Key points
- D1 is " D1: "The Prednisone-Sparing Effect of Anti-IL-5 Antibody (SB-240563)" details of Clinical Trial NCT00292877"
- " Document D1 describes a phase II clinical trial entitled "The prednisone-sparing effect of anti-IL-5 antibody (SB-240563)". The purpose of the clinical trial is "to determine if the treatment with anti-IL-5 antibody has a prednisone-sparing effect in patients with symptomatic eosinophilic bronchitis (with or without asthma)" (page 1, "Purpose"). '
- " Like the opposition division and the parties, the board considers the disclosure of this phase II clinical trial to constitute an appropriate starting point for assessing whether the claimed subject-matter involves an inventive step. Indeed, it concerns the treatment of patients with the same medical condition (i.e. steroid-dependent EB) using the same substance (i.e. a humanised antibody to IL-5) with the same objective (i.e. a reduction in prednisone administration)."
- " The therapeutic application defined in the claim differs from the disclosure in document D1 in that (i) an effective treatment is not inferable from the document since it does not disclose any results of the clinical trial and (ii) whereas the claim specifies a minimum level of prednisone-sparing effect - 90% - none is specified in the document."
- " t was undisputed that the patent discloses the results of the clinical trial as known from document D1, including a prednisone sparing effect as required by the claim."
- " In the board's view, the disclosure of a clinical trial with the same substance for the treatment of the same medical condition, and having the prednisone-sparing effect as the primary outcome measure of the clinical trial, there being no other distinguishing characteristics of the therapeutic application claimed than the efficacy, provides the skilled person with an expectation of success for the treatment (see also decision T 2506/12, Reasons 3.10 and decision T 239/16, Reasons 6.5). It was therefore obvious for the skilled person to conduct the treatment in document D1 with a reasonable expectation of success, unless the state of the art provided the skilled person with reasons for not pursuing the solution envisaged in the clinical trial or, in other words, unless the state of the art provided the skilled person with an expectation of failure (see also decision T 2506/12, Reasons 3.11 and decision T 239/16, Reasons 6.5, second paragraph)."
- Compare T0108/21: "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." However, inventive step is always fact-specific.
- The Board reviews a number of other documents and then concludes: " In view of the above considerations, the skilled person had no reason to expect that the treatment described in document D1 would not succeed. The solution provided in the claim, specifying the level of reduction in prednisone to be 90%, is a consequence of pursuing the treatment described in document D1, for which the skilled person had a reasonable expectation that a prednisone reduction would be achieved without exacerbations. Therefore, the specific level of reduction of 90% recited in the claim does not play a role in the assessment of what the skilled person would do when faced with the problem formulated above, i.e. the provision of an effective treatment for prednisone-dependent EB with less side effects."
- Claim 1 is held to lack an inventive step.
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/2022/07/t-112316-clinical-trial-document-kills.html
