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Danish Maritime and Commercial High Court rejects motion for preliminary injunction due to lack of inventive step and non-infringement

On Friday 3 September 2021, the Danish Maritime and Commercial High Court rejected Fresenius Kabi Deutschland GmbH's motion for a preliminary injunction against FUJIFILM Diosynth Biotechnologies Denmark ApS' and Biogen (Denmark) A/S' manufacture, sale etc. of the drug Imraldi®. Imraldi® is a biosimilar version of the world's best selling drug, Humira®.

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The request was based on an allegation that FUJIFILM's and Biogen's activities infringed Fresenius' patent and utility model. Samsung Bioepis NL B.V. had intervened in support of FUJIFILM's and Biogen's case.

The Court rejected the motion for preliminary injunction due to lack of inventive step and non-infringement. It is ground-breaking that the Court rejected a PI on the basis of a finding that the patent and utility model were likely to be invalid for lack of inventive step, without support in a decision from the European Patent Office or DKPTO.

This decision leaves scope for future argumentation on lack of inventive step in PI cases, at least in situations where the lack of inventiveness is rather clear.

Kromann Reumert (Nicolai Lindgreen) acted for FUJIFILM Diosynth Biotechnologies Denmark ApS and Biogen (Denmark) A/S while Bech-Bruun acted for Samsung Bioepis NL B.V.

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