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New WIPO Standard ST.26 for the submission of Biological Sequence Listings will be mandatory from July 01, 2022

On July 1, 2022, the ST.26 standard entered into force, which dictates how biological sequence listings must be presented in patent applications.

To meet the sufficiency requirement in the description, inventions based on biological sequences (nucleic acids and proteins) must present, together with the description, a list in an electronic format that identifies in detail the sequences that are part of the invention. This list also allows patent offices to search for the sequences of the invention in the databases to prepare search reports.

Until now, the list was prepared following the ST.25 standard, in force since 2009. But the progress in the field of biotechnology and the search to find a uniform representation of the lists in all the industrial property offices of the world has led the WIPO (World Intellectual Property Organization) to evolve to a new standard that has been implemented simultaneously worldwide on July 1, 2022.

In addition to the change in the file format, from the text (.txt) to extensible markup language (.xml), the ST.26 standard allows molecules to be represented in the list as nucleotide analogs, branched proteins, or D-amino acids. Another advantage is that the new format is compatible with biological sequence databases (INSDC, International Nucleotide Database Collaboration), and is available to any user. The list is made up of a common structure and a series of identifiers for each sequence (elements and attributes) that allow characterizing the particularities of each sequence.

WIPO recommended simultaneous implementation in all offices for all patent applications that included sequence listing, with the exception of cases where the application had been filed without listing before that date. However, in practice, each national office has adapted the standard to its legislation, with differences in the format of the list when the new application derives from another filed before July 1, 2022, and therefore in ST.25. To avoid subsequent requests from the offices, it is necessary to know the differences in application in relation to key aspects such as priority claim, entry into the national/regional phase, or the application of divisional ones.

At ClarkeModet we have a group of experts in preparing the appropriate format in each office.

The implementation of this new standard highlights the global interest in industrial property for generating universal tools that adapt to the technological development of a sector as innovative as biotechnology.

Lorena Vega