Protecting Traditional Knowledge in India

1. Protecting Traditional Knowledge in 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