Art. 1, no. 66

Reasonable expectation of success

In the discussion of the “reasonable expectation of success”, it is held:

Eine 50%ige Wahrscheinlichkeit, dass die Lösung funktionieren wird, gehört nach der Rechtsprechung des Bundespatentgerichts aber immer noch in den Bereich der “Hoffnung”; die Erfolgserwartung muss deutlich über 50% liegen (BPatGer, Urteil S2017_001 vom 1. Juni 2017, E. 4.6). Wenn es rational nicht möglich ist, eine Vorhersage über die Erfolgswahrscheinlichkeit zu machen, liegt keine begründete Erfolgserwartung vor (BPatGer, Urteil S2017_001 vom 1. Juni 2017, E. 4.6).

I disagree, in particular in the pharma field when clinical trials are necessary. The overall likelihood of approval for a drug candidate is only about 10%, i.e. clinical trials have a failure rate of about 90%; see e.g. here. If the above was correct, any patent pertaining to a drug that has obtained a market authorization would effectively be sacrosanct because there was only a 10% chance that the candidate would pass clinical trials. This cannot be it.

On the contrary, case law of the BoA of the EPO holds that even a try-and-see attitude for inventions involving clinical trials on humans may be sufficient; see T 259/15, ¶1.3.

I further disagree with the emphasis on predictability; see this Blog here (last part) for further details.

Martin WILMING

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