TWN Info Service on Intellectual Property Issues (Sept23/02)
4 September 2023
Third World Network

WIPO: IGC special session to discuss draft text on legal instrument on IP and genetic resources amidst biopiracy legitimisation concerns

Geneva, 4 September (K M Gopakumar) – The special session of the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) will discuss a draft international legal instrument amidst concerns that this will legitimise biopiracy.

This will take place on 4 to 8 September at the headquarters of the World Intellectual Property Organization (WIPO) in Geneva.

The draft text is relates to intellectual property (IP), genetic resources (GRs) and traditional knowledge (TK) associated with genetic resources amongst the concern of legitimising biopiracy. The special session is organised as part of the preparation for the Diplomatic Conference to finalise the international legal instrument as mandated by the  WIPO General Assembly in 2022. It was decided to hold a diplomatic conference to conclude an International Legal Instrument Relating to IP, GRs and TK Associated with Genetic Resources. 

The decision “directed the IGC to meet in a special session for five days in the second half of 2023, preceding the Preparatory Committee, to further close any existing gaps to a sufficient level. It is understood that the Preparatory Committee will invite Observer Delegations and Observer.”

It also decided to convert the IGC Chair's text as the basis for negotiation:  "… agreed that document WIPO/GRTKF/IC/43/5, the Chair’s text of a Draft International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources will constitute the substantive articles of the Basic Proposal for the Diplomatic Conference”.

The Chair's text was prepared by then Chair of IGC Mr. Ian Gross of Australia and submitted to the IGC in 2019. The IGC was established in 2000 when developed countries argued that the Convention on Biological Diversity was not the appropriate forum to address misappropriation of genetic resources and associated traditional knowledge commonly known as biopiracy, an issue that was largely placed on the table by the Africa Group. Negotiations over several years saw little progress as divergence between developing and developed countries remained.

Through the 2022 General Assembly decision, the Chair’s text replaced the consolidated text used for the negotiations until the 43^rd session of IGC (30 May- 3 June 2022).

However, Member States are allowed to make contributions and subject to the agreement reached in the Special Session such contribution could be made part of the basic proposal. The General Assembly decision states: “The Preparatory Committee shall incorporate in the Basic Proposal such further agreements of the IGC as are reached pursuant to paragraph (d) above, with the understanding that any Member State and the Special Delegation of the European Union may make proposals at the Diplomatic Conference.”

As of 3 September India had submitted extensive amendments to the Chair’s draft text.

The international instrument originally aimed to propose a disclosure regime along with remedies and sanctions to prevent the misappropriation of GR and associated TK. The disclosure of the geographical source of GR also helps to enforce compliance with access and benefit sharing regimes under the Convention on Biological Diversity (CBD) and its Nagoya Protocol.

Key concerns on the Chair’s text are as follows.

Objectives

The draft text sets the following objectives of the instrument:

(a) enhance the efficacy, transparency and quality of the patent system with regard to GRs and Associated TK, and

(b) prevent patents from being granted erroneously for inventions that are not novel or inventive with regard to GRs and Associated TK.

Thus, the suggested objectives of the instrument are to enhance the efficacy and transparency of the patent system related to GRs and associated TK, and to prevent “erroneous” grant of patents on GR and associated TK, which are not novel and inventive. The draft text thus ignores the very purpose of the international legal instrument i.e., prevention of the biopiracy of GR and the associated TK using IP especially patents. Often individuals and companies, especially from developed countries, patent the GRs and associated TK fully or in part without complying with the benefit sharing requirements under national and international law.

The Chair’s text provides the following justifications for the exclusion: "… there is no reference to issues related to access and benefit-sharing or to misappropriation, as these issues are already dealt with in other international instruments, such as the Convention on Biological Diversity (CBD), the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (Nagoya Protocol), the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) of the Food and Agriculture Organization of the United Nations”

One of the central concerns of the IGC is to check such misappropriation. To address this concern India added the following words to the chapeau: “… contribute to the protection of GRs and associated TK within the IP system by”. The chapeau now reads: “The objectives of this instrument are to [IN: contribute to the protection of GRs and associated TK within the IP system by …”

The second objective indirectly conveys that there could be patents on GRs and associated TK if there is novelty and inventiveness. However, there are WIPO Member States that exclude TK from the patent protection. For instance, Section 3(p) of the Indian Patents Act excludes TK from patent protection “an invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components”.

Definitions

The draft text defines GRs as “genetic material of actual or potential value”. Further, genetic materials are defined as “any material of plant, animal, microbial or other origin containing functional units of heredity”. According to the Chair’s explanation, “The definitions of genetic resources, genetic material, country of origin and in situ conditions detailed in the list of terms have been taken directly from existing multilateral agreements relating to the GRs, notably the CBD”.

This current definition raises two concerns. First, the definition excludes the use of digital sequence information (DSI) from the scope of the international instrument. Developments in the technology have enabled the development of products without physical access to the genetic material. Secondly, these definitions reduce the scope of the instruments to the genetic materials and not their derivatives. The scope of benefit sharing under the Nagoya protocol covers derivatives. Under the Nagoya Protocol a “Derivative” means “a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity”.

A further concern is related to the definition of the term “materially/directly based on". The draft text defines this term as follows: “ [Materially/Directly] based on" means that the GRs and/or Associated TK must have been necessary or material to the development of the claimed invention and that the claimed invention must depend on the specific properties of the GRs and/or Associated TK”.

According to the Chair explanation the term “materially/directly based on” specifies the relationship between the claimed invention and the GRs and Associated TK which activates the obligation to disclose”.  The Chair also provided the following rationale for the word “materially”:  “Currently there is a significant divergence in triggers at the national and regional levels e.g. directly based on, based on, based on or derived from, is the basis of, used in an invention, invention concerns, relates to or makes use, an invention-creation accomplished by relying on genetic resources. There is also significant ambiguity regarding the meaning of these terms. In order To maximise legal certainty, two amplifying adverbs (materially/directly) have been proposed, in addition to the trigger concept "based on", for consideration by Member States, reflecting discussions held during IGC 36 in June 2018. The alternate term "materially" has been included as the term "directly" has been contentious within the IGC's deliberations.”

“A contentious issue related to the concept of “directly based on”, which is included in the proposal of the EU first tabled in 20056 , is the requirement for the inventor to have physically accessed the GRs. This touches on different views within the IGC as to whether or not physical access to a GR is still required by an inventor noting technological advances in this area. To address this difference of view, the definition is now silent on this issue. In addition, it was also proposed by the EU that the definition includes the phrase “must make immediate use”. In my view, respectfully, there is a lack of clarity in relation to the meaning of this term. To address this issue, the terms “necessary” and “material to” have been included to reduce ambiguity. In addition, the phrase “the claimed invention must depend on the specific properties of the GRs and Associated TK” is included in the definition”.

However, the term "materially based on" gives discretion to the patent applicant as well as Parties to the international instrument to decide on a case-to-case basis whether the disclosure is to be made. In other words, this definition would compromise the disclosure requirement and limit it to only those inventions “materially based” on GRs and associated TK.

India’s submission points out that “The current definition proposes a very narrow trigger, thereby, requiring disclosure only in such instances where there is a very strong causal link between the GR and/or ATK used and the claim of invention in the patent application. This could possibly be interpreted very differently to the obligations under other international legal instruments such as CBD and the Nagoya Protocol and could lead to inconsistency in interpretation and implementation. Therefore, substantive changes have been proposed in the definition to make the scope broader and clearer in terms of requiring disclosure where either of the conditions have been fulfilled”.

India proposes the following amendments to the definition: “ Materially /Directly based on” means that the GRs and/or Associated TK  must have been  necessary or material to the development of the claimed invention, and or that the claimed invention  must depends on the specific properties of the GRs and/or Associated TK”.

Disclosure Requirements

Article 3 of the draft text sets out the disclosure requirements. Paragraph 1 makes it compulsory to disclose the country of origin GRs if the claimed invention in a patent application is [materially/directly based on GRs. If the applicant is not aware of the source or origin then the applicant need not disclose.

Paragraph 2 sets the same conditions for associated TK. Paragraph 3 states that Parties shall require the applicant to make a declaration if the information in Paragraphs 1 and 2 is not known to the patent applicant. Paragraph 4 obligates patent offices to provide guidance to patent applicants to meet the disclosure requirements, including the rectification of incorrect or erroneous disclosure. Paragraph 5 obligates Parties not to create an obligation on patent offices to verify the authenticity of the disclosure made by the patent applicant.. Paragraph 6 proposes an obligation to “make the information disclosed available in accordance with patent procedures, without prejudice to the protection of confidential information”.

As mentioned above the disclosure requirement under Article 3 is very narrow and gives the room for bypassing the strict implementation of the disclosure requirementsThe disclosure requirements aim to prevent the misappropriation of GR and associated TK as well as to ensure the compliance with access and benefit sharing. WIPO’s report on  disclosure requirements identified the following three types of national laws.

·         to disclose any GRs/associated TK actually used in the course of developing the claimed invention;

·         to disclose the actual source of the GRs/associated TK – this may concern the country of origin or the country from which the resource or knowledge was acquired;

·         to provide an undertaking or evidence of compliance with relevant access and benefit-sharing requirements - this may entail showing that GRs/associated TK used in the claimed invention were obtained with prior informed consent and used in compliance with mutually agreed terms and applicable laws in the country of origin.

The explanation in the draft text identifies 30 countries already having such disclosure requirements. The Indian Patents Act, for example, requires the patent applicant to disclose the geographical origin of the biological materials when used in an invention. Section 10.4.(d)(ii) (D) requires a patent applicant to “disclose the source and geographical origin of the biological material in the specification, when used in an invention”.

India suggested amendments to Article 3. First, India proposed the deletion of the word “direct” from Paragraph 3.1 and 3.2.  It also suggested replacing the words “country of origin” with “source of origin” in Paragraph 3.1 (a) and 3.2 (b) and making it compulsory to disclose the source of origin instead of country of origin. Further, India also proposed amendments to disclose the country of origin if it is known to the applicant.

India provides the following rationale for its amendments: “In terms of the content of disclosure, the current formulation gives precedence to the country of origin in case of GRs, and the indigenous people or local community for associated TK, which may or may not be known, while the inventor and/or the applicant would always be aware of the source of the GRs and/or ATK on which the research is carried out or from where the knowledge of the properties has been obtained. Further the interpretation of the country of origin leads to ambiguity on the scope whether it means the country from which GR is obtained or the geographical origin of the GRs. Therefore, a revised formulation has been proposed to provide precedence to source which is clearer and easier to determine and almost always known or ought to be known. Additionally, the same has been supplemented in case of GRs with country of origin where it is known and applicable and with indigenous people or local community or holders and practitioners of TK which are also important constituents and often the source of providing traditional knowledge. This when read with the changes made in the definition of source of GR and ATK make easier and clearer for the applicants to make the disclosure as part of their application.”

Sanctions and Remedies

Article 6 of the draft text deals with sanctions and remedies. According to Paragraph 2, an opportunity to be given to the applicant to rectify the  failure to include the minimum information detailed in Article 3, before implementing sanctions or directing remedies. 

Paragraph 3 is the most controversial provision. It states that “Subject to Article 6.4, no Contracting Party shall revoke or render unenforceable a patent solely on the basis of an applicant’s failure to disclose the information specified in Article 3 of this instrument”.  Paragraph 4 of Article 6 allows sanctions only on “fraudulent intent in regard to the disclosure requirement in Article 3”. It is difficult to prove fraudulent intent. 

In countries like India, mere non-disclosure of geographical origin constitutes a ground for revocation. According to Section 64(p) of the Indian Patents Act, "that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention” constitutes a ground for revocation of patents.

The draft text thus drastically reduces the effectiveness of the disclosure requirement and can perversely legitimise the misappropriation of GR and associated TK through patents.+