BIODIVERSITY ACT 2002

P. ILANANGAI
IP CONSULTANT
ALTACIT GLOBAL
 Biodiversity means
 Biological diversity, or "biodiversity," refers to the
variety of life on earth. It includes diversity of
ecosystems, species and genes, and the ecological
processes that support them. India is one of the 12-
mega biodiversity countries of the world.
 Patenting Life Form
 Article 27(3) of the TRIPS agreement exclude plants
and animals other than micro-organisms, and
essentially biological processes for the production of
plants or animals other than non-biological and
microbiological processes from patentability.
 This can be barrier to the technological and economic
development of the least developed countries, but such
exclusion in their respective country does not protect
the same from patentability in other region or country.
 Example includes the issuance of U.K. patent covering
nuclear transfer technology, which was used to clone
the first animal, the famous „Dolly the Sheep‟
 Biopiracy
 Biopiracy is the illegal appropriation of life --
microorganisms, plants and animals (including
humans) -- and the traditional cultural knowledge
that accompanies it.
 Biopiracy commonly operates through the
application of Intellectual Property Rights (IPR)
(primarily patents) to genetic resources and
traditional knowledge.
Bioprospecting
 Bioprospecting is the search for biological
resources and accompanying indigenous
knowledge primarily for the purpose of
commercial exploitation.
 Legal Cases
 TURMERIC: In 1995, two non resident Indians at the University of
Mississippi Medical Centre, Jackson, (Suman K.Das and Hari Har
P.Cohly) were granted a US patent (Patent number 54015041) for
turmeric to be used for healing wounds. The Indian Council for
Scientific and Industrial Research (CSIR) filed a re-examination case
with the US Patent Office challenging the patent on the grounds of
“prior art”, i.e. existing public knowledge . The claim had to be backed
by written documentation claiming traditional wisdom. CSIR submitted
a document proof in the form of research paper published in 1953 in the
Journal of the Indian Medical Association. The US Patent Office upheld
the objection and cancelled the patent in 1997.
 Neem
 India's 10-year-long battle against the grant of a patent on the use of
NEEM as a fungicide has finally been won at the European Patent
Office (EPO).
 Patent rights on a method for controlling fungi on plants by the aid of a
hydrophobic extracted neem oil had originally been granted by the EPO
in September 1994 to the United States Department of Agriculture
(USDA) and the New York-based multinational agribusiness
corporation WR Grace.
 In June 1995, a legal opposition to the grant of this patent was filed
jointly by Dr Vandana Shiva, director of Delhi-based Research
Foundation for Science, Technology and Ecology (RFSTE), Ms Magda
Aelvoet of the Green Group in European Parliament and Ms Linda
Bullard of International Federation of Organic Agriculture Movements
(IFOAM).
 Consequently, the EPO revoked the patent in May 2000. The MNC,
however, appealed the patent revocation. It is against this appeal that
the EPO has finally upheld its earlier decision, thereby revoking in its
entirety the patent rights once and for all on March 8, 2005.
 Convention on Biological Diversity (CBD)

 The Convention is founded on the principle that

local communities generate and are dependent on
biodiversity and should continue to benefit from it.
 Signed in 1992 at the 1992 UN Conference on
Environment and Development (UNCED) in Rio de
Janeiro entered into force on 29 December 1993.
 more than 170 countries
 India became a signatory to the Convention on
Biological Diversity (CBD) in June 1992.
Three goals
 To promote the conservation of biodiversity
 the sustainable use of its components and
 the fair and equitable sharing of benefits arising out
of the utilization of genetic resources.
 Why do we need this legislation on biodiversity?
 To realize equitable sharing of benefits arising out of the use of
biological resources and associated knowledge. The proposed
legislation primarily addresses the issue concerning access to biological
resources by foreign individuals, institutions or companies.
 to combat what has been termed biopiracy.

How will the proposed legislation check biopiracy?

 The proposed legislation provides that access to biological resources
and associated knowledge is subject to terms and conditions, which
secure equitable sharing of benefits. Further, it would be required to
obtain the approval of the National Biodiversity Authority before
seeking any IPR based on biological material and associated knowledge
obtained from India.
 The Structures of Biodiversity Act- 2002
 National Biodiversity Authority (NBA): All matters relating to
requests for access by foreign individuals, institutions or companies,
and all matters relating to transfer of results of research to any foreigner
will be dealt with by the National Biodiversity Authority.
 State Biodiversity Boards (SBB): All matters relating to access by
Indians for commercial purposes will be under the purview of the State
Biodiversity Boards (SBB). The Indian industry will be required to
provide prior intimation to the concerned SBB about the use of
biological resource. The State Board will have the power to restrict any
such activity, which violates the objectives of conservation, sustainable
use and equitable sharing of benefits.
 Biodiversity Management Committees (BMCs): Institutions of local
self government will be required to set up Biodiversity Management
Committees in their respective areas for conservation, sustainable use,
documentation of biodiversity and chronicling of knowledge relating to
biodiversity.
 Salient features of the Biological Diversity Act, 2002:-
 to regulate access to biological resources of the country;
 to conserve and sustainably use biological diversity;
 to respect and protect knowledge of local communities
related to biodiversity;
 to secure sharing of benefits with local people as
conservers of biological resources and
 holders of knowledge and information relating to the use of
biological resources;
 conservation and development of areas of importance from
the standpoint of biological diversity by declaring them as
biological diversity heritage sites;
 protection and rehabilitation of threatened species;
 involvement of institutions of state governments in the
broad scheme of the implementation of the Biological
Diversity Act through constitution of committees.
 Regulation of Access to Biological Diversity[sec (3)]

 A person who is not a citizen of India or who is a citizen of

India but is a non-resident , or a body corporate, association
or organization that is not incorporated or registered in
India or if incorporated or registered in India has any non-
Indian participation in its share capital or management, is
prohibited from obtaining any biological resource occurring
in India or knowledge associated thereto for research or
commercial utilization or for bio-survey or bio-utilization
without the prior approval of the National Biodiversity
Authority
Application for intellectual property rights not to
be made without approval of NBA[Sec (6)]
 previous approval of the NBA before making
application
 on approval, NBA impose benefit sharing fee or
royalty or both or impose conditions including the
sharing of financial benefits arising out of the
commercial utilization of such rights.
 Prior intimation to SBB for obtaining biological
resource for certain purposes [Sec(7)]
 Any biological resource for commercial utilization, or
bio survey and bio utilization for commercial
utilization shall be obtained after giving prior
intimation to the SSB.
 Exemptions- shall not apply to the local people and
communities of the area, including growers and
cultivators of biodiversity, and vaids and hakims, who
have been practicing indigenous medicine.
 The main functions of the NBA [sec(18)]
 To lay down procedures and guidelines to govern the
activities provided under Section 3, 4, and 6. (Permission
to foreigners/NRI‟s foreign companies)
i)For obtaining any biological resource (Section -3)
ii)For transferring the results of any research (Section -4)
iii)Certain collaborative research projects exempted
(Section 5)
 To encourage setting up State Biodiversity Boards
 To build up database and documentation system
 To create awareness through mass media
 The benefits
 While granting approvals, NBA will impose conditions,
which secure equitable share in the benefits arising out of
the use of biological resources occurring in India or
knowledge relating to them.
 These 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.
 For individuals , the monetary benefits will be paid directly
to them.
 Otherwise, the amount will be deposited in the National
Biodiversity Fund.
 Amendments to the Biodiversity Act
 The Biodiversity Act was amended in May 2009 to specify that bioprospecting
permits are only required for the commercialization phase of bioprospecting
projects and/or for export.
 The Minister of the Department of Water and Environmental Affairs must be
given notice of a bioprospecting project before the discovery phase begins.
 An undertaking by the project leaders to comply with the requirements of the
Act if the project enters the commercial phase also needs to be given.
 Researchers should note that a bioprospecting project will be regarded as
having entered the commercialization phase once a complete patent application
has been filed, irrespective of the actual commercial prospects of the project at
that stage.
 The interests of specific individuals who possess traditional knowledge have
now also been protected. Anyone who carries on the commercialization phase
of a bioprospecting project based on the traditional knowledge of a specific
individual, must now enter into a benefit sharing agreement with the individual.
Prior to this amendment, the Act only applied to traditional knowledge which
belonged to indigenous communities; and
 The penalties for contravening the Act have been increased to a fine of up to R5
million for a first offence and up to R10 million for a subsequent offence,
and/or imprisonment for up to 10 years
THANK YOU