T 0899/14 - Plausibility

Key points

• This a rather straightforward case of a medical patent application being insufficiently disclosed due to lack of plausibility of the efficacy of the claimed medical use in the application as filed. 
• The Board: “in order to meet the requirement of sufficiency of disclosure, the efficacy of the product to be manufactured in the claimed therapeutic indication must therefore be disclosed”. 
• “Contrary to the [applicant's] view, it is thus not sufficient merely to describe an administration regimen to be followed, without any evidence of the therapeutic efficacy of the proposed treatment.”
• “The question to be answered is whether the information presented in the examples can render the alleged efficacy credible, or at least establish its initial plausibility”
• The Board concludes that the examples did not render the alleged efficacy credible. 
• The Board: “While results of clinical trials or animal studies are not always necessary to establish sufficiency of disclosure, a mere verbal statement in the application is not enough to establish even the initial plausibility of an alleged therapeutic benefit.”
• The post-filed evidence showing the efficacy is therefore disregarded by the Board.
• “Otherwise, this would result in a patent being granted for a technical teaching which was achieved, and thus for an invention which was made, at a date later than the effective date of the patent. [] Therefore, the additional evidence provided in document D13 cannot be taken into account in favour of the sufficiency argumentation of the appellant.”

EPO T 0899/14 -  link

2.5 According to the established case law of the Boards of Appeal, where a medical application is claimed in the so-called "Swiss-type" format (as in the present instance), attaining the claimed therapeutic effect is regarded as a functional technical feature of the claim (see for example T 0609/02 of 17 October 2005, Reasons: 9). In order to meet the requirement of sufficiency of disclosure, the efficacy of the product to be manufactured in the claimed therapeutic indication must therefore be disclosed, unless this was already known to the person skilled in the art.

2.6 Contrary to the appellant's view, it is thus not sufficient merely to describe an administration regimen to be followed, without any evidence of the therapeutic efficacy of the proposed treatment.

2.7 Hence, the issue of sufficiency of disclosure revolves around the question of evidence of the efficacy of the treatment protocols defined in the independent claims for the prevention of pulmonary dysplasia.

2.8 Sufficiency of disclosure must be satisfied at the effective date of the patent, i.e. on the basis of the information in the patent application as filed, together with the common general knowledge then available to the person skilled in the art (see T 0609/02, Reasons: 8).

2.9 In the present case, the appellant did not argue that the benefit of the treatments according to claims 1 and 7 in the prevention of BPD was common general knowledge (see point IX.(a) above), but relied instead on the examples described in the application as filed (present in identical form in the patent in suit).

2.10 Thus the question to be answered is whether the information presented in the examples can render the alleged efficacy credible, or at least establish its initial plausibility (see point IX.(b) above).

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2.11.2 Hence, example 2 has no relevance to the disclosure of the claimed subject-matter, since it does not relate to a treatment for the prevention of BPD and does not disclose the required dosage regimen.

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2.12.3 Thus example 1 does not contain any evidence of the efficacy of the treatments defined in claims 1 and 7.

2.13 Nor do the application as filed and the patent in suit provide any theoretical or technical reasons why the proposed treatment would be effective in preventing BPD.

2.14 While results of clinical trials or animal studies are not always necessary to establish sufficiency of disclosure, a mere verbal statement in the application is not enough to establish even the initial plausibility of an alleged therapeutic benefit.

2.15 Subsequently filed supplementary evidence (in the present case, the content of document D13) may only be taken into account to back up any findings in the patent application, but may not be used to establish sufficiency of disclosure on its own. Otherwise, this would result in a patent being granted for a technical teaching which was achieved, and thus for an invention which was made, at a date later than the effective date of the patent.

2.16 Therefore, the additional evidence provided in document D13 cannot be taken into account in favour of the sufficiency argumentation of the appellant.

2.17 As a consequence, the subject-matter of independent claims 1 and 7 as granted is not disclosed in a manner that is sufficiently clear and complete for it to be carried out by a person skilled in the art, and thus the ground for opposition pursuant to Article 100 (b) EPC prejudices the maintenance of the patent.