On February 19, the Brazilian PTO issued Official Gazette number 2511, which contains an important communication: Creation of new codes whose lack of compliance could end with a shelved application.
Those new codes are as follow:
- 11.18 –Application to be considered as definitively shelved due to non-compliance related to Article 229-C of the LPI: In case of not obtaining the consent of ANVISA referring to the provisions of article 229-C of the law 9279 (requirement for granting patents of pharmaceutical products and processes) the patent will be definitively shelved.
- 6.6.2 – Formal requirement –Brazilian genetic heritage access: Request for the applicant to inform if there was access to the national (Brazilian) genetic heritage or associated traditional knowledge, according to art. 38 (I) of Law 13.123/2015. In order to comply adequately with this formal requirement (either positive or negative access), the applicant is ought to generate a Collection Union Guide (GRU) for replying such requirement:
- For a response with positive access content, the GRU needs to be issued under code 264.
- For a Declaration of Negative Access, the GRU needs to be issued under code 273.
This 6.6.2 code of formal requirement will not be issued automatically by the INPI, conversely, only if the INPI understands that there is a possibility that the patent has been obtained through access to the Brazilian genetic heritage, then the applicant will be asked to comply with this requirement.
This will be regardless of whether the patent application has previously received a requirement of this nature (under codes 6.6 or 6.6.1) and even in the following situations:
- The INPI can ask applicants to meet this requirement again, even to those who already responded that there was access to genetic heritage to build the patent, but this access is still in process of regularization before the "CGEN" (Genetic Heritage Management Council of Brazil).
- It can be also asked if the applicant already informed that there was access to the genetic heritage when submitting the application, however it did not include the registration number or authorization of genetic access obtained before the CGEN at the moment of submitting the application.
- It is possible that the code 6.6.2 is issued in applications that were submitted on paper and in which there was no information, at the time of submission, whether or not there was access to the genetic patrimony.
The non-manifestation of the applicant within a 60(sixty) days term counted from the publication of the code in the official gazette, shall have as a result the application shelved, in accordance with Art. 34 of the Brazilian patent law no. 9279.
– 6.6.3 – Formal requirement – sequence listing: The submission of sequence listing (of nucleotides and/or amino acids) through electronic media by complying with Resolution 187/2017, has now to be accompanied with a payment generated by Collection Union Guide (GRU) under code 207.
The non-manifestation of the applicant within 60 (sixty) days from the publication of the code in the official gazette, will have as a result the application shelved, in accordance with Art. 34 of the Brazilian patent law no. 9279.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.