The Brazilian Patent and Trademark Office (BRPTO) published on December 29, 2020, a new Ordinance (Ordinance/BRPTO/PR Nº 405) related to the filing of Sequence Listings in patent applications. The crucial point of this new Ordinance refers to the new Sequence Listing format that will be accepted as from January 2021.
These new rules establish that WIPO Standard ST.26 format (XML) is the new acceptable format, which will become mandatory as from January 01, 2022. Nonetheless, until the end of 2021, Applicants are able to file Sequence Listings in both formats TXT/ST.25 and XML/ST.26.
It is important to highlight that WIPO’s members agreed that all sequence listings being part of a patent application submitted at the national and international level must be compliant with WIPO Standard ST.26 as from January 1, 2022.
To support the implementation of Standard ST.26, WIPO has developed a tool named WIPO Sequence, so that the sequence listing in XML format is created, edited and checked. The WIPO Sequence tool is available for download on the WIPO website along with the respective user’s manual.
It is noteworthy that, on December 1st, 2020, the New Examination Guidelines for Biotech Patent Applications entered into force. In this new Resolution, the BRPTO ratified its understanding regarding the characterization of biological molecules and the importance of sequence listing for such characterization. In this sense, it was reiterated that biological molecules (such as polypeptide and polynucleotide) is only considered to be clearly and precisely defined, if characterized by its specific nucleotide and/or amino acid sequences (SEQ ID NO.). BRPTO still does not allow patent applications with biological molecule characterized by its similarity, percent identity to another sequence, functional characterization and indirect characterization.
Furthermore, it is important to highlight that the filling of a Sequence Listing is mandatory to the assessment of the sufficient disclosure requirement of patent applications that aim to protect modified biological molecules.
We will keep you updated in case of any upcoming modifications.
In the meantime, in case of any doubt, please feel free to contact Thais Merida (tmerida@@clarkemodet.com.br) and Larissa Santana (email@example.com).