T 1909/23 - 2nd medical use claim for individualized RNA cancer vaccine

Key points

III. Claim 1 of the patent reads as follows:

"1. An individualized cancer vaccine for use in a method of treating a cancer patient, said method comprising the steps:

(A) providing the individualized cancer vaccine by a method comprising the steps:

(a) identifying cancer specific somatic mutations in a tumor specimen of the cancer patient to provide a cancer mutation signature of the cancer patient, comprising

(aa) ...  and

(b) providing an RNA vaccine featuring the cancer mutation signature obtained in step (a), wherein the RNA vaccine comprises RNA encoding a recombinant polyepitopic polypeptide comprising mutation based neo-epitopes; and

(B) administering the individualized cancer vaccine to the cancer patient."

• Claim 1 of the present patent [is very similar to] claim 1 of EP 2 714 071, dealt with in decision T 2168/21, [and differs from it] in the addition of steps (aa), (bb) and (cc) and in the absence of the further characterisation of the RNA vaccine as "featuring the mutation signature of the patient".
• T 2168/21 was published in June 2024. I missed it back then.

No cross-case res judicata effect

• "The decision in case T 2168/21 is formally not binding on the present board due to the independency of the proceedings between parent and divisional application(s). Neither has it an effect of res iudicata for the present proceedings due to the lack of identity of facts and claimed subject-matter (cf. e.g. T 1270/20, Reasons 3.8.2; T 2084/11, Reasons 1.3; see also Benkard, EPÜ (4th edition), Art. 76, Rn 10). However, in view of the very similar wording of claim 1 of both patents, the conclusions drawn in the present case and the reasoning of this decision are similar to those of T 2168/21."

Medicine preparation steps limiting

• “The claim relates to a purpose-limited product in the sense of Article 54(5) EPC. Both method steps (A) and (B), including the sub-steps (a) and (b), constitute characterising and limiting features of the claimed subject-matter because they form an integral part of the method of treating a patient, which is a method referred to in Article 53(c) EPC. Without these steps, the claimed "individualized cancer vaccine" cannot be implemented and would not be defined.”
• “The patient to which an individualised cancer vaccine is administered is therefore the same patient from which a tumour specimen for the identification of cancer-specific mutations originated giving rise to a cancer mutation signature of this very patient. Since these steps are mandatory to obtain the individualised cancer vaccine under consideration, the legal fiction of a purpose-limited product in accordance with Article 54(5) EPC applies at least to step (A), including the sub-steps (a) and (b), and step (B) of the method, which are thus limiting on the claim.”
  
  
  
• I wonder how infringement of this kind of claim will be evaluated. It seems to me there will not be any generic supplier of the vaccine? 

EPO 

The link to the decision is provided after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t231909eu1