An international protocol of this nature seems to be rather distant now especially since developing and developed countries are finding it impossible to arrive at a consensus even on relatively lesser controversial issues of disclosure requirements in patents and prior informed consent (PIC).
One of the submissions to trigger off the North-South debate on dislcosure requirements and PIC was the Indian submission made on 12th July, 2000 (IP/C/W195). This submission called for a harmonization between the Convention on Biological Diversity (CBD) and the Agreement on Trade Related Intellectual Property (TRIPS) in order to ensure greater transparency in disclosure of patent information in patent applications. Subsequent submissions by the Indian delegation sought to make the lack of disclosure of biological sources a ground for revoking patents. Indian legislators followed up on this proposal at a domestic level by amending the Patents Act, 1970 to make the lack of disclosure of biological sources a ground to revoke or oppose patents or patent applications.
This proposal was crystallized in a follow up submission (WT/GC/W/564) by India and other bio-diversity rich countries, made on the 31st May, 2006. In this submission, developing countries sought to introduce a new provision – Article 29 bis titled ‘Disclosure of Origin of Biological Resources and/or Associated Traditional Knowledge’. This proposed provision aims to make disclosure requirements a TRIPS obligation.
The U.S. delegation however has opposed the proposal through its submission – IP/C/W/434 – on the ground that such measures “would add uncertainties in patent rights that may undermine the role of the delicately balanced patent system in its primary purpose of encouraging innovation, technological progress and economic development.” The U.S. is one of the few countries which despite signing the CBD has failed to ratify it due to the political climate in the U.S. Senate. In its submissions the U.S. has stated that it is in complete agreement with the principles of (i) Prior Informed Consent (ii) Benefit Sharing & (iii) Prevention of Erroneously Granted Patents. The U.S. however was of the opinion that this could be achieved either through contract law or a completely independent mechanism which has no nexus with the Patent system. The reality as usual lies somewhere in-between.