Regulations Relating to the Indication of the Origin of Genetic Material in Patent Applications

As informed in the article "Indication of the Origin of Genetic Material in Patent Applications", published in Dannemann Siemsen News of December 2006, up to that time, Brazilian authorities had not yet clearly defined the mechanisms for introducing information regarding the origin of genetic material relating to patent applications filed in the country.

A Work Group (GT) was formed by the Genetic Heritage Management Council (CGEN), under the Ministry of the Environment (MMA), to discuss ways to implement article 31 of Provisional Measure (PM) No. 2,186-16, of August 23, 2001, previously published as PM no. 2,052, of June 29, 2000, which focused on regulating access to Brazilian genetic heritage and the associated traditional knowledge.

Therefore, in the aim of regulating the procedures for the granting of patents of this nature, the CGEN edited Resolution no. 23, published on December 28, 2006, which the Brazilian Patent and Trademark Office (BPTO) sought to bring into effect through the recently edited Resolution no. 134/2006, which came into force on January 02, 2007.

In summary, the Resolution of the BPTO establishes that: (i) as of January 2, 2007, all patent applications filed in Brazil, including those that relate to domestic phase of international PCT applications, must contain a declaration by the applicant stating whether or not the subject of the application was obtained from any samples of components of Brazilian genetic heritage accessed on or after June 30, 2000.

Therefore, the BPTO’s new Resolution establishes two new obligations. The first, which takes effect as of this year, obliges the applicants of any patent applications to state whether or not their applications relate to Brazilian genetic heritage (if accessed after June 30, 2000) and, if so, it requires that they provide evidence that such access was gained with the government’s authorization.

On this point, note that, under the pretext of establishing the procedures to implement the PM and its regulation by the CGEN, the BPTO unnecessarily increased the requirements of said regulations. The reason for this is that, under Resolution 134/2006, the BPTO now requires that the applicants of each patent application provide a declaration stating the relationship between the subject matter of their application and components of Brazilian genetic heritage. However, neither the PM nor the CGEN Resolution establish the need to provide a negative declaration when the patent in question has no relation to Brazilian genetic heritage.

On the other hand, the second obligation created by the BPTO is, to a certain extent, surprising. From the time the PM was edited (in 2000) to the beginning of this year, the BPTO itself deemed the need to submit, upon filing patent applications, proof of the government’s authorization to access the genetic heritage on which the subject of the patents was based unnecessary. However, the CGEN’s recently-edited Resolution, which in general terms requires that all patent applications filed since June 30, 2000, be adapted, the BPTO contradicted its own previous understanding and established a retroactive obligation for the applicants of patent applications.

Discussions on the matter have been promoted by trade associations in order to obtain more information, particularly with regard to the implementation of the new rules. In any case, it is recommended that potential applicants seek more detailed advice regarding this issue, if the invention to be protected is related to Brazilian genetic heritage or traditional knowledge.

* co-authored with Fabio Riva