The guidelines for examination in the European Patent Office instruct on the practice and procedure related to the examination of European patent applications and patents at the EPO in accordance with the European Patent Convention and its implementing regulations.
The EPO revises the guidelines annually to update them in view of the latest developments and to address feedback received from public users, and the 2024 revisions took effect on March 1.1
Of particular note, the latest guidelines include significant changes relating to priority right presumption at the EPO and plausibility, guidance on disclosure requirements for artificial intelligence-related inventions and antibodies, the introduction of electronic signatures for registering transfers of rights, and guidance on how selection inventions are defined and assessed for novelty, which are discussed below.
Priority Right
The EPO's assessment of priority entitlement has historically been notoriously strict. The decision by the EPO's Enlarged Board of Appeal on Oct. 10, 2023, in G 1/22 and G 2/22,2 now reflected in the guidelines, has greatly relaxed it.
Previously, the EPO required all applicants named on a priority application or their successors in title be named on the application claiming priority. If the priority right was challenged, the EPO required written evidence that the priority rights had been transferred prior to the filing of the application claiming priority, and that the transfers of the priority right predated the filing of the subsequent application.
Such requirements caused problems when the priority application was not in the name of an applicant, e.g., a U.S. provisional application.
Many applicants file U.S. provisional applications naming inventors only. When a Patent Cooperation Treaty application claiming priority to such a U.S. provisional application was filed in the name of the applicant — without having previously executed an assignment from the inventors — the EPO used to consider the priority claim invalid.
These onerous requirements have largely been removed in the updated guidelines.
Section A-III, 6.1, has been updated to recite that "the priority right ... must be assessed under the EPC, regardless of any national laws. The European Patent Convention does not set out any formal requirements for the transfer of the priority right." This is a drastic shift in practice from strict formal requirements for the transfer of priority rights to the recognition of even informal or tacit transfers of priority rights.
Section A-III, 6.1, has further been updated to recite
absent any substantiated indication to the contrary, there is a strong rebuttable presumption under the European Patent Convention 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 must prove that this entitlement is missing..., the mere fact of the joint filing implies an agreement between the applicants..., unless substantial facts indicate otherwise (see G 1/22 and G 2/22).
Thus, the burden of proof is no longer on the applicant to prove that the priority right had been validly transferred. This may benefit U.S. applications where the priority application was filed by the inventors, but the application claiming priority was filed by their employer.
An implied agreement or obligation to assign the priority right would likely meet the EPO's new standards.
It is less likely that third parties can prove the absence of an agreement to transfer priority rights, thus leading to fewer priority entitlement challenges in opposition proceedings with the new standards.
The Concept of Plausibility and Evaluation of Evidence
The highly anticipated March 23, 2023, decision of the EPO Enlarged Board of Appeal in G 2/21 dealt with the concept widely referred to as "plausibility," and several updates have been made to the guidelines in view of this decision.
Plausibility generally concerns the idea that a purported effect of the claimed invention — e.g., the treatment of a particular disease — must have been credible to the skilled person at the time of filing of the application based on the disclosure in the application as filed.
G 2/21 considered the extent to which the purported effect must be supported by the application as filed, and the extent to which post-publication evidence may be relied upon in this context.
Regarding the extent to which the purported effect must be supported by the application as filed, Sections G-VII, 5.2, and G-VII, 11, have been updated to state that new effects in support of the inventive step can only be taken into account if "the skilled person, having the common general knowledge at the effective filing date 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." This wording is taken directly from the G 2/21 decision.
However, no further guidance is provided on how this rather vaguely formulated test is to be applied in practice. This is perhaps unsurprising given the lack of case law following the G 2/21 decision. Practitioners will therefore need to keep an eye on case law developments in this area to understand how this new test is to be applied in practice.3
Regarding the extent to which post-published evidence may be relied upon to support a purported technical effect, Section G-VII, 11, has been updated to state that "any evidence submitted to prove a technical effect ... is assessed in accordance with the principle of free evaluation of evidence ... and may not be disregarded solely on the ground that it is post-published."
In other words, post-published evidence may be considered when assessing whether a purported technical effect is achieved. Section E-IV, 4.1, has been updated similarly in the context of the "free evaluation of evidence."
Artificial Intelligence
Sections G-II, 3.3.1, and F-III, 3, have been expanded to provide guidance concerning the level of detail required in the written description to meet the requirements of sufficiency under Article 83 of the European Patent Convention for inventions based on AI and machine learning, or ML. The EPO evaluated sufficiency of such inventions in the same manner as computer-implemented inventions in general.
The 2024 update to the guidelines, however, appears to introduce an additional requirement specific to AI and ML-based inventions. Specifically, the updated Section F-III, 3, states that a lack of sufficiency may result if mathematical methods and the training datasets are disclosed in insufficient detail to reproduce the technical effect over the whole range claimed.
The updated Section G-II, 3.3.1, also states that, although comprehensive proof is not required, the technical effect achieved by an ML algorithm may be established by explanations, mathematical proof or experimental data.
The updated Section G-II, 3.3.1, provides expanded guidance on the level of detail required for training data. Specifically, if a technical effect is dependent on particular characteristics of the training dataset used, those characteristics required to reproduce the technical effect must be disclosed unless the skilled person can determine them without undue burden using common general knowledge.
However, this does not mean that specific training datasets need to be disclosed. The guidelines go on to clarify that "in general, there is no need to disclose the specific training dataset itself (see also sections F‑III, 3 and G‑VII, 5.2)."
In summary, the level of detail required in the description for AI and ML inventions will depend on the scope of protection defined by the claims, and whether the invention is in possession of the skilled person given the claims, the detailed description, and the common general knowledge within the field at the time of filing.
The information in the detailed description must be disclosed in sufficient detail to reproduce the technical effect of the invention over the whole scope of the claims.
Patent applicants should be cognizant that, depending on the nature and scope of the claims and the complexity and predictability of the AI models used, patent applications for AI and ML inventions may require more implementation details than traditional computer-implemented inventions, including the disclosure of the types of training data and methods used to train the AI systems.
Section A-III, 7, has been updated to state that the EPO will check whether the designated inventor is a natural person. This update stems from the Legal Board of Appeal's decision in December 2021 in J 8/20 — concerning an AI machine called DABUS, which stands for Device for Autonomous Bootstrapping of Unified Sentience — finding that an AI cannot be designated as an inventor.
Antibodies
Section G-II, 6.2, has been updated to provide further guidance with respect to the level of disclosure required when claiming antibodies. Specifically, the updates place the burden of proof on the applicant for demonstrating the novelty of antibodies defined on the basis of their epitope and/or other functional features.
The applicant must now show that prior art antibodies do not bind to the same epitope. Furthermore, the applicant must show that a prior art antibody binding to the same target antigen as the claimed antibody does not demonstrate the claimed functional features.
Section G-II, 6.2, has also been updated to remove the requirement that, if the technical effect relied upon for inventive step includes an improved binding affinity, the antibody framework regions must be included in the definition of the claimed antibody.
The specific requirements relating to the definition of linear and discontinuous epitopes have been removed entirely from the updated guidelines, potentially providing greater flexibility in how to format antibody claims.
While the functional claiming of antibodies is still acceptable before the EPO, such claiming methods would likely be problematic before the U.S. Patent and Trademark Office with respect to the written description and enablement requirements of Title 35 of the U.S. Code, Section 112.
Electronic Signatures
The decision J 0005/23 dated Sept. 4, 2023, from the Legal Board of Appeal held that assignments must be signed using wet signatures, with electronic signatures no longer accepted. However, a notice from the EPO on Feb. 9, 2024,4 concerning Rule 22 of the EPC, superseded the decision.
From April 1, 2024, the EPO accepts electronic signatures — as well as handwritten signatures, facsimile signatures and text string signatures — for registration of transfers of rights and licenses for European patent and unitary patent procedures. Section E-XIV, 3, of the guidelines has been updated to reflect this change.
The EPO also offers the option to file such requests in MyEPO Portfolio, a web-based tool replacing My Files, and administration and legacy mailbox services will be decommissioned in June 2024. Requests for registration filed via MyEPO Portfolio will not incur any administrative fee.5
Selection Inventions
Section G-VI, 7, concerning selection inventions has been updated to provide more detailed guidance on how selection inventions are defined and assessed for novelty, with numerous new examples added.
Scenarios are outlined for one or multiple selections, either from lists of individual elements or subranges of numerical ranges. While not representing any substantive shift in law, the newly updated section G-VI, 7, provides useful additional guidance on the assessment of selection inventions.
Guidance is also provided on what constitutes a list of a certain length when assessing whether selections from multiple lists have been made. The guidelines now state that a list is usually considered to have a certain length if it contains at least two or three elements, but that this has to be decided on a case-by-case basis.
Outlook
Although the guidelines are prepared by the EPO to direct the work of their employees, they provide invaluable insight for patent attorneys and applicants seeking to obtain patents from the EPO.
The EPO solicited feedback on the updated guidelines, and the anonymized comments will be discussed with a working group. Reports of the group will be published under updates on the guidelines revision cycle website.6
This annual revision cycle is an effective mechanism for ensuring that all interested parties have access to current, accurate and detailed information on the process and legal requirements for obtaining European patents.
In addition, by monitoring and adhering to the updated requirements set forth in the guidelines each year, prosecution and other procedures can be facilitated as applicants and applications may be better prepared for the rigors of the European Patent Convention.
Footnotes
1. https://www.epo.org/en/legal/guidelines-epc/2024/m.html.
2. For further in-depth analysis see our previous Law360 article "EPO Decision Significantly Relaxes Patent Priority Approach" - https://www.law360.com/articles/1736888.
3. See "Patent Plausibility Uncertainty Persists, EPO Petition Shows" - https://www.law360.com/articles/1811361.
4. OJ EPO 2024, A17.
5. https://www.epo.org/en/news-events/news/transfers-and-licences-changes-1-april-2024.
6. https://www.epo.org/en—/legal/guidelines-revision-cycle.
Originally published by Law360.
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