Text Box: School Brief
Biotechnological Patents, Traditional Knowledge and the TRIPS Council
by Adithya Krishna Chintapanti

India is one of the most biologically diverse countries of the world. Indians are aware of the therapeutic and medicinal properties of various biological resources available in the country. Furthermore, Indians have been applying this knowledge for generations (traditional knowledge, henceforth TK) in their daily activities, especially to treat ailments. However, in recent times, biotechnological patents have been claimed on the well known fungicidal and hypoglycemic properties of some of the well known natural resources, viz. neem and bitter gourd, and the wound healing properties of turmeric. This has raised apprehensions about misappropriation of biological resources and traditional knowledge of communities (biopiracy) and commercial concerns associated therewith.

 

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 India and Other Developing Countries

 

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, India and other interested developing countries provided details on the substantive and procedural content of the aforementioned criteria for patentability.[2]  They define the source and country of origin of the biological resource involved in patenting as, either the country which is the original repository of the said resource (country of origin) or a country other than the country of origin from which the resource is obtained. In case of the latter, the applicant is required to disclose the details of both the countries which would help determine novelty and inventive step by facilitating ascertaining the TK associated therewith.

 

In the opinion of India and other developing country members, furnishing a document indicating PIC by the concerned national authority or community would satisfy the evidentiary requirements of PIC. As regards the proof of fair and equitable benefit sharing (ABS), the applicant needs to either annex the contract of benefit sharing and/ or a certificate issued by the concerned authority established by domestic legislation.

 

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 India along with Brazil and Peru is playing an active role in molding the terms of the debate. However, there has been no breakthrough in the negotiations so far, as the different players are reluctant to change their stance. India and other developing countries may need to rethink their strategy, and if need be, call for a reevaluation of the terms of negotiations so as to quickly arrive at some mutually accepted middle-ground. The potential loss from a larger number of such frivolous patents granted on misappropriated traditional knowledge and biological resources would continue to mount with time.

 

Home Page
 

 



[1]   Submissions to the Council for TRIPS by India, Brazil and Others, (IP/C/W/356) – 24 June 2002,  http://docsonline.wto.org/DDFDocuments/t/IP/C/W356.doc

[2]   Submissions to the Council for TRIPS by India, Thailand and Others, (IP/C/W/470), http://docsonline.wto.org/DDFDocuments/t/ip/c/w470.doc . This submission also clarifies certain concerns of the developed countries with regard to the terminology used in the developing country submissions and especially with regard to the Swiss submission (IP/C/W/446) dated 30 May 2005.

[3]   Submissions to the Council for TRIPS by the European Union and its member States, (IP/C/W/383) – 17th October 2002, http://docsonline.wto.org/DDFDocuments/t/IP/C/W383.doc .

[4]   Submissions to the Council for TRIPS by Switzerland, (IP/C/W/400/Rev.1)-18 June 2003, http://docsonline.wto.org/DDFDocuments/t/IP/C/W400R1.doc.

[5]   Submissions to the Council for TRIPS by  the United States of America,  (IP/C/W/434) - 26 Nov 2004, http://docsonline.wto.org/DDFDocuments/t/IP/C/W434.doc

[6]   Submissions to the Council for TRIPS by  the United States of America, (IP/C/W/469), http://docsonline.wto.org/DDFDocuments/t/ip/c/w469.doc.