1

PROTECTION OF

TRADITIONAL KNOWLEDGE

2

Traditional Knowledge(TK)

TK associated with the biological resources is the knowledge about a country’s biodiversity; the applied uses and applications of biological resources and the prevalent practices.

It is an intangible component of the resource itself. TK has the potential of being transformed into commercial opportunity, providing useful leads for development of products and processes.

Hence, a share of benefits must accrue to creators and holders of Traditional Knowledge (TK).

3

What is Biodiversity?

Biological diversity comprises all species of plants, animals and microorganisms and the variation between them, and the ecosystems of which they form a part.

4

Biopiracy Misappropriation of TK for

the purpose of seeking exclusive patent ownership over that knowledge.

The process through which the rights to genetic resources and knowledge are “erased and assumed by those who have exploited indigenous knowledge and biodiversity.

5

Key Issues Surrounding Biopiracy

Understanding the precise legal status of genetic resources and traditional knowledge,

Understanding the exact boundaries of biopiracy in order to ensure more effective measures to confront this phenomenon,

At present, bioinformatics, proteomics, genetic engineering and synthetic biology, among others, promote more subtle ways of misappropriation and illegal access to and use of genetic resources and traditional knowledge.  

6

Some Examples of Biopiracy of Traditional Knowledge

Colgate Case Colgate, the world’s largest producer of toothpaste, patented a tooth

cleaning powder. American household goods giant was granted the patent in the U.S.

in June for what it claimed was a groundbreaking “red herbal dentifrice.”

Indian activists claim that the patent is bogus because the ingredients - including clove oil, camphor, black pepper and spearmint - have been used for the same purpose for hundreds, “if not thousands,” of years on the subcontinent.

However, its patent filing argues that the use of red iron oxide, which is less abrasive than ingredients in traditional toothpaste, is new.

According to Colgate the old recipe has become new, and through this “legal contraption”, the American company intends not to pay royalties.

India is in the process of creating 34 million web pages to help prevent the “biopiracy” of its ancient folk remedies that document the techniques and claim them as Indian property.

The matter is pending before the USPTO.

7

Turmeric Case In 1995, two Indian nationals at the University of

Mississippi Medical Centre were granted US patent no. 5,401,504 on "use of turmeric in wound healing".

The Indian Council of Scientific and Industrial Research (CSIR) requested the US Patent and Trademark Office (USPTO) to re-examine the patent.

CSIR argued that turmeric has been used for thousands of years for healing wounds and rashes and therefore its medicinal use was not novel.

Their claim was supported by documentary evidence of traditional knowledge, including an ancient Sanskrit text and a paper published in 1953 in the Journal of the Indian Medical Association.

Despite arguments by the patentees, the USPTO upheld the CSIR objections and revoked the patent.

8

Basmati Rice Case In late 1997, an American company RiceTec Inc,

was granted a patent by the US patent office to call the aromatic rice grown outside India ‘Basmati’. RiceTec Inc, had been trying to enter the International Basmati market with brands like ‘Kasmati’ and ‘Texmati’ described as Basmati-type rice with minimal success.

CSIR challenged the rice patent. After reexamination, the USPTO disallowed all

the physical characteristic claims. The Indian Government, a strong advocate of

geographical indications for food products, claimed victory when the USPTO limited the number of claims granted to RiceTec.

RiceTec still has a patent and can still call its rice Basmati.

9

Examples of Biopiracy of TK: An International Perspective

Hoodia Cactus Case Hoodia, a succulent plant, originates from the Kalahari Desert of South

Africa. For generations it has been known to the traditionally-living San people as an appetite suppressant.

In 1995 CSIR patented Hoodia’s appetite-suppressing element (P57). In 1997 they licensed P57 to the UK biotech company, Phytopharm. In 1998, Pfizer acquired the rights to develop & market P57 as a

potential slimming drug & cure for obesity from Phytopharm for upto $32 million.

The San people eventually learned of this exploitation of their traditional knowledge, and in June 2001, launched legal action against South African CSIR and the pharmaceutical industry on grounds of bio-piracy.

The CSIR claimed they had planned to inform the San of the research and share the benefits, but first wanted to make sure the drug proved successful.

In March 2002, an understanding was reached between the CSIR and the San whereby the San, recognised as the custodians of traditional knowledge associated with the Hoodia plant, will receive a share of any future royalties.

Thus San are likely to end up with only a very small percentage of eventual sales.

10

Ayahuasca (Banisteriopsis caapi Mort.) Case For generations, Shamans of indigenous tribes throughout the

Amazon basin have processed the bark of B. caapi Mort. to produce a ceremonial drink known as “Ayahuasca”. The Shamans use Ayahuasca (which means “wine of the soul”) in religious and healing ceremonies to diagnose and treat illness, meet with spirits, and divine the future.

An American, Loren Miller obtained US Plant Patent 5,751 in June 1986, granting him rights over an alleged variety of B. caapi Mort. which he had collected from a domestic garden in Amazon and had called “Da Vine”. The patent claimed that Da Vine represented a new and distinct variety of B. caapi Mort., primarily because of the flower colour.

The Coordinating Body of Indigenous Organisations of the Amazon Basin (COICA), which represents more than 400 indigenous tribes in the Amazon region, along with others, protested about a wrong patent that was given on a plant species.

They protested that Ayahuasca had been known to natives of the Amazon rainforest and it is used in traditional medicine and cultivated for that purpose for generations, so Miller could not have discovered it, and should not have been granted such rights, which in effect, appropriated indigenous traditional knowledge.

On reexamination, USPTO revoked this patent on 3rd November 1999. However, the inventor was able to convince the USPTO on 17th April

2001, the original claims were reconfirmed and the patent rights restored to the innovator.

11

Convention on Biodiversity (CBD)

Signed by 150 government leaders at the 1992 Rio Earth Summit.

Came into force on 29 December 1993. India is also a party to the CBD.Secured rights to control access to

genetic resources for the countries in which those resources are located.

Article 8(j) of the CBD deals with issues relating to traditional knowledge associated with biological resources.

12

Main Objectives of CBD

conservation of biological diversity

sustainable use of the components of biological diversity

fair and equitable sharing of the benefits arising out of the utilization of genetic resources

13

National Attempts to Protect TK- India

National Biological Diversity Act, 2002

Patents Act, 1970 through its amendments in 2005

Protection of Plant Varieties and Farmers’ Rights Act, 2001

Geographical Indications Act, 2003

14

Biological Diversity Act, 2002

Gives effect to the mandate of CBD and to some extent the Treaty of Plant Genetic Resources for Food and Agriculture (PGRFA), 2001.

Addresses generally issues of biodiversity management, and PGR management in particular.

Main focus is to address the issue of bio-piracy and to protect, respect and conserve TK related to PGRs of local people.

Nodal Agency – National Biodiversity Authority; State Biodiversity Boards, Biodiversity

Management committees are also created Biodiversity Funds at central, state and local

levels. To check bio-piracy, access to PGRs is regulated.

15

Main Provisions of the ActAct provides for the prior approval of the NBA:

• By foreign individuals, companies or associations to obtain any biological resources occurring in India or knowledge thereto for research, commercial utilization, bio-survey or bio-utilization.

• Transfer of research result relating to these resources, publication of research papers etc. is exempted; collaborative research projects also exempted; if guidelines are followed.

• Prior permission is also required if inventor seeking any kind of IPR in or outside India of an invention based on biological research or information on a biological resource obtained from India.

• For patent, prior permission of the NBA required after the acceptance of the patent but before the sealing of the patent by the patent authority concerned.

• The NBA may take steps to oppose the grant of IPRs outside India.

• NBA may impose benefit sharing fee or royalty or both on the commercial utilization of such IPR related product.

16

The NBA, while granting approval, will ensure equitable sharing of benefits on mutually agreed terms – between persons seeking approval, local bodies concerned and the benefit claimers.

NBA to frame guidelines on access and benefit sharing – Benefit Sharing may be in monetary or non-monetary terms, including joint ownership of IPRs with the NBA or identified claimers (sec. 21).

National Bio-diversity Fund to channel benefits to the claimers.

17

Patents (Amendment) Act, 2005

Makes biological processes as patentable, including biochemical, biotechnological and microbiological processes (sec. 5).

Microorganisms are patentable (sec. 3(j)). For patent on biological material,

specifications must disclose the source and geographical origin of the biological material used in the invention (sec. 10(d)).

Non-disclosure a ground for opposition of the patent (sec. 25)

18

A patent is refused or revoked for giving wrong information about the source of geographical origin of biological material (sec. 64(p)(q)).

Plant varieties or essentially biological processes are non-patentable (sec.3).

An invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component/s is also non-patentable (sec.3 (p)).

19

Protection of Plant Varieties and Farmers’ Rights Act, 2001

Makes provisions for benefit-sharing and compensation for traditional, rural and tribal communities.

Creates a nodal body – Plant Varieties and Farmers’ Rights Protection Authority at the national level.

Provides for a National Gene Fund.Authority is empowered to determine the

benefit sharing for individuals or groups when a protected variety is developed, using their genetic material.

20

Amount of compensation dependent upon the extent and use of their genetic material and the commercial utility of the variety.

Amount from the benefit sharing will be credited in the Gene Fund, village community be paid out of it for conservation and sustainable use of GRs

21

Geographical Indications Act, 2003

GIs are collective rights owned by the concerned communities. In India 'The Geographical Indications of Goods (Registration and Protection) Act (GI Act) was enacted in 2003 in compliance with India's obligations under TRIPS at the WTO.

GI acts as a signaling device that helps producers differentiate their products from competing products in the market and enables them to build a reputation and goodwill around their products, which often fetch a premium price.

22

Interface Between Geographical Indication & Traditional Knowledge

Geographical Indications can be applied to the tangible manifestations of traditional knowledge that can be identified with a geographical region.

GI Law can be used to make a policy that facilitates growth based on TK across geographical regions of the country.

The law of GI’s is a law facilitating holistic economic development and public policy to that effect.

It gives rights to community organization and association of manufacturers of goods to exploit GI leading to more equitable and distributed growth potential.

Marries social justice and sustainable growth with Intellectual Property Law.

23

What is TKDL?? Traditional Knowledge Digital Library (TKDL), an

electronic database which provides information on traditional knowledge existing in the country.

TKDL acts a bridge between the traditional knowledge information existing in local languages and the patent examiners at IPOs.

It is a collaborative project between CSIR, Ministry of Science & Technology and Department of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy), Ministry of Health & Family Welfare and is being implemented at CSIR.

This database enables the Patent Offices all over the world to search and examine any prevalent prior art, and thereby prevent incorrect grant of patent on products/processes based on knowledge in public domain.

24

Documentation of Bio-diversity TKDL

The Bio-diversity Management Committees (at local level) are entrusted with the documentation of bio-diversity – in order to monitor and protect bio-resources to curb bio-piracy and effectively challenge the IPRs granted in foreign jurisdictions.

Varied private experiments in documentations are already underway – open registers and close registers modes exist

Other successful peoples’ biodiversity registers are Shristi and Honey bee.

25

New TKDL Disclosures by Indian Patent Office

The official Indian Patent Office Website has put up a list of all the applications that are pending and belong, as per the judgment exercised by the Patent Office, to the category of Traditional Knowledge.

The list contains, in its present form, the application number, date of filing, the publication date, the title of the invention and the name and address of the applicant.

In case of any discrepancy, one has been asked to contact delhi-patent@nic.in

26

Sr.NoAPPLICATION

NUMBERDATE OF FILING

TITLE OF INVENTIONAPPLICANT

NAMEAPPLICANT

ADDRESSPUBLICATION

DATE

1 348/DEL/2010 17-Feb-2010

"AYURVEDIC CHOCOLATE COMPOSITION AS DELIVERY SYSTEM FOR NUTRIENTS AND MEDICATIONS WITH ACTIVE AMOUNT OF HERBS INCLUDING SHILAJEET AND COW URINE CONTENTS."

ARVIND KUMAR

D-38, INDUSTRIAL AREA, HARIDWAR, UTTRAKHAND, INDIA

27-Jul-2012

2 5212/DELNP/2011

06-Jul-2011COSMETIC COMPOSITION CONTAINING A LOCUST BEAN GUM HYDROLYSATE

PIERRE FABRE DERMO-COSMETIQUE

45, PLACE ABEL GANCE, F- 92100 BOULOGNE-BILLANCOURT, FRANCE,

27-Jul-2012

3 3851/CHE/2010 15-Dec-2010

A COMBINATION OF PARTS OF FIVE PLANTS PROCESSED IN COCONUT MILK THAT REDUCE PAIN CAUSE BY MIGRAINE

MAMPUZHACKAL THOMAS GEORGE VAIDYAR

MAMPUZHACKAL(HOUSE), CHEMPERI (P.O), KANNURE (DT.) - 670 632.

20-Jul-2012

27

4 2371/CHE/2012

14-Jun-2012

A HERBAL FORMULATION FOR CONTROLLING VECTOR MOSQUITOES

SAVARIMUTHU IGNACIMUTHU

ENTOMOLOGY RESEARCH INSTIUTE, LOYOLA COLLEGE, CHENNAI - 600 034

13-Jul-2012

5 2382/CHE/2012

14-Jun-2012

A PROCESS FOR PREPARATION OF 3-HYDROXY-2-METHOXY SODIUM BUTANOATE, A NOVEL CYTOKINE MODULATOR FROM THE LEAVES OF CLERODENDRUM PHLOMIDIS L.F.

SAVARIMUTHU IGNACIMUTHU

ENTOMOLOGY RESEARCH INSTITUTE, LOYOLA COLLEGE, NUNGAMBAKKAM, CHENNAI-600 034

13-Jul-2012

6 2450/CHE/2012

20-Jun-2012

HERBAL CREAM FOR THE TREATMENT OF LEUCODERMA

Y. MADHUSUDAN RAO

5-11-509, OPP. ALL INDIA RADIO, UNIVERSITY ROAD, VIDYARANYAPURI, WARANGAL

13-Jul-2012

Contd.

28

TKDL and Access Agreements

At the end of the day the TKDL is increasing the quality of the patents that are granted in their foreign jurisdictions. Thus even these foreign countries are gaining from access to the TKDL. It’s a win-win situation for both India and other countries. 

TKDL Access Agreement has in-built safeguards on non-disclosure to protect India’s interest against any possible misuse. Under the agreement, the patent examiners at International Patent Offices can utilize TKDL for patent search and examination purpose only and cannot reveal the content to any third party unless it is necessary for citation purpose.

29

ABS Mechanism

30

Access and Benefit sharingfor export of neem leaf (Azhadirachta

indica)

Bio India Biologicals (Indian firm) exported neem leaf accessed from Andhra Pradesh.

Royalty of 0.053 Million received by NBA

In 2010, NBA has transferred an amount of Rs.20,000/- to Amarchinta BMC in Andhra Pradesh towards benefit sharing. The amount utilized for awareness programme; planting saplings and fencing.

31

Access to Sea Weed (Kappaphycusalvarezii) from

coastal districts of Tamil Nadu Ms. Pepsico India Holdings Pvt. Ltd (MNC)

and M/s. Ganesan and Sons (Indian firm) submitted applications for exporting the dry sea weed.

The sea weed was collected from the Self Help Groups (SHGs) of Coastal

Tamil Nadu having the knowledge and skills of sea weed cultivation and exported for commercial purpose.

The agreements were signed with NBA and the royalty amount was paid.

32

TKDL Outcome Against Biopiracy

GINGER CASE: British Pharma firm filed for

patent in 2006 for pharmaceutical composition using ginger, claiming it discovered use of ginger and kutki plant in treatment of cold.

India cited medicinal texts dating back to the 18th century on use of ginger to treat cough, asthma & lung diseases using TKDL database.

British patent office accepts Indian evidence, rejects application 5 years later.

33

TKDL REMEDIES THROUGH GI’s

GI Law can be used to make a policy that facilitates growth based on traditional knowledge across geographical regions of the country.

GI law facilitates holistic economic development and public policy to that effect. It gives rights to community organisation and association of manufacturers of goods to exploit GI leading to more equitable and distributed growth potential.

34

GI-TKDL MERGER

Under Articles 1 (2) and 10 of the Paris Convention for the Protection of Industrial Property, geographical indications are covered as an element of IPRs. They are also covered under Articles 22 to 24 of the Trade Related Aspects of Intellectual Property Rights (TRIPS)  Agreement, which was part of the Agreements concluding the Uruguay Round of GATT negotiations. India, as a member of the World Trade Organization (WTO), enacted the Geographical Indications of Goods (Registration & Protection)Act, 1999 has come into force with effect from 15th September 2003. Examples of GI in Tamilnadu: Madurai Jasmine, Tanjore Veena, Bhavani Jamukkalam, Salem Mango, Kanjeepuram Silk, Bodi Cardamom etc.

Further, there was a ground-breaking deal between UNCLE

CHIPS and potato growers in Punjab wherein it was agreed that GI indications would be accorded to in order to protect interests of the potato growing farm communities in Punjab.

35

Some More Examples of GIMultani Mitti:

It was one of the earliest substances to ever be used as a beauty mask.

It consists of a lime-rich clay from the far northwestern region of India to which is added rice bran and milk. Although it is an effective clay for improving the facial complexion, it is also used to draw toxins from the skin of the entire body.

Scientifically, it has been shown to be bacteriostatic against gram positive bacteria; it can even be administered internally in cases of poisoning to decrease the absorption of the harmful substance.

Because of its high mineral content and moisturizing effect, it helps nourish the skin, nails, and hair. It is reputed to help reduce arthritic pain caused by inflammation.

Generally speaking, mud reduces the pain associated with burns, insect, and bee stings (bears roll in the mud when they’re stung) and will draw out heat through the skin.

36

GOOD LOOK Wayco Wipes: GOOD LOOK Wet Wipes, a product of Wayco Research (UK) Ltd.,

London, gives perfect remedy from the humanity and wipe out the fear factor of perspiration & odour which results after rain and makes life miserable.

Also brings freshness as it leaves behind a pleasing fragrance of lemon or jasmine and soothing coolness when applied to face or any other part of the body which precipitates the most.

One of their major ingredients is ALOE VERA- Aloe vera, also known as the true or medicinal aloe, is a species of succulent plant in the genus Aloe that is believed to have originated in the Sudan.

Aloe vera grows in arid climates and is widely distributed in Africa, India, and other arid areas.

The species is frequently cited as being used in herbal medicines and cosmetics.

Many scientific studies of the use of aloe vera suggest that Aloe vera extracts are useful in the treatment of wound and burn healing, minor skin infections, sebaceous cyst, diabetes, and elevated blood lipids in humans.

These positive effects are thought to be due to the presence of compounds such as polysaccharides, mannans, anthraquinones, and lectins.

37

Calamine Lotion: Kaolinite is one of the

most common minerals used in calamine lotions; it is mined, as kaolin, in Brazil, India, Australia, Korea, the People's Republic of China.

There is always a Predominance of kaolin in tropical soils. Kaolinite clay occurs in abundance in soils that have formed from the chemical weathering of rocks in hot, moist climates- for example in tropical rainforest areas.

38

Veet Veet, is a current trademark of chemical

depilatory internationally-sold products manufactured by Reckitt Benckiser Hair removal creams, mousses and gels, and waxes are produced under this brand.

Nelumbo nucifera is one of the ingredients of Veet, which is known by number of names including Indian Lotus, Sacred Lotus, Bean of India, or simply Lotus, is a plant in the monogeneric family Nelumbonaceae.

This plant is an aquatic perennial. Native to Tropical Asia and Queensland, Australia, it is commonly cultivated in water gardens.

The pink lotus is the national flowers of India. Nelumbo nucifera flower extract is the INCI (International Nomenclature of Cosmetic Ingredients) term for lotus blossom extract from Indian lotus flowers. It has excellent astringent properties, for example, thus refining the skin.

39

3 Phases of TK Management

Before documentationDuring documentationAfter documentation

40

Before Documentation- 5 Steps

Planning the documentation processBroadly understanding indigenous

peoples and community interests and needs

Defining the objectives: what is sought ?

Participation and prior informed consent

Assessing legal issues: IP considerations

41

IP Issues

Conducting an IP AssessmentAssessing the subject matter to be

documentedAssessing applicable IP lawsAssessing other applicable legal

regimesDeveloping an IP Management

Strategy to implement the IP Objectives

42

During Documentation- 2 Steps

Obtaining, organizing, systematizing, maintaining and transmitting TK

Continuously informing indigenous peoples and communities about progress in documentation process

43

During Documentation- Check List

Ensure appropriate PIC documentation (or evidence) has been obtained (or is obtained during this phase of the process)

Document TK in a precise and standardized manner (including through indigenous and local nomenclature or classifications or local management systems)

Do not disclose non disclosed or confidential TK Follow agreed guidelines or conducts, obligations and

legislation and regulations (including ABS) in place Regularly inform stakeholders, especially indigenous people

and communities, about advances and progress in the documentation process

Verify whether technological safeties for processing and managing data are operational (safety of the database or registration devices)

Adapt technology to local needs (if documentation involves interaction directly with indigenous peoples and communities)

Ensure appropriate disclaimers are developed and made visible

44

During Documentation- IP Issues

Recording TK and Associated GRManaging DisclosureManaging ConfidentialityKey IP clauses for confidentiality

contracts among documentation partners

Sample confidentiality contracts which have been used in documentation initiatives

45

After Documentation- 3 Steps

Promoting the TK documentation database or register

Monitoring uses and users of documented TK

Verifying whether initial planning objectives and milestones have been met

46

After Documentation- Check List

Verify that TK documentation planning objectives have been met

Verify that comments and inputs made by stakeholders (especially indigenous peoples and communities) have been appropriately addressed

Check who is accessing and using TK (if this was the case)

Check whether and how national IP offices are using the documented TK

Inform indigenous peoples and communities about the progress and results of the TK documentation process

Ensure management of the database or register is in hands of competent and technologically savvy professionals (or a well trained community member(s) if they are to ultimately create and manage the database).

47

After Documentation- IP Issues

Positive Protection: Acquisition of IP Rights

Defensive Protection: Public Disclosure

Establishment and Use of Databases

Enforcement of IP Rights

48

http://ebookcashstreams.com/HotNewsBlog/tag/mahyco-monsanto/

nbaindia.org/www.nbaindia.org/docs/exhibition_reportfinal.pdfenvfor.nic.in/legis/legis.htmlwww.elaw.org/node/1341http://www.google.co.in/search?

q=colgate+biopiracy+of+toothpaste&hl=en&rlz=1R2RNSN_enIN389&prmd=ivns&ei=y2xTTv3XGsLprAfot53aDg&start=60&sa=N&bav=on.2,or.r_gc.r_pw.&biw=1280&bih=568&emsg=NCSR&noj=1&ei=GW1TTvLAKI3JrQe42fTkDg

http://groups.google.com/group/spicyip?hl=en.

BIBLIOGRAPHY

49

Thank You!For further information, please feel free

to write on:unitedpatent_ipr@sify.comNeha Sharma (Associate)

M/s United Overseas Trade Mark Company

M/s United Overseas Patent Firm