intellectual property right regime -...

SESSION 8

Intellectual Property Right Regime

Intellectual Property Rights (IPRs) –Access and Benefit Sharing (ABS)

Interlinkages

Regulation

INTERNATIONAL -• The Convention on Biological Diversity,

1992

NATIONAL -• The Biological Diversity Act, 2002• The Biological Diversity Rules, 2004

CBD OBLIGATIONSThe Convention on Biological Diversity:- Recognises the sovereign rights of States

over their biological resources(Article 3 & 15)

- Stipulates that access to biological resources can only occur with the ‘prior informed consent’ of states (Article 15.5)

CBD OBLIGATIONS

The Convention on Biological Diversity:

Requires countries to protect and promote the rights of communities, farmers and indigenous peoples vis-à-vis their biological resources and knowledge systems

(Article 8j & 10)

CBD OBLIGATIONS

The Convention on Biological Diversity:

- Establishes access to biological resources of developing countries on a quid pro quo basis with technology transfer from the industrialised countries

(Article 16)

CBD OBLIGATIONS

The Convention on Biological Diversity:

- Mandates the equitable sharing of benefits arising from the commercial use of the biological resources and knowledge of communities

(Article 15.7)

CBD OBLIGATIONS

The Convention on Biological Diversity:

- Asserts that intellectual property rights must not conflictwith the conservation and sustainable use of biodiversity

(Article 16.5)

“Regulating” access

Against BIOPIRACY

For BIOTRADE

“Regulating” access

Role of the government…

Cracking BIOPIRATES Or Cracking BIODEALS!

“Regulating” access

Industry: NO IPRS, NO BENEFIT SHARING

No clear mandate against the privatization of life forms through patents,

indigenous people fear the regime will simply legitimize bio-piracy and make it easier to access genetic resources.

Negotiating an international regime on access

Negotiating an international regime on access

Group of Like-Minded Megadiverse Countriesexpects the international regime to address

benefit sharing and to take the form of a new legally binding instrument

The Relationship between TRIPS & CBDFebruary 2004

Submission by Bolivia, Brazil, Cuba, Ecuador, India, Peru, Thailand, Venezuela

CHECKLIST OF ISSUES• Disclosure of source and country of origin of the

biological resource and of the traditional knowledge used in the invention

• Disclosure of Evidence of prior informed consentunder the relevant national regime

• Disclosure of Evidence of benefit sharing under the relevant national regime

The PressureMay 2004

US puts India on its Patent Watch List

The US has once again put India on the “priority watch list” of its Special 301 provision of the trade law over inadequate protection of IPR…India’s amended patent law became effective in May 2003. But the US has termed it inadequate, saying it exempts from patent protection subjects like biotechnological inventions, processes for the treatment of humans, animals and plants…

Proposed Amendments in the Patent Law

Disclosure of the origin of materials like plants, animals and micro-organisms to be a mandatory pre-requisite for patents of inventions using such material or associated knowledge.

In the patent application, the disclosure has to be made upfront. Absence of the disclosure can be held as reason for opposition to or rejection or revocation of a patent, it has been freshly clarified.

The Biological Diversity Act, 2002

REGULATING” ACCESS

The law prohibits transfer of Indian genetic material outside the country, without specific approval of the Indian Government.

The National Biodiversity Authority has to issue guidelines for regulating access and benefit sharing.

It is to ensure that the terms & conditions secure equitable benefit sharing & is as per mutually agreed terms between person/s seeking

approval, local bodies concerned & benefit claimers.

The Biological Diversity Act, 2002

STRUCTURE

The Act proposes to set up bodies at three levels• National: National Biodiversity Authority• State: State Biodiversity Boards• Local: Biodiversity Management Committees

Community representation in implementing agencies absent

The Biological Diversity Act, 2002

ACCESS PROCEDURE- Application to NBA- In prescribed Form I- Fee of Rs.10,000/-- NBA consults with “concerned local body”

NBA Approves on terms & conditionsOR revokes access/approvalOR imposes restrictions [Rules 14 to 16]

The Biological Diversity Act, 2002BENEFIT SHARINGThrough:- transfer of technology

- location of production, research and development units in such areas which will facilitate better living standards to the benefit claimers

- association of Indian scientists, benefit claimers and the local people with research and development in biological resources and bio-survey and bio-utilisation

- setting up of venture capital fund for aiding the cause of benefit claimers

- payment of monetary compensation and other non-monetary benefits to the benefit claimers as the National Biodiversity Authority may deem fit

- grant of joint ownership of intellectual property rights to the National Biodiversity Authority, or where benefit claimers are identified, to such benefit claimers

The Biological Diversity Act, 2002

“BENEFIT CLAIMERS”

means the conservers of biological resources, their by-products, creators and holders of knowledge and information relating to the use of such biological resources, innovations and practices associated with such use and application;

The Biological Diversity Act, 2002

INTELLECTUAL PROPERTY RIGHTS

THE ACT DOES NOT SAY NO TO IPRS

Anyone wanting to take a patent or other intellectual property right (IPR) for any “invention” based on any research or information on a biological resource, must seek approval of the National Biodiversity Authority.

[Section 6]

Procedure for seeking approval for an IPR from the NBA does not provide for prior informed consent of local communities.

[Rule 18]

The Biological Diversity Act, 2002

INTELLECTUAL PROPERTY RIGHTS (contd.)

The National Biodiversity Authority may, on behalf of the Central Government take any measures necessary to oppose the grant of intellectual property rights in any country outside India on any biological resource obtained from India or knowledge associated with such biological resource which is derived from India.

If biopiracy cases such as these happened today post-legislation- Turmeric- Neem- BasmatiWHAT WOULD THE NBA DO?

Biodiversity Regulation

National Seeds Policy, 2002:

Plant Genetic Resources for food and agriculture crops will be permitted to be accessed by research organisations and seed companies from public collections as per the provisions of the ‘Material Transfer Agreement’ of the

International Treaty on Plant Genetic Resources and the Biological Diversity Law.

Biodiversity Regulation

OTHER DRAFTS IN INDIA

• Biodiversity Related Community Intellectual Rights Act, 1994

• Karnataka Community Intellectual Rights Bill 1994

• Traditional Knowledge (Preservation & Protection) Bill, 2000

Biodiversity Regulation

BANGLADESH BIODIVERSITY AND COMMUNITY KNOWLEDGE PROTECTION ACT

(Draft)A Community, that lives interactively within an ecosystem and whose

lives and livelihoods are results of that interaction and thus constitute the ecology, biodiversity and related knowledge of that

system, will be recognized by this Act as the primary ''owner" of the biodiversity and genetic resources and related knowledge, practices

and innovations on behalf of all the Communities of Bangladesh. The term 'Residual Title' articulates this right as defined by this Act to make it distinct from individual ownership. Communities holding

Residual Titles shall have both the usufruct, as well as the custodial and stewardship titles of genetic and biological resources under

question.

Biodiversity Regulation

BANGLADESH BIODIVERSITY AND COMMUNITY KNOWLEDGE PROTECTION ACT

(Draft)The Act declares and reaffirms that the patenting of the life forms is

against the moral, intellectual and cultural values of the people of Bangladesh. Accordingly, the access and use of biological and

genetic resources will be guided by these values. Any privileges, protection and/or rewards, if ever extended to new innovations, will have to remain consistent with this particular provision of the Act.

Biodiversity Regulation

COSTA RICAN BIODIVERSITY LAW

The right of local communities and indigenous peoples to oppose any access to their resources and associated knowledge, be it for cultural, spiritual, social, economic or other motives, is recognized.

(Article 66)

Biodiversity Regulation

COSTA RICAN BIODIVERSITY LAWSui Generis Community Intellectual Rights

The State expressly recognises and protects, under the common denomination of sui generis community intellectual rights, the knowledge, practices and innovations of indigenous peoples and local communities related to the use of components of biodiversity and associated knowledge. This right exists and is legally recognised by the mere existence of the cultural practice or knowledge related to genetic resources and biochemicals; it does not require prior declaration, explicit recognition nor officialregistration…

(Articles 82-85)

We need to learn from Costa RicaLet’s model their bio-law not their mistakes…

The infamous INBio-Merck contract of 1991

THE PROMISES· Up-front money for conservation· Eventual royalties to the country· Economic revenue· New & cheap medicines & products available· Tropical forests undisturbed· Technology transfer

UNFULFILED· Bio prospecting has FAILED as a conservation tool· Advance payments DID NOT prevent deforestation· There have been no pharmaceutical hits, so NO royalties· Techniques are NOT always non-invasive· LIMITED & second-rate technology transfer· Rights have been abdicated to third parties

We need to –

- facilitate empowerment & control of communities through their own definition of their rights over their biodiversity & knowledge

- assert that any discussion on access & benefit-sharing take in to account the intrinsic value of biodiversity for local life & livelihoods

- argue for strong community rights and against any privatisation & other forms of misappropriation of their resources and/or knowledge

Written laws are like spider's webs;

they will catch, it is true, the weak and the poor, but would be torn in pieces by the rich and powerful.

Anacharsis, 600 BC, Scythian Philosopher