The Nagoya Protocol to the Convention on Biological Diversity12 is aimed at fleshing out the Convention’s provisions on what is called access and benefit sharing: the state obligations on access to their genetic resources, and obligations on those using that material to share the benefits derived from it. The ultimate objective of those provisions is to better protect biological diversity by providing powerful incentives to preserve it.
To fully support the implementation of the Nagoya Protocol, trade agreements’ IPRs provisions would mandate that domestic patent law should demand, as part of the application process, to know the origin of any genetic material used as a basis for innovation, and demand certification that it was obtained in accordance with the Protocol’s provisions (i.e., that it was obtained after prior informed consent and on mutually agreeable terms negotiated with the host government and/or traditional knowledge holders from whence it came). Where these conditions are found to have not been met, domestic law should provide for appropriate penalties, including possibly revocation of the patent.
Without these requirements, domestic patent authorities have no way of knowing whether applicants have in fact acted in accordance with the Nagoya Protocol provisions, and have no recourse if it is found that they have not.
Option 1:Text obliging domestic patent law to require disclosure of the origins of genetic resources on which innovation is based, and certification that it was obtained in accordance with the provisions of the Nagoya Protocol.
Implementation of the Nagoya Protocol’s provisions creates strong incentives for the preservation of biological diversity.
Examples
- “For the purposes of establishing a mutually supportive relationship between this Agreement and the Convention on Biological Diversity, [Parties] shall have regard to the objectives, definitions and principles of this Agreement, the Convention on Biological Diversity, and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, in particular its provisions on prior informed consent for access and fair and equitable benefit sharing.
- Where the subject matter of a patent application involves utilization of genetic resources and/or associated traditional knowledge, [Parties] shall require applicants to disclose: (i) the country providing such resources, that is, the country of origin of such resources or a country that has acquired the genetic resources and/or associated traditional knowledge in accordance with the CBD; and, (ii) the source (including details of whom in the providing country such resources were obtained from) in the country providing the genetic resources and/or associated traditional knowledge. [Parties] shall also require that applicants provide a copy of an Internationally Recognized Certificate of Compliance (IRCC). If an IRCC is not applicable in the providing country, the applicant should provide relevant information regarding compliance with prior informed consent and access and fair and equitable benefit sharing as required by the national legislation of the country providing the genetic resources and/or associated traditional knowledge, that is, the country of origin of such resources or a country that has acquired the genetic resources and/or associated traditional knowledge in accordance with the CBD.
- [Parties] shall publish the information disclosed in accordance with paragraph 2 of this Article jointly with the publication of the application or the grant of patent, whichever is made first.13
- [Parties] shall put in place appropriate, effective and proportionate measures so as to permit effective action against the non-compliance with the obligations set out in paragraph 2 of this Article. Patent applications shall not be processed without completion of the disclosure obligations set out in paragraph 2 of this Article.
- If it is discovered after the grant of a patent that the applicant failed to disclose the information set out in paragraph 2 of this Article, or submitted false and fraudulent information, or it is demonstrated by the evidence that the access and utilization of genetic resources and/or associated traditional knowledge violated the relevant national legislation of the country providing genetic resources and/or associated traditional knowledge, that is, the country of origin of such resources or a country that has acquired the genetic resources and/or associated traditional knowledge in accordance with the CBD, [Parties] shall impose sanctions, which may include administrative sanctions, criminal sanctions, fines and adequate compensation for damages. [Parties] may take other measures and sanctions, including revocation, against the violation of the obligations set out in paragraph 2.”14
How Commonly Used
- 12
- 13
Various RTIAs have text urging respect for the Nagoya Protocol’s obligations, but none contain effective obligations of the sort cited here. This is unadopted draft text submitted by some WTO Members in urging reform of the TRIPS Agreement. “Draft Decision to Enhance Mutual Supportiveness between the TRIPS Agreement and the Convention on Biological Diversity”, (TN/C/W/59) June 2011.
- 14
Various RTIAs have text urging respect for the Nagoya Protocol’s obligations, but none contain effective obligations of the sort cited here. This is unadopted draft text submitted by some WTO Members in urging reform of the TRIPS Agreement. “Draft Decision to Enhance Mutual Supportiveness between the TRIPS Agreement and the Convention on Biological Diversity”, (TN/C/W/59) June 2011.