Disclosure of the Origin of Genetic Resources in Patent Applications

The Convention on Biological Diversity (CBD), signed at the 1992 Earth Summit on Environment and Development, in Rio de Janeiro, protects genetic resources and traditional knowledge associated with biological diversity that are owned by regional and indigenous communities. It is intended to establish an international exchange of genetic resources, technology transfer and fair and equitable sharing of benefits. This exchange, however, must be regulated by the national laws of each country of origin of the genetic resource.

In Brazil, Provisional Measure (PM) No. 2,186-16, of August 23, 2001, established, among other things, the application of intellectual property mechanisms for products or processes obtained from the access to traditional knowledge of indigenous and traditional groups, and required obligatory clauses providing for intellectual property in benefit-sharing agreement.

Provisional Measure No. 2,186-16/01 states that in order to ensure this benefit sharing, the party interested in filing a patent application whose invention involves traditional knowledge and/or genetic resources has to demonstrate compliance with the law to the Patent Trademark Office. This entails authorization from the Genetic Heritage Management Council (CGEN), under administration of the Ministry of the Environment (MMA) and the interested party must also specify the origin of the accessed traditional knowledge and genetic resource. In Brazil, a certificate of legal provenance (including declaration of origin) was chosen as a tracing mechanism for benefit sharing. PM No. 2,186-16/01 also establishes that failure to disclosure the origin of genetic resource may be grounds for cancelling a patent.

Recently, the Federal Audit Courts (TCU), after an auditing process, indicated that the Brazilian Patent and Trademark Office (BPTO) was not complying with PM No. 2,186-16/01, specifically its Article 31, which requires the patent application to disclosure about the origin of genetic resource and associated traditional knowledge (if applicable), thereby compromising one of the CBD’s objectives.

The BPTO argued that it is not yet applying Article 31 of the Provisional Measure because it considers that it is not immediately effective and is subject to regulation by the Executive Branch.

The MMA asserts that granting of patents involving traditional knowledge and/or genetic resources became subject to proof of compliance with the provisions set forth in the Provisional Measure, independent of regulation. Recently, MMA issued an opinion confirming such understanding.

On these grounds, the TCU determined that the Office of the Federal Attorney General (AGU) should issue an opinion about the application of the rule, and also recommended that the MMA and the BPTO discuss the measures necessary for prompt compliance with the Provisional Measure’s Article 31. Additionally, the CGEN formed a Work Group to address methods for implementing the PM’s Article 31. However, until the closure of this newsletter’s edition, an opinion about this matter had not been divulged.

As can be seen, objections may possibly arise against Brazilian patent documents that do not specify the origin of genetic resources and associated traditional knowledge (if any). However, mechanisms and requirements for introducing the disclosure of the origin of these genetic resources in Brazilian patent applications remain undefined, but the establishment of rules on the matter are expected in the near future, at which time we will release our specific recommendations.