Report of the Biotechnological Committee
Below is an update of activities in our Biotechnology Committee (BC) since the last Q3_2024 report:
1. Change of the name of the BC Committee
The name of this committee is now “Biotechnology Committee” (the former name was “Committee on Biotechnological Inventions”). It has been made shorter and has the same format (the word “committee” as suffix) as other committee names. There is no change in remit. By Laws was consulted. This was decided at the recent Council Meeting (C98) in Budapest.
2. EPO - Meeting of BC with DG1 | Nov. 29, 2024
Before the pandemic this was an annual event. No such meetings took place for a number of years afterwards (a shame, as it was a good example of epi co-operation with the EPO) but we have been able to persuade the EPO (with the kind help of Chris Mercer) to restart the annual meetings.
Thus a meeting took place on 29 November 2024 in the Hague and will be hybrid (in person and ViCo).
Both the Chair and Secretary will attend in person, as well as some of BC’s members (Benjamin Quest; Thorlakur Jonsson; Marta Kawczynska and Jan G.M. Desomer. A lot of our BC’s members also attended the meeting online.
On the EPO side, attendees were Sönke Holtorf (director operations, Biotech & Immunology, DNA, Peptides & Cells), Sytse De Jonge (director operations, a.i., Pharma, Chemical Compositions & Formulations); Tangy Michotte, Harald Schmitt Yodiee and Razik Menidjel. Other EPO members also took part from time to time, depending on their expertise and the subjects addressed.
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WIPO treaty on Genetic Resources and Associated Traditional Knowledge
The EPO is not yet obliged under the new WIPO Rules to check the information put by the applicant, but the office can offer to rectify the information, for example, about the origin. If the origin is missing, the sanction could be the withdrawn of the patent application if after having received an office action, no reaction / answer is provided by the applicant. However, if the EPO receives any information about this origin, the formality is deemed to have been fulfilled. The EPO never checks whether this information is correct (or not).
Regarding the implementation by the EPO of the treaty, it remains to be seen if there is any interest from EPC member states. A working group has been set up at contracting states level to ascertain whether the contracting states wish to go further in terms of implementation. -
NGT plants
A compromise has been put forward by the Belgium presidency of EU. It seems that Poland (which will have the next EU Presidency from January 1, 2025) might want to advance the file starting from the latest Belgian position including a “patent waiver”, which is only slightly better that the “patent ban” adopted by the EU Parliament. Anyway, it’s not a good model to have patent ban or waiver for NGT plants in Europe. epi called for a close collaboration between epi and EPO on that topic.
The epi reminded that EPO is not bound the EU law. The EPO has also concerns regarding having a full team in Munich only working on plants. -
Life Science prosecution matter: Searches, Fees and Unity of invention issues
epi expressed concerns about the too mechanistic approach used by the EPO when dealing with unity of invention, especially for sequence-based inventions and marker-based inventions. The epi asked the EPO and examiners to be more understanding when considering Unity.The EPO agreed that Unity of Invention can be an issue. They argued that they have already made great progress on it. EPO said that the cases presented seemed specific and that the EPO examiners are usually advised to consider the technical effect(s) presented in the application and not merely dividing the subject-matter exclusively based on structural features. EPO also reminded us there are non-unity experts at the EPO who can be consulted if we think that the search is poor. It will be great for epi’s members to use that possibility on a regular basis. EPO also agreed to share the examples by epi to remind to examiners that EPO should not take an academic approach. epi also made the remark that having the EPO talk first to the Applicant before identifying an excessive number of inventions could solve a lot of issues.
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G1/24 referrals and amendments of description
G1/24: The oral proceedings on case G 1/24 (“Heated aerosol”, claims interpretation) before the EPO Enlarged Board of Appeal will be held on 28 March 2025. The public and members of the media will be able to follow the proceedings online via livestream.
Amendments of the description: there are 2 distinguished camps / positions on that matter. The EPO decided to not stay proceedings on that case. Early next year, the EPO will consider the next steps, depending also on the G1/24 decision which is expected in Summer of 2025. EPO will currently not follow decision T56/21. -
Plant and animal-related inventions
epi commented on CPL/61 (yearly status report plant and animal-related inventions), particularly regarding the mentioning of 4 pending appeals of which only 1 can be expected to provide additional guidance on Art 53 b) EPC. According to the epi, there are currently 3 different definitions of the “Essentially Biological Process” ( EBP) [Re. Rule 26(5); G1L06 and G2/07 and Guidelines Part G/II.5.4] with a lot of inconsistency, and only limited case law for support, emphasizing the role of meiosis in “sexual crossing of whole plant genomes” Meiosis is not involved in generation of genome-edited haploid plants by haploid inducers, nor in hybrid seed production.EPO Jürg Bilang downplayed the importance of meiosis for a process to be defined as EBP. The term “crossing” includes the formation of gametes which is achieved by meiosis. Only in cases of haploid induction can there be some doubt. Jürg Bilang also informed epi that EPO does not always use the EU terms. As an example, we are talking about CRISPR Cas9 and plants generated by using this technology for many years, but in that case any product obtained from this technology is not considered by EPO as an NGT product. The EPO has its own definition of the NGT category and has not been influenced by EU terms.
Furthermore, about EBP, looking at G decisions, it has been argued that the technological step was the selection step, it’s why the current decisions referred to this. EPO examiners must view not only the sexual crossing of plant but also the selection step.
Regarding the Guidelines Part G/II.5.4, EPO is making a difference regarding product or a product-by-process. Product-by-process claim is treated as a different product only if the production process leaves a characteristic in the product. Product-by-process formulation is not sufficient to distinguish a genome-edited plant from a plant wherein the mutation occurs naturally. The disclaimer solution is preferred.
EPO also highlighted that its team has now a reduced capacity on plant cases. For some months now all the stays have been lifted, and examination has been resumed. More than 300 files have been impacted. Since the last G decision, there are still some pending examination files, but the old ones are prioritized to provide the users with a legal certainty as soon as possible. -
WIPO Standard ST.26 for filing sequence listings epi spent a lot of time going over all the various issues involved in using ST.26, the new software imposed by WIPO, point by point. Some suggested improvements which can be made were shared with the EPO and epi requested the EPO for support to push those ideas at WIPO. Amongst the issues highlighted, the main ones are the following:
- Bulk editing properties in WIPO Sequence are underdeveloped, resulting in the necessity of a high volume of manual interventions.
- Impossibility to change the molecule type.
- A lot of manual manipulation with ST26 is not practical and has a high risk of errors.
- The usability of the software is questionable, especially with a lot of SEQs, and the validation of projects can be very slow, in particular for large projects – it is difficult and there are large risks.
- Conversion from ST25 to ST26 in case of divisional applications:
- Excessive changed-data table to which we have to go through if we want to be able to sign the declaration that there is not added matter is impractical as attorneys have to we have look through very large documents - sometimes 450 pages (or so)!
- Complexity of what needs to be adopted under ST26 (but not under ST25).
- Mixed DNA/RNA –> cannot be reasonably implemented at a practical level! Impossible to use the XML files, what was possible with ST25 does not work anymore.
epi also pointed out that the support for applicants from the official resources of the EPO is rather thin (partially misleading FAQs, no link to other resources for support, no specific email address or whatsever).
epi also highlighted the issues met regarding Mega SEQ listings. EPO was not aware about such an extreme case. Limitation of the file size is new for the EPO.
EPO (Leslie Ripaud, examiner and expert in SEQ listings) informed us they will support us on ST26. The EPO always forwards users’ complaints and lists of improvements to WIPO.
EPO also informed us that a new version of ST.26 software will be available before the end of 2024 containing a lot of improvements. The number of SEQ listings should be more manageable. In 2025, improvements in the changed-data table will be also available. EPO has not yet received the final version for testing.
Furthermore, WIPO will have a survey to get feedback from users about SEQ listing, in particular, the allowance to include short sequences (less than 10 defined nucleotides, less than 4 defined amino acids). The survey will be available in Feb 2025.
Finally, epi concluded by saying that the SEQ listing issues is really a huge burden, resulting in exorbitant costs much more on the users’ shoulders than on the EPO’s. The epi said that it would have been great to have EPO consult us before implementing of the ST.26 and hopes to be consulted in future on other changes. Finally, epi highlighted the existing risk in future opposition cases on added matter, especially when dealing with parent/divisional cases.
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Antibodies: Practice of patenting inventions comprising antibodies
After briefly presenting the situation of the pharmaceutical and innovative market in Europe on antibodies, the epi addressed the subject of the definition of antibodies by epitopes and returned to the very strict approach adopted by EPO when examining the inventive step of innovations based on antibodies. epi requested that for a series of applications (parent and sequence of divisional) the standards of the parent case should be applied to the divisionals, not the evolving stricter standard as currently done.epi stressed that sometimes the restrictions requested by EPO went much further than what was required by the European Medicines Agency for the development of Biosimilars, by systematically requesting that the claims defining an antibody by the required CDRs be also limited to the framework (FW) region or to the entire VH and VL chains. epi referred to the part of the guidelines that dealt with this subject and this was removed in the last updated 2024 version of the Guidelines for examination since this issue was a technical issue and not a legal one.
EPO defended itself from having a strict approach when dealing with inventive step of an antibody directed to a known target. EPO is managing antibody files on a case-by-case basis and in practises. If the applicant has information in their hands proving that the FW has no impact on the binding of the antigen to the antibody, then the restriction to the FW is not required. If this is the case, it is important to request an oral interview with the examiner and seek to escalate the problem using the EPO complaint box.
Again, epi cautioned against a systematic approach by EPO, sharing recommendations that had been copied from official letters and were not in the official EPO Guidelines for examination as published in March 2024. EPO suggested reminding 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. EPO also reminded that it is possible to provide additional data after filing.
The meeting finished with a warm thank you from both the epi and EPO. The epi said it would follow up on matters discussed.
3. Education and training
After the great success of the 1st epi’s podcast dedicated to NGT plants, the Chair and the Secretary of the BC gave a one-hour webinar on 20 November 2024 on Biotech and Life Science legal matters, addressing various issues relating to the protection of biotechnology innovations. Some subjects deserve to be addressed in greater detail at other, more specific seminars. We will be thinking about this for 2025, to ensure that our members are fully informed on all topics that are currently important. The feedback poll from the participants on the webinar chat for this 1st webinar are given below.
A further webinar early next year will cover the issues of Traditional Knowledge, CBD, Disclosure of Origin, Nagoya and digital sequence information etc. following a discussion and initiative between the Chair and President (Peter Thomsen).
4. BC meeting
An online meeting of DG1 participants of the BC took place on 19 November 2024. This last meeting was essentially dedicated to preparing for the meeting of 29 November with DG1, to decide topics (and speakers) and start preparation of slides. No other meeting is planned for 2024.
The date of a main BC meeting scheduled for 2025 will be announced in early 2025. An in-person reunion is planned for spring 2025. The date and venue will be chosen soon (depending on the budget allocated to the BC).