TWN Info Service on Health Issues (May24/12)
22 May 2024
Third World Network

WIPO: Proposed definition in new legal instrument may promote biopiracy

Geneva, 22 May (K M Gopakumar and Chetali Rao) – The proposed definition on the trigger for mandatory disclosure of country of origin or source of genetic resources in patent applications based on these resources and associated traditional knowledge risks promoting biopiracy.

This definition that will drastically narrow the scope of such mandatory disclosure is part of the negotiations at the Diplomatic Conference of the World Intellectual Property Organization (WIPO) that is taking place from 13 to 24 May in Geneva to facilitate the adoption of the International Legal Instrument on Genetic Resources and Associated Traditional Knowledge (GRATK).

The legal instrument is originally mandated to address the misappropriation of GRATK through patents and thus contribute to the effective implementation of access and fair and equitable benefit sharing under the Convention of Biological Diversity and its Nagoya Protocol.

The negotiations are taking place in two main committees mostly in an informal mode. Main Committee1(MC 1) is negotiating on Articles 1 to 10 and Main Committee 2 (MC2) on Articles 11 to 23. These committees deal with the substantive provisions of the treaty.

The first meeting of MC 1 took place on 14 May. Since then, four meetings of MC 1 have been held that discussions on all the substantive provisions except Article 2 i.e. definitions.  Negotiations in MC 1 are conducted through the Ad hoc Contact Group, which does not allow the participation of all Member States.  

The most contentious areas are Articles 2 and 3 dealing with definitions and mandatory disclosure as well as Article 6 on sanctions.

Definition and mandatory disclosure (Articles 2 and 3)

The definitions and the mandatory disclosure requirement constitute the core element of the treaty. Article 3 obligates the Contracting Parties to make it mandatory for the patent applicant to disclose the country of origin or the source of generic resources or the associated traditional knowledge when a claimed invention is materially/directly based on genetic resource.

Article 2 provides the definitions on terms such as “materially/directly”, “genetic resources” and “genetic materials”.  In short, these definitions set the scope of the trigger for disclosure under Article 3, i.e. when the disclosure becomes mandatory.

According to Article 3 a patent applicant must disclose the country of origin or source of genetic resource (GR) and/or associated traditional knowledge (ATK) only when the patent application is material or directly based on GR or ATK. The scope of the disclosure is thus based on the definition of “materially” and “directly”. The definition reads:

“Materially/Directly] based on” means that the genetic resources and/or traditional knowledge associated with genetic resources 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 genetic resources and/or traditional knowledge associated with genetic resources”.

Thus, the definition has two conditions to make a patent application on GRATK subject to the disclosure requirement. First, “the genetic resources and/or traditional knowledge associated with genetic resources must have been necessary or material to the development of the claimed invention. Second, the claimed invention must depend on the specific properties of the genetic resources and/or traditional knowledge associated with genetic resources”. This clearly narrows the number of patents application that fall within the scope of the disclosure requirement. (See analysis: Exclusion of DSI undermines the effectiveness of WIPO’s Proposed International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge.)

During the first meeting of MC 1 on 14 May developing countries including the Africa Group, Group of Latin America and the Caribbean (GRULAC), and like-minded countries proposed the deletion on “materially” and “directly” from Article 3.1 and 3.2. During the Contact Group discussion on 20 May on these paragraphs the Chair explicitly excluded the issue of deletion of these terms from the discussion.

In the latest definition that has emerged from the Contact Group discussion on the definition of the words “materially/directly based on” the words “materially” and “directly” are dropped and now the definition covers only on the term “based on”. The definition states:

“ [Materialy/Directly ] based on “means that the genetic resources and /or traditional knowledge associated with genetic resources must have been  necessary  or material to the development of  for the claimed invention, and that the  claimed  invention must depend on the specific properties of the genetic resources and/or  on traditional knowledge associated with genetic resources”.

According to this proposed definition a patent application based on GR and ATK falls under the mandatory disclosure requirement under Article 3 only when it satisfies two conditions. First, GR and ATK must have been necessary for the claimed invention. Second, the claimed invention must depend on the specific properties of the genetic resources and/or on traditional knowledge associated with genetic resources. This means not all patents based on GR and ATK need to be subjected to mandatory disclosure.

The definition does not provide any explanation on the word “necessary” and therefore a two-step test of necessity is to be applied to the patent application to find out whether the GR and ATK must have been necessary to the claimed invention. First, whether the invention is necessary to the claimed invention. Second, the necessary element should be a “must have been necessary” link. This is a high degree of burden.

Further, as per the definition the claimed invention must depend on the properties of the GR and ATK. There is no shared understanding on the term “specific properties”. In the absence of a definition the term can be interpreted in different ways by different parties.  A broad interpretation could mean that the claimed invention is based on the GR and ATK.  A narrow interpenetration could mean that the term “specific properties” means only the physical properties such as colour, density, volume etc or the chemical properties i.e. the characteristics or behaviour of a substance while undergoing chemical change.  A narrow interpretation could exclude many patent applications from the mandatory disclosure requirement.  

These two requirements in the definition thus bear the danger of making the trigger of disclosure a case-to-case basis and reduces the effectiveness of the disclosure requirement.  GRULAC and India did not fully endorse the text and stated that they will come back on the text at a later point of time.

Further, the term "claimed invention" is understood differently by different parties. It can be interpreted as the invention mentioned in a claim or it can be viewed as the invention described in the specifications. The former interpretation narrows the trigger for the disclosure.

There were no discussions on the definition of “genetic materials”. The current definition excludes digital sequence information (DSI) and thus drastically reduces the effectiveness of the mandatory disclosure because most of the patents on genetic resources use DSI instead of the physical form of genetic materials. The definition of genetic material reads: Genetic material" means any material of plant, animal, microbial or other origin containing functional units of heredity”.

However, if the concept of genetic material is understood narrowly – focusing only on the original or current state of knowledge – it may have limitations in addressing the future potential value of genetic material, especially when it is used in cutting-edge fields like synthetic biology or other new bioeconomic technologies. This narrow definition would legitimise the exclusion of GRATK-based patent applications using the latest technologies from the mandatory disclosure under the instrument. 

During the MC 1 informal and Contact Group discussions Iran proposed text to include DSI within the scope of mandatory disclosure. However, these suggestions are yet to find a place in the negotiation text.