Danish Maritime and Commercial High Court rejects motion for a preliminary injunction
On Thursday 20 June 2019, the Danish Maritime and Commercial High Court rejected Fresenius Kabi Deutschland GmbH's motion for a preliminary injunction against Biogen (Denmark) Manufacturing ApS' and Biogen (Denmark) A/S' manufacture and sale etc. of the drug Imraldi® due to the existence of prior user rights and added matter.
Imraldi® is a biosimilar version of the world's best selling drug, Humira®. Biogen manufactures Imraldi® to the European market at its plant in Hillerød.
The request was based on the allegation that Biogen's activities infringed Fresenius' utility models. Samsung Bioepis UK Limited had intervened in support of Biogen's case.
The Court rejected the motion for preliminary injunction with reference to the existence of Biogen's so-called prior user rights to manufacture and sell in Denmark because substantial preparations to this exploitation were made before Fresenius applied for its rights. The Court further held that the utility models were invalid due to added matter during the application process, cf. Section 18 of the Utility Models Act. This is the first time in many years that prior user rights have been acknowledged, and the first time ever that this has led to the rejection of a preliminary injunction. Also, this is the first time that added matter in a patent or a utility model has led to the rejection of a preliminary injunction.
Fresenius was ordered to pay Biogen and Samsung Bioepis a total of about 8 mill. DKK in legal costs, which is a very large amount of legal costs for a preliminary injunction case.
Kromann Reumert (Nicolai Lindgreen and Nicolaj Bording) acted for the Danish Biogen companies in the case while Bech-Bruun (Klaus Ewald Madsen and Søren Christian Søborg Andersen) acted for Samsung Bioepis UK.
Read the full decision in Danish