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NO – Actelion Pharmaceuticals v. Icos / Tadalafil

21 Sep 2017

Actelion Pharmaceuticals Ltd v. Icos Corporation, Oslo District Court, 11 July 2017, Case no. 15-177113TVI-OTIR/07

The present dispute concerns the validity of Icos Corporationʼs Norwegian patent NO 321 602 B2 (“NO ʼ602”) which pertains to tadalafil of a specified particle size and, in particular, the issue of whether micronisation of tadalafil, which was a known active ingredient, exhibits a sufficient inventive step.

The revocation action against NO ʼ602 was filed by Actelion Pharmaceuticals. By its judgment 11 July 2017 the Oslo District Court revoked the patent due to lack of inventive step and granted the claimant full compensation for its legal costs.

The Court based its assessment on the problem-and-solution approach. WO 96/38131 (“Butler”) pertaining to the co-precipitation of tadalafil, was applied as the closest prior art. The Court ruled that the objective technical problem to be solved was how to bring about (in relation to tadalafil) a more rapid effect and improved absorption and bioavailability.

The Court concluded that it would have been obvious to the skilled person, starting from Butler, to solve the problem by micronisation as defined in the patent claim. In the Courtʼs view, micronisation was the art’s standard solution to the problem and an approach that the skilled person would attempt before co-precipitation, which was a more complicated and complex approach.

Of interest is the courts statement that “Even if the closest prior art points in one direction, it will not prevent the skilled person from exercising common general knowledge in the art, especially not when it is so well known in the art”.

Read the judgment in English here.
Read the judgment in Norwegian here.

Headnote: Lars Erik Steinkjer and Åse Røynestad Konsmo, Wikborg Rein