Protecting Traditional Knowledge in India

March 22, 2012

Anuradha R.V.Partner, Clarus Law Associates New Delhi, India

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

TK- Main Conceptual debates in IndiaBroad 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?

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

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

Biodiversity Act

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

Principles of Benefit SharingNBA 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.

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.

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.

Protection of Plant Varieties and Farmers Rights Act

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.

Patents Act

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

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

Geographical Indications Act

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

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

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.

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

Traditional Knowledge Digital Library

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

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

Discussion Points

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