Elements of the obligation to disclose the source and country of origin of biological resource and/or traditional knowledge used in an invention

IP/C/W/429

21 September 2004

(04-3967)

Council for Trade-Related Aspects of Intellectual Property Rights

Original: English

ELEMENTS OF THE OBLIGATION TO DISCLOSE THE SOURCE AND COUNTRY OF ORIGIN OF BIOLOGICAL RESOURCE AND/OR TRADITIONAL KNOWLEDGE USED IN AN INVENTION

Submission from Brazil, India, Pakistan, Peru, Thailand, and Venezuela

The following submission, dated 20 September 2004, is being circulated at the request of the Delegations of Brazil, India, Pakistan, Peru, Thailand and Venezuela. _______________ I. INTRODUCTION

1. By a communication dated 2 March 2004 (hereafter, the Communication) the delegations of Bolivia, Brazil, Cuba, Ecuador, India, Peru, Thailand and Venezuela submitted a Checklist of Issues on the relation between the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) and the Convention on Biological Diversity (CBD) with the aim of facilitating more focused, structured and result-oriented discussions on this issue. Focussed, structured and result-oriented discussions on the relationship between the TRIPS Agreement and the CBD are crucial in ensuring that the TRIPS Council fulfils the Doha mandate to address this issue. The purpose of the checklist, which was drawn up on the basis of the issues raised by various delegations since 1999 and which took into account various notes prepared by the Secretariat, especially documents IP/C/W/368 and IP/C/W/370 was therefore to assist and expedite the process and not to limit the ambit of the discussions.

2. At the TRIPS Council meeting held on 8 March 2004, at which the Checklist of Issues was first discussed, virtually all members agreed on the need for focussed and structured discussion on this issue. In addition, most Members agreed that the Checklist of Issues identified in the Communication formed a good basis for further deliberations in the Council. In particular, many Members expressed the view that issues relating to disclosure of the source and country of origin of biological resource and/or traditional knowledge used in an invention were prime candidates to move the discussion forward and as such an area on which there were significant possibilities for convergence of views. In the TRIPS Council meeting held on 16 June 2004, some Members made useful substantive comments on the issues included in the checklist. This Communication is aimed at carrying the process forward by developing some of the issues relating to first of the three sets of issues identified in the checklist i.e., the disclosure of source and country of origin of biological resources and/or traditional knowledge used in inventions.

II. HOW WOULD AN OBLIGATION FOR DISCLOSURE OF SOURCE AND COUNTRY OF ORIGIN OF BIOLOGICAL RESOURCE AND ASSOCIATED TRADITIONAL KNOWLEDGE USED IN AN INVENTION HELP IN BETTER EXAMINATION OF PATENTS AND IN PREVENTING CASES OF BAD PATENTS?

3. A number of cases have been documented where patents have been issued with respect to genetic resources and products or processes that have been known and used by traditional or local communities for many years and even centuries. Cases such as those relating to turmeric, Neem tree, Hoodia and ayahuasca have been widely publicised and discussed. These cases involving various levels of bio-piracy have raised serious questions about the quality of patent examination. One argument that has been advanced in defence of patent examiners is that the relevant prior art was not available to them and there was no way of knowing that the claimed invention was in fact not a patentable invention at all. A number of possible principles and mechanisms to improve patent examination with respect to genetic resources and traditional knowledge have been proposed mainly aimed at improving the availability of prior art information relating to these resources. However, none of these mechanisms is likely to make available all prior art information while addressing important cultural and religious sensitivities associated, in particular, with traditional knowledge.

4. Many of these mechanisms are also voluntary and provide no guarantee that in fact patent examiners in different countries will consider this information in the prior art search. Consequently, a legally binding obligation to disclose the source and country of origin of biological resource and/or traditional knowledge used in inventions will guide the patent examiners in ensuring that all relevant prior art information is available to the patent examiners. Disclosure will also be relevant in helping patent examiners determine whether the claimed invention constitutes an invention that is excluded from patentability under Article 27 paragraphs 2 and 3 of the TRIPS Agreement. Further, disclosure would serve as part of a process to systematise available information of biological resources and traditional knowledge that will continuously build the prior art information available to patent examiners and the general public.

5. In addition to matters relating prior art, patentability and exclusions to patentability, the disclosure requirements will also be useful in cases relating to challenges to patent grants or disputes on inventorship or entitlement to a claimed invention as well as infringement cases. It has already been shown in the TRIPS Council that patent challenges involve a great cost in terms of time and resources, and are not a suitable option for developing countries. Patent grant challenges, cases on inventorship or entitlement as well as infringement cases form an important component of processes that ensure patent quality. In this regard, it is noteworthy that disclosure requirements of various types are already an accepted norm in international patent law practice.

6. Some national patent laws require patent applicants to inform the patent authorities of information that may be useful in assessing the validity of patent claims or in understanding the invention. At the international level, Article 29 of the TRIPS Agreement, for example, obliges Members to require that patent applicants disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode to carry out the invention known to the inventor. That article further permits Members to require an applicant to provide information concerning the applicant's corresponding foreign applications and grants. These existing rules on disclosure of various types of information are meant to ensure the quality of patents that are granted as well as to ensure transparency. It is clear therefore that an obligation to disclose source and country of origin of biological resource and/or traditional knowledge used in an invention would play a critical role in ensuring patent quality.

III. WHAT IS THE MEANING OF DISCLOSURE OF SOURCE AND COUNTRY OF ORIGIN OF BIOLOGICAL RESOURCE AND OF THE TRADITIONAL KNOWLEDGE USED IN THE INVENTION?

7. A number of questions have been raised relating to the meaning of the proposed obligation to disclose the source and country of origin of a biological resource and traditional knowledge used in an invention. Among others, the questions relate to whether the obligation would be a substantive or formal requirement relating to patentability; what level of use of the resource in the invention would be sufficient to trigger the obligation; and, what the administrative and cost burdens of such an obligation would be.

8. The disclosure of source and country of origin of biological resource and/or traditional knowledge used in an invention will have both substantive and formal implications. Similarly, any use, the disclosure of which is necessary to determine the existence of prior art, inventorship or entitlement to the claimed invention, the scope of the claim and/or is necessary for understanding or carrying out the invention would be sufficient to trigger the disclosure obligation. In this regard, even where the use was only incidental, it would be sufficient to trigger the obligation if the disclosure of the source and country of origin is relevant for prior art, inventorship or entitlement determinations, the scope of the claim and/or for understanding or carrying out the invention. Among others, the uses that would be relevant for prior art, inventorship or entitlement determinations, the determination of the scope of the claims and/or for understanding or carrying out the invention could include, among others, where the biological resource and/or traditional knowledge is used:

(a) to form part of the claimed invention;

(b) during the process of developing the claimed invention;

(c) as a necessary prerequisite for the development of the invention;

(d) to facilitate the development of the invention; and,

(e) as necessary background material for the development of the invention.

9. Suggestions have also been made to the effect that a disclosure obligation relating to the source and country of origin of biological resources and/or traditional knowledge would impose a significant administrative and cost burden on patent applicants. While there will be administrative implications and there may be cost implications for applicants as they are expected to at least employ all reasonable measures to determine the country of origin and source of the material to meet this obligation, it is not foreseen that administrative procedures and costs related to meeting the obligation would be in any way burdensome. As a matter of patent law practice there are a number of other disclosure requirements including disclosure of best mode. As already noted, there are already a number of Members that require such a disclosure of source and country of origin of biological resources and/or traditional knowledge used in an invention.

10. The collection and recording of the information necessary to meet the obligation should not require applicants to undertake significant additional recording and documentation outside what would be done in the process of developing an invention even where there is no disclosure obligation. The only significant difference would be that from the information that is usually collected and recorded in the process of invention, the applicants would have to cull out information relating to use of biological resource and/or traditional knowledge. The disclosure obligation as envisaged, taking into account existing practice would therefore not impose any burdensome administrative or costs on applicants.

IV. WHAT WOULD BE THE LEGAL EFFECT OF WRONGFUL DISCLOSURE OR NON-DISCLOSURE?

11. There has been significant debate on the legal effect on the application or granted patent in cases where there is insufficient, wrongful or no disclosure of the biological resource and/or traditional knowledge used in an invention. As already noted, the proposed disclosure requirement will have both formal and substantive components and implications. The nature of the legal effect of insufficient, wrongful or no disclosure will depend on whether one is dealing with a formal or substantive component of the disclosure and whether it is at the level of pre or post-grant.

12. In this context, where the insufficient, wrongful or no disclosure is discovered before the examination or grant of a patent, the legal effect could be that the application would not be processed any further until the submission of the necessary disclosure declaration. This could be accompanied with penalties and time limits within which the proper disclosure should be made otherwise the application could be deemed withdrawn. In essence, the insufficient, wrongful or no disclosure of the source and country of origin of biological resource and/or traditional knowledge should justify the non-processing of the application as it affects the determination of prior art, inventorship or entitlement to the claimed invention, the scope of the claim and/or whether it is necessary for understanding or carrying out the invention.

13. Where the insufficient, wrongful or lack of disclosure is discovered after the grant of a patent, the legal effect could include:

" Revocation of the patent where it is determined that the proper disclosure would have led to the refusal to grant the patent either on the grounds of lack of novelty due to the existence of prior art or on grounds of ordre public or morality and where there is fraudulent intention for the insufficient, wrongful or lack of disclosure. In addition, to revocation criminal and/or administrative sanctions may also be imposed, for example, where the insufficient, wrongful or lack of disclosure amounts to a false representation;

" Full or partial transfer of the rights to the invention where full disclosure would have shown that the another person or community or governmental agency is the inventor or part inventor or would otherwise be entitled to all or part of the claimed invention; and,

" Narrowing the scope of the claims where parts of the claims are affected due to lack of novelty or fraudulent intention or where full disclosure would have led to refusal to admit those parts of the claims.

We are mindful that the above-mentioned concepts will be further developed where Members may need to reflect on the mechanism to implement such concepts, which could include judicial review, as necessary. While a certain level of leeway may be given here on the exact legal effect for each infraction, each Member should nevertheless have an obligation to ensure that the effect of insufficient, wrongful or no disclosure is effective in terms of its deterrent, compensatory and equity value.

14. It should be noted here also that apart from the above possible legal effects of insufficient, wrongful or no disclosure of the source and country of origin of biological resource and/or traditional knowledge used in an invention there may be separate and additional legal effect related to enforcing obligations related to prior informed consent (PIC) and benefit sharing (BS) which are not discussed here.

V. ON WHOM SHOULD THE BURDEN OF PROOF LIE?

15. An application will be deemed to prima facie comply with the disclosure requirement if it contains a declaration in a prescribed form indicating the source and country of origin of the biological resource and/or traditional knowledge used in an invention. However, this will only cover the basic part of the question of burden of proof. It is anticipated that while the submission of a declaration of the source and country of origin of a biological resource and/or traditional knowledge used in an invention would - facie establish compliance with the disclosure requirement, the applicant will be required to positively discharge a burden of proof that the genetic resource and/or traditional knowledge was legally and legitimately accessed and that benefit sharing had or would take place if a patent is granted with respect to the invention that used the biological resource and/or traditional knowledge. The issue of how the disclosure under the patent system would relate to prior informed consent and access and benefit sharing regimes would be dealt with in the second and third sets of the issues in the Checklist of Issues.

VI. IN WHAT MANNER SHOULD THE PROPOSED OBLIGATION OF DISCLOSURE OF SOURCE AND COUNTRY OF ORIGIN AND ASSOCIATED TRADITIONAL KNOWLEDGE BE INTRODUCED IN THE TRIPS AGREEMENT?

16. The obligation on applicants to disclose the source and country of origin of a biological resource and/or traditional knowledge used in an invention contemplates a positive obligation to be imposed on patent applicants. A number of Members already require patent applicants in their territories to disclose the source and country of origin of a biological resource and/or traditional knowledge used in the invention.

17. However, bio-piracy is a global problem and more often than not, involves the acquisition of material in one country and seeking of a patent in another country. This means that relying on national measures alone is not sufficient to address the bio-piracy problem. To ensure the effectiveness of the contemplated obligations on the applicants, a positive and mandatory obligation needs to be imposed on Members to require the disclosure by patent applicants in their territories of the source and country of origin of the biological resources and/or traditional knowledge used in inventions. Such a positive and mandatory obligation could be introduced into the TRIPS Agreement either by appropriately amending the existing provisions or by introducing a new article in the Agreement.

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