In a process that has spanned more than 2 decades, WIPO has sought to obtain consensus among its member states on protection for genetic resources and associated traditional knowledge (TK). The process has been a slow and, until now, generally not produced the desired outcome for countries in support of protecting genetic resources and traditional knowledge.

Much of the deliberations focused on requiring the national laws of member states to require disclosure of the origin of genetic resources (where the invention related to these) as well as a disclosure of the traditional knowledge on which the invention relied (insofar as this was the case).

FICPI has been involved in the process since its inception. In 2004 FICPI passed the following resolution:

 “Proposal on Disclosure Requirements Relating to Genetic Material Resources”

FICPI, the International Federation of Intellectual Property Attorneys, broadly representative of the free profession throughout the world, assembled at its Executive Committee held in Venice from 4 – 6 October 2004, passed the following Resolution:

Whereas FICPI has previously indicated that it supports a reduced number of issues to be included in the SPLT to enable the SPLT to progress;

Noting that some member states of WIPO have proposed provisions requiring a declaration in a patent application of the source of any genetic material on which the invention is based; and

Also noting the desire of some member states to have the source of any traditional knowledge on which a patent is based acknowledged, but observing that traditional knowledge, as prior art, is completely different from genetic resources and should be dealt with separately;

Urges that if any such provisions relating to genetic resources should be adopted then the following should apply:

1| The declaration requirements must be clearly and precisely defined;

2| The applicant should be required to identify only the source from which the genetic material was actually obtained by the inventor;

3| If there is a requirement to share any benefit accruing from the invention then there must be an appropriate authority in the country from which the genetic material was obtained and which the applicant for the patent can contact in order to enter into negotiations;

4| Any such requirement should apply only to genetic material obtained after such provisions have come into force; and

5| The applicant should be entitled to an opportunity to rectify any failure to comply properly with the declaration requirements, and the consequence of any ultimate failure to meet such requirements shall not, in the absence of fraudulent intent, be invalidation or unenforceability of the patent.

Diplomatic Conference

In June 2022, in a move which surprised many, WIPO member countries decided to fast track negotiations by convening a Diplomatic Conference by no later than June 2024. Diplomatic Conferences are rare, high-level meetings which are geared to achieving a successful outcome. In this case, an internationally binding legal agreement is sought which requires applicants seeking patents for inventions that are based on genetic resources and associated traditional knowledge to disclose the source or origin of the genetic resources and associated traditional knowledge.

The proposed relevant proposed text, at this stage, reads as follows:

ARTICLE 3

DISCLOSURE REQUIREMENT

3.1 Where the claimed invention in a patent application is [materially/directly] based on GRs, each Contracting Party shall require applicants to disclose:  (a) the country of origin of the GRs, or,  (b) in cases where the information in sub paragraph (a) is not known to the applicant, or where sub paragraph (a) does not apply, the source of the GRs. 

3.2 Where the claimed invention in a patent application is [materially/directly] based on Associated TK, each Contracting Party shall require applicants to disclose:  (a) the indigenous peoples or local community that provided the Associated TK, or,  (b) in cases where the information in sub paragraph (a) is not known to the applicant, or where sub paragraph (a) does not apply, the source of the Associated TK. 

3.3 In cases where none of the information in paragraphs 3.1 and/or 3.2 is known to the applicant, each Contracting Party shall require the applicant to make a declaration to that effect.

 3.4  Offices shall provide guidance to patent applicants on how to meet the disclosure requirement as well as an opportunity for patent applicants to rectify a failure to include the minimum information referred to in paragraphs 3.1 and 3.2 or correct any disclosures that are erroneous or incorrect. 

3.5 Contracting Parties shall not place an obligation on Offices to verify the authenticity of the disclosure. 

3.6 Each Contracting Party shall make the information disclosed available in accordance with patent procedures, without prejudice to the protection of confidential information.

 

It will be noted that the proposal is broadly in line with the 2004 FICPI resolution.

Preparatory to the Diplomatic Conference, WIPO has convened an IGC Special Session to be held 4 to 8 September 2023 and a Preparatory Committee to be held 11 to 13 September 2023. We will be attending the IGC Special Session and will be represented by Bastian Koster and Rowan Joseph. For a number of years, Bastian was a regular attendee on behalf of FICPI of the WIPO deliberations and has significant historical context. Rowan is currently monitoring these important deliberations on behalf of FICPI.

Next steps

Any of the national groups which are aware of their intellectual property office having expressed a position on this topic, should please feed that information through to Rowan Joseph.

If you would like to become involved in this topic, please contact Robert Watson or Rowan Joseph.

Read more about the Diplomatic Conference, including official WIPO documents, at https://www.wipo.int/diplomatic-conferences/en/genetic-resources/index.html .

 

 

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