Thursday, October 15, 2020 T 421/14 - Sufficiency for a composition with non-responders

No response for a subpopulation

How credible should evidence for a composition be? In this case, the opponent argued that the initial analysis of therapeutic efficacy lacked statistical significance. Only a post hoc analysis revealed a  significantly better response for a treatment group compared to a placebo group. Moreover, the effect only occurred in a subpopulation of responders, not for the general population. Is one allowed to claim a composition for a general group even if the majority are non-responders, or should one disclaim the non-responders?  

Another issue, was the public availability of two documents C30 and C31.  C30 was poster and C31 a slide show, both allegedly displayed at a public conference by the proprietor. Both were also included in the IDS statement for a corresponding US patent. Who should prove the public availability in this situation, and what is the appropriate standard?

A related case T 799/16 sharing some of its reasons with the present decision has also been decided. 

Tuesday, September 12, 2017 T 1329/04 - Post-published evidence cannot be sole basis of inventive step

In the decision T 488/16, recently discussed in this blog, it became again clear that the EPO is strict in allowing post-published evidence to prove inventive step. The core decision where this follows from is this decision, T 1329/04. 

The cathwords of this decision: The definition of an invention as being a contribution to the art, i.e. as solving a technical problem and not merely putting forward one, requires that it is at least made plausible by the disclosure in the application that its teaching solves indeed the problem it purports to solve. Therefore, even if supplementary post-published evidence may in the proper circumstances also be taken into consideration, it may not serve as the sole basis to establish that the application solves indeed the problem it purports to solve.

Thus, post-published evidence of a technical effect/advantage is allowed as long as there was enough information in the application as filed to make this 'new' information already plausible. 

Friday, August 04, 2017 T 488/16 - Not plausible at the filing date

Is it plausible that the compound had the effect?

In this opposition appeal the effect (inhibiting PTK activity) of the claimed compound (dasatinib) was supported with post-published documents: documents (9) and (10) filed during the Examination procedure and documents (36) and (37) filed with the statement of the grounds. 

The application as filed contains a large number of compounds of which one is selected in the claim under appeal. The decision does not contest that the post-published documents show that this compound works, indeed works very well. The question is, whether this was plausible at the filing date. The board maintains the revocation of the patent.