Setterwalls has successfully acted on behalf of Sandoz in a patent dispute against Eli Lilly and ICOS Corporation. In the judgement from 7 February 2020, the Patent and Market Court decided to invalidate ICOS Corporation’s patent covering unit dosage forms comprising tadalafil due to lack of inventive step, both in its issued and in all reformulated wordings. Thus, the patent cannot prevent Sandoz’ marketing of a competing drug on the Swedish market.
Since 2017, Setterwalls has successfully acted on behalf of the drug company Sandoz in a patent dispute against Eli Lilly and ICOS Corporation. On 7 February 2020, the Patent and Market Court issued its judgement to invalidate ICOS Corporation’s patent for a certain dose interval of tadalafil due to lack of inventive step.
In 2018, Eli Lilly sued Sandoz under the allegation that Sandoz’ marketing of a competing drug was infringing a patent covering a unit dosage form with 1 – 5 mg tadalafil. Tadalafil is a so-called PDE5 inhibitor used for the treatment of erectile dysfunction. Sandoz then sued for revocation of the patent and contested infringement on the ground that the patent was invalid.
The case was comprehensive and the main hearing lasted for seven trial days. The Patent and Market Court decided on inter alia whether results from pre-clinical studies would motivate a person skilled in the art to initiate clinical trials to find the lowest effective side effect minimizing dose, and whether such trial work was routine for the person skilled in the art. The judgement can have a large impact for future cases involving dose regimen patents and sheds light on how Swedish courts view clinical study results as a basis for new inventions.
The Patent and Market Court invalidated the patent in all claimed wordings and Sandoz got full coverage for its litigation costs.