UK: The New Standard For Sequence Listings

Many patent applications in the biotech sector disclose nucleotide and/or amino acid sequences. Some of these applications include hundreds or even thousands of such sequences – each of which can be very long.

On 1 July 2022 (after considerable delays), the World Intellectual Property Office (WIPO) Standard ST.26 replaced ST.25 for sequence listings, and all IP offices of WIPO member states implemented it immediately for new patent applications. According to WIPO, the new standard aimed to harmonise sequence listing practices across offices, reflect advances in biotechnology and meet international sequence database requirements.

Notably, ST.25 did not capture sequence types such as branched sequences, D-amino acids and nucleotide analogues. There was also a concern that data could be lost when transferred from ST.25 to sequence databases.

A fundamental change in the new standard is that the file format is now required to be XML, rather than the more universally accessible TXT formats of the ST.25 standard. Due to this, and the considerable differences which can arise between the representation of the same sequences in the two formats, the conversion of an ST.25 sequence listing to one conforming to ST.26 can be a very considerable task.

To support applicants, WIPO released a new tool called WIPO Sequence to generate ST.26 sequence listings, to help transform ST.25 into ST.26 and to allow reading of the new file format. WIPO also published an FAQ on the implementation, including lengthy discussions on how to convert between the two formats without adding or losing content. Following problems reported with the software, it released a new version with a fix on 5 August.

However, questions have arisen regarding divisional applications. While WIPO required the use of ST.26 for new applications, it was left to individual patent offices to decide whether to require the ST.26 format for divisional applications filed after 1 July 2022, where the parent had a ST.25 sequence listing.

At least in Europe, divisional applications arise from the subject-matter included in a 'parent' application. The addition of subject-matter not present in the parent application is not permitted. Divisional applications inherit the filing date, and where applicable the priority dates of the parent, such that they are generally compared against the same state-of-the-art as the parent application before them.

Source:keltie.com-Paul Waldron

Editor:IPR Daily-Selly