Laura Karanja

PRESENTED AT KALRO-NJORO 28.9.2015

Objectives Introduction – True case histories An overview of International Regulatory

Framework Genetic resources and IP protections

relevant to KALRO What can KALRO borrow to improve

their IPR Protection

To give an overview of the International Regulatory Framework and implementation on the Genetic Resources

To understand the IPR associated with genetic resources and their management

Reflect over regulatory options from which KALRO could borrow for future

To help each other to recognize the importance of managing intellectual properties

Case history 1: Starch “Gene” (US)

Researcher isolates genetic material that increases production of starch in potatoes

Colleague from industry visits Researcher “loans” “gene” Company patents and restricts access Researcher not able to work with

“gene” as anticipated

Case history 2: Malaria treatment Researcher discovers unique

treatment (India) University administrators tell

researcher to do whatever he wants with the idea

Administrators urged to take steps to help

Researcher asks for assistance from others, none received

Publishes the study and the unique treatment is not being used

Intellectual Properties Are:

IDEAS Ideas! IDEAS!

Word or phrase Books/Protocols/Recipes Symbol Invention Biotechnology innovation New plant variety

CBD /ABS= Convention on Biological diversity 1992/93/Access and Benefit sharing

TRIPS = Trade Related Intellectual Property Rights/WTO,1994/95

FAO-IT-PGRFA = FAO International Treaty for Plant Genetic Resources for Food and Agriculture, 2001/2004

UPOV = International Union for the Protection of Plant Varieties, 1991/97

WIPO –IGCGRTKF/Nagoya = World Intellectual Property Organization; Inter-Governmental Committee on Genetic Resources, Traditional Knowledge and Folklore, 2000

Biosafety protocol = Cartagena, 2002 IPPC = International Plant Protection Convention, 1997 GDCT = Global Diversity Conservation Trust) PCT – Patent Cooperation Treaty

Minimum common denominators? Access Knowledge InnovationThe FAO-IT-PGRFA, CBD, TRIPS, UPOV, WIPO-

IGC etc• They provide: New legal boundaries =

freedom to operate/innovate -under different regimes- for a range of biological material

Genetic Resource and their importance CBD/ABS FAO –ITPGRFA UPOV Institutional IP policies/management

practices

• Genetic resources have historically been considered to be freely available.

• In 1983, the UN Food and Agriculture Organization (FAO) proposed that ‘plant genetic resources are a heritage of mankind and should be available without restriction.

• Developing countries with abundant genetic resources voiced their opposition to the way resources were treated, including monopolization by patent rights.

• Since then, how to address concerns about the misappropriation of genetic resources and traditional knowledge have been high on the agenda of a variety of multilateral forums.

Genetic resources are needed because new traits are desired:

By consumers (taste, convenience etc.)By the processing industry (shelf life, commodity market, new processing techniques etc.)By the grower (new growing techniques, new pest resistances, demands for lower input etc.)

CBD applies to all genetic resources, including plant genetic resources.

The CBD provides for the conservation and sustainable utilization of genetic resources and a regime for access and benefit-sharing.

The CBD has almost universal application (193 parties).

Means any genetic material of plant origin of actual or potential value for food and agriculture

The objective of this Treaty is the conservation and sustainable use of plant genetic resources for food and agriculture and the fair and equitable sharing of the benefits arising out of their use

The value in agricultural genetic resources lies in diversity within a crop, not at a species level.

Intra-specific diversity is important for resistance to diseases and environmental challenges, as well as for maintaining yields.

Plant genetic resources are essential for future food security.

Levels of Dependency on genetic resourcesCountry Dependen

cy (%)Main source of energy

supplyPrimary region of diversity of crops

ChinaJapanRepublic of Korea

46 - 5543 - 6130 - 54

Non-native - wheat, sugar, maize, potatoNative - rice and soybean

East Asia - rice, soybean, orange, Brassica, millet, tea, onion

BangladeshIndiaNepal

14 - 2135 - 4747 - 57

Non-native - wheat, maizeNative - rice, sugarcane, millet

South Asia - rice, banana, sugarcane, sesame, millet, Brassica rapa, B juncea

KenyaSouth AfricaEthiopia

89 - 9890 - 9828 - 56

Non-native - Phaseolus, maize, sweet potato, potato, cassava, banana, plantain, wheat, riceNative (for Ethiopia) - tef, Avena Abyssinian, Brassica carinata

East and Southern Africa - sorghum, millet, yam

BrazilAndean Region Argentina Colombia

81 - 94

89 - 9584 - 94

Non-native - wheat, sugar, rice, maize, soybean, plantain, bananaNative - potato, Phaseolus (for Andean Region); cassava (Brazil)

Andean region – pineapple groundnut, sweet potato, tomato, cocoa, Phaseolus, potato, cassava,

USCanada

77 - 10084 - 99

Non-local - wheat, sugar, soybean, potato, maize, barley, rice, groundnut

North America - sunflower

Source: Palacios (1998)

Access and Benefit Sharing (ABS) rules Convention on Biological Diversity (CBD) International Treaty on Plant Genetic

Resources for Food and Agriculture Intellectual Property (IP) rules

Plant variety protection (PVP) Patents

Unprotected varieties

Free for further breeding

PVP Protected varieties

Breeders’ exemption

Patented varieties License agreements

Additional national ABS requirements may be relevant

Conditions research institute Public Private

ABS rules in country where institute is based Public Private

Conditions of owners

Biodiversity legislation, in particular ABS rules Convention on Biological Diversity (CBD)

Nagoya Protocol International Treaty on Plant genetic

Resources for Food and Agriculture (IT PGRFA)

Standard Material Transfer Agreement (SMTA)

General provisions including definitions Rights and obligations of provider

Allowed usesBenefit sharing

Rights and obligations of recipientClear cut-off point until whereAny enclosure of genetic materialContract in perpetuity

Dispute settlement

"Any access to a biological resource, innovation, practice, knowledge or technology, shall be subject to the prior informed consent (pic) of the concerned community or communities ensuring that women fully and equally participate in decision making."

Common heritage International Undertaking; IU (1983) Sovereign rights Convention on Biological diversity; CBD (1993) Bonn Guidelines on Access and benefit Sharing

(2002) International Treaty on Plant genetic resources

for Food and Agriculture; IT PGRFA (2004) Standard Material Transfer Agreement: SMTA

(2006) Nagoya Protocol on Access and benefit Sharing

(2010) Fair and equitable benefit sharing

Facilitated access, which is, itself, a major benefit

Exchange of information Access to and transfer of technology Capacity building The sharing of monetary and other

benefits of commercialization

Monetary benefit sharing Obligatory payment of 1.1 % of Sales minus

30%, if material is not free for research and breeding

Voluntary contribution when material is free for research and breeding; recognition of the breeders’ exemption

Alternative payment system.

Non-monetary benefit sharing Information sharing

Recognition of the enormous contribution that farmers and their communities have made and continue to make to the conservation and development of plant genetic resources.

Farmers’ rights include the protection of traditional knowledge and the right to participate equitably in benefit-sharing and in national decision making about plant genetic resources.

Governments are responsible for realizing these rights.

To provide and promote an effective system of plant variety protection, with the aim of encouraging the development of new varieties of plants, for the benefit of society

Plant breeding is long and expensive BUT Plant varieties can be easily and

quickly reproduced Breeders need protection To recover Investment To provide and promote an

effective system of plant variety protection (PVP)

A right to exclude others from commercial use of what is patented

A temporary right: usually 20 years Requires fee payments for

maintenance Can be granted upon application, if the

patentability criteria are fulfilled: Novelty and New

:

Plant and animal varieties not be patentable. BUT Inventions which concern plants or animals shall be

patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety.”

Not meant to cover discoveries or natural phenomena but to foster new inventive technical processes and products

Nowadays: Patents are granted on gene sequences, plants and animals ...

Ethical reasons: living nature is not a technical invention

Scientific arguments: a gene sequence is not a normal chemical substance but a code of information with a lot of different functions. A holder of a patent which describes one commercial use should not get a monopoly on all possible functions.

Social and economic reasons: Patents can block access to genetic resources. This is a problem in agriculture, plant breeding and health care.

NEW! NOVEL! IDEAS! Word or phrase Symbol Invention Biotechnology innovation New plant variety Food and food processing Forestry Herbal medicines

Direct the use of the intellectual property Reserve the right for future state protection Ensure proper distribution of the intellectual

property Potential financial gain Recognition of innovators’ efforts Gain prestige for the institution Benefiting society – the most important

reason

How can KALRO use this info (Kakamega case)

Capture all ideas even those without immediate benefit and document these within a database

Collect all experimental data manuals and carefully archive these

Be vigilant in MTA enforcement

Maximise scientists knowledge bind them after leaving KALRO from sharing information for some years

Benefits to the scientist (Breeders rights) Support scientists on innovative but

crazy ideas Packaging IPR TRAINING DIFFERENTLY

to include all:

IP policy for the organization will benefit everyone from the highest level administrator to lowest level worker, and especially society.

“Information is not Knowledge”

Albert Einstein