Mr Chairman,

We believe that there is a general consensus between WTO Members that the TRIPS Agreement and the Convention on Biological Diversity (CBD) can and should be implemented in a mutually supportive manner. We have identified no inconsistencies between the two treaties, but we do believe that the interaction between the two treaties would be greatly enhanced by an obligation in the TRIPS Agreement to disclose the origin of genetic resources and traditional knowledge in patent applications.

An obligation under the TRIPS Agreement to disclose the source and origin of genetic resources when applying for patent protection would make it easier for parties to enforce their rights to their own genetic resources when these are the subject of a patent application. This in turn would make the CBD provisions on prior informed consent and benefit-sharing more effective. Furthermore, in Norway’s opinion, a disclosure requirement should go beyond the scope of the CBD and also apply to traditional knowledge which is not directly linked to genetic resources.

A disclosure requirement could also help to establish whether the criteria of novelty and inventive step have been met. This could contribute to reducing the risk for providing unlawful patent protection. A general obligation to disclose any traditional knowledge upon which an invention is based would help to prevent erroneously granted patents.

Mr Chairman,

In Norway’s opinion, the TRIPS Agreement should be amended to include an obligation to disclose the source and origin of genetic resources and traditional knowledge in patent applications. A disclosure obligation should be based on the following key principles:

First, when applying for patent protection, the applicant should be obliged to include information on the supplier country (and the country of origin, if known and different) of genetic resources and traditional knowledge in patent applications. The supplier country (or country of origin, if relevant) of traditional knowledge must be disclosed even if the traditional knowledge has no connection with genetic resources. If the national law of the supplier country or country of origin requires consent for access to genetic resources or traditional knowledge, the disclosure obligation must also encompass a duty to state whether such consent has been given. If the country of origin is unknown, that fact must be disclosed.

Second, the disclosure obligation should apply to all patent applications (international, regional and national). An identical disclosure requirement should thus also be reflected in other international instruments such as those of the WIPO and regional or bilateral agreements.

Third, if the applicant is unable or refuses to give information despite having had an opportunity to do so, the application should not be allowed to proceed. At the application stage, a breach of the disclosure obligation should be treated as a formal error, i.e. the application should not be processed until the required information has been submitted.

Fourth, if, however, the breach of the disclosure obligation is discovered only after the patent has been granted, it should not in itself affect the validity of the patent. Such breach should rather be subject to appropriate and effective sanctions outside the patent system, for example criminal or administrative penalties. Upholding post-grant patent protection despite non-compliance with the disclosure obligation is important to avoid creating unnecessary uncertainty in the patent system. Revoking a patent as a consequence of non-compliance with the disclosure obligation would not benefit those who consider themselves to be entitled to a share of the benefits of the invention. Once patent protection is revoked, there are no exclusive rights from which benefits could be derived.

On the other hand, a patent can be revoked if the substantive patentability criteria have not been met. In that case it would not be the breach of the disclosure obligation which is the reason for invalidity, but rather e.g. the lack of inventive step.

Fifth, in order to increase transparency a simple notification system should be introduced, under which patent offices send all declarations of origin they receive to the CBD Clearing-House Mechanism.

Mr Chairman,

Norway believes that a disclosure of source and origin obligation based on these principles would support the aims of the CBD. A disclosure obligation would also be useful in ensuring that patents are not granted contrary to the fundamental principles of patent law. A disclosure obligation would thus serve to benefit the implementation of the CBD as well as strengthening the patent system.

The obligation to disclose source and origin is linked to the patent application, but does not constitute a substantive patent criterion. In Norway’s opinion, it would therefore be most appropriate to introduce a new provision in the TRIPS Agreement immediately following Article 29, which contains provisions on the disclosure of information related to the invention.

In summing up Mr Chairman,

Norway supports the amendment of the TRIPS Agreement to introduce a mandatory obligation to disclose the source and origin of genetic resources and traditional knowledge in patent applications. We are ready to engage in text based negotiations with a view to adopting such an amendment as soon as possible. In this respect we would like to thank Brazil, India, Pakistan, Peru, Thailand and Tanzania for their communication and proposal for a new article 29bis as contained in WT/GC/W/564.

Thank you, Mr. Chairman.