Key points
- Claim 1 is a second medical use claim directed to: "A composition comprising at least one peptide that inhibits plasma kallikrein for the use in the treatment of ophthalmic disorders in a patient in need thereof, ..."
- Patentee "had several lines of argument as to why document D2 did not disclose subject matter anticipating that of claim 1. They were i) that document D2 was not enabling for the medical treatment as defined in claim 1, because the experiments reported in document D2 did not constitute an actual treatment of any ophthalmic disorder, ..."
- "The appellant's first line of argument is based on the observation that "the experiments of D2 do not constitute an actual treatment of any ophthalmic disorder at all". This, however is not the right test for deciding whether a document discloses a medical use in such a way that it can be carried out by a person skilled in the art. Instead, the document should disclose the suitability of the product for the particular therapeutic application"
- "In view of [the experimental results in] document D2 [a PCT application establishes at least an initial plausibility that the compounds mentioned in claim 1 (of document D2), i.e inhibitors of the pathway set out in Fig. 6 of document D2, are suitable for achieving the therapeutic aim."
- " To counter this initial plausibility, evidence in the form of verifiable facts would be required to show that serious doubts exist about the claimed peptides' suitability for achieving the therapeutic effect. No such evidence has been put forward by [the patentee].
- "[The opponent] was of the view that subject-matter of this claim request is not entitled to the earliest priority date, 16 February 2006 because the application [P1] from which priority is claimed (EP 06360008) does not sufficiently disclose the suitability of the claimed compounds for the claimed therapeutic use"
- "According the established case law of the boards, a claimed second medical use meets the requirements of Article 83 EPC if the patent discloses the suitability of the product for the claimed therapeutic application, if this was not known to the skilled person at the relevant date []. This standard applies to priority documents equally, because the priority document must disclose the invention claimed in the subsequent application in such a way that it can be carried out by a person skilled in the art "
- " document P1 contains no experimental data or other evidence of any kind that goes beyond a mere allegation that the peptides defined in that document are indeed suitable for treatment of any of the ophthalmic disorders listed. That the peptides mentioned are suitable is not at all self-evident because it is the essence of the contribution to the art of the invention purportedly made in document P1. In the absence of such evidence, it cannot be concluded that document P1 provides even an initial plausibility that the claimed compounds are suitable for treating the disorders in question. "
- As a comment, it seems that a sentence stating verbatim "compound X is suitable for treating disease Y", is not a disclosure that compound X is suitable for treating disease Y in this context. Perhaps the term "disclose" is not entirely precise in the sense that what is required is something different from the gold standard test of G 2/10. See also T 2842/18.
- "the passages cited by [the patentee] on page 6 [of P1] are not evidenc/e but mere allegations of suitability. In conclusion, document P1 does not disclose the invention of claim 1 in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. The invention claimed in claim 1 of the main request is therefore not the "same invention" in the sense of Article 87(1) EPC* as the invention disclosed in document P1. Thus, the invention claimed in claim 1 of the main request cannot validly claim priority from document P1."
- * = Note, it might have been the same invention in the sense of G 2/98; at least this aspect of the disclosure in P1 is not disputed.
- As a comment, the Board apparently saw no need to wait for G 2/21 even though one of the proposed answers in that referral is "no plausibility requirement at all" (in the context of inventive step, admittedly).
EPO
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.
source http://justpatentlaw.blogspot.com/2023/03/t-041119-plausibility-for-novelty-and.html
