Report of the Biotechnological Committee
Below is an update of activities in our Biotechnology Committee (BC) since the last Q4_2024 report:
1. SEQ Listing and WIPO Standard ST.26
During the DG1 meeting which took place on 29 November 2024 in the Hague with the EPO we were agreed about the following action to be taken on the WIPO Standard ST.26:
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software and to push WIPO to improve the tool in the near future.
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EPO should improve the support for applicants form the official resources of the EPO is rather thin (partially misleading FAQs, no link to other resources for support, no specific email address or whatsoever).
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epi will appreciate if EPO share as soon as possible a version for testing the new version of ST.26 expected in 2025.
Since that meeting, epi has been reached-out in view of a survey on WIPO Standard ST.26 that the International Bureau has recently launched to investigate the impact of the WIPO ST.26 minimum length requirement on applicants and sequence searchers.
On the initiative of the Sequence Listing Task Force of the Committee on WIPO Standards (CWS), the International Bureau has now launched a specific survey. epi’s President, Peter Thomsen, kindly requested that the BC submits the feedback on behalf of epi and informs him about the input provided. The survey is open for feedback until 31 March 2025.
Furthermore, John Gray (Chair, epi Online Communications Committee) attended WIPO PCT WG meeting 18-20 Feb. The BC has now connected with Emma Francis (IP Data Expert & WIPO Sequence Product Owner, Standards Section, International Classifications & Standards Division) of WIPO. A meeting should take place on 26 February with epi’s experts on sequence listing and ST.26.
2. Patenting Antibodies
During the DG1 meeting which took place on November 2024, epi’s BC also highlighted the too systematic EPO’s approach when dealing with inventive step of antibodies. It has been proposed by the EPO/DG1 to remind its Examiners that EPO’s approach should not be strict and non-debatable and that cases should be treated on a case-by-case basis based on the information present and the experiences supporting the invention. The epi will push also EPO to make publicly available any internal guidelines, if any, used when dealing with patentability of antibody.
Since that meeting, two articles (parts 1 and 2) were published in the epi Information by Tamaris Bucher, a Principal Patent Attorney at Novartis Pharma AG, on the issue of the granting of patents to antibody inventions at the EPO. Bucher’s article points the spotlight directly on Part G.II.6.2 of the EPO Guidelines (2024 version) focusing on inventive step. We are looking forward to reviewing Part 3 of the article to be published in February 2025 which promises to outline a new proposal for the formulation of the objective technical problem for antibody inventions.
Inventive step of antibodies is a key and hot issue. Antibodies are the essential basis of future medicines currently being developed or to be developed to meet the patients’ needs and there is a misconception at the EPO that antibody engineering and the development of highly complex pharmaceutical products is nothing more than routine work. It can take more than 12 years to develop this type of medicine and it’s far from a routine work. It is necessary for the EPO to review its practice on this point, and it seems that the epi’s comments made in previous years regarding the Guidelines have not at all caused the EPO to change its way of examining these inventions.
3. Biotech meeting
An in-person Biotech meeting took place on March 14 at Krakow. This meeting was preceded by a joint meeting with the EPPC on the afternoon of March 13 to discuss the subject of divisional applications, G2/24 (right of Interveners), and the quality of examination at the EPO.
