It's that time of year when those lovely people at the European Patent Office (EPO) release updates to the Guidelines for Examination in the European Patent Office, the latest version of which entered into force on 1 March 2024. The Guidelines is essentially the EPO user manual for practitioners, and is updated every year to take account of developments in law and practice. 

The big-ticket, headline changes included in the latest version take into account the Enlarged Board of Appeal decisions in G 2/21 and G 1/22 (concerning “plausibility” and entitlement to priority respectively). 

Thus, sections E-IV-4.1 and G-VII-5.2,11 of the Guidelines now refer to the decision in G 2/21, i.e. that a patentee may rely upon a technical effect for inventive step if the effect is “encompassed by the technical teaching and embodied by the same originally disclosed invention”. Whatever that means. 

And in section A-III-6.1, following G 1/22, the Guidelines have been updated to confirm that the burden of proof has shifted with regard to proving entitlement to claim priority, there now being a rebuttable presumption that the applicant(s) for a European patent IS entitled to the claimed priority, unless proven otherwise (for example, by the Examining Division or a third party in an Opposition). Which is good news for patentees/bad news for opponents.

Other changes include disclosure requirements for AI inventions (sections F-III-3 and G-II-3.3.1); confirmation that the latest ST.26 standard for sequence listings applies to divisional applications filed from July 2022 (even if the parent sequence was in ST.25), but that no excess page fees will apply to the parent sequence listing if included in the divisional description (section A-IV-5); the circumstances in which a genus of antibodies may be claimed (section G-II-6.2); and confirmation that the designated inventor for a patent application must be a natural person (not an AI computer, section A-III-7).

Adaption of the description of a European patent application in line with the claims is another current hot topic of EPO practice, with a referral to the Enlarged Board of Appeal imminent. In the meantime, the Guidelines have merely been updated to confirm that adaption of the description also applies to amendment during Opposition proceedings, as well as before the Examining Division (section D-V-5).

And in other news…the Technical Board of Appeal in T1252/20 has considered the definition of “substance or composition” in connection with “medical use" claims. Under the European Patent Convention, methods of medical treatment are excluded from patentability, but ”substances or compositions" for use in medical treatments are not. Medical use claims are construed as being limited to the particular use defined in the claim.; however, this exception only applies to “substances or compositions” for medical uses. 

In the patent in question (EP 2919826), a composition was claimed for use in reducing or eliminating cancerous cells comprising a peptide defined by its specific amino acid sequence. The mode of action of the composition was physical, rather than chemical, and on this basis the Examining Division concluded that it was a “device”, not a “substance or composition”. As such, the composition did not qualify for a “medical use” claim and hence lacked novelty.

The Board of Appeal disagreed, and concluded that a product may be considered a "substance or composition" for medical use purposes if the claim defines the chemical composition of the product and/or does not define “device-like” features of the product. 

Whilst this decision represents a welcome broadening of the definition of “substance or composition” for medical use purposes, the question of precisely where the dividing line between “substance” and “device” will be a matter for determination case-by-case.