erythrocyte Binding Antigen

(EBA-175), Merozoite

Surface Antigen 1&2 (MSA-

1&2)

Specific for species and stage;

cannot abort an infection;

prevents invasion of

erythrocytes, thus reducing

severity of infection

3. Gametocytes &

gametes

Pfs 25, 48/45k, Pfs 20 Prevents infection of

mosquitoes; antibody to this

antigen prevents either

fertilization or maturation of

184 Babu Tondu (2019) “Loliondo no longer the promised land,” Standard, Nairobi, at

https://www.standardmedia.co.ke/ureport/article/2001341327/loliondo-no-longer-the-promised-land (accessed

22/6/2020). The Loliondo herbal cure gained its prominence between 2010 and 2012 after Ambilikile Mwasapile

alias Babu wa Loliondo, a self-declared miracle healer in Tanzania, claimed that he had discovered a miracle cure

that could cure a myriad of diseases including HIV/AIDS.

37

gametocytes, zygotes or

ookinetes; is of use in endemic

aresa but not suited for

travelers; antibody blocks

transmission cycle

4. Combined vaccine

(cocktail)

SPf 66 (based on pre-

erythrocytic and asexual blood

stage proteins of Pf

Based on incorporation of

antigen from different stages

into one vaccine to produce an

immune response, blocking all

stages of the parasite

development

Source: World Health Organisation (WHO)185

As discussed, malaria remains a major killer in Kenya and Africa. It has become resistant to the

main therapies. R&D continues on diagnostics, therapies and vaccines.

Third, a typology of invention and innovation that focuses on the applicable IP regime for

instance, inventions that are patentable or protected by utility model, trade secret, unfair

competition, or branding that falls under trade mark….186

Significantly there are at least three methodologies or approaches to new or novel diseases, or in

the case of a resurgence. In the case of the novel COVID-19 the three approaches are, first,

applying pre-existing treatments… by analogy… Hence the debate on the relevance of malaria

and other drugs like Dichlorodiphenyltrichloroethane (DDT),187

hydroxychloroquine….188

aspirin189

…

Dichlorodiphenyltrichloroethane, commonly known as DDT, is a colorless, tasteless, and almost

odorless crystalline chemical compound, an organochlorine.190

US President Donald Trump even recommended injection with a disinfectant…191

185 World Health Organisation website, at

https://www.who.int/immunization/research/development/malaria/en/ (accessed 3/6/2020). 186 187 See James Speight (2019) Natural Water Remediation: Chemistry and Technology, Butterworth-

Heinemann Publishers, Oxford, at 177. 188 189 190 See Speight (2019) Natural Water Remediation: Chemistry and Technology, op. cit. 191 BBC (2020) “Coronavirus: Outcry after Trump suggests infecting disinfectant as treatment,” BBC News, at

https://www.bbc.com/news/world-us-canada-52407177 (accessed 7/6/2020); Telegraph (2020) “The Lancet urges

Americans to vote out Trump over coronavirus handling,” The Telegraph, at

https://www.telegraph.co.uk/news/2020/05/15/medical-journal-lancet-urges-americans-vote-trump-coronavirus/

38

Second, by modifying preexisting drugs or applying a combination e.g. the combination

therapies that (were and are) applied in HIV/AIDS192

and the combination drugs for cancer…193

In the case of COVID-19 the pre-existing or combination drugs include chloroquine or

hydroxychloroquine, alone or in combination with a class of antibiotics….194

Third, introducing or intensifying R&D for new diagnostic kits, therapies or drugs and vaccines.

This may result in “discovering” a new use of a pre-existing drug like asprin… or consider lifting

the ban on a drug.

In the case of malaria, the use of dichlorodiphenyltrichloroethane (DDT) was banned in the

1970s because of the side effects…195

In similar vein, some have used dexamethasone196

while others have recommended aspirin and

other drugs for the treatment of COVID-19.197

Aspirin has a complex IP life. First, it was patented by the German company Bayer

Pharmaceuticals on March 6, 1899 as a pain reliever198

… When the patent expired in 1917

(accessed 7/6/2020); Wrap (2020) “Lancet editor corrects Trump on medical journal’s COVID-1 coverage,” The

Wrap, at https://www.thewrap.com/lancet-trump-coronavirus/ (accessed 7/6/2020); NDR (2020) “Replace Trump and bolster the CDC, a leading medical journal urges,” … ; CGTN (2020) “Is Trump wrong about the Lanceet in his

letter to WHO?” at https://news.cgtn.com/news/2020-05-21/Is-Trump-wrong-about-The-Lancet-in-his-letter-to-

WHO--QFyGoApZyo/index.html (accessed 7/6/2020). See… A (fake?) report indicated a one page publication in

Lancet regarding Trump’s recommendation…. 192 Chris Rathbun (2019) “Antiretroviral Therapy for HIV Infection,” Medscape, at

https://emedicine.medscape.com/article/1533218-overview (accessed 7/6/2020). 193 CancerNet ((2019) “HIV/AIDS-Related Cancer: Types of Treatment,” at https://www.cancer.net/cancer-

types/hivaids-related-cancer/types-treatment (accessed 7/6/2020). 194 Kelly Servick and Martin Enserink (2020) “A mysterious company’s coronavirus papers in top medical

journals may be unraveling,” ScienceMag, at https://www.sciencemag.org/news/2020/06/mysterious-company-s-

coronavirus-papers-top-medical-journals-may-be-unraveling (accessed 7/6/2020); Kai Kupferschmidt and Jon

Cohen (2020) “WHO launches global megatrial of the four most promising coronavirus treatments,” ScienceMag, at https://www.sciencemag.org/news/2020/03/who-launches-global-megatrial-four-most-promising-coronavirus-

treatments (accessed 7/6/2020).

195 Cristobal Berry-Caban (2020) “DDT and Silent Spring: Fifty years after,” Volume 19 No. 4. Journal of

Military and Veterans’ Health, at https://jmvh.org/article/ddt-and-silent-spring-fifty-years-after/ (accessed

16/6/2020). 196 Michelle Roberts (2020) “Dexamethasone proves first life-saving drug,” BBC News, at

https://www.bbc.com/news/health-53061281 (accessed 19/6/2020). Dexamethasone has also been used in the

treatment of including rheumatic problems, a number of skin diseases, severe allergies, asthma, chronic obstructive

lung disease, croup, brain swelling, eye pain following eye surgery, and along with antibiotics in tuberculosis. See

The American Society of Health-System Pharmacists website, at https://web.archive.org/web/20170831175940/https://www.drugs.com/monograph/dexamethasone.html (accessed

22/6/2020). 197 See. US National Library of Medicine website, at https://clinicaltrials.gov/ct2/show/NCT04365309

(accessed 7/6/2020). 198 See Bayer website, at https://www.bayer.com/en/aspirin.aspx (accessed 20/6/2020). Cf. Klaus Jennewein,

Thomas Durand and Alexander Gerybadze (2010) “When brands complement patents in securing the returns from

39

during the First World War (1914-1918), Bayer lost its trade mark or brand in various states.199

It

then became generic in the trade mark sense because it was used as a common noun for a pain

reliever.200

The National Center for Biotechnology Information (NCBI) states that;

“Finally in 1950, the physician Lawrence Craven recognized that Aspirin reduced the risk of

heart attacks in men.”201

Was Aspirin later patented now as a drug for heart ailments?202

What (other) IP protection does

Aspirin enjoy in Kenya and Africa?

Table 6: Drugs or Therapies for COVID-19203

Drugs Innovator or Inventor Manufacturer

Hydroxychloroquine204

Advanz Pharma

Teva Pharmaceutical

Industries Ltd

Sanofi205

Aspirin206

Dr Felix Hoffmann207

Bayer Industries

technological innovation: The Case of Bayer Aspirin,” Volume 14, Issue 3, Journal of International Management,

73–86. 199 ibid. 200 See Sihanya, IPILKA 1 & 2. 201 Robert Godley and Eduardo Hernandez-Vila (2016) “Aspirin for primary and secondary prevention of

cardiovascular disease,” Texas Heart Institute Journal, at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4979389/

(accessed 22/6/2020). 202 203 To iIclude all the drugs in use or proposed…. New or existing drugs are increasingly being used or

proposed to cure or manage COVID-19. See James Nurton (2020) “Drug repurposing and the COVID-19

pandemic,” WIPO Magazine, at https://www.wipo.int/wipo_magazine/en/2020/02/article_0004.html (accessed

22/7/2020); Brian Ambani (2020) “UK firm says virus drug trial a success,” Daily Nation, Nairobi, 22/7/2020, at 6;

Elizabeth Merab (2020) “Study trials arthritis drug on virus patients,” Daily Nation, Nairobi, 22/7/2020, at 9; BBC

(2020) “Oxford varsity vaccine ‘safe for use’ experts say,” Standard, Nairobi, 22/7/2020, at 6; Mercy Korir (2020)

“Virus drug trials begin at Nairobi’s Agha Khan hospital,” Standard, Nairobi, 22/7/2020, at 7; John Muchangi

(2020) “COVID vaccine near but focus urged on prevention,” Star, Nairobi, 22/7/2020, at 6; Magdaline Saya (2020)

“States discuss vaccine access as fears emerge of possible inequity,” Star, Nairobi, 22/7/2020, at 2.a 204 WHO (2020) “WHO discontinues hydroxychloroquine and lopinavir/ritonavir treatment arms for COVID-19,” WHO, at https://www.who.int/news-room/detail/04-07-2020-who-discontinues-hydroxychloroquine-and-

lopinavir-ritonavir-treatment-arms-for-covid-19 (accessed 22/7/2020). 205 See Data Bridge Market Research website, at https://www.globenewswire.com/news-

release/2020/04/30/2025670/0/en/How-COVID-19-Impact-on-Hydroxychloroquine-Market-Report-Industry-Share-

Size-Growth-Trends-Top-leader-Advanz-Pharma-Teva-Pharmaceutical-Industries-Sanofi-Novartis-AG-Lupin-

Laurus-La.html (accessed 20/6/2020).

40

Dichlorodiphenyltrichloroethane

(DDT)

Dr Othmar Zeidler Velsicol Chemical

Corporation

Michigan Chemical

Corporation

Dexamethasone 208

Thomas J. Macek and Carl

Nelson209

Hikma Pharmaceuticals

Source: Sihanya, IPILKA 1 & 2, and ongoing research at Sihanya Mentoring (SM) and

Innovative Lawyering (IL)…

There is already a debate on at least ten (10) candidate vaccines for COVID-19 which are

undergoing clinical evaluation…

Researchers at the Kenya Medical Research Institute (KEMRI) identified at least nine (9) strains

of the COVID-19 virus in Kenya.210

Prof Yeri Kombo, the Director General of KEMRI remarked;

“This successful segmenting for the novel coronavirus SARS-COV2 in Kenya is a significant

milestone in the response to the pandemic in Kenya and the entire world, as this will strengthen

surveillance for tracking mutations of the virus and aid in tracking of the source.”

Thus the quest for approved drugs and vaccines becomes more complex in the light of numerous

strains of COVID-19 in Kenya and Africa.

206 See Bayer website, at https://www.bayer.com/en/aspirin.aspx (accessed 20/6/2020). 207 ibid. 208 Michelle Roberts (2020) “Dexamethasone proves first life-saving drug,” BBC News, at https://www.bbc.com/news/health-53061281 (accessed 19/6/2020); BBC 2020) “Coronavirus: What is

dexamethasome and how does it work?” Sunday Standard, Nairobi, 21/6/2020, op.cit. 209 See USPTO at https://patents.google.com/patent/US3231468A/en (accessed 20/6/2020). 210 See Elizabeth Merab (2020) “KEMRI researchers release their analysis of the coronavirus strains,” Daily

Nation, Nairobi, Wednesday, 3/6/2020; Nation Team (2020) “We’re dealing with 9 strains of new coronavirus,

KEMRI researchers say,” Daily Nation, Nairobi, Thursday, 4/6/2020, at 8.

41

In the quest for a COVID-19 vaccine six (6) leading pharmaceuticals are promising to deliver

COVID-19 vaccine before the end of 2020.211

These include Pfizer USA, Mordena USA, Merck

USA, Johnson and Johnson USA, AstraZeneca British Swedish and SinoVac China.212

Table 7: Ten Candidate Vaccines for COVID-19 in Clinical Evaluation213

Platform Type of Candidate Vaccine Developer

1. Non-Replicating

Viral Vector

CHAdOx1-S University of

Oxford/AstraZeneca

2. Non-Replicating

Viral Vector

Adenovirus Type 5 Vector CanSino Biological

Inc./Beijing Institute of

Biotechnology

3. RNA LNP-encapsulated mRNA Moderna/NIAID

4. Inactivated Inactivated Wuhan Institute of Biological

Products/Sinopharm

5. Inactivated Inactivated Beijing Institute of Biological

Products/ Sinopharm

6. Inactivated Inactivated + alum Sinovac

7. Protein Subunit Full lengh recombinant SARS

CoV-2 glycoprotein

nanoparticle vaccine

aduvanted with Matrix M

Novavax

8. RNA 3 LNP-mRNAs BioNTech//Fosun

Pharma/Pfizer

9. Inactivated Inactivated Institute of Medical Biology,

Chinese Academy of Medical

Sciences

10. DNA DNA plasmid vaccine with

electroporation

Inovio Pharmaceuticals

211 Jonathan Corum, Denise Grady, Sui-Lee Wee, and Carl Zimmer (2020) “Coronavirus vaccine tracker,”

New York Times, at https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html (accessed

23/7/2020). 212 ibid. 213 World Health Organisation (WHO) website, at https://www.who.int/who-documents-detail/draft-landscape-

of-covid-19-candidate-vaccines (accessed 30/5/2020). See also Daily Nation, Nairobi, 29/5/2020, at… Elizabeth

Merab (2020) “KEMRI researchers release their analysis of the coronavirus strains,” Daily Nation, Nairobi,

Wednesday, 3/6/2020. As at 21/7/2020, there were reports of at least 190 vaccine candidates at various stages with 3

being at an advanced stage in the UK, US and China. And that production and distribution is set to begin by October

2020 in some cases. See Claire Felter (2020) “What is the world doing to create a COVID-19 vaccine?” Council on

Foreign Relations, at https://www.cfr.org/backgrounder/what-world-doing-create-covid-19-vaccine (accessed 22/7/2020); Brian Ambani (2020) “UK firm says virus drug trial a success,” Daily Nation, Nairobi, 22/7/2020, at 6;

Elizabeth Merab (2020) “Study trials arthritis drug on virus patients,” Daily Nation, Nairobi, 22/7/2020, at 9; BBC

(2020) “Oxford varsity vaccine ‘safe for use’ experts say,” Standard, Nairobi, 22/7/2020, at 6; Mercy Korir (2020)

“Virus drug trials begin at Nairobi’s Agha Khan hospital,” Standard, Nairobi, 22/7/2020, at 7; John Muchangi

(2020) “COVID vaccine near but focus urged on prevention,” Star, Nairobi, 22/7/2020, at 6; Magdaline Saya (2020)

“States discuss vaccine access as fears emerge of possible inequity,” Star, Nairobi, 22/7/2020, at 2.

42

Source: Sihanya, IPILKA 1 & 2, and ongoing research at Sihanya Mentoring (SM) and

Innovative Lawyering (IL)…214

See also the Annex on recurrent debates on potential COVID-19

vaccines

Table 8: Incidence of COVID-19 Cases in Kenyan Counties215

County Confirmed

Covid-19 Local

Cases (June

2020)

Confirmed

Covid-19

Local

Cases

(July

2020)

Confirmed

Covid-19

Imported

Cases(June

2020)

Confirmed

Covid-19

Imported

Cases(July)

2020)

1. Mombasa216

1279 1779 16 41

2. Kwale 42 46 9 0

3. Kilifi 51 89 1 6

4. Tana River 2

5. Lamu 20

6. Taita Taveta 16 38 1

7. Garissa 21 39 2

8. Wajir 3 5 4 4

9. Mandera 15 17 0

10. Marsabit 1 6 0

11. Isiolo 7 13 0

214 ibid. 215 See Ministry of Health (2020) “COVID-19 outbreak in Kenya: Daily Situation Report, July 19,” Ministry

of Health, at https://www.health.go.ke/wp-content/uploads/2020/07/Kenya-COVID-19-SITREP-124-19-Jul-

2020.pdf(accessed 20/7/2020); Ministry of Health (2020) “Disease outbreak situation report as at June 22, 2020-EPI

week 25,” Ministry of Health, at https://www.health.go.ke/wp-content/uploads/2020/06/Epi-Week-25-Disease-Outbreak-SITREP.pdf (accessed 25/6/2020). 216 Patrick Vidija (2020) “This is why you are more likely to get virus in Mombasa-CAS Mwangangi,” The Star,

Nairobi, 24/6/2020, at https://www.the-star.co.ke/news/2020-06-24-this-is-why-you-are-more-likely-get-virus-in-

mombasa-cas-mwangangi/ (accessed 24/6/2020); Bernadine Mutanu (2020) “Covid-19 risk greater in Mombasa

County,” Daily Nation, Nairobi, 24/6/2020, at https://www.nation.co.ke/kenya/news/covid-19-risk-greater-in-

mombasa-county-932948?view=htmlamp (accessed 24/6/2020).

43

12. Meru 15 25 0

13. Tharaka Nithi 2

14. Embu 2 2 0

15. Kitui 10 17 0

16. Machakos 42 383 0

17. Makueni 3 70 0

18. Nyandarua 2

19. Nyeri 9 22 0

20. Kirinyaga 1 1 0

21. Murang’a 6 17 0

22. Kiambu 147 724 5 7

23. Turkana 8 15 7

24. West Pokot 0 0

25. Samburu 0 0

26. Trans Nzoia 1 1 0

27. Uasin Gishu 41 141 21 22

28. Elgeyo Marakwet 1 1 0

29. Nandi 1 8 0

30. Baringo 0 0

31. Laikipia 3 20 0

32. Nakuru 27 187 3 5

33. Narok 3 34 0

44

34. Kajiado217

146 611 32 32

35. Kericho 2 18 0

36. Bomet 1 2 0

37. Kakamega 2 12 0

38. Vihiga 1 9 0

39. Bungoma 6 11 0

40. Busia 279 504 63 99

41. Siaya 11 31 0

42. Kisumu 18 38 0

43. Homa Bay 4 5 0

44. Migori 28 184 21 21

45. Kisii 3 14 0

46. Nyamira 1 4 0

47. Nairobi218

2176 7322 148 178

Source: Sihanya, IPILKA 1 & 2, and ongoing research at Sihanya Mentoring (SM) and

Innovative Lawyering (IL)… See also the Annex on the latest cases…

217 See Saada Hassan (2020) “Nairobi, Mombasa, Kajiado hotspots for Covid-19 asymptomatic cases,”

Standard, Nairobi, 22/6/2020, at https://www.standardmedia.co.ke/article/2001376045/nairobi-mombasa-kajiado-

hotspots-for-covid-19-asymptomatic-cases (accessed 23/6/2020). 218 See Judah Ben-Hur (2020) “Nairobi leads in covid-19 cases as Kenya records 155 new infections,”

Standard, Nairobi, 23/6/2020, at https://www.standardmedia.co.ke/2001376179/nairobi-leads-in-covid-19-cases-as-

kenya-records-155-new-infections (accessed 23/6/2020); Mercy Asamba (2020) “Covid-19: Why you are more

likely to be infected in Mombasa than in Nairobi, Standard, Nairobi, 24/6/2020, at

https://www.standardmedi.co.ke/health/article/2001376329/covid-19-why-you-are-more-likely-to-be-infected-in-

mombasa-than-in-nairobi (accessed 24/6/2020).

45

Table 9: Incidence of COVID-19 Cases in Kenya and Africa219

Country Cases Recoveries Deaths

Kenya220

13 353 (as at

20/7/2020)

5 206 (as at

24/6/2020)

5 122 (as at

20/7/2020)

1 823 (as at

24/6/2020)

234 (as at 20/7/2020)

130 (as at (24/6/2020)

South Africa221

364 328 (as at

20/7/2020)

111 796 (as at

24/6/2020)

191 059 (as at

20/7/2020)

56 874 (as at

24/6/2020)

5 033 (as at

20/7/2020)

2 205 (as at

24/6/2020)

Nigeria 36 663 (as at

20/7/2020)

22 020 (as at

24/6/2020)

N/A (as at 20/7/2020)

1 457 (as at

24/6/2020)

789 (as at 20/7/2020)

542 (as at 24/6/2020)

Ghana 27 060 (as at

20/7/2020)

15 013 (as at

24/6/2020)

23 044 (as at

20/7/2020)

11 078 (as at

24/6/2020)

145 (as at 20/7/2020)

95 (as at 24/6/2020)

Senegal222

8 669 (as at

20/7/2020)

5 859 (as at

20/7/2020)

61 (as at 20/7/2020)

219 The data on COVID-19 is subject to change on a daily basis with new cases, recoveries and deaths being

reported. See World Health Organisation (2020) “WHO Coronavirus Disease (COVID-19) Dashboard,” WHO

website, at https://covid19.who.int/ (accessed 25/6/2020). 220 See Graham Kajilwa (2020) “5, 206 cases, but how many have we tested?” The Standard, Nairobi,

25/6/2020, at https://www.standardmedia.co.ke/health/article/2001376382/5-206-cases-but-how-many-have-we-

tested (accessed 25/6/2020); Sharon Maombo (2020) “Kenya’s Covid-19 cases jump to 5,206 after 254 new cases

recorded,” The Star, Nairobi, 24/6/2020, at https://www.the-star.co.ke/news/2020-06-24-kenyas-covid-19-cases-

jump-to-5206-after254-new-cases-recorded/ (accessed 24/6/2020); Sharon Maombo (2020) “Virus cases hit 4, 952

as 155 more people test positive,” Star, Nairobi, 23/6/2020, at https://www.the-star.co.ke/news/2020-06-23-virus-

cases-hit-4952-as-155-more-people-test-positive/ (accessed 24/6/2020). 221 See Standard Reporter (2020) “South Africa roll out continent’s first trials for COVID-19 vaccine,”

Standard, Nairobi, 24/6/2020, at https://www.standardmedia.co.ke/article/2001376389/south-africa-rolls-out-

continent-s-first-trials-for-covid-19-vaccine (accessed 24/6/2020). 222 See Xinhua (2020) “Senegal’s Covid-19 cases rise to 6, 034 after 64 new infections,” Daily Nation,

Nairobi, 24/6/2020, at https://www.nation.co.ke/kenya/news/africa/senegal-covid-19-cases-surpass-6000-894436

(accessed 24/6/2020).

46

6 129 (as at

20/7/2020)

4 072 (as at

24/6/2020)

56 (as at 24/6/2020)

Uganda223

1 062 (as at

20/7/2020)

805 as at 24/6/2020)

10 23 (as at

20/7/2020)

717 (as at 24/6/2020)

0 (as at 20/7/2020)

0 (as at 24/6/2020)

Tanzania 509 (as at 24/6/2020) N/A 21

Egypt 87 172 (as at

20/7/2020)

59 561 (as at

24/6/2020)

27 868 (as at

20/7/2020)

15 935 (as at

24/6/2020)

4 251 (as at

20/7/2020)

2 450 (as at

24/6/2020)

Source: Sihanya, IPILKA 1 & 2, and ongoing research at Sihanya Mentoring (SM) and

Innovative Lawyering (IL)… See Annex on new case development

31.5 The Bar and Bench’s Response to COVID-19 in Kenya

IP, innovation and technology transfer are equally crucial and uncertain in at least three contexts.

First, in health (service) delivery in ordinary occasions as discussed in this Chapter.224

Second, in

(individual) emergency medical treatment225

which is a right under article 43(2) of the

Constitution of Kenya.226

Third, in health delivery in the context of health or related emergency,

disaster or war, including disease outbreak in the form of endemic, epidemic or pandemic like

HIV/AIDs, COVID-19, Malaria and cholera… This third category is governed by articles 43(2),

58, 132(4), and 241(3) and other provisions.227

223 See Jonathan Kamoga (2020) “Uganda registers 87pc Covid-19 recoveries, no deaths,” The EastAfrican,

24/6/2020, at https://www.the-eastafrican.co.ke/news/ea/Uganda-Covid-recoveries/4552908-5581812-

68mul0/index.html (accessed 24/6/2020). 224 Chapter 31 IPILKA 2. 225 This mainly means individual accident and emergency (A&E)…. 226 See Ministry of Health (2019) “Kenya emergency medical case policy,” Government Printer, Nairobi. Cf.

SA… 227 Cf. Health Act 2017, Public Health Act 2012 (1986), Public Order Act Cap 56, Preservation of Security Act (PSA) Cap 57, Constitution of South Africa 1996, Constitution of the Federal Republic of Nigeria 1999,

Constitution of Uganda 1995 (amended 2005). See also Ben Sihanya (forthcoming 2020) “Judicial power, structure,

and independent accountability in Kenya and Africa: Interests, process and outcomes,” Part 2, Chapter 8B, in Ben

Sihanya (2020) Constitutional Democracy, Regulatory and Administrative in Kenya and Africa Vol. 1: Presidency,

Premier, Bureaucracy and Administrative Justice in Kenya, Sihanya Mentoring & Innovative Lawyering, Nairobi &

Siaya. See Annex… to this essay.

47

How have courts responded to the Coronavirus disease 2019 (COVID-19) pandemic in Kenya,228

South Africa,229

Nigeria, Malawi,230

Uganda, Tanzania, the United Kingdom and USA?

There are numerous issues arising in the context of COVID-19 some of which may be litigated

immediately or well into the future.231

These include proposed labour laws and regulations….232

There are at least three issues. First, cases have been filed and some decided in Kenya,233

Malawi,234

and South Africa,235

among others, to question the scope of COVID-19 regulations

and protocols on lockdown, curfew, quarantine, (self and forced) isolation….236

Second, in Kenya, Chief Justice David Maraga237

and the National Council on Administration of

Justice (NCAJ) has issued various and even contradictory practice directives and directions,

228 Law Society of Kenya v. Hillary Mutyambai & Others, Petition No. 120 of 2020 (COVID 025) (on the constitutionality of the State ordered curfew of March 26/3/2020);. Joan Akoth Ajuang and Anor v. Michael Owuor

Osodo, Chief Ukwala Location & 3 Others (2020) op. cit. on the “dog-like” burial of Oyugi in Kamaluanga,

Ugenya, Siaya County, on Easter Sunday, 12/4/2020. See Dickens Wasonga (2020) “Siaya burial: County distances

itself amid criticism,” Daily Nation, April 13, 2020, at https://www.nation.co.ke/counties/siaya/Siaya-man-burial-

sharp-criticism-county-distances/1183322-5522504-hjrqdyz/index.html (accessed 6/5/2020)…. Cases on police

brutality during curfew? ….cases on police detention, quarantine and demand for bribes include.... General and

COID-19 related litigation were affected by the closure of courts and the subsequent limited and slow up scaling...

Mohamed Ahmed (2020) “Maraga suspends open court sessions in Mombasa over Covid-19,” Daily Nation,

19/6/2020, at https://www.nation.co.ke/kenya/news/maraga-suspends-open-court-sessions-in-mombasa-over-covid-

19-733308 (accessed June 19, 2020); Jillo Kadida (2020) “Why courts are unfit for use during Covid-19,” Star,

Nairobi, 24/6/2020, at https://www.the-star.co.ke/news/big-read/2020-06-24-why-courts-are-unfit-for-use-during-

covid-19/ (accessed 24/6/2020). 229 A court ruled that an individual could not go to burry a family member…. See Franny Rabkin (2020) “High

Court refuses application to cross provinces for funeral,” Mail & Guardian, Johannseberg, South Africa, March 28,

2020, at https://mg.co.za/article/2020-03-28-high-court-refuses-application-to-cross-provinces-for-a-funeral/

(accessed 21/4/2020). Some have demonstrated and litigated against lockdown, forced and self-quarantine, social

distancing… see… 230

Human Rights Defenders Coalition (HRDC) v. Attorney General, High Court of Malawi.... 231 …. 232 Cf. Cyrus Ombati & Roselyn Ombaka (2020) “Return to work for workers who test positive for COVID-19

patients,” Sunday Standard, Nairobi, 3/5/2020, at 19, at

https://www.standardmedia.co.ke/article/2001369951/return-to-work-rules-for-workers-who-catch-virus (accssed

6/5/2020). 233 …. 234 …. 235 High Court of South Africa Mpulamalange Division (per Justice Roelofse AJ (Ag Judges) judgement of

27/3/2020. 236 …. 237

Practice Directions for The Protection of Judges, Judicial Officers, Judiciary Staff, Other Court Users and the

General Public from the Risks Associated with the Global Corona Virus Pandemic, Gazette Notice No. 3137, Kenya

Gazette Vol. Cxxii—No. 67 Nairobi, 17th April, 2020.

48

respectively in the age of COVID-19.238

These included limiting physical appearance in court

and enhancing online court processes; then upscaling;239

then reversing the up scaling decision,

then up scaling slowly….240

Third, the Law Society of Kenya’s (LSK’s) presidential and council transition to President

Nelson Andayi Havi from President Allen Waiyaki Gichuhi, was effected through digital

platforms, including Facebook, Zoom, Microsoft Teams, Microsoft Video Conference,241

Google

meet, Google video calls, Google Classroom,….

Numerous LSK and legal academic actions have also been processed online, including a call for

articles for a special edition of the Advocate magazine on legal aspects COVID-19 (Corona

virus) in Kenya and the July 2020 LSK Annual General Meeting (AGM)….242

Some Law

Society of Kenya (LSK) Constinuous Professional development (CPD) seminars.

Significantly, President Havi led the LSK in litigating243

matters related to Executive’s and Chief

Justice’s (in)actions on COVID-19.244

He and Vice President Caroline Kamende Daudi also led

LSK in raising funds for needy or vulnerable LSK members and Kenyan public.245

The question for a balanced approach to lawyering and judicial work including adjudication is at

least four pronged. First, the life and health of judges, magistrates, kadhis, judicial officers and

staff, lawyers, and court users…. Second, the Constitution, the rule of law, human rights, and

constitutional democracy demand that at any given time, all the three arms of Government must

check and complement one another.

238

National Council on the Administration of Justice (2020) press statement: Statement on the Justice sector

operations in the wake of COVID-19 pandemic.. 239 …. 240 Cf. Sekou Owino (2020) “Virus or no virus, Courts must dispense justice,” Sunday Nation, Nairobi,

3/5/2020, at 33, at https://www.nation.co.ke/oped/opinion/Virus-or-no-virus--courts-must-dispense-justice/440808-

5540744-6swe9uz/index.html (accessed 6/5/2020). 241 See Judiciary (2020) Video Conferencing (VC) Guidelines… 242 See circulars on transition by President Nelson Andayi Havi and former President Allen Waiyaki

Gichuhi…. March 2020. 243 … 244 See… 245 ….

49

Significantly, the National Assembly and the Senate recognized this and started a balanced

minimal approach while observing the Ministry of Health’s (MOH’s) COVID-19 protocols, and

enhanced or up scaled online processes….

Third, in the absence or limited presence of the Judiciary, Executive, and especially, police

brutality, execution, and tyranny increased. Fourth, legal and judicial services are professional

and occupational to many. It is also a bread and butter question. Does the Chief Justice’s

abdication mean that judicial and legal services are totally dispensable? What about the fact and

claims that limited and reduced Judiciary funding has reduced its capacity to operate online and

physically in the time of COVID-19?246

31.5A The Universities’ response to COVID-19 in Kenya

The announcement by President Uhuru Kenyatta of COVID-19 containment measures in March

15, 2020 triggered at least three responses in the Kenyan universities. First, some closed

immediately while others closed within the week as directed.247

Second, some focused on online

learning and online classes soon thereafter. Third, a few universities and especially individual

lecturers focused on innovation research and development (R&D) to address COVID-19, or to

prepare for the (post) COVID-19 age.

Appropriate application of technology and especially ICT and digital or online technologies is

good for university Education, Training, Research, Innovation, and Mentoring (ETRIM).

Appropriate technology is the present and future and Kenyan lecturers and students have always

adopted and adapted appropriate in ETRIM, including sharing materials with students online,

using LCD projectors…..

But new, untested, inappropriate, business meeting, or general social communication

technologies adopted in the rushed online learning and exams are always value laden and not

value neutral. Technology is not always accessible, inclusive or fair to all. New and hi-tech,

unlike appropriate tech, is always exclusive and unfair to most and especially in the context of

social economic pressure from COVID-19. This is partly because of differentials in funds,

technology or technological sophistication (given limited timing) to access equipment like smart

phones, lap tops; software or code; bandwidth, architecture or network; and content including

data, graphics or voice, Related challenges are access to electricity, Social distancing vis-a-vis

shared resources in the age of COVID-19?

246 How have procurement for COVID-19 related facilitiesabeen handled…? Regulated? 247

50

And yet equitable promotion and sharing of copyright, trade secret, and related IP have not been

addressed. These differentials are sometimes acute and are related to region, tribe, youth….

Accessible, equitable and quality university ETRIM is not negotiable as part of shared prosperity

given Kenya’s historical exclusion. Adoption of technology for students admitted to face-to-face

programmes should248

be preceded by participation of stakeholders in decision-making for

inclusion - not exclusion- and shared prosperity under Arts 10, 22, 23, 24, 27, 43, 46, 47, 53...of

the Constitution.249

Universities should promote, diversify, intensify and deepen - not just widen

- teaching, learning... or ETRIM is the practice in universities with progressive top managers and

administrators in South Africa, the US, UK….

Kenyan Universities should impart appropriate Skills Knowledge Attitudes Values and

Innovation (SKAVI), including appropriate and relevant skills, lifelong learning and application

in the quest of the Oracle’s Shrine. COVID-19 demonstrates that there are challenges and

opportunities which SKAVI may address through equity, evidence based decision making and

participation. These are the basic ties that bind students, lecturers and staff and management and

the requirements of the 3Cs: contractual commitments, good corporate governance, and

constitutional democracy.250

These ad hoc measures will have devastating impact on equity, equality in the present and future

generations.

All progressive forces should strongly advocate for the right thing to be done and to be done

right for accessible, equitable and quality university ETRIM in the post COVID-19 age. This

may be backed up by participation of stakeholders in decision making for inclusion, not

exclusion and shared prosperity in Kenya.251

This is in spite of targeting and intimidation of

those who have dissenting views252

on national values and principles of governance (article 10);

enforcement of Bill of Rights (article 22); authority of courts to uphold and enforce Bill of

Rights (article 23); balancing rights (article 24); equity, equal protection and non-discrimination

(article 27); economic and social rights (article 43); consumer or user rights (article 46); fair

administrative action (article 47); right to education (article 53)…

248 These clauses address stakeholder and public participation under Arts 10, 22, 23, 24, 27, 43, 46, 47, 53...of

the Constitution of Kenya 2010. 249 These articles address public participation. 250 Edward Ontita (2020) “Mandatory mass online learning a farce,” Daily Nation, Nairobi, 26/4/2020, at

https://www.nation.co.ke/blogs/Mandatory-mass-online-learning-a-farce/1949942-5535348-format-xhtml-

7rfcoq/index.html (accessed 25/7/2020). 251 An early draft of this section was a think piece shared in the University of Nairobi WhatsApp group. The

students who were (potentially) affected by the online classes and exams requested to use the argument and cited

authorities in the case Daniel Chege & Ors v. University of Nairobi & Ors Petition 213 of 2020. 252

51

Three proposals are key in the uncertain (post) COVID-19 age.253

First, the phased resumption of studies and remedial teaching and learning should be at the

appropriate time and for the weeks that were left in the semester at the time of closing due to

COVID-19. The remedial classes should be for students who did not or could not participate in

the online classes as well as students who participated. It is clear there has been exclusion, with

some classes having less than 20% participation, and serious concerns regarding quality,

standards and relevance even for the online participants.254

Second, after the remedial face to face classes, two weeks should be dedicated to physical exams

that ensure quality and integrity. No appropriate technology nor regulations have been

formulated in a participatory manner or at all hence serious concerns with quality and integrity

regarding “online exams.”255

Third, the resumption should be phased on the basis of consultation and participation with the

students, lecturers and staff. Resumption should follow and be attended by appropriate

preparation in accordance with COVID-19 protocols recommended by World Health

Organisation (WHO), Ministry of Health (MoH) and Ministry of Education.256

Remarkably, numerous leading universities in Kenya, the US, UK, South Africa have pursued an

equitable, participatory and phased process on resumption of education, training, research,

innovation and mentoring (ETRIM). And incrementally integrating appropriate and affordable

technology in an equitable, participatory, and seamless manner is part of the process.257

Remarkably, a lot needs to be done to make Kenyan universities implement standards, quality,

and research in the integrated and holistic process I call education, training, research, innovation

and mentoring (ETRIM).

253 This was … a plea for consideration based on concerns by various students …. 254 Kaliope Azzi-Huck and Tigran Shmis (2020) “Managing the impact of COVID-19 on education systems

around the world: How countries are preparing, coping, and planning for recovery,” World Bank Blog, at

https://blogs.worldbank.org/education/managing-impact-covid-19-education-systems-around-world-how-countries-

are-preparing (accessed 25/7/2020). 255 UNESCO (2020) “COVID-19 and higher education: Today and tomorrow,” at

http://www.iesalc.unesco.org/en/wp-content/uploads/2020/05/COVID-19-EN-130520.pdf (accessed 25/7/2020). 256 Douglas Harris (2020) “A broad strategy for schools during the COVID-19 pandemic,” Brown Center

Chalkboard, at https://www.brookings.edu/blog/brown-center-chalkboard/2020/03/27/a-broad-strategy-for-schools-

during-the-covid-19-pandemic/ (accessed 25/7/2020). 257 Cf. Processes at Stanford, Harvard, Yale, MIT, and in the relevant South African universities.

52

31.6 Promoting Health through Intellectual Property in Kenya and Africa258

In this context the relationships among researchers or scholars or employees and the research

institutes, university, or pharmaceutical corporations relevant to R&D enterprise. It is also

significant in determining the new incentives, including salaries, remuneration, compensation or

other rewards or incentives received…

Increasingly, the Constitution, statutes, rules, regulations, policies, practices, and traditions make

provision for equitable benefit sharing among researchers, scholars, or employees and the

relevant state ministries, departments and agencies (MDAs), state agencies government agencies

(SAGAs), R&D institutions, universities, private or NGO institutions259

…

Kenyan and African patent and science, technology and innovation laws have always provided

that the inventor be named, unless the inventor writes to the Managing Director of Kenya

Industrial Property Institute (KIPI) that they do not wish to be named.260

How have Kenya, South Africa, Nigeria, Uganda, Tanzania, UK and USA addressed the issue of

employee and researcher compensation. In the leading UK case of Prof Ian Shanks in Shanks v.

Unilever PLC and Others. The UK Supreme Court decided that;

“Where it appears to the Court or comptroller on an application made by an employee within the

prescribed period that the employee has made an invention belonging to the employer for which a

patent has been granted, that the patent is (having regard among other things to the size and nature of the employer’s undertaking) of outstanding benefit to the employer and by reason of

those facts it is just that the employee should be awarded compensation to be paid by the

employer, the court or the comptroller may award him such compensation of an amount

determined under Section 40 of the Patents Act 1977.”261

258 Define and discuss these key diseases, incidences and … (earlier on) in Kenya. 259 For instance, researchers and employees are to be named when they invent (section 33… IPA, 2001

(2016)). 260 See section 33 of the Industrial Property Act 2001 (2016); Section 48 & 49 of South Africa Patent Act

1978; Section 2(2) Nigeria Patent and Designs Act 1990. Cf. Science Technology and Innovation Act 2013, Science

and Technology Act Cap 250 1977 (1980) (repealed and replaced by the STI Act, ibid). 261 Shanks v. Unilever PLC and Others [2019] UKSC 45 On appeal from: [2017] EWCA Civ 2.

53

Prof Shanks was an employee of Unilever UK Central Resources Limited (CRL), a wholly

owned subsidiary of Unilever PLC (Unilever). In the 1980s, Shanks invented a method of using

biosensors in disposable devices to measure glucose for monitoring diabetes.262

The rights to the invention were then assigned to Unilever, which successfully registered various

patents across the world, eventually yielding a return to the company of over £24m in revenue by

way of licensing deals. Shanks claimed that the patents resulting from his invention provided an

outstanding benefit to his employer, thereby granting him a statutory entitlement to a fair share

of the profits.263

As discussed above, developing counties have for a long time experienced challenges on access

to medicine or pharmaceutical products and processes because of the restrictive application of

intellectual property rights. This is because medicine is protected, drug registration, and patent-

plus264

measures.

What are some of the COVID-19 innovations and inventions in Kenya?265

Under the Kenyan and African state IP laws, patents owners are granted exclusive rights over

their pharmaceutical products for a period of up to 20 years.266

They are usually considered as a

262 ibid. 263 See the judgement, at https://www.supremecourt.uk/cases/docs/uksc-2017-0032-judgment.pdf (accessed

16/6/2020). 264 These may be trade related restrictive and measures, including tied aid, that are not valid or legitimate

under patent… 265 In the early days of COVID-19 pandemic, there were many (problematic) … innovators. Some were

approved later. These include KU ventilators see Star Reporter (2020) “KU develops Sh500,000 ventilator prototype

in war on Covid-19,” Star, Nairobi, 11/4/2020, at https://www.the-star.co.ke/news/2020-04-11-ku-develops-

sh500000-ventilator-prototype-in-war-on-covid-19/ (accessed 17/6/2020), fabrications of UON… ventilators Kitui

county converted textile factory into a masks manufacturer see Max Beerak (2020) “The Kenyan factory that

transformed into a surgical mask assembly line overnight,” Washington Post, at

https://www.washingtonpost.com/world/africa/the-kenyan-factory-that-transformed-into-a-surgical-mask-assembly-line-overnight/2020/04/08/fac04912-783e-11ea-a311-adb1344719a9_story.html (accessed 17/6/2020)… First pedal

machine hand washing see BBC Reporter (2020) “Kenyan boy who made hand-washing machine awarded,” BBC

News, at https://www.bbc.com/news/world-africa-52898797 (accessed 17/6/2020) … 266 Section 60 Industrial Property Act 2001… See also Clause 86 Intellectual Property Bill of Kenya 2020

…Section 46 SA Patents Act, Nigeria Patent Act 1979, Uganda Patent (Amendment) Act 2002, Tanzania Patent Act

1987…

54

reward for the research and development (R&D) and especially the cost financial implications

for developing the drugs or medicines.

Patent is provided for under several international agreements. These include the Agreement on

Trade-Related Aspects of Intellectual Property Rights (TRIPs) of 1994 and the Doha Declaration

on the TRIPs Agreement and public health of 2001.267

African regional patent regimes include the African Regional Intellectual Property Organization

(ARIPO)268

and African Intellectual Property Organization (OAPI).269

31.6.1 Health Patent Regime in Kenya270

The main health patent regime in Kenya is provided for under the Industrial Property Act

2001.271

The Act provides for the grant and registration of an invention that provides a solution

to public health related methods of use or uses of any molecule or other substances whatsoever

used for the prevention or treatment of any disease which the Minister of Health responsible for

matters relating to health may designate as a serious health hazard or as a life threatening

disease.272

Registration of health patents is facilitated by the Kenya Industrial Property Institute (KIPI).

KIPI’s functions include examining applications for, and granting industrial property rights,

267 268 The African Regional Intellectual Property Organisation (ARIPO) was established in 1976 under the

Lusaka Agreement to cater for English speaking countries on industrial property. This followed a regional seminar

held in Nairobi in the early 1970s on patent and copyright for African countries. 269 The Africa Intellectual Property Organization (OAPI) was established under the Libreville Agreement of

September 13, 1962 effective January 1, 1964. The agreement was revised by the Bangui Accord of March 2, 1977

and the Regulations made in terms of the revisions which were effective on February 8, 1982. The member

countries are Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Republic of Congo, Djibouti,

Gabon, Guinea, Ivory Coast, Mali, Mauritania, Niger, Senegal, Togo and Guinea-Bissau. 270 Section 22 of the Industrial Property Act 2001 provides for patentable inventions in Kenya while section 26

provides for non-patentable inventions. Cf. Clause 48 of the Intellectual Property Bill 2020 provides for patentable inventions while clause 52 of the Bill provides for non-patentable inventions. 271 Equally important IP regimes and the Science Technology and Innovation (STI) Act 2012 (which repealed

and replaced the Science and Technology Act, 1977 (1980), the Seeds and Plant Varieties Act 2012, Cap 326, Anti-

Counterfeit Act, 2008. See also Intellectual Property of Kenya Bill 2020… 272 See section 21(1)(e) of Industrial Property Act 2001. Cf. Clause 47(1)((e) of Intellectual Property Bill

2020. ..

55

screening technology transfer agreements and licences, providing patent information to the

public, and promoting inventiveness in Kenya.273

What lessons can Kenya and Africa learn from the debates regarding innovation, patent,

technology transfer and … policies, political economy and legal sociology of HIV/AIDs drugs

especially KEMRON, real omega and the Loliondo274

herbal “cure”?275

31.6.2 Pharmaceutical Patent under ARIPO and OAPI, EAC, COMESA, ECOWAS,

SADC, and AfCFTA

There are two main regional bodies that are responsible for the administration of pharmaceutical

patents in Africa. These are the African Regional Intellectual Property Organization (ARIPO)

and the Africa Intellectual Property Organization (OAPI). OAPI was created by the Bangui

Agreement in March 2, 1977 before the Agreement was subsequently amended in 1999.

The African Regional Intellectual Property Organization (ARIPO) was established with the

adoption of the Lusaka Agreement in Lusaka, Zambia on 9 December 1976.276

ARIPO is a regional mechanism that administers the filing, examination and grant of

(pharmaceutical) patents for 18 countries in the region that are contracting parties to the Harare

Protocol. This Protocol is the legal framework that sets out the rules for the administration of

patents, utility models and industrial designs for parties to the Protocol.277

In 2018, ARIPO received 831 applications were filed compared to 747 filed in 2017, reflecting a

10% growth in filings.278

Out of the 831 applications, a total of 284 patents were granted. In

2017, ARIPO granted 453 patent applications. Our ongoing research indicates that the data from

273 See section 5 of Industrial Property Act 2001. Cf. Sihanya (2016; reprinted 2020) Intellectual Property and

Innovation Law in Kenya and Africa: Transferring Technology for Sustainable Development, op. cit., 91. 274 See Martin Siele (2020) “Kenya turns to herbal “Loliondo Medicine” in search for Covid-19 cure,”

https://www.kenyans.co.ke/news/54317-kenya-turns-herbal-medicine-search-covid-19-cure-video (accessed

16/6/2020). 275 See Sihanya, IPILKA 1 & 2; Sihanya (2003) “Patent wars raging over Aids cure,” op. cit. John Kamau

(2020) “KEMRON: The HIV?AIDS cure that never was,” Daily Nation, Nairobi, at https://www.nation.co.ke/kenya/news/kemron-the-hiv-aids-cure-that-never-was-287542 (accessed 16/6/2020). 276 Sangeeta Shashikant (2014) “The African Regional Intellectual Property Organization (Aripo) Protocol on Patents: Implications for Access to Medicines,” South Centre Research Paper 56, at https://www.southcentre.int/wp-

content/uploads/2014/11/RP56_The-ARIPO-Protocol-on-Patents_ENl.pdf (accessed 22/5/2020). 277 Sihanya (2016; reprinted 2020) Intellectual Property and Innovation Law in Kenya and Africa:

Transferring Technology for Sustainable Development, op. cit., at 86. 278 ARIPO (2018) “ARIPO annual report 2018,” at https://www.aripo.org/wp-

content/uploads/2019/07/ARIPO-Annual-Report-2018.pdf (accessed 27/5/2020).

56

online reports is general, disintegrated and does not indicate how many patents were granted or

registered for pharmaceuticals, or the relevant key diseases like malaria, TB, HIV/AIDS, cholera,

and cancer, or how many patents have been worked or performed….279

The OAPI patent is a single patent which extends to the 16 Member States. There is a single

patent law that is applied by courts of each country hence there is no national phase or national

patent.280

In the event a patent is invalidated in any jurisdiction or country, it stands invalidated

in all OAPI countries.281

The OAPI Patent Office is in Yaounde in the Republic of Cameroon where the applications from

outside the Union countries are filed. Patent application procedures must be accompanied by the

following requirements. First, an application form. Second, a power of attorney. Third, a deed of

assignment (where relevant). Fourth, three copies of the specification in French or English;

priority documents together with sworn translations in French or English where applicable. And

fifth, the prescribed fees.282

31.6.3 Pharmaceutical Patent under Pan African Intellectual Property Organization

PAIPO

The Pan African Intellectual Property Organization (PAIPO) was adopted on January 30, 2016

with the mandate for intellectual property and other emerging issues related to intellectual

property in Africa. PAIPO was also to promote the effective use of the intellectual property

system as a tool for economic, cultural, social and technological development.283

PAIPO is tasked with the responsibility to develop policy guidelines using best practices and

training modules to support member states to achieve world class intellectual property systems284

and promote the harmonization of intellectual property systems of its member states with

279 There is need for further research on patents and utility models, etc, granted and registered in, worked in, or

that have impact in Kenya, South Africa, Nigeria, Uganda, Tanzania and the relevant African states 280 See Regional Patent Systems in Africa, at http://www.ficpi.org/library/montecarlo99/patentsafrica.html

(accessed 30/9/2010; 26/5/2020). See also Chapter 2 of IPILKA 1. 281 See Regional Patent Systems in Africa, ibid. See also Sihanya (2016; reprinted 2020) Intellectual Property

and Innovation Law in Kenya and Africa: Transferring Technology for Sustainable Development, op. cit., at 86. 282 ibid. 283 Article 3 of the Statute for the Pan-African Intellectual Property Organization 2016, at https://au.int/sites/default/files/treaties/32549-treaty-0053_-_paipo_e.pdf (accessed 26/5/2020). 284 Article 4(j) of the Statute for the Pan-African Intellectual Property Organization 2016, ibid.

57

particular regard to protection, exploitation, commercialization and enforcement of intellectual

property rights.285

31.6.4 Patent Protection under the Agreement of Trade Related Aspects of Intellectual

Property, Including Trade in Counterfeit Goods (TRIPs) 1994

According to the IP, innovation and technology transfer literature, promotion and protection of

an invention in the health or pharmaceutical sector is mainly by way of patent.286

The reality

shows that the policy options, and even IP options are more varied and include patent and IP

complements or substitutes287

such as (government) subsidy, (preferential) licensing, or

procurement, tax rebates….288

The TRIPs Agreement 1994 established minimum standards on IP doctrines. On patent, the

TRIPs Agreement adopts the Diamond v. Chakrabarty289

standard, which states that everything

or anything under the sun made by a human being is patentable. There should be no arbitrary

exclusion of any invention from patentability.290

Under Article 29 of the TRIPs Agreement, members are obligated to require that applicants

disclose the invention in a manner sufficiently clear and complete for the invention to be carried

out by a Person Having Ordinary Skill in The Art (PHOSITA).291

Members may require the

applicants to disclose the best method of implementing or working the patent.

Article 30 provides for limited exceptions to the exclusive patent rights conferred under Art 28.

However, these limited exceptions must “not unreasonably conflict with a normal exploitation of

285 Article 4(i) of the Statute for the Pan-African Intellectual Property Organization 2016, ibid. 286 287 Paul Goldstein (1997) “Copyright and its Substitutes,” 1997 Wis. L. Rev. 65–872. 288 See Sihanya, IPILKA 1&2, Cf. Calestous Juma, Cleophas Torori and CM Kirima (1993) The Adaptive

Economy: Economic Crisis and Technological Innovation, African Centre for Technology Studies (ACTS),

Nairobi, Kenya. 289 Diamond v. Chakrabarty 177 US 303 (1980), op. cit. Cf. D.S. Chisum et al. (2004) Principles of Patent

Law Foundation Press, New York, op. cit.; Sihanya, “Patent law and practice in Kenya” op. cit. 290

See Art 27 (1) & (2) of TRIPs. Cf. Diamond v. Diehr, 450 US 175 (1981) which helped provide the basis

for software protection. Both cases aided tremendous investment in biotechnology, pharmaceuticals, software and

ICT generally. 291 I have capitalized the first letters from which the acronym is formed. Some patent lawyers simply state it

thus: “a person skilled in the art.” See Chapter 3.5.3.1 in Sihanya (2016; reprinted 2020) IPILKA 1; Sihanya

(forthcoming 2020) IPILKA 2.

58

the patent”292

and should not unreasonably prejudice the legitimate interests of the patent owners

and third parties.

Article 31 provides for compulsory licensing293

and government use294

of patents. It has

numerous provisions limiting or restricting (but not prohibiting) compulsory licensing. This

clause has been contentious. Kenya and many African countries were and still are keen to have

the power to compulsorily license pharmaceuticals and other patents and also to have the

Government use clause.

Amendment to Article 31 was agreed in Hong Kong conference.295

But Kenya and most African

states have not yet operationalized the amended compulsory licensing clause which is one of the

key TRIPs and related IP flexibles.

What was the pre-Doha context in Kenya, Nigeria, South Africa, Uganda, Tanzania, Uganda,

Ghana and Senegal and especially with regard to IP and public health?296

Under Article 33, a patent is protectable for at least 20 years. Like in most African states a patent

is protected for 20 years in Kenya under section 60 of the Industrial Property Act 2001.297

Under Article 34, the burden of proof may be reversed in the case of process patent. For instance,

if a product is manufactured in certain circumstances, it will be assumed that the infringer used

the legitimate patent procedures or process. Some critics have thus argued that TRIPs is over-

protective of patentees and investors. It is important to analyse the TRIPs flexibilities too.

Drugs for AIDS are expensive in Kenya, South Africa, Nigeria, Uganda, Tanzania and other

African states. This is partly because of royalties that must be paid to patent holders under the

292 That is, the limitation or exceptions must be reasonable and consistent with the normal exploitation of a

patent. 293 See Chapter 29 of Sihanya (forthcoming 2020) IPILKA 2…..and the following provisions of patent law in

Kenya. Sections 72, 73, 74, 75, 76 and 77 of Industrial Property Act 2001 and Clauses 98, 99, 100, 101 and 102

Intellectual Property of Kenya Bill 2020. South Africa (Section 55 and 56 of Patents Act no. 57 of 1978); Nigeria

(Patent Act 1970…); Uganda (Patents (Amendment) Act 2002…); Tanzania (Patent Act 1987…); Senegal (s…). 294 ibid. 295 Mathew Rimmer (2007) “The Hong Kong Amendment to the TRIPs Agreement: A Submission to the Joint

Standing Committee on Treaties,” May 2007, at http:// works.bepress.com/Mathew_rimmer/58 (accessed

4/10/2010); Decision on “Amendment of the TRIPs Agreement,” WTO document WT/L/641… 296 Sihanya (2003) “Patent wars raging over Aids cure,” Opinion: Pandemic, Daily Nation (Nairobi),

Wednesday, 17/12/2003, at 9, op. cit.; Cf. Sihanya, IPILKA 1. 297 Clause 86 of Intellectual Property of Kenya Bill 2020.

59

national laws, technology transfer agreements, contractual commitments, and the TRIPs

Agreement. Drugs are also expensive because of limited R&D on (tropical or orphan)298

diseases affecting Kenyans.299

Significantly, non-governmental organizations (NGOs) such as Médecins Sans Frontières

(MSF), Action Aid and other health campaigners argued that more than 50% of Kenyans live on

US$1 a day in 2003 and could not afford the expensive antiretroviral (ARV) drugs or to maintain

optimal nutrition levels associated with effective drug use.300

In 2019, World Bank reported that Kenya is still grappling with high levels of poverty at 29.2

percent (14.2 million people).301

The report indicated that many people cannot access basic needs

due to extreme poverty caused by unemployment. More than 3.4 billion people all over the world

are still struggling to meet basic needs living on $3.20 dollar a day.302

There have also been controversies regarding compulsory licensing under the TRIPs Agreement.

First, many stakeholders argue that Kenyan and other African firms do not have the internet or

capacity to manufacture or distribute such drugs.303

Second, NGO activists and others argue that

the pharmaceutical industry in Kenya is largely oligopolistic and firms have not been keen to

process drugs under a compulsory licence.

To maximize and capitalize on the available market in Kenya and Africa, pharmaceutical

companies have also undergone mergers and acquisitions. Indeed, the big pharmaceutical

manufacturers (pharmas) in Kenya and Africa, which have undergone mergers and acquisitions

298 299 ibid. 300 ibid. 301 Valentine Kiondo (2019) “World Bank report says poverty still high in Kenya at 29.2 percent,” Standard, Nairobi, at https://www.standardmedia.co.ke/article/2001299505/wb-report-poverty-still-high-in-kenya (accessed

2/6/2020). 302 ibid. 303 Sihanya (2008) “How IMF policies constrain policy space in Kenya’s health sector,” in Ben Sihanya (ed)

The Impact of IMF Policies on Education, Health and Women’s Rights in Kenya, Action Aid International Kenya,

Nairobi, Part IV, pp. 65-95.

60

(M&A) or adopted oligopolistic cartel behaviour.304

These include GlexoSmithkline (GSK),

Bayer EA Ltd … 305

Some of the pharmas are horizontally and vertically integrated…306

Third, accessing COVID-19, malaria and AIDS drugs has revealed more serious health policy

problems: even non-patented drugs have not been easily accessible, or they have expired in the

central storage facilities, or they have been pilfered through rent-seeking Ministry of Health

bureaucrats.307

31.6.5 Doha Declaration on the TRIPS Agreement and Public Health 2001

The Doha Round of negotiations was adopted by the WTO Ministerial Conference of 2001. The

Declaration sought to assure members of the flexibility of TRIPS with regards to legally

circumventing patent rights to ensure access to medicines due to public health reasons. The

conference recognized the role intellectual property plays in the development of pharmaceutical

drugs to combat diseases and also recognized its effect on accessibility and pricing of the

drugs.308

304 Betty Nyaga (2009) Doctors' Perception of Mergers and Acquisitions in the Pharmaceutical Industry in

Kenya, An LLM Thesis submitted at the University of Nairobi, at http://erepository.uonbi.ac.ke/handle/11295/21253

(accessed 8/6/2020); Muthiani Mwikali (2008) Cross Cultural Perspective of Mergers and Acquisitions: The Case

of GlaxoSsithkline Kenya PLC, An LLM Thesis submitted at the University of Nairobi, at

http://erepository.uonbi.ac.ke/handle/11295/23325 (accessed 8/6/2020). 305 See list of Kenyan Pharmaceutical manufacturers, under the Kenya … website, at … ; Jackson Okoth (2014) “Mergers and acquisitions sweep corporate kenya as global innovators shop for source bets,” Standard,

Nairobi, 11/2/2014, at https://www.standardmedia.co.ke/article/2000104374/mergers-and-acquisitions-sweep-

corporate-kenya-as-global-investors-shop-for-sure-bets (accessed 8/6/2020). 306 See United Pharmas wWbsite, at http://unitedpharma.co.ke/ (accessed 8/6/2020). United Pharma (K) Ltd is

a recognized importer, wholesalers, and distributors of pharmaceutical and medical devices in East Africa. Cf.

Competition Act 2010, Consumer Protection Act 2012, unfair competition rules under Industrial Property Act 2001,

Intellectual Property of Kenya Bill 2020, TRIPs Agreement 1994, Paris Convention on the Protection of Industrial

Property 188 (1967). See also Chapter 31.2.2 above. 307 ibid. There are numerous complaints regarding drug cartels in Kenya Medical Supplies Authority

(KEMSA); the National Government’s Ministry of Health (MOH) (Afya House) and County Governments… See

Samwel Owino (2020) “KEMSA taken to task over expired drugs,” Daily Nation, Nairobi, at https://www.nation.co.ke/news/Kemsa-taken-to-task-over-expired-drugs/1056-4773216-jsyqicz/index.html

(accessed 2/6/2020). Angela Oketch (2020) “Scanty information on theft of donated Covid-19 equipment,” Daily

Nation, Nairobi, 20/6/2020, at https://www.nation.co.ke/kenya/news/scanty-information-on-theft-of-donated-covid-

19-equipment-733440 (accessed June 20, 2020). 308 Sihanya (2016; reprinted 2020) Intellectual Property and Innovation Law in Kenya and Africa:

Transferring Technology for Sustainable Development, op. cit….

61

As a result Doha declaration allowed least developed countries (LDCs) up to 2016 to meet patent

related standards in pharmaceutical patents. This was further extended to 2033.309

Uganda and

Tanzania belong to LDCs. Uganda enacted its pharmaceutical patent law under the Industrial

Property Act in 2014 and the Industrial Property Regulations in 2017.310

Tanzania enacted Patent Registration Act 2002 in 2002311

. Kenya, South Africa, and Nigeria are

classified under developing countries…. and were to comply with TRIPs patent clauses by 2000

although most of them they did later. Kenya revised its IPA 1989 in 2001 and the Trade Mark

Act in 2002. Nigeria still retains the Patent and Design Act (PDA) of 1970.312

What was the case and controversy of IP, HIV/AIDS and access to drugs about in South

Africa?313

What has South Africa done on patent and IP reform especially regarding pharmas?

Remarkably, some countries argued in the context of the Seattle, Doha and Cancun rounds of the

WTO that instead of focusing on reviewing the implementation of TRIPs (how TRIPs has been

implemented) the WTO ought to focus on reviewing the terms and clauses of TRIPs itself.314

This is partly because TRIPs has contested standards. And Article 27(3) on patentability of life

forms was cognizant of this fact and provided that the “provisions of this sub-paragraph shall be

reviewed four years after the date of entry into force of the WTO Agreement.315

309 See WHO (2015) “WTO members agree to extend drug patent exemption for poorest members,” WHO website, at https://www.wto.org/english/news_e/news15_e/trip_06nov15_e.htm (accessed 8/6/2020). 310 See David Bakibinga and Ronald Kakungulu (2016) Intellectual Property in East Africa, LawAfrica

publishing, Nairobi, Kenya. 311 Asherry Magalla (2018) “The Patentability of Inventions as Described by the Patents (Registration) Act

(CAP.217, R.E. 2002),” at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3124049 (accessed 8/6/2020). 312 See Adejoke Oyewumni (2015) Nigerian Law of Intellectual Property, University of Lagos Press, Lagos,

Nigeria. South Africa reviewed its Patent Act in 1978… See Caroline Ncube (2015) Intellectual Property Policy,

Law and Administration in Africa: Exploring Continental and Sub-Regional Co-operation, Routledge Taylor and

Francis Group, London and New York; Caroline Ncube and Lucienne Abrahams (2014) “Effects of the South

African IP regime on generating value from publicly funded research: An exploratory study of two Universities,”

Innovation and Intellectual Property: Collaborative Dynamics in Africa, at 292. 313 See Sihanya, IPILKA 1 & 2. Cf. Catherine Tomlinson, John Ashmore, Anele Yaw and Julia Hill (2015)

“Reforming South Africa’s procedure for granting patents to improve medicine access.” South African Medical

Journal, at http://www.samj.org.za/index.php/samj/article/view/9966 (accessed 8/6/2020). 314 ibid. 315 See also UNCTAD/ICTSD (2004) Resource Book on TRIPS and Development: An Authoritative and Practical

Guide to the TRIPS Agreement, op. cit., at 388.

62

It is thus important that the clauses themselves be reviewed. Patentability of life forms under

Article 27(3),316

parallel importation under Article 6317

and compulsory licensing under Article

31318

have been particularly controversial. Article 31 was reviewed and amended at the Hong

Kong Ministerial Conference (2005).319

Reviewing the terms of the TRIPs Agreement means that the relevant clause or provision is

reviewed to be retained or changed on its own merits or terms individually. The US generally

opposes review of clauses; it prefers to focus on how countries have implemented TRIPs rather

than its terms. This has been a problem especially since the 1999 Ministerial conference in

Seattle (and even before).320

Interestingly, at the beginning of his administration US President Donald Trump (2016- )

focused on at least three important IP issues. First, that the WTO (including the TRIPs) regime

compromised the US IP and trade interests and favoured China, given that China had acceded as

a developing country.321

Second, that China was cheating on IP and especially infringing US IP or tying authorization for

investment by US corporations to access to US IP by Chinese firms or the Chinese Government

316 To quote earlier and cross reference here 317 318 See Chapter 31.4 of Sihanya (forthcoming 2020) IPILKA 2 below. 319

Vanessa B Kerry & Kelley Lee (2007) “TRIPS, the Doha declaration and paragraph 6 decision: what are

the remaining steps for protecting access to medicines?,” at http://www.globalizationandhealth.com/content/3/1/3

(accessed 7/12/2011). Cf. “The WTO Hong Kong Conference in Perspective,” at

http://www.sudanvisiondaily.com/modules.php?name=News&file=print&sid=20513 (accessed 7/12/2011). 320 Sihanya (2016; reprinted 2020) Intellectual Property and Innovation Law in Kenya and Africa:

Transferring Technology for Sustainable Development, op. cit. 321 The White House (2018) “President Donald J. Trump is Confronting China’s Unfair Trade Policies,” at

https://www.whitehouse.gov/briefings-statements/president-donald-j-trump-confronting-chinas-unfair-trade-

policies/ (accessed 8/6/2020). Cf. AFT (2020) “China failed to release virus data on time for WHO to act,”

Standard, Nairobi, 3/6/2020, at 25.

63

contrary to IP rules under WTO (TRIPs).322

What is the debate on IP and technology transfer on

China-Africa ….323

Third, that the WTO TRIPs Agreement needed amendment or changing. Does that mean

reviewing TRIPs substantive clauses on pharmaceutical patent or only treating China as a

developed country?

Trump has not followed through with TRIPs amendment proposals unlike President Ronald

Reagan, George W. Bush I, and Bill Clinton who led the WTO process through the Uraguay

(GATT) Round of trade negotiations during 1986-94….324

During the Doha WTO Ministerial conference of 2001, the WTO reaffirmed that countries are

allowed to decide what constitutes a health emergency and to issue compulsory licences as well

as engage in parallel importation.325

The Doha Declaration has made a meaningful impact on several aspects of anti-retroviral

therapies (ART) availability and accessibility in South Africa and other African states.

Government bodies ordering pharmaceutical companies to grant generic licences directly cited

the declaration. Pharmaceutical companies also cited it as a motivator to diversify into generic

drug production.326

The downstream effects of the declaration also include reduced drug pricing, increased generic

licensing and increased coverage. While the gain in accessibility and use of ART drugs in South

322 Alice de Jonge (2018) “Why China is a leader in intellectual property (and what the US has to do with it),”

The Conversation, at https://theconversation.com/why-china-is-a-leader-in-intellectual-property-and-what-the-us-

has-to-do-with-it-93950 (accessed 8/6/2020); AFT (2020) “Trump cuts ties with WHO as virus grips Latin

America,” Sunday Standard, Nairobi, at 33, [“US president internally suspended funding to the organization last

month… more signals to end to hundreds of millions of dollars in funding to the UN agency just when it needs it the

most (especially due to COVID-19)]. 323 Anshan Li (2016) “Technology transfer in China–Africa relation: myth or reality,” 8(3), Transnational

Corporations Review, 1-13. 324 Carlos Braga and Bernard Hoekman (2017) Future of the Global Trade Order, European University

Institute, at

https://edisciplinas.usp.br/pluginfile.php/4270556/mod_resource/content/0/Future_Global_Trade_Order_2ndEd.pdf (accessed 8/6/2020). 325 ibid. 326 Sopphie Huddart and Madlen Nash (2017) “The Doha declaration in Action: An examination of patent law

flexibilities in the South African acquired immunodeficiency syndrome epidemic,” Journal of Health Specialties, at

http://www.thejhs.org/article.asp?issn=2468-

6360;year=2017;volume=5;issue=1;spage=30;epage=34;aulast=Huddart (accessed 30/5//2020).

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Africa is not solely caused by the Doha Declaration’s support of the TRIPs flexibilities, it is

likely that without it, many of the public health advancements would not have occurred as

quickly. As such, the authors believe that the Doha Declaration was successful in its aim to

promote access to essential medicines.327

The (post-) Doha discussions on drug policy, exhaustion of rights, parallel importation and

compulsory licensing are relevant for COVID 19, malaria, TB, hypertension, cholera and, cancer

in Kenya and Africa.328

31.7 Compulsory licensing in the Health Sector in Kenya and Africa

Patent licensing like any other is the granting of permission to a third party to perform a function

or duty that would otherwise be unlawful. Usually, licensing takes two broad forms i.e. voluntary

licensing also referred to as contractual or consensual licensing and involuntary or compulsory

licensing.329

In contractual licensing, the licensor and licensee agree to the terms of the

licence,330

while compulsory licensing or government use occurs where a Government agency

authorizes a third party to exploit the licence.331

Compulsory licences are very important in the health or pharmaceutical industry especially in

developing countries like Kenya and other African countries. This is because for long major

pharmaceutical companies have had the tendency to file good,332

bad,333

and poor334

patent

applications in Kenya, South Africa, Nigeria, Uganda, Tanzania and Africa.

327 ibid. 328 WHO (2006) “Public health, innovation and intellectual property: Report of the commission on intellectual

property rights, innovation and public health,” World Health Organisation, at

https://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf?ua=1 (accessed

8/6/2020). 329 See the discussion on licensing of innovation and intellectual property in Chapter 29.1.1. Cf. WIPO (2017)

Intangible Capital in Global Value Chains, World Intellectual Property Organiation Report 2017, Geneva. 330 ? See section 69 Industrial Property Act 2001, Clause 94 Intellectual Property Bill 2020; section 33 of the

Copyright Act, 2001 (as amended). See also Sihanya, IPILKA 1 & 2. 331 Copyright and patent maybe subject to compulsory license. A patent may be the subject of Government use

under section 80 of the Industrial Property Act 2001. Trade Mark should not be compulsorily licensed under Article

37 (2) of the TRIPS Agreement. 332 333 334 Compare one challenge of Patent trolls also called patent hoarding. A patent troll is “ a categorical or

pejorative term applied to a person or company that attempts to enforce patent rights against accused infringers far

beyond the patent’s actual value or contribution to the prior art, often through hardball legal tactics (frivolous

litigation, vexatious litigation, strategic lawsuit against public participation (SLAPP), chilling effects, and the like).”

65

Most African countries lack the interest, Government support and necessary pharmaceutical

manufacturing capacity for effective use of compulsory licensing. Among sub-Saharan countries,

only South Africa has a limited primary manufacturing capacity (i.e. it is capable of producing

active pharmaceutical ingredients).335

It is equally notable that the existing frameworks for

compulsory licensing in several African countries are not fully compliant with the TRIPS

Agreement.

Exceptions include countries such as Ghana and Rwanda, which have fully incorporated into

their national law the provisions of international conventions on intellectual property law to

which they are signatories.336

This poses a major challenge to Kenya or the African states where

the patent has been filed in as it curtails or bars the development or manufacturing of generic

drugs.

This in turn contributes to the high cost of such drugs as the big pharmaceutical companies (big

pharmas) have the monopoly,337

monopolistic,338

or oligopolistic Control339

over the production

and distribution of the drugs thus making them inaccessible to the poor and needy people in

Kenya or African states who need the drugs most.340

A good example of this challenge is the HIV/AIDs epidemic or pandemic341

that has affected

most African countries. People suffering from HIV/AIDs are dependent on antiretroviral drugs

…. A patent troll is also called patent hoarding. President Barrack Obama complained about patent trolls. See Diana

Bartz (2014) “Obama urges Congress to pass anti-patent troll bill,” Reuters, at https://www.reuters.com/article/us-

usa-obama-patent/obama-urges-congress-to-pass-anti-patent-troll-bill-idUSBREA0S07V20140129 (accessed

22/6/2020). 335 Olasupo Ayodeji Owoeyea (2014) “Compulsory patent licensing and local drug manufacturing capacity in

Africa,” WHO Bulletin, at https://www.who.int/bulletin/volumes/92/3/13-128413.pdf?ua=1 (accessed 30/5/2020). 336 Buch F. Ijsselmuiden C, M. Moran Guzman (2010) “Strengthening pharmaceutical innovation in Africa:

designing strategies for national pharmaceutical innovation: Choices for decision makers and countries,” African

Union, Council on Health Research for Development & the New Partnership for Africa’s Development… 337 338 339 340 Cf. Mercy Kingori (2020) “Intellectual property rights in pandemics: The case of the novel corona virus in

developing countries,” Strathmore University Centre for Intellectual Property and Information Technology Law

(CIPIT), at https://blog.cipit.org/2020/04/06/intellectual-property-rights-in-pandemics-the-case-of-the-novel-

corona-virus-in-developing-countries/ (accessed 6/5/2020)…. 341 Is it still an epidemic or pandemic according to WHO? According to which states?

66

(ARVS). The ARVs are categorised into first line, second line and third line.342

Most people do

not benefit from first and second line ARVs due to drug resistance and side effects thus need

third line.343

According to Olasupo Ayodeji Owoeyea;

“Multinational pharmaceutical corporations have raised minimal objections to the lack of

compliance with the TRIPS Agreement because the necessary infrastructure for aggressive use of

compulsory licenses does not exist in Kenya and Africa.” 344

Owoeyea adds;

“As recently as 2008, 90% of the medicines available in sub-Saharan African countries were

imported from outside Africa and 80% of the drugs used to treat human immunodeficiency virus

(HIV) infection across the continent were imported.”345

However, the former is still under patent making the drugs very expensive and not accessible in

public health facilities.346

In order to fight against this challenge, many developing countries like Kenya have since

promulgated laws relevant to access health services,347

and products as well as technology

transfer.348

Most of these laws begin with the market approach; that is parties to a technology

transfer contract are free to agree on the terms.

The State will only come in to settle disputes if the terms of the contract are oppressive,

inequitable or illegal, in which case the contract will be voidable. Kenya’s High Court and Court

342 Sihanya (2005) “Patents, parallel importation and compulsory licensing of HIV/AIDS drugs in Kenya,” in

Peter Gallagher, Patrick Low, and Andrew L. Stoler (eds) Managing the Challenges of WTO Participation, op. cit… 343 ibid. 344 Owoeyea (2014) “Compulsory patent licensing and local drug manufacturing capacity in Africa,” op. cit. 345 ibid. 346 Kingori (2020) “Intellectual Property Rights in Pandemics: The Case of the Novel Corona Virus in

Developing Countries,” ibid. 347 Article 43 Constitution of Kenya 2010; Section 5 Health Act No. 21 of 2017. Cf Patents Bill of … 348 Examples include the Law of Contract Act Cap 23, Sale of Goods Act Cap 31, Insurance Act Cap 486,

Income Tax Act, Cap 470.

67

of Appeal have addressed access to pharmaceutical products in the context of pharmaceutical

patents and generics.349

The state can also come in by way of issuing a compulsory licence. In Kenya, compulsory

licensing is provided for Part X of the Industrial Property Act, 2001.350

The Act defines them as

“compulsory licences for non-working and similar reasons.” The Act provides that;

“a person may apply to the Tribunal for a licence to exploit the patented invention on grounds

that a market for a patented invention is not being supplied on reasonable terms.”351

A compulsory license may be granted in Kenya an Africa in at least four situations. First, Where

the intellectual property owner does not produce sufficient products to supply the relevant

market; Second, where the intellectual property owner refuses to grant a licence; Third, where

the intellectual property owner grants a licence on inordinate or inequitable terms. 352

Fourth, where two patents are interdependent that one cannot be performed without infringing on

the other(s).353

The Industrial Property Act 2001 also provides for the exploitation of a patented invention by the

government or by third parties authorized by the Government. Government use applies where the

public interest, in particular, national security, nutrition, health, environmental conservation, or

the development of any other vital sector of national security requires so.354

This means that the Government can grant a local pharmaceutical company a compulsory license

to use a patented invention in the wake of the COVID-19 (corona virus) pandemic to come up

with a drug affordable and accessible to the people.

349 See Chapter 31.6 IPILKA 2, below. 350 See Part X (sections 64-69) Industrial Property Act 2001; Clauses 90-96 Intellectual Property Bill 2020. 351 See Section 72 Industrial Property Act 2001…. 352 All the foregoing are related to or may be summarized as failure to work or perform the pharmaceutical

patent. See sections 72 and 73 Industrial Property Act 2001…. Clauses 97 and 98 IPOK 2020. Sihanya (2016;

reprinted 2020) Intellectual Property and Innovation Law in Kenya and Africa: Transferring Technology for

Sustainable Development, op. cit., at 40-41…. 353 See section 73 of the Industrial Property Act 2001. Clause 98, Intellectual Property of Kenya Bill 2020… 354 See Section 80(1)(a) Industrial Property Act 2001.

68

Under sections 72, 73, 74, 75, 76, 77 of the Industrial Property Act 2001355

and article 31 of the

TRIPs Agreement 1994, the compulsory license is bound by at least three important rules.356

First, compulsory licence is to be issued only after the applicant has sought a contractual,

voluntary or consensual licence or alternatively in the case of a national emergency like COVID-

19.357

Second, the compulsory licence must pay reasonable license fees. Third, the licence is non-

exclusive and may be transferable under strict conditions358

and access to the Industrial Property

Tribunal (IPT) and the High Court is guaranteed.359

However for compulsory licensing to be effective there is need for necessary national policy,

infrastructure, and development. The COVID 19 pandemic has exposed how Kenya and other

African states are unprepared and lack the necessary infrastructure to tackle pandemics. Various

counties in Kenya have cited shortages of funds, infrastructure and health workers as the main

challenges in the battle against COVID-19.360

There is therefore the need for Kenya and other African states to invest more in the prevention of

pandemics. This can only be done by improving the already available infrastructures, policies,

and work force.361

-

31.8 Parallel Importation in the Health Sector in Kenya and Africa362

Parallel importation occurs where a third party imports and sells intellectual property (IP)

protected products from one country where they have been lawfully distributed (by the right

355 Clauses of 97, 98, 99, 100, 101 and 102 of the Intellectual Property Bill of Kenya 2020. Cf. Section 80

Industrial Property Act 2001, Government use; Clause 105 Intellectual Property Bill 2020. 356 357 Section 74 of Industrial Property Act 2001. 358 Section 76 of Industrial Property Act 2001. 359 Article 40, 260 of the Constitution of Kenya 2010; Industrial Property Act 2001, Intellectual Property Bill

2020. 360 Barry Salil (2020) “Stop Nairobians from moving to other counties, says Sang,” Star, Nairobi, at

https://www.the-star.co.ke/news/2020-04-01-stop-nairobians-from-moving-to-other-counties-says-sang/ (accessed

8/6/2020); Oscar Kaikai (2020) “Shortage of resources cripples W. Pokot's Covid-19 war,” Daily Nation, Nairobi,

28/5/2020, at https://www.nation.co.ke/dailynation/counties/west-pokot/shortage-of-resources-cripples-w-pokot-s-covid-19-war-308912 (accessed 30/5/2020); Nation Reporter (2020) “Cases of COVID-19 in Mt Kenya show it is

being spread locally,” Daily Nation, Nairobi, 2/6/2020; Nation Reporter (2020) “COVID-19 cases reach 2000 as

focus turns to counties,” Daily Nation, Nairobi, 2/6/2020. 361 Mulango Baraza (2020) “Stimulus package to fight covid 19 good but invest more in prevention,” Daily

Nation, Nairobi, 29/5/2020. 362 Also called grey market products.

69

holder or under a licence agreement) to another country usually against the right holder’s

wishes.363

The relationship between parallel importation and access to pharmaceutical products has been a

central issue in the debate surrounding IP rights and public policy objectives for many years.

Recently, the HIV/AIDS crisis faced by Kenya, South Africa, Nigeria, Ghana, Uganda, Tanzania

and other African states has focused increasing attention on the role that parallel importation

may play in the field of public health.364

Kenya and other African states are confronted with chronic anti-retroviral (ARV) drug shortages

and must contend with exorbitant prices for those medicines that are available. As a result,

millions of people in developing countries cannot gain access to ARV therapy or other essential

medicines for diseases prevalent in the developing world.365

Kenya adopts the doctrine of international exhaustion of rights as regards parallel importation of

patented products. Section 58(2) of the Industrial Property Act (IPA) 2001 states that the “rights

under the patent shall not extend to acts in respect of articles which have been put on the market

in Kenya or in any other country or imported into Kenya.”366

This provision is understood as stipulating international exhaustion because once the patented

product has been put in the market anywhere in the world, the product can be freely imported

363 See Lionel Bently & Brad Sherman (2009) Intellectual Property Law, OUP, London (3rd ed), op. cit; at 14-

15 (general), 144-6 (Copyright), 15, 553-8 (international), 544 (Patent), 591 (PBR), 673 (registered design), 942-58,

959-74 (trade mark); David Bainbridge (2009) Intellectual Property, Pearson Longman, Harlow, England, at 20,

828, 831-2, 835 (7th ed.). Cf. Lionel Bentley & Brad Sherman (2018) Intellectual Property Law, Oxford University

Press. See also David Bainbridge (2018) Intellectual Property, Longman Publishers Group. 364 Sarah McKeith (2014) “Pharmaceutical Patents in Developing Nations: Parallel Importation and the

Doctrine of Exhaustion,” Vol. 6, Issue 2-3, African Journal of Legal Studies, , at 287-314, at https://brill.com/view/journals/ajls/6/2-3/article-p287_7.xml?language=en (accessed 30/5/2020). 365 ibid. 366 My emphasis to explain the dynamics and implications for national and international patent exhaustion.

The italicised phrase was added, deleted, and again added in negotiations among Kenyan stakeholders roughly led or

represented by the Ministry of Health (international exhaustion competition; consumer protection perspective); and

the Ministry of Trade and the Kenya Industrial Property Institute (KIPI) (national exhaustion, trade interests)….

70

into Kenya.367

The Industrial Property Regulations 2002 seek to clarify that s. 58 only extends to

articles which have been legitimately put in the market in the other country.368

The classic legal statement of parallel importation in the context of (pharmaceutical) patents

include article 6 of TRIPs, section 58(2) of Kenya’s Industrial Property Act 2001.

Article 6 of TRIPs states:

“For the purposes of dispute settlement under this Agreement, subject to the provisions of

Articles 3 and 4 [on national treatment (NT) and most favoured nation (MFN) treatment] nothing

in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.”

369

This was an agreement to disagree thus allowing WTO member states to have their own (and not

necessarily uniformly binding) rule on patent (or IP) exhaustions parallel importation.

Section 58(2) of Kenya’s Industrial Property Act states:

“The rights under the patent shall not extend to acts in respect of articles which have been put on

the market in Kenya or in any other country or imported into Kenya.”370

Parallel importation generally facilitates access to drugs from multiple markets or sources, and

tends to lower the price.

In Beecham Group Ltd v. International Products Ltd and Bristol, the plaintiff brought an

application for a temporary injunction pending disposal of an infringement suit. 371

The plaintiff

had invented a penicillin drug (ampicillin) and had patented it in many countries, including the

US, Panama and Kenya. The plaintiff had licensed it to the second defendant (Bristol) to

manufacture, use and sell the drug in return for payment of royalties in many countries but not in

Kenya.

The second defendant manufactured another penicillin drug called netacillin and sold some to the

first defendant (International Products Ltd) in Panama, who in turn imported it into and sold it in

367 See Sihanya (2005) “Patents, parallel importation and compulsory licensing of HIV/AIDS drugs in Kenya,” op. cit; Jackline Nyaga (2009) Implementing Parallel Importation and Licensing Mechanisms to Increase Access to

Medicines in Kenya, op. cit. 368 Clause 37 Industrial Property Regulations 2002 (Kenya). 369 My interpolation. 370 See also Clause 84(2) Intellectual Property Bill 2020; Cf. IPILKA 1 & 2. 371 Beecham Group Ltd v. International Products Ltd. and Bristol [1968] EA 398.

71

Kenya. The plaintiff alleged infringement of the patent claiming that netacillin was substantially

similar to ampicillin and that it was an infringement of Beecham’s patent rights in Kenya.372

The first defendant argued that it had obtained a good line to the drug, free from all plaintiffs’

patents in any part of the world, including Kenya as the sale had been authorised by the plaintiff

under the licence and the royalty had been paid.

The court held, inter alia, that there had been infringement since the patentee was not the vendor.

Where the patentee herself has sold the patented article, she is freed from all her rights in the

absence of any specific reservation because the purchaser gets all the vendor’s rights in respect

of the patented article.373

However, in this case, the US and Panama patents were not the same as that registered in Kenya.

A release from the US or Panama patents, therefore, did not necessarily apply to the Kenyan

patent. On that ground, a temporary injunction was issued against the defendants.

Parallel imports are goods produced genuinely under a trade mark, patent or copyright, placed

into circulation in one market (like South Africa), and then imported into a second market (like

Kenya) without the authorisation of the local owner of the IP right.374

The importation in this

instance is unauthorised with the missing authorisation being that of the IP right holder.

Parallel importation encourages the generic manufacture of pharmaceuticals. It also means that a

patentee may license a manufacturer in another territory. And that such a manufacturer may sell

the pharmaceutical products produced there at a price cheaper than that in the country where the

research and development (R&D) took place.

The cheaper and easier reproduction is also associated with copyright. One can more easily

reproduce copyrighted products which are expensive to produce such as films and other

372 373 374

See Keith E. Maskus (2000) “Parallel imports,” Vol. 23(9) The World Economy…, Wiley Blackwell

Publishers, Oxford, pp. 1269-1284, at 1269. See also Jackline Irene Muthoni Nyaga (2009) Implementing Parallel

Importation and Licensing Mechanisms to Increase Access to Medicine in Kenya, a thesis submitted to the Stanford

Program in International Legal Studies (SPILS), at Stanford Law School, Stanford University, in partial fulfillment

of requirement for the Degree of Masters of the Science of Law, JSM, op. cit.

72

audiovisual works. She can afford to sell them at cheaper prices in areas where the circumstances

demand.375

Demand for diagnosis, therapy and related health products and services is closely associated with

patented or trade marked pharmaceutical products or processes. Once a drug or procedure has

been invented to address a disease, the demand may be met without necessarily referring to the

inventor or the licensee in the relevant market. The products or processes may be sourced from

other (lawful and illegal) markets.376

In South Africa, the Medicines and Related Substances Control Amendment Act of 1997

included a provision permitting the Minister for Health to establish the conditions under which

parallel importation of patented medicines would be authorised.377

31.9 Scenarios and Reforms in the (Post-) COVID-19 Age: Constitutional, Legislative,

Policy, and Administrative Options on IP, Innovation and Technology Transfer in Health

in Kenya and Africa

Constitutional options include consolidating and clarifying the incoherent, scattered and

insufficient provisions on IP and health in the…. (Arts 11, 40, 260…378

); utilizing the balance

between IP rights and access (art 24).379

The IP statutes, rules, regulation and other laws …. should be reviewed substantially and not just

by uncritically merging IP institutions.380

Important legislation policy and administrative

measures include strengthening preventive health care, …. treatment and referral381

….

Processes. Support for preferential procurement for Kenyans and Africans engaged in IP and

375 See Sihanya (2016; reprinted 2020) Intellectual Property and Innovation Law in Kenya and Africa:

Transferring Technology for Sustainable Development, op. cit., at 442-443. 376 ibid. 377

UNCTAD & ICTSD (2004) Resource Book on TRIPS and Development:

An authoritative and practical guide to the TRIPS Agreement, ICTSD, op. cit, at

http://www.iprsonline.org/unctadictsd/ResourceBookIndex.htm (accessed 20/12/2011). 378 379 380 381

73

health R&D to address malaria, TB, HIV/AIDS, cancer, hypertension, cholera, COVID 19, and

other diseases.382

What are some of the key impacts or effects of malaria and COVID-19? What are the vision of,

and strategies and preparations for a (post) COVID-19 age? What must the Kenyan Government

and Kenyans do in the context of the COVID-19 disruption? 383

What are the appropriate

creatively disruptive innovations, processes, laws, and norms to apply or adapt?

Some of the (post) COVID-19 strategies relate to copying, recovery or revival and restructuting

and rejuvenation.... and include the following three.

First, economic recovery, economic stimulus,384

and economic and business restructuring. What

technologies and innovators are key?385

What jobs, companies or industries are likely to be lost?

What new ones, may arise? What restructuring is needed?386

Second, progressive and responsive politics and governance…387

Third, standards, quality, and relevant education training, research innovation and mentoring

(ETRIM) that is accessible, inclusive and technology enabled. ETRIM that will impart skills,

knowledge, attitude, values and innovation (SKAVI).

382 Cf. Article 227 of the Constitution of Kenya; the buy Kenya build Kenya slogan; and the reality of

economic, health, and security nationalism in the COVID-19 pandemic where most exporting states like China, US,

etc refused or failed to export key health products including personal protective equipment (PPEs)…. Kenya and

African states had to mainly acquire their own 383 Victor Ndururu (2020) “Rethinking the role of the state in the wake of the COVID-19 pandemic,” Sunday

Standard, Nairobi, at 27; UN (2020) “COVID-19 and reaffirming State-people governance relationships” United

Nations, at https://www.un.org/development/desa/dpad/publication/un-desa-policy-brief-75-covid-19-reaffirming-

state-people-governance-relationships/ (accessed 22/7/2020); “COVID-19 and the role of governance”…; Mathew

Goodwin (2020) “COVID-19 will reshape our relationship with the State,” ChatHam House, at

https://www.chathamhouse.org/expert/comment/covid-19-will-reshape-our-relationship-state (accessed 22/7/2020). 384 Cf. Economic stimulus in the context of the depression (New Deal, Marshal Plan); global economic crisis

of 2008 …. The latter coincited with the effects of Kenya’s post election violence (PEV) of 2007/2008… See

Sihanya, CODRALKA 1 & 2… 385 BBC (2020) “How African firms are adapting to COVID-19,” Sunday Standard, Nairobi, at 31. 386 How did Kenya, South Africa, the US, UK, etc respond to new technologies or innovations or emergencies

in the past?

387 Constitutions, laws, rules, regulations and political processes as well as leaders … strategies must not only

reformed but must also be implemented…

74

COVID-19 has called attention to the imperative to address basic (human) needs and especially

health, food, water, security, education and related needs...388

Clearly cultural and religious doctrines and practice have to be adapted having regard to three

basic human values of dignity, liberty, equity or justice….389

Hence popular condemnation of

treatment of some deceased persons and the bereaved in Siaya,390

Kisumu,391

and Meru.392

National, regional and international cooperation is crucial to address malaria and COVID-19, and

especially when COVID-19 has been likened to a third world war.393

How have Kenya’s National and County Governments addressed the (post) CIVID-19 challenges

and opportunity? What are the key measures and missteps since the outbreak of COVID-19?

What lessons have been learnt?394

Have the National and 47 County Governments appreciated

that COVID-19 is a health as well as a social economic and political matter? That it needs short,

medium, and long processes, term, and strategies. Ultimately, the role of the Kenyan Executive

and especially the President and the 47 County Governors is crucial in addressing all the key

388 Cf. The Basic Needs Approval (BNA)… Sustainable Development Goals…. Vision 2030… 389 390 Dickens Wesonga (2020) “Mourners who traveled to Siaya from Mombasa isaolated,” Daily Nation,

Nairobi, at https://www.nation.co.ke/kenya/counties/siaya/mourners-who-travelled-from-mombasa-to-siaya-

isolated--655044 (accessed 16/6/2020). 391 See the police forced burial of Abenny Jachiga the ohangla musician famous for “Meano kasinde.” (that’s

her cousin) and “Maraga odagi” (Maraga has rejected…). None of them died of COVID-19 in any case. And WHO

and MOH have reasonable protocols on disposal of COVID-19 bodies. The Nation is not accurate to say they died

of COVID-19. Some had not been tested, diagnosed or been the subject of a conclusive post mortem or autopsy.

See Chapter 31.1 above. See Dation Reporter (2020) “COVID: Lives and stories of the ones we have lost,” Daily

Nation, Nairobi, at 1. 392 Wainaina Nd’ung’u (2020) “Hell for man forced to spend night alone with wife’s corpse,” Standard, Nairobi, 31/5/2020, at https://www.standardmedia.co.ke/article/2001373441/hell-for-man-forced-to-spend-night-

alone-with-his-wife-s-corpse (accessed 17/6/2020). 393 Raila Odinga (2020) “The US and Europe cannot abandon their leadership roles,” The Star, Nairobi, at

https://www.the-star.co.ke/opinion/star-blogs/2020-05-18-raila-the-us-and-europe-cannot-abandon-their-leadership-

roles/ (accessed 8/6/2020); Uhuru Kenyatta (2020) “…. 394 Xinhua (2020) “Kenyan leader to convene crisis meeting to review surge of COVID-19 infections,”

XinhuaNet, at http://www.xinhuanet.com/english/2020-07/20/c_139227240.htm (accessed 22/7/2020); Luke Awich

(2020) “Uhuru calls COVID-19 crisis meeting,” Star, Nairobi, 21/7/2020, at https://www.the-star.co.ke/news/2020-

07-20-uhuru-calls-covid-19-crisis-meeting/ (accessed 22/7/2020); Star Team (2020) “The Morning Brief: Uhuru

calls Governors' meeting as Covid cases rise,” Star, Nairobi, 21/7/2020, at https://www.the-star.co.ke/the-morning-

brief/2020-07-21-the-morning-brief-uhuru-calls-governors-meeting-as-covid-cases-rise/ (accessed 22/7/2020);

Cyrus Ombati and Roselyn Obala (2020) “Uhuru calls crisis meeting as virus cases, deaths rise,” Standard, Nairobi,

21/7/2020, at https://www.standardmedia.co.ke/article/2001379470/uhuru-calls-crisis-meeting-as-virus-cases-

deaths-rise (accessed 22/7/2020).

75

(post) COVID-19 emergencies and related challenges and opportunities through constitutional

law, IP law, and general law and the political economy.

31.10 Summary of Findings, Conclusions, and Proposed Reforms on Intellectual Property,

Innovation, Technology Transfer in Kenyan and African (Public) Health

This Chapter sought to investigate analyze, and make reform proposals on the role of IP,

innovation, and technology transfer in health in Kenya and Africa. I adopt a three pronged

methodology and approach.

First my overarching argument is that intellectual property can play a facilitative, restrictive, or

neutral role in the health, health services, and health generally in Kenya and Africa. A lot

depends on the policy options, regulatory regime, and institutional design.

About four forms of IP are relevant to innovation and technology transfer in health in Kenya and

Africa namely; patent, utility model, trade secret, unfair competition, and trade mark…

Significantly, researchers in Kenya, South Africa, Nigeria, Ghana, Egypt, Uganda, Tanzania, and

other African states are already using biotechnology to develop diagnostics, therapies, vaccines,

caring or coping mechanisms and related innovations in critical areas like the Corona virus

(COVID-19), HIV/AIDS, malaria, tuberculosis (TB), and Ebola vaccine for these diseases.395

Second, the key finding is that Kenya and other African states have for a long time suffered at

the hands of big pharmaceutical companies which have a tendency to file applications for and

secure grant of good, bad, and poor patent in Kenya and Africa.396

This poses a major challenge

as these big pharmaceutical companies curtail the development or manufacturing of generic

drugs in Kenya and other African states where patents have been filed.

395 See Sihanya (2003) “Patent wars raging over Aids cure,” Opinion: Pandemic, Daily Nation (Nairobi),

Wednesday, 17/12/2003, op. cit., at 9,; IPILKA 1. Cf. Ben Sihanya (2008) “How IMF policies constrain policy

space in Kenya’s health sector,” in Ben Sihanya (ed) The Impact of IMF Policies on Education, Health and

Women’s Rights in Kenya, Action Aid International Kenya, Nairobi, Part IV, pp. 65-95. 396 Good patents are those which are scientifically, technologically and technically sound or viable. They

address health, food, education, and other challenges in “industry.” …They are commendable … Bad patents or

poor patents are patents that are poorly written that it is impossible to understand what it protects… See Paul

Morinville and Gene Quinn (2018) “Is a ‘bad patent’ really that bad?” IP Watchdog, at

https://www.ipwatchdog.com/2018/01/30/is-a-bad-patent-really-that-bad/id=92966/ (accessed 22/6/2020). …

Examples of bad patents include…

76

This in turn leads to the high cost of drugs since these big pharmaceutical control the market and

monopolize or oligopolize over production and distribution of the pharmaceutical products and

processes making them inaccessible to the poor and needy people in Kenya and the African

states.397

Third, in the context the foregoing issues, arguments, methodology, evidence, analysis, and

findings, the following three reforms are key. First, Kenya, South Africa, Nigeria, Uganda,

Tanzania, Senegal, and Ghana need to review the policy and (then the) constitutional framework

on health, IP, innovation, and technology transfer… This should be with a view to promoting

health research and development (R&D) as well as access to pharmaceutical products for

COVID-19, malaria, TB, Ebola, obesity, cancer, diabetes, cholera and hypertension, among

others.

Second, Kenya and African states should review their national, transnational, sub-regional and

regional or Africa wide health and patent laws, rules and regulations including ARIPO and

OAPI….

Third, there is need to review the TRIPs Agreement as well as UNESCO and WHO regulations

to provide favourable patent and IP provisions to Kenya and Africa. This will help Kenya and

Africa deal appropriately with health R&D. These and related measures will help address

COVID-19, malaria, TB, HIV/AIDS, and the diseases in Kenya, South Africa, Nigeria, Uganda,

Tanzania and Africa generally even as they effectively regulate transnational and oligopolithic…

...may wisdom flow from the Oracle’s shrine and back as the discourse continues in class,

articles, books, online, in the blogosphere, social media, and appropriate fora…

© Prof Ben Sihanya, JSD (Stanford), 1st & earlier drafts revised 23/5/2020, 27/5; 3/6; 5/6; 8/6;

17/6; 22/6; 25/6; 17/7; 20/7; 21/7/2020; 22/7/2020; 24/7/2020 email: sihanyamentoring@gmail.com; sihanya@innovativelawyering.com (use both)

url: www.innovativelawyering.com

397 Kingori (2020) “Intellectual property rights in pandemics: The case of the novel Corona Virus in

Developing Countries,” op. cit.

77

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Annex 1: COVID-19 status in Kenya and Africa

103

Annex 2: Daily or Regular Tracking of COVID-19 in Kenya and Africa

Annex 3: Potential COVID-19 Vaccines

Annex 4: The Judiciary in Emergencies, War, Crises and Revolutionary Situations in Kenya and

Africa398

8.21 The Judiciary in Emergencies, Crises and Revolutionary Situations in Kenya and Africa

What is the role of the judiciary when there is a war or a constitutional, political, electoral, economic

health, environmental, security or related emergency, disaster, stress, insurrection, insurgency, strain,

crisis or in a revolutionary situation in Kenya and Africa?399

–

Some argue that there are three options. First, the Judiciary, the law, lawyers, and the Constitution must

always speak, argue, litigate, arbitrate, indicate and serve justice. That in any event, the Constitution and

transnational legal instruments provide for and regulate emergencies, war, disaster….400

Second, the lawyers, judges, magistrates and law should be silent.401

It is the Executive’s mandate to deal

with emergencies, war, disaster, disease outbreaks, endemics, epidemics, pandemics,402

….

What of when the Executive itself is shaken to the core by an emergency, outbreak, endemic, epidemic or

pandemic, partly because of underlying injustices, economic exploitation, corruption and poor

governance?403

The science, technology, politics and meta discourse underlying the novel corona virus

2019 (COVID-19) aside, many African states including Kenya could not implement a lock down because

of fear of demonstration leading to starvation and revolt.404

For instance, they feared that the residents of

398 Ben Sihanya (forthcoming 2020) Constitutional Democracy, Regulatory and Administrative Law in Kenya

and Africa Vol. 1: Presidency, Premier, Legislature, Judiciary, Commissions, Devolution, Bureaucracy and Administrative Justice in Kenya, Sihanya Mentoring & Innovative Lawyering, Nairobi & Siaya, Chapter 8B

“Judicial power, structure, and independent accountability in Kenya and Africa: Interests, process and outcomes.” 399 Cf ICJ Kenya (2019) 60 Days of Independence: Kenya’s judiciary through three presidential election

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coronavirus-response (accessed 6/5/2020); Protus Onyango (2020) “Crime, violence on the rise in slums amid

pandemic,” Sunday Nation, Nairobi, 3/5/2020, at https://www.standardmedia.co.ke/article/2001369956/crime-

violence-on-the-rise-in-slums-amid-pandemic (accessed 6/5/2020). 404 The health, medical or scientific literature indicates that “SARS–COVID-2 is the virus that causes COVID-

19.” SARS means severe acute respiratory syndrome. It is defined as “an infectious disease with symptoms

104

the named informal settlements may seek support from or invade the leafy suburbs mentioned in brackets,

among others. These includes Kibera (Karen?), Mathare (….Muthaiga?),…405

What is the role of law? Lawyers? The Judiciary?

The argument that in the face of arms, the laws are silent has been expressed and debated as “inter arms

leges silent.” Lord Atkin provided an excellent theoretical and pragmatic postulate and rebuttal to the

Executive tyranny that requires law(yer)s to remain silent. My considered opinion is that Lord Atkin’s

dissent in the war time case of Liversidge v. Anderson (1941)406

is the law:

“In England [as is in Kenya and Africa], amidst clash of arms, the laws are not silent. They may

be changed, but they speak the same language in war as in peace. It has always been one of the

pillars of freedom. One of the pillars of liberty for which on recent authority we are now fighting,

that judges are not respecters of persons, and stand between the subject and any attempted encroachment on his liberty by the Executive, alert to see that any coercive action is justified in

law….”

Third, the lawyers, judges, magistrates, Constitution and the law generally should remain “neutral.”

407

The main rebuttal is that to be “neutral” or non-partisan in the context of oppression or a clash of values is

to be partisan on the side of the oppresors….408

Liversidge v. Anderson is important and famous for the quote by Lord Atkin:

“I view with apprehension the attitude of judges who … when face to face with claims involving

the liberty of the subjects, show themselves more executive-minded than the executive.”409

What has been the conduct of the judiciary during electoral crises in 2007/2008? 2017/2018. What is the

role of the judiciary in the contexts on an emergency, war, disaster in historical, contemporary and future

perspectives? These are related to: mutiny,410

coup attempt, coup plot, coup, (popular) uprising; demos,411

revolt, or insurgency, or protests412

including fever and cough and in some cases progressing to pneumonia and respiratory failure. It is caused by

coronavirus.” 405 See…. 406

Liversidge v. Anderson (1941) UKHL 1. 407 …. 408 409 Liversidge v. Anderson (1941) ibid. 410 Cases on anti IEBC demonstrations (Justice Onguto? Chacha Mwita?), Mpeketoni, Boni curfew? NASA v.

IG of Police & Others… 411

Upendra Baxi (2014) “Demosprudence versus jurisprudence: The Indian judicial experience in the context

of comparative constitutional studies,” LJ 14 Macquarie, 3; Upendra Baxi (2016) “Law, politics and constitutional

hegemony: The Supreme Court, jurisprudence, and demosprudence,” The Oxford Handbook of the Indian

Constitution, ….94-109….. 412 cf IEBC....

105

How has the Judiciary performed in an emergency, war, disaster, revolution, curfew, lockdown,413

voluntary and compulsory testing, self or forced quarantine, self or forced isolation, contact tracing in the

context of COVID-19 or other diseases414

in Kenya?415

How have the Judiciary performed in the Sudan,

Algeria, France 2018/2019...416

South Africa,417

Malawi,418

Hong Kong,419

Venezuela… India?420

…

In such and related contexts, how do Kenyans and Kenyan courts address Executive and especially police

brutality and police excesses? How have judiciaries addressed “political justice” which public interest

lawyer Dr Oki Ooko Ombaka contextualizes as the use of the criminal justice system (CJS) for political

objectives?421

Some of the relevant provisions include Arts. 1, 10, 37, 38, 58, 132(4), 238? 240?422

Do courts have to address only three options or questions? First, not to question any Executive and

legislative action, omission, or intention and threat?423

Second, to question all Executive or legislative

conduct in the usual manner?424

Third, to craft appropriate procedures, processes (Art. 159) and remedies

under Art. 23, 159….?

What is a revolution in the Kelsenian? Marxian system? How have courts addressed cases before,

including in ex parte Matovu;425

Grace Stuart Ibingira;426

Opoloto427

(Uganda), Lakanmi (Nigeria),428

Madzimbamuto (Southern Rhodesia, Zimbabwe),429

USA,430

UK?431

413 Cf Graham Kajiwa (2020) “Lockdown lowers virus cases by 40% in Africa, says World Health

Organisation,” Sunday Standard, Nairobi, 3/5/2020, at 19, at

https://www.standardmedia.co.ke/article/2001369952/lockdown-lowers-virus-cases-by-40pc-in-africa-says-who

(accessed 6/5/2020). 414 Cholera, TB, Ebola, HIV/AIDs 415 Cases on anti IEBC demonstrations (Justice Onguto? Chacha Mwita?), Mpeketoni, Boni curfew? NASA v.

IG of Police & Others… Pre 2017 elections on plots to deploy military…. 416 …. 417 James Gant (2020) “Virus triggers African unrest: Riots break out in Johannesberg over food shortages and

Lesotho’s under-fire Prime Minister deploys army to restore order as COVID-19 claims 1000 lives across the

constinent-including Nigerian Presidential aide,” Daily Mail Online, April 18, 2020, at

https://www.dailymail.co.uk/news/article-8232649/Virus-triggers-unrest-Africa-Riots-break-Johannesburg-food-

shortages.html (acessed 27/4/2020). 418 …. 419 …. 420 …. 421 Oki Ooko Ombaka (1982) “Political justice in Kenya: Prelogomena to an inquiry into the use of legal

procedure for political purposes in post Kenyatta era,” Varfassung und Recht in Ubersee/Law and Politics in Africa,

Asia and Latin America, 393-420. 422 See also Chapter 6 on Legislative Power, Structure and Process in Kenya and Africa (state of

emergency….) 423 Lord Atkin in Liversidge v. Anderson, “….the law and the Judiciary must speak even in war or

revolutions.” Cf. in the face of arms, the law(yer)s are silent? “inter-arms leges: silent…?” No. Lawyers must always

speak, even during COVID-19 pandemic…. to pursue a balance on life, liberty, security, health and justice 424 Cf An English judge stated “the justice of the common law will supply the omissions of the Legislature.”

See…. 425

Uganda v. Commissioner of Prisons, Ex Parte Michael Matovu, [1966] 1 EA 514. The issues in this case

and in some of the East African cases cited below are reproduced and discussed in William Burnett Harvey (1975)

106

How has the Kenyan Judiciary addressed the emergencies and disasters discussed above and below in

terms of three issues. First, applying and proposing or adapting new substantive laws, rules and

regulations through analogic and dialogic legal reasoning and analysis….432

Second, adapting and

proposing rules of evidence and addressing the emergencies and disasters.

Third, adapting or proposing new rules of practice including filing, hearing, delivery of rulings and

judgements….

The emergencies and disasters include the following nine (9) sets: First, mutiny (1964). Second, coup plot

(1971) or coup attempt (1982). Third, coup (Cf Uganda-West African “Coup belt”) of the 1960s through

1990s…. Fourth, secession (“Shifta”) “war”433

between the Kenya Somali and Kenya Government in the

1960s. Fifth, HIV/AIDS epidemic cases.434

Sixth, the 2007/08 post election violence (PEV). Seventh, Al

Shabaab terror attacks. Eighth, and the war in Somalia (2011-?).435

Ninth, demonstrations and protests

against electoral fraud, economic oppression, and poor governance under Kenyatta I, Moi, Kibaki and

Kenyatta II….?436

How have courts responded to the corona virus (COVID-19) in Kenya,437

South Africa,438

Nigeria,

Malawi,439

Uganda, Tanzania, the United Kingdom and USA? There are numerous issues arising in the

An Introduction to the Legal Systems in East Africa, EALB, Nairobi. They are also captured the debate arising from

the 1967 constitutional crisis that included Abu Mayanja…. This was in the context of Prime Minister Apollo

Milton Obote imposing a new Constitution and usurping the powers of President Kabaka Mutesa…. Was it a

Kelsenian revolution? Did it establish revolutionary legality based on necessity? See Sihanya, CODRALKA 1&2;

Yash Pal Ghai (1987) “The rule of law, legitimacy and governance in the political economy of law,” Oxford

University Press, 253-261; Ben Nwabueze (1974) Presidentialism in Commonwealth Africa, St Martins Press,

Abuja. 426

Grace Stuart Ibingira v. Uganda [1966] EA 445. 427

Shabani Opoloto v. Attorney-General of Uganda [1969] EA 631…. 428

Lakanmi v. A-G Western State (1974) 4 ECSLR, 713…. 429

Madzimbamuto v Lardner-Burke and Another [1968] UKPC 18…. The person who brought the suit died in

July 2020. 430 …. 431 …. 432 …. 433 Technically, there can be no “war” between a state a people subject to its sovereignty in international law. 434 …. 435 Cf. General Robert Kariuki Kibochi to lead the Kenyatta succession and Kenya’s withdrawal from

Somalia? See Cyrus Ombati (2020) “New top soldier to oversee handover of power and KDF exit from Somalia,”

Standard Digital, May 2, 2020, at https://www.standardmedia.co.ke/article/2001369849/the-powerful-man-in-

uhuru-succession (accessed 6/5/2020). Mary Wambui (2020) “General Kibochi takes over as head of KDF,” Daily

nation, Nairobi, May 12, 2020, at 9. 436 See decisions by Justices Chacha Mwita, George Odunga, Weldon Korir, Patrick Kiage, Mumbi Ngugi,

Louis Onguto,…. Supreme Court…. 437 Law Society of Kenya v. Hillary Mutyambai & Others, Petition No. 120 of 2020 (COVID 025); at page 70

on (cite and IFLAC)…. “dog-like” burial of Oyugi in Kamaluanga, Ugenya, Siaya County, (2020). See Dicken

Wasonga (2020) “Siaya burial: County distances itself amid criticism,” Daily Nation, April 13, 2020, at

https://www.nation.co.ke/counties/siaya/Siaya-man-burial-sharp-criticism-county-distances/1183322-5522504-

hjrqdyz/index.html (accessed 6/5/2020)…. Any cases on police brutality during curfew? ….Police detention or

quarantine and demand for bribes?....

107

context of COVID-19 some of which may be litigated immediately or well into the future.440

These

include new and proposed labour laws and regulations….441

There are at least three issues regarding legislative, and regulatory texts and judicial decisions during the

(post) COVID-19 age. First, cases have been filed and some decided in Kenya,442

Malawi,443

and South

Africa,444

among others, to question the scope of COVID-19 regulations and the interpretations and

implementation of World Health Organization (WHO) and Ministry of Health (MoH) protocols on

lockdown, or containment measures such as curfew, quarantine, isolation….445

Second, in Kenya, Chief Justice David Maraga446

and the National Council on Administration of Justice

(NCAJ) issued various and even contradictory practice directives and directions, respectively in the age of

COVID-19.447

These include limiting physical appearance in court and enhancing online court processes;

then upscaling;448

then reversing the upscaling decision; then upscaling again partly due to pressure from

the Council of the Law Society of Kenya (LSK)….449

Third, the Law Society of Kenya’s (LSK’s) major functions and activities have largely been effected

through digital platforms, including Facebook, Zoom, Microsoft Teams, Microsoft Video Conference,450

Google meet, Google video calls, Google Classroom,…. These include the transition of the offices of the

LSK President and Council to President Nelson Andayi Havi from President Allen Waiyaki Gichuhi.

Numerous LSK activities have also processed online, including conducting Annual General Meeting

(AGM), processing articles for a special edition of the Advocate magazine on legal aspects COVID-19

438 A court ruled that an individual could not go to burry a family member…. See Franny Rabkin (2020) “High

Court refuses application to cross provinces for funeral,” Mail & Guardian, Johannseberg, South Africa, March 28,

2020, at https://mg.co.za/article/2020-03-28-high-court-refuses-application-to-cross-provinces-for-a-funeral/

(accessed 21/4/2020). Some have demonstrated and litigated against lockdown, forced and self-quarantine, social

distancing… see… 439

Human Rights Defenders Coalition (HRDC) v. Attorney General, High Court of Malawi…. 440 …. 441 Cf. Cyrus Ombati & Roselyn Ombaka (2020) “Return to work for workers who test positive for COVID-19

patients,” Sunday Standard, Nairobi, 3/5/2020, at 19, at

https://www.standardmedia.co.ke/article/2001369951/return-to-work-rules-for-workers-who-catch-virus (accssed

6/5/2020). 442 …. 443

…. 444 High Court of South Africa Mpulamalange Division (per Justice Roelofse AJ (Ag Judges) judgement of

27/3/2020. 445 …. 446

Practice Directions for The Protection of Judges, Judicial Officers, Judiciary Staff, Other Court Users and

the General Public from the Risks Associated with the Global Corona Virus Pandemic, Gazette Notice No. 3137,

Kenya Gazette Vol. Cxxii—No. 67 Nairobi, 17th April, 2020. 447

National Council on the Administration of Justice (2020) press statement: Statement on the Justice sector

operations in the wake of COVID-19 pandemic…. 448 …. 449 Cf. Sekou Owino (2020) “Virus or no virus, Courts must dispense justice,” Sunday Nation, Nairobi,

3/5/2020, at 33, at https://www.nation.co.ke/oped/opinion/Virus-or-no-virus--courts-must-dispense-justice/440808-

5540744-6swe9uz/index.html (accessed 6/5/2020). 450 See Judiciary (2020) Video Conferencing (VC) Guidelines…

108

(corona virus) in Kenya.451

The elections to the LSK’s Advocates Benevolent Fund, LSK Nominee to the

Senior Council Committee and elections to the LSK’s Nairobi Branch have also been conducted online.

Some Law Society of Kenya (LSK) Constinuous Professional development (CPD) seminars or webinars

have also been online, including the 4th anniversary of the brutal murder of lawyer Willie Kimani and his

boda boda (cyclist) client Josephat Mwenda, and their taxi driver, Joseph Muiruri....452

Significantly, President Havi has led the LSK in litigating453

matters related to Executive and Chief

Justice’s (in)actions on COVID-19.454

He and Vice President Caroline Kamende Daudi also led LSK in

raising funds for needy or vulnerable LSK members and Kenyan public.455

The question for a balanced approach to lawyering and judicial work is at least four pronged. First, life

and health of judges, magistrates, Kadhis, judicial officers and judicial staff, lawyers, and court users….

Second, the Constitution, the rule of law, human rights, and constitutional democracy demand that at any

given time, all the three arms of the National Government and the two arms of the County Government

must complement and check one another or each other. And the National Assembly and the Senate

recognized this and started a balanced minimal approach while observing the Ministry of Health COVID-

19 protocols, and later enhanced or upscaled online processes….

Third, in the absence of the Judiciary, the Executive, and especially, police brutality, execution, and

tyranny increased. Fourth, legal and judicial services are professional and occupational commitments or

concerns to many. They are also a bread and butter question. Did the Chief Justice’s early abdication

mean that judicial and legal services were or are totally dispensable?

Happily, the Chief Justice engaged the LSK and the National Commission for Administration of Justice

(NCAJ) and upscaled judicial services in spite of the budgetary constraints imposed through Executive

and Legislature weaponisation of the budget.456

[This is only for the Annex. The rest of Chapter 8B that have not been annexed addres the following

issues]

8.22 Securing Independence, Performance and Accountability of the Judiciary in Kenya and

Africa457

8.22.1 Challenges to the judicial functions in Kenya and Africa

451 See circulars on transition by President Nelson Andayi Havi and Allen Waiyaki Gichuhi…. March 2020. 452 …. 453 … 454 See… 455 …. 456 See…. The author is a co-counsel for the Law Society of Kenya in that case intended to secure equity,

certainty, and presidential fairness in funding the Judiciary in all circumstances, including in the case of “austerity”

measures, emergencies…. amended appropriations, or supplementary budgeting…. 457

Roles of JSC; Magistrates and judges…. Roles of the Chief Justice (CJ); President, Principal, Presiding Judges…. election of judges and magistrates to Judicial Service Commission (JSC), KMJA …. power to sermon “any person”

109

8.22.2 Separation of Powers as an Aid Judicial Independence in Kenya and Africa

8.22.3 Political Engagement for Judiciary Independence and Reforms in Kenya and Africa

8.23 Contempt of Court 458

Sub Judice, Fusion of Powers and Impunity v. Rule of Law… in Kenya

and Africa

8.24 Summary of Findings, Conclusions and Reforms Judiciary in Kenya and Africa

...may wisdom flow from the Oracle’s shrine and back as the discourse continues in class, articles, books, online, in the blogosphere, social media, and appropriate fora…

© Prof Ben Sihanya, JSD (Stanford), Revised 27/2/2013; 26/9/2013; 14/6/2014; 14/10/14; 16/02/15;

16/06/15; 31/08/2015; 10/2/2016; 29/6/2016; 14/4/17; 10/4/2018; 7/2/19; 11/2; 24/4; 30/4; 2/9; 26/11/19; 22/3/2020; 25/3/2020; 14/4/2020; 16/4/2020; 19/4; 21/4; 25/4; 27/4/20203/5/2020; 6/5/2020; 13/5/2020;

21/7/2020; 22/7/2020; 25/7/2020 email: sihanyamentoring@gmail.com; sihanya@innovativelawyering.com (use both)

url: www.innovativelawyering.com

458

Cf. authority, dignity, integrity of judiciary, courts….what of NA? Senate? County Assembly?