26 August 2021

The upcoming G 2/21 referral on plausibility

 As reported already on numerous other blogs, Board 3.3.02 intends to refer questions to the Enlarged Board in case T 116/18 (concerning EP2484209B1) regarding plausibility (file wrapper).


I personally find the article of Arnie Clarke (of Gill Jennings & Every), "Is Dasatinib Dead? – An Incredible Change to the Plausibility Threshold"  (4 May 2021) to be the most useful primer to the controversy, at least for European patent attorneys working in the chemistry/pharma field. 


"It is just over four years since Board 3.3.01 of the EPO Boards of Appeal delivered its much-anticipated decision in the Dasatinib case (T 488/16).

Having been closely involved in that case on behalf of one of the opponents, it was obvious to me that the decision represented a potential step-change in the EPO’s attitude towards the assessment of inventive step, and the concept of plausibility in particular. It appeared that the threshold for meeting the requirement of a plausible technical disclosure had been raised.

However, two recent decisions (T 2015/20 [Almirall; Board 3.3.07] and T 184/16 [Mitsubishi; Board 3.3.02, i.e. the presently referring Board) by different boards of appeal may signal a turning of the tide on what many in the pharmaceutical industry considered to be too great a burden on patent applicants to support their inventions. (...)

Dasatinib unquestionably raised the bar for the assessment of plausibility. It asked the positive question “Is there any verifiable information in this patent which allows a conclusion that the alleged contribution to the art is at least plausible? (...)

The Mitsubishi decision is arguably consistent with this approach. (...) 

Where the Almirall decision appears to shift radically is in posing a negative question, rather than a positive one – essentially, the board asks whether an effect is not implausible, rather than whether it is plausible. As long as a stated effect is not at odds with the prevailing technical opinion, it is deemed to pass the plausibility threshold. This is clear from the headnote which specifically sets the bar at avoiding patent protection for “propositions that are prima facie implausible”, rather than only awarding patent protection to inventions that are plausible. (...)
As much as Dasatinib raised the plausibility threshold, Almirall appears not just to return the bar to its previous position but significantly lowers it, if not quite removing it completely. As much as the pharmaceutical industry should be pleased to see a relaxation of the Dasatinib standard, the volte face by this EPO board of appeal could be a significant impediment to industry, with “not implausible” armchair inventions blocking legitimate innovation and development. Will other boards follow it? (...)"


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