7.2.2 Evidence of therapeutic effect
Overview
The question is whether or not the skilled person, having regard to the disclosure of the patent and the common general knowledge at the relevant date of the application, would have considered that the compounds referred to in the claim are suitable to achieve the therapeutical effect (see T 609/02, point 9 of the Reasons). Or, in other words, whether it was plausible (or, in yet other words, whether it was credible) that the therapeutic effect could be achieved by the claimed composition (as recapitulated in T 966/18).
Either the application must provide suitable evidence for the claimed therapeutic effect or it must be derivable from the prior art or common general knowledge. The disclosure of experimental results in the application is not always required to establish sufficiency, in particular if the application discloses a plausible technical concept and there are no substantiated doubts that the claimed concept can be put into practice (T 950/13 citing T 578/06).
A claimed therapeutic application may be proven by any kind of evidence as long as it reflects the therapeutic effect on which the therapeutic application relies (T 814/12, referring to T 609/02 in particular).
- T 728/21
Catchword:
In accordance with the jurisprudence exemplified by T 609/02 (see section 9), the suitability of the claimed composition for the defined therapeutic use needs to be disclosed in the patent, "unless this is already known". This jurisprudence confirms in the Boards view that the disclosed utility of the claimed composition may also derive its credibility from the prior art, even if this prior art does not represent common general knowledge (see point 3.3).
- G 2/21
Headnote:
I. Evidence submitted by a patent applicant or proprietor to prove a technical effect relied upon for acknowledgement of inventive step of the claimed subject-matter may not be disregarded solely on the ground that such evidence, on which the effect rests, had not been public before the filing date of the patent in suit and was filed after that date.
II. A patent applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.