1. Protecting Traditional Knowledge in India March 22, 2012 Anuradha R.V. Partner, Clarus Law Associates New Delhi, India

2. Overview India does not have a law on Traditional Knowledge However, legislative innovations in past decade provide the basis for protecting TK- ▫Protection of TK against Misappropriation ▫Fair and Equitable Benefit Sharing ▫Rights of TK holders Discussions ongoing for passing a law on TK; but lack of consensus on key issues relating to scope of protection

3. TK- Main Conceptual debates in India Broad categories: ▫Widely held TK ▫TK in close communities ▫Secret TK- narrower subset within a community ▫Also mainstreaming of Traditional Medicine- academic rigour, standardization - In each case- knowledge is dynamic and evolving.. Not static. Objective of a TK Law: ▫Recognition of Rights through Registration etc.? ▫What other forms should positive protection take? ▫Should focus only be on ability to prevent misappropriation?

4. TK- Main Conceptual debates in India  Control over knowledge  Ability to deny/authorize access and use  Prevention of Misappropriation: Prior Informed Consent  Benefit Sharing  Disclosure norms in Patent Applications

5. Laws so far dealing with TK issues National Biological Diversity Act Patents Act Protection of Plant Varieties and Farmers Rights Act Geographical Indications Act Scheduled Tribes and Other Traditional Forest Dwellers (Recognition of Forest Rights) Act, 2006

6. Biodiversity Act

7. Institutional Set-up ▫National Biodiversity Authority (NBA)  Regulates access by a foreigner/ NRI/ body corporate having foreign participation  Prior permission by any entity seeking IPRs “based on knowledge/resource obtained from India” ▫State Biodiversity Board (SBB)  Regulates access by Indian citizen/ body corporate controlled by Indian citizens ▫Biodiversity Management Committees  Preparation of Peoples’ Biodiversity Registers  Respond to requests from NBA and SBB

8. Principles of Benefit Sharing NBA has power to impose conditions for securing equitable share in the benefits arising out of use of: ▫Biological resources occurring in India or ▫Knowledge relating to them. Benefits could include ▫Monetary gains, ▫Grant of joint ownership of IPRs, ▫Transfer of technology, ▫Association of Indian Scientists in R&D, ▫Setting up of venture capital fund, etc.

9. Principles of Benefit Sharing Benefits for whom? In cases where specific individuals, or group of individuals are identifiable, the monetary benefits will be paid directly to them. Otherwise, the amount will be deposited in the National Biodiversity Fund.

10. TK under BD Act Section 36(5): Obligation on Govt. to respect and protect TK relating to BD through measures such as: ▫Registration; or ▫Sui generis protection Draft Protection, Conservation and Effective Management of TK Relating to Biological Diversity Rules, 2009- yet to be brought into effect ▫Significant role for TK holders in decision making process ▫Prior Informed Consent ▫How TK representatives would be selected, is however not clear.

11. Protection of Plant Varieties and Farmers Rights Act

12. Key Provisions Benefits can be claimed when genetic material used in development of a new variety Farmers would always have right to “save, use, sow, resow, exchange, share or sell his farm produce”. Farmers have right to register their varieties. Reward for conservation of genetic resources.

13. Patents Act

14. TK under Patents Act Section 3: What are NOT Inventions: ▫(p): an invention which in effect, is TK or which is an aggregation or duplication of known properties of traditionally known component/s Section 10: Disclosure Norm Applications pertaining to Biological Material should disclose Source and Geographical Origin of Biological Material Form 1 under Patent Rules ▫Declaration by Applicant that Biological Material used from India has been obtained after permissions from relevant authority ▫No evidence of BD Act permissions however required

15. Opposition and Revocation of Patent  Wrongful disclosure of source or origin  Invention claimed is based on something available (oral or otherwise) with a local or indigenous community in any country

16. Geographical Indications Act

17. GI Act Provisions First IPR law providing for “collective rights” GI acts as an authenticity/ quality mark for the quality, reputation and characteristics of the product Applicant can be: ▫Any association of persons, producers, organisation or authority established by law; ▫Must represent the interest of the producers. Protection for Producers and “Authorized Users” Registration for 10 years; can be renewed every 10 years. No time limit

18. Scheduled Tribes and Other Traditional Forest Dwellers (Recognition of Forest Rights) Act, 2006

19. Forest Dwellers Act Historic in terms of content: ▫Early Forest laws in India- focus was State control over resources; conservation New Act: ▫Grants legal recognition to the rights of traditional forest dwelling communities ▫Makes a beginning towards giving communities a voice in forest and wildlife conservation.

20. Forest Dwellers Act (cont’d) Criteria for Protection: ▫Primarily residing in forests or forest lands; ▫Depends on forests and forest land for livelihood (namely "bona fide livelihood needs") Categories of Rights: ▫Rights to Land ▫Rights of Use over Forest Resources ▫Rights to Protect Forest ▫Right of access to biodiversity and community right to intellectual property and traditional knowledge related to biodiversity and cultural diversity

21. Traditional Knowledge Digital Library

22. What is the TKDL?  Database on the codified knowledge for the Indian Systems of Medicine -Ayurveda, Siddha, Unani and Yoga  NOT a diagnostic or usage database  Main Objective: To Help Patent Examiners to determine Prior Art

23. TKDL- Experience  Pilot project- not a comprehensive documentation of TK  Access MoUs signed with EPO, JPO, USPTO  “Free Access” to patent offices has been criticized  No effective mechanisms yet to prevent leakage

24. Discussion Points

25. Learning through Experiences.. Any desire to protect all of TK in a single legal framework- a ambitious approach India- on route to drafting a TK Law ▫To have a single law protecting TK still appears to be a significant challenge Multiple approaches seek to fill in the gaps Not perfect; but provide valuable tools to address rights of TK holders