Key points
- The post title oversimplifies the decision at hand but indicates the point of contention.
- “Claim 1 is drafted as a second medical use claim pursuant to Article 54(5) EPC, thus attaining the claimed therapeutic effect is a functional technical feature of the claim.”
- Under Art. 123(2), the question is whether the claim has basis in Example 3 of the application as filed.
- “In a first line of argument the appellants [patentees] put forward that the requirements of Article 123(2) EPC were met because the language "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" was disclosed verbatim in the application as filed.”
- The Board: “Claim 1 was amended during opposition proceedings to include the therapeutic effect of "[medical effect, see above]" as a technical feature of the claim. As a consequence, for the purpose of assessing the requirements of Article 123(2) EPC, it has to be examined whether or not there is a disclosure in the application as filed from which it is directly and unambiguously derivable that this is the effect achieved when the treatment is carried out as claimed.”
- “Example 3 of the application describes a phase III randomised, double-blind, placebo-controlled multicenter study of retreatment with rituximab in subjects with rheumatoid arthritis (RA) receiving background methotrexate ”
- “No results of the envisaged retreatment study are reported.”
- “while the wording "preventing or slowing down (...) rheumatoid arthritis" is disclosed in the application, see point 43., the board concludes that the skilled person does not derive from page 129, lines 20 to 22, when read alone or in the context of Example 3 as a whole, a clear and unambiguous disclosure that the therapeutic effect of "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" is achieved when patients with active RA are retreated under the protocol described.”
- As a comment, I wonder how this analysis would work out if claim 1 at issue would have been included verbatim in the claims of the application as filed and was granted unamended.
- As a further comment, I do see that the concept of disclosure must be the same for novelty and Art. 123(2) and that for lack of novelty of second medical use claims, it is (under current case law) not sufficient that the cited prior art document verbatim discloses the claim wording if it does not make the medical effect plausible / demonstrate that the effect is actually achieved.
- “The [pantentees submitted] that the board was wrong to include considerations of plausibility when assessing compliance with the requirements of Article 123(2) EPC. ... the board's conclusion with respect to Article 123(2) EPC, see points 50. and 51., are not based on considerations of plausibility but on the established criteria for assessing the requirements of Article 123(2) EPC”
T 2842/18 -
https://www.epo.org/law-practice/case-law-appeals/recent/t182842eu1.html
Claim construction
31. Claim 1 is drafted as a second medical use claim pursuant to Article 54(5) EPC, thus attaining the claimed therapeutic effect is a functional technical feature of the claim. The disease to be treated is "joint damage in a subject with rheumatoid arthritis (RA)", while the therapeutic effect achieved by the treatment is "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis".
32. This was not disputed by the appellants.
Amendments (Article 123(2) EPC) - claim 1
33. This claim request was identical to the claim request of auxiliary request 14 in the proceedings before the opposition division. The opposition division held that the subject-matter of claim 1 derived "directly from Example 3" (see decision under appeal, page 23, point 4.1).
34. Respondents VI, VII, VIII contested this finding of the decision under appeal and submitted that the features "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis", "at least one prior course of treatment with rituximab and (...) at least one further course of treatment with rituximab" and "wherein the treatment comprises administration of rituximab and methotrexate" of claim 1 were not directly and unambiguously derivable from the application as filed (see section VI. for the complete wording of the claim).