If nucleotide/amino acid sequences are disclosed in a patent application, the description must contain a sequence listing. A sequence listing is a list of biological sequences in the format prescribed by WIPO Standard ST.25 (Presentation of nucleotide and amino acid sequence listings) using controlled vocabulary (i.e., defined terms for certain features). Patent offices may require applicants to file sequence listings in a standardized format when no sequence listing is furnished for the sequences referred to in the description, claims, and/or figures of a patent application. The sequence listing itself recognizes the gene or protein by an “SEQ ID NO” (e.g., SEQ ID NO: 1) and provides the complete sequence, which is then made directly accessible in the patent application.
Sequence listings enable biological sequence data in patent applications to be collected and transmitted to search databases that are used by the Patent Offices and by the public. It is therefore important that all the biological sequences that meet the criteria set forth in the standard, regardless of whether they are naturally occurring, artificially synthesized, or randomly generated for exemplary purposes be included in the sequence listing. Biological sequences serve as prior art and as references for future research and innovation. The presentation of the biological sequence data in the standardized format of a sequence listing facilitates both publication and inclusion in searchable databases.
On July 1, 2022, the change in the standard of presentation of the Biological Sequence Listing, from WIPO Standard ST.25 (TXT) to WIPO Standard ST.26 (XML), defined by the World Intellectual Property Organization – WIPO for applications as of 07/01/2022 the representation of nucleotide and/or amino acid sequences in the sequence listing must follow the standard WIPO ST.26, through a single XML format file, according to the rules on the Brazilian Patent Office (BR PTO) website.
WIPO has indicated that there will be no transition period, although it has accepted that exclusions to this standard may be allowed in exceptional circumstances. In the case of Brazil, applications filed until 06/30/2022 that submitted the Sequence Listing in WIPO Standard ST.25, in case of resubmission of the Sequence Listing, must maintain WIPO Standard ST.25, by the rules on the Brazilian Patent Office (BR PTO) website on the Internet.
Given the changes introduced by the new standard, WIPO has developed a new free tool known as “WIPO Sequence” which is available together with a user manual, a test data set, and a sequence validator for the generation of complex sequence listings following the new standard. The WIPO Sequence tool will be available for download on the Brazilian Patent Office (BR PTO) website, together with the respective user manual. From July 1, 2022, the sequence listings will be accessible on the Brazilian Patent Office (BR PTO) website, in XML or TXT format.
In conclusion, it should be noted that the change introduced by the new standard is radical and hides what is a significant revision of this important aspect of the drafting of a biotechnology patent application, starting with achieving compatibility with the requirements of the International Nucleotide Sequence Database Collaboration (INSDC). In fact, the new ST.26 standard not only solves the problems existing in the old St.25 standard, but also introduces new specifications and attributes that allow better access to information.