Based on internal debates and Public Consultation with more than 20 entities, including ABPI, BPTO published Normative Instruction BPTO/PR nº 118, which institutes a new version of the patent examination guidelines in the biotechnology area. “Improvements and continuous reviews are essential for better internal harmonization of the technical examinations on the subject matter, focusing on the continuous improvement of the patent examination in the field of biotechnology, as well as in other fields”, explains the BPTO.
Gabriela Neves Salerno, the co-coordinator of ABPI’s Biotechnology Study Committee, considered the new version of the Guidelines to be positive and highlighted two changes. One refers to the inclusion of a paragraph, in response to the consultation of the General Patent Consultancy (CGPAT II), on the application of the Biosafety Law to applications with processes or compositions involving human embryonic stem cells. “There was a controversy in this regard, but the BPTO made it clear in its new guidelines that the marketing prohibition established in that Law has no relation to the granting of patents to which the matter refers, since marketing and patenting are distinct activities”, explains Gabriela Salerno.
Another positive point highlighted by ABPI’s co-coordinator in the new exam guidelines was the acceptance, in the description of the invention, of degenerate nucleotide (DNA) sequences, as long as they generate the same protein, without the need to present each of the possibilities of nucleotide sequences in the sequence listing section. “However, some points brought by the main associations have not yet been considered in this new version of the guidelines, such as the acceptance of the definition of nucleotide or protein sequences regarding their respective percentage of identity and/or similarity”, points out Gabriela Salerno.
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