T 1752/19 - Second medical use and Art.83

Key points

•  The decision was taken 30.06.2022 and issued in writing on 05.10.2023, i.e. more than one year later (!). No communication under Art. 15(9) informing the applicant of the delay is visible in the online file.
• The decision seems to be fully in line with G 2/21, which was given in March 2023, without citing that decision.
• "The applicant argued, referring to decision T 1842/06, that the applicant bears the burden to show that the claimed invention is reproducible only in cases where the invention relates, for example, to a technical effect that is a priori contrary to the laws of physics."
• "The board is not convinced by this argument because, as stated in point 2., it is established case law that the suitability of the product for the claimed therapeutic application must be derivable from the application unless already known to the skilled person. The board notes that the decision referred to by the appellant does not deal with a claim for a medical use and its content is, therefore, not relevant for the case in hand."
• "It is undisputed that the application does not include experimental results showing that a progesterone antagonist as defined in claim 1 was suitable for preventing cancer. Rather, to demonstrate the mechanism underlying the claimed therapeutic application, namely that abnormal autocrine hCG production causes carcinogenesis, the appellant relied on a theoretical explanation. The board concurs with the appellant that, in principle, the suitability of a composition for a claimed therapeutic application may be derivable from the application or common general knowledge even in the absence of experimental results."
• After a detailed analysis: "In conclusion, the application presents a theory which has not been validated by any experimental evidence. The appellant refers to prior art documents and to a theoretical concept consisting of steps A to E to show that the only logical conclusion is that hCG production is the cause of cancer. However, in the board's view document D5 shows that alternative theoretical conclusions are possible. In fact, the application acknowledges that the author of document D5 came to a different conclusion despite having investigated the functions of hCG in cancer and embryogenesis (see application, page 7, third paragraph). Document D39 does not support the idea that cell proliferation can be inhibited in all cancers by antagonising hCG, as claimed. In light of the above, the board concludes that prevention of carcinogenesis by inhibiting hCG production is not disclosed in a manner sufficiently clear and complete (Article 83 EPC)."

• EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

https://www.epo.org/en/boards-of-appeal/decisions/t191752eu1

1. Claim 1 is drafted in the form of a purpose-limited product claim, pursuant to Article 54(5) EPC, a so-called second or further medical use. The claim is directed to a composition comprising progesterone antagonists binding to steroid receptors for use in the prevention of carcinogenesis in adult humans. The therapeutic application is further defined by the mechanism "by inhibiting autocrine Human Chorionic Gonadotropin", the dose and the frequency of administration.

2. In the case law of the boards of appeal, where a therapeutic application is claimed in the form according to Article 54(5) EPC, attaining the claimed therapeutic effect is a functional technical feature of the claim. As a consequence, in order to fulfil the requirements of Article 83 EPC, the suitability of the product for the claimed therapeutic application must be derivable from the application, unless this is already known to the skilled person at the priority date (see T 609/02, point 9 of the Reasons and T 895/13 of 21 May 2015, points 3 to 5 of the Reasons).

3. Thus, in the case in hand, the suitability of a progesterone inhibitor as defined in the claim for preventing cancer must be assessed.

4. The applicant argued, referring to decision T 1842/06, that the applicant bears the burden to show that the claimed invention is reproducible only in cases where the invention relates, for example, to a technical effect that is a priori contrary to the laws of physics.

5. The board is not convinced by this argument because, as stated in point 2., it is established case law that the suitability of the product for the claimed therapeutic application must be derivable from the application unless already known to the skilled person. The board notes that the decision referred to by the appellant does not deal with a claim for a medical use and its content is, therefore, not relevant for the case in hand.