Key points
- This case is about the particular approach to novelty for 2nd medical use claims: such claims appear to be novel over public disclosure of the verbatim claim wording if the publication lacks Phase II clinical results. In this case, the claim is also found to be inventive over a prior art document disclosing the phase I clinical results and announcing the Phase II clinical study of precisely the medical use now being claimed. The patent application does not contain the Phase II results but the results of animal studies.
- The claim is directed to the therapeutic treatment of RRMS using an oral daily dose of 0.5 mg of fingolimod.
- "Document D10 includes the following two technical teachings. (a) Results from a clinical phase II study showing sustained efficacy and good tolerability over 18 months in RRMS patients treated with an oral daily dose of 1.25 mg fingolimod (see point 4.2 above), immediately followed by (b) the announcement of a clinical phase III study including more than 1000 patients with RRMS to be equally randomised to receive either 1.25 mg or 0.5 mg of oral fingolimod or placebo once daily for up to 24 months (see page 2, third to fifth full paragraphs)."
- "The examining division considered (see point 16.2.11 of the impugned decision) that any prior art describing the therapeutic effect of an oral daily dose of 1.25 mg of fingolimod in the treatment of RRMS and then explicitly disclosing the use of an oral daily dose of 0.5 mg of fingolimod (albeit without data) anticipated the subject-matter of a claim directed to a therapeutic treatment of RRMS using an oral daily dose of 0.5 mg of fingolimod. "
- "The board does not agree. In accordance with the settled case law of the boards, for prior art to anticipate the subject-matter of a claim, it must, as a first requirement, disclose directly and unambiguously all the technical features of this claim in combination. As a further requirement, this disclosure must be enabling, in the sense that the skilled person must be able to carry out this disclosure on the basis of the information provided in this prior art, if required, by using common general knowledge, at the date of public availability of this prior art."
- " In the case at hand, document D10 does not anticipate the subject-matter of claim 1 for failure to meet the first requirement. As set out in point 6.2 above, document D10 discloses the claimed dosage regimen in the context of a phase III study involving the therapeutic treatment of RRMS patients with the claimed fingolimod dosage regimen. Page 2, fourth full paragraph of document D10 states that this study "has begun enrolling patients in several European countries". No further details are provided in this regard. In particular, no mention is made of the therapeutic efficacy of this dosage regimen in the treatment of RRMS. [] In view of the foregoing, the board concludes that document D10 does not directly and unambiguously disclose the effective therapeutic treatment of RRMS using the claimed dosage regimen. The subject-matter of claim 1 is thus novel pursuant to Article 54 EPC over this document."
- " this announcement [of the phase III clinical trial] would have provided the skilled person with a reasonable expectation of solving the objective technical problem with fingolimod at an oral daily dose of 0.5 mg, unless a teaching in the prior art would have dissuaded the skilled person from considering this dosage regimen as a solution to the technical problem posed. In the case at hand, the board is satisfied that the prior art teaches away from the claimed invention. As set out in point 5.4(b) above, the skilled person would have inferred from document D28 that a threshold of lymphocyte reduction of at least 70% was required for a therapeutic treatment of RRMS. Moreover, the board agrees with the appellant's position that the teachings of documents D26 and D27 taken in combination with the teaching of document D23 would have led the skilled person to conclude that an oral daily dose of 0.5 mg fingolimod would be insufficient for reaching this threshold and hence would not be therapeutically effective in the treatment of RRMS (see points 5.4(c) and 5.4(d) above). In light of these particular circumstances, the board finds that the announcement of the phase III trial in document D10 would have given the skilled person hope of success but not a reasonable expectation of it."
- The claim is also inventive. " the board finds that the announcement of the phase III trial in document D10 would have given the skilled person hope of success but not a reasonable expectation of it. A mere hope of success does not suffice as motivation to render the claimed subject-matter obvious. As a consequence, the subject-matter of claim 1 involves an inventive step starting from D10's disclosure of the successful phase II trial with an oral daily dose of 1.25 mg fingolimod."
- " For the reasons given above regarding sufficiency of disclosure, the board is satisfied that the claimed fingolimod dosage regimen provides an effective therapeutic treatment of RRMS."
- The Board found the application to be plausible based on the results of animal studies disclosed in the patent application.
- " Under these circumstances, post-published evidence may be taken into account (see point 5.3 above). In this context, the appellant referred, inter alia, to document D11. This document discloses the results of a clinical study in 1153 patients with RRMS who had a recent history of at least one relapse. Patients received either oral fingolimod at a daily dose of either 1.25 mg or 0.5 mg or intramuscular interferon beta-1a (an established therapy for MS) at a weekly dose of 30 myg. Figure 2A illustrates a significantly greater reduction in the annualised relapse rates in both fingolimod groups than in the interferon group, confirming the results of the EAE study reported in the application.'"
- As a comment, the animal study results in the application seem to work as a kind of stepping stone to the post-published clinical trial results which make the claim patentable.
- As a comment, the District Court The Hague found the claim to be obvious in preliminary relief proceedings, in a decision issued 21 June 2022, after duly taking note of the Board's written decision issued on 3 June 2022 and submitted by the parties on 13 June. The case is unusual in that the patentee had initiated proceedings for an injunction even before the publication of the mention of the grant (but after the oral decision of the Board). Rechtbank Den Haag 21 juni 2022, ECLI:NL:RBDHA:2022:5898 and Rechtbank Den Haag 22 maart 2022, ECLI:NL:RBDHA:2022:2490. The President of the District Court The Hague essentially found that D28 did not amount to a technical prejudice in the field after a careful analysis of D28.
EPO T 0108/21
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/2022/07/t-010821-novel-and-inventive-over-phase.html
