Zusammenfassung von EPC2000 Art 083 für die Entscheidung T0728/21 vom 16.11.2023

In T 728/21 the invention was a pharmaceutical composition for use in treating cystic fibrosis. The patent was objected to inter alia based on lack of inventive step and lack of sufficiency of disclosure. The appellant (opponent) submitted that the patent merely presented a statement but failed to provide any experimental data supporting the therapeutic efficacy and concluded with reference to T 609/02 and T 2059/13 that the patent did not sufficiently disclose the suitability of the claimed composition for the defined therapeutic efficacy with such mere verbal statements. Further, the proprietor could not rely on some specific prior art to support the suitability of the claimed composition for the defined use, because the sufficiency of the disclosure could only be based on the content of the patent and the common general knowledge. The opponent also argued that post-published document D15 submitted by it raised serious doubts and that these serious doubts could not be overcome by reference to the post-published evidence in document D20 submitted by the proprietor. The board first acknowledged that the technical effect demonstrated in post- published experimental evidence (D20) could be taken into account in accordance with the principle established in G 2/21 for the assessment of inventive step. Concerning the allegation of lack of sufficiency of disclosure, the board recalled that if a patent defined a new therapeutical utility of a composition in a claim in the format of Art. 54(5) EPC, it was necessary according to the established jurisprudence that the patent at the date of its filing rendered it credible that the claimed composition was indeed suitable for the defined therapeutic use (G 2/21, point 74 of the Reasons). A deficient disclosure cannot be remedied by post-published evidence (G 2/21, point 77 of the Reasons; compare G 1/03, points 2.5.2 to 2.5.3 of the Reasons). The board came to the conclusion that the patent did not describe the activity of ivacaftor as a CFTR potentiator in the form of a simple verbal statement, which might in line with the considerations in T 609/02 be considered not to be sufficient, but rather as specific and verifiable technical information supporting the defined therapeutic indication. According to the board this information in the patent provided a rational basis for the claimed invention, which rendered the utility of the claimed composition in the treatment of patients credible at the date of its filing. The board specified that in accordance with the jurisprudence exemplified by T 609/02 (point 9 of the Reasons), the suitability of the claimed composition for the defined therapeutic use needed to be disclosed in the patent, "unless this is already known". This jurisprudence confirmed in the board's view that the disclosed utility of the claimed composition may also derive its credibility from the prior art, even if this prior art did not represent common general knowledge (Catchword). The board considered that the prior art confirmed the credibility of the disclosed utility of the claimed composition. In as far as a patent provides a credible disclosure of the claimed invention, a convincing objection of lack of sufficiency of disclosure presupposes according to the established jurisprudence that serious doubts substantiated by verifiable facts have been raised. The appellant argued that the post-published document D15 raised serious doubts regarding the utility of ivacaftor in the treatment of patients. According to the board, D15 reported measurable effects, and the mere lack of an observed clinical effect from treatment with ivacaftor alone as reported in D15 did not qualify as verifiable evidence that raised serious doubts regarding the credibly disclosed suitability of the claimed composition. The main request met the requirements of sufficiency of disclosure.