by Adithya Krishna Chintapanti
Such instances of
biopiracy point to the significance of traditional knowledge in guiding ongoing
research in biotechnology and drug development by reducing the time and
investment in prospecting and identification of active ingredients. However,
those who obtain patents on properties of biological resources which are common
knowledge in the country of origin of the said resources do not share the
benefits (pecuniary) arising out of the patent’s commercial exploitation. In
certain cases the biological resources are even smuggled from the source
country without the prior authorization of the concerned community/government.
Activism on
biotechnological patents is gradually picking up pace. So far, most patents on
misappropriated biological resources and traditional knowledge of the
biologically diverse developing countries have been granted in the
technologically advanced and IPR-savvy developed countries. Though many such
patents have been successfully contested and revoked, individually challenging
each patent application is time-consuming and financially prohibitive. Hence,
developing countries like India, Brazil, Thailand etc. are advocating a
systemic solution by providing for appropriate legal and institutional means
for recognizing the rights of communities on their TK.
A Way Forward
Mandatory disclosure
of the source of the biological resource and TK associated therewith as a
pre-condition for grant of a patent under the TRIPS Agreement (criteria for
patentability) is one of the proposals submitted by WTO Members to pre-empt
grant of patents on misappropriated biological resources and TK. The proposal
has its roots in Article 15 of the Convention on Biological Diversity (CVD)
1992, which affirms the sovereign rights of States over their biological
resources. The article makes access to genetic resources conditional upon
obtaining prior informed consent (PIC) of the state providing genetic
resources. It also requires members who have been granted access, to share the
benefits arising out of the commercial exploitation of the said natural
resources in a fair and equitable manner, with the member country providing
access (Access and Benefit Sharing requirement (ABS)).
The Hong Kong
Ministerial Declaration of November 2005 reiterates the commitment of the WTO
Members to the Doha Mandate urging them to explore the relationship between the
TRIPS Agreement and the Convention on Biological Diversity with regard to
protection of traditional knowledge and folklore. The ongoing negotiations in
the Council on TRIPS are in pursuance of the above.
Submissions by
The basic thrust of
these proposals is in urging the TRIPS Council to recommend certain amendments to
the TRIPS Agreement, requiring the applicant of a biotechnological patent to
furnish as a prerequisite for grant of
patent:‘(i) a disclosure of the source and country of origin of the
biological resource and of the traditional knowledge used in the invention;
(ii) evidence of prior informed consent (PIC) through approval of
authorities under relevant national regimes; (iii) furnish proof of fair and equitable benefit sharing
under relevant national regimes (ABS) ’.[1]
In a recent
submission to the TRIPS Council dated 21st March 2006,
In the opinion of
The Indian submissions
also recommend a range of sanctions for non-disclosure and non-adherence to PIC
and ABS, from revocation of the patent to a partial transfer of rights on the
country which was the repository of the genetic material or the community which
was the custodian of the TK.
Counter Submissions
This proposal of
making disclosure a prerequisite for patenting within the TRIPS regime is
however not acceptable to the developed countries. The three alternatives
suggested by the latter include:
(i) the
European Unions’ proposal for an international disclosure regime outside the
TRIPS Agreement. The EU also believes that the same should not contain access
and benefit sharing requirements especially in light of the fact that many countries do not have
appropriate domestic regulatory mechanisms to issue ‘certificates of evidence’
to that effect[3] ;
(ii) the Swiss
proposal for a system whereby national legislation would deal with the
disclosure requirement with regards to biological resources and traditional
knowledge associated with the patent applications[4]; and
(iii) the
American submission on the need for having strong national laws outside the
patent system so as to ensure equitable benefit sharing (ABS) and prior
informed consent (PIC) and propose a contract based model to implement the
same.[5] They are of the
view that a mere disclosure of source of origin in the absence of a strong PIC
and ABS is an exercise in futility, as there would be no mechanism to ensure
that adequate compensation has been paid even if a transgression of the duty to
disclose has been identified.[6]
Some Observations
The current
negotiations are encouraging in two respects, viz, developed countries are
being forced to react to alternate models of IP regulations put forth by the
developing countries, and
[1] Submissions to the Council for
TRIPS by
[2] Submissions to the Council for
TRIPS by
[3] Submissions
to the Council for TRIPS by the European Union and its
[4] Submissions to the Council for
TRIPS by
[5] Submissions
to the Council for TRIPS by the
[6] Submissions
to the Council for TRIPS by the