http://ipkitten.blogspot.com/2024/02/highlights-from-new-epo-guidelines-for.html
The updated EPO Guidelines for Examination will enter into force on 1 March 2024. A draft version of the Guidelines can be previewed here. The main updates this year reflect the recent decisions from the Enlarged Board of Appeal (EBA) in G2/21 (Evidence standard for inventive step/plausibility) and G 1/22 (Entitlement to priority). There are also updates on the sufficiency requirements for AI inventions, ways to define antibodies and acceleration of opposition proceedings in cases pending before the UPC.
| Is the Broad CRISPR appeal coming back from the dead? |
Entitlement to priority (A-III-6.1)Following G 1/22 (and G 2/22), A-III-6.1 has been updated to state “absent any substantiated indication to the contrary, there is a strong rebuttable presumption under the EPC that an applicant or joint applicants claiming priority in accordance with Art. 88(1) and Rule 52 are also entitled to the claimed priority. The burden of proof is shifted, and the examining division, opponent or third party challenging an applicant’s entitlement to priority has to prove that this entitlement is missing. Especially where an international application under the PCT is filed by joint applicants, including the priority applicant, but without naming the priority applicant as applicant for the European designation, the mere fact of the joint filing implies an agreement between the applicants allowing all of them to rely on the priority right, unless substantial facts indicate otherwise (see G 1/22 and G 2/22)”.
An interesting question following G 1/22 is the potential consequences for the Broad Institute’s CRISPR cases. In T 0844/18, The Broad Institute famously lost a critical CRISPR patent in view of an invalid priority claim (IPKat). At the time, T 0844/18 was considered the end of the road for the patent. However, with the shift in the approach to priority represented by G 1/22, might the Broad now have a shot at maintaining a patent in this family? Citing G 1/22 and G 2/22, the Broad has already filed an appeal against the opposition decision to revoke the divisional patent EP3144390.
The impact of G 2/21 on inventive step and free evaluation of evidence (E-IV-4.1, G-VII-5.2,11)
The decision of the EBA in G2/21 left plenty of scope for interpretation. The EBA concluded in G2/21 that a patentee “may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention” (Headnote II, G2/21). Recent Boards of Appeal decision have provided some clarity as to what it means for a technical effect to be “encompassed and embodied” (IPKat). The Guidelines have been updated to reflect the EBA’s decision, but provide no further guidance on how it should be interpreted (G-VII-5.2,11). The decision in G2/21 on the principle of the free evaluation of evidence has also been included in an updated to E-IV-4.1.
Disclosure requirements for AI inventions (F-III-3, G-II-3.3.1)
Inventions relating to AI require supporting data and examples akin to the disclosure requirements for inventions in the biotech field (IPKat). This requirement has now been explicitly called out in the guidelines:
“Occasionally applications are filed in which there is a fundamental insufficiency in the invention in the sense that it cannot be carried out by a person skilled in the art […] another example can be found in the field of artificial intelligence if the mathematical methods and the training datasets are disclosed in insufficient detail to reproduce the technical effect over the whole range claimed. Such a lack of detail may result in a disclosure that is more like an invitation to a research programme” (F-III-3)
and
“The technical effect that a machine learning algorithm achieves may be readily apparent or established by explanations, mathematical proof, experimental data or the like. While mere allegations are not enough, comprehensive proof is not required, either. If the technical effect is dependent on particular characteristics of the training dataset used, those characteristics that are required to reproduce the technical effect must be disclosed unless the skilled person can determine them without undue burden using common general knowledge. However, in general, there is no need to disclose the specific training dataset itself” (G-II-3.3.1)
ST.26 sequence listings and divisionals (A-IV-5)
The ST.26 standard for sequence listings came into force in July 2022 and applies to all new European applications filed after this date, including divisionals. Applicants are now therefore required to convert a ST.25 sequence listings filed for a parent case into the ST.26 format for any new divisionals. However, converting from ST.25 to ST.26 has the potential to add matter (as acknowledged by the WIPO itself). A solution to this problem is to add the ST.25 sequence listing to the end of the description of the divisional, and file the ST.26 after the initial filing date. However, applicants following this approach might incur high excess page fees if the sequence listing is very long. In response to pressure from epi, the EPO therefore agreed to waive the excess page fees for adding the ST.25 sequence listing to the description (IPKat). This provision has now been added to the Guidelines: “By way of exception, an additional fee is not due either for a parent application’s ST.25 sequence listing filed in PDF format as part of a divisional application” (A-IV-5).
Designation of the inventor (A-III-7)
A-III-7 now states that the EPO will check whether the designated inventor is a natural person. This update follows the decision in J 8/20 (DABUS) that an AI cannot be designated as an inventor (IPKat).
Acceleration of opposition proceedings in cases of pending actions before the UPC (D-VIII-1.2)
The EPO recently announced new provisions for accelerating opposition in (IPKat). The Guidelines have been updated to reflect the latest notice:
“oppositions are to be given priority […] if a party to the proceedings has submitted a reasoned request for accelerated processing in a case where an infringement action in respect of the European patent is pending before the Unified Patent Court or a national court of a contracting state, or if the EPO is informed by the Unified Patent Court, a national court or competent authority of a contracting state that infringement actions are pending” (D-VIII-1.2)
Antibodies (G-II-6.2)
At the EPO it is possible to claim a genus of antibodies according to their target antigen or epitope (IPKat). The Guidelines have been updated to further clarify the circumstances in which these types of claims are permitted, including the sufficiency requirements and the burden of proof with respect to prior art antibodies (G-II-6.2) (IPKat). The updates to the Guidelines on antibodies also reflect Boards of Appeal case law in this field (IPKat). Interestingly, however, specific guidance relating to the definition of antibodies according to their epitope has been removed.
Adaptation of the description
We are currently awaiting a referral on the legality of forcing applicants to amend the description in line with the allowed claims (IPKat). Controversy over description amendments began with a significant tightening to the requirement in the 2021 Guidelines (IPKat). This year, the Guidelines for opposition have been updated to explicitly state that adaptation of the description may also be required if the patent is amended during opposition:
“the description of the patent may be examined for compliance with the requirements of Art. 84 only when, and then only to the extent that, an amendment of the patent introduces non-compliance with Art. 84. In particular, inconsistencies between the description and the claims resulting from amendments during opposition proceedings and casting doubt on the subject-matter for which protection is sought must be avoided” (D-V-5)
Further reading
- 2019: Updates to the EPO Guidelines for Examination – the highlights
- 2021: Highlights from the new EPO guidelines for examination 2021: ViCo oral proceedings, description amendments and antibodies
- 2022: Changes in the draft 2022 EPO Guidelines for Examination on description amendments: Substantial changes or window-dressing?
- 2023: Highlights from the new EPO Guidelines for Examination 2023: Erroneous parts, UPC and sequence listings
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