Samsung Bioepis has developed a biosimilar of Humira® (the best-selling medicinal product in the world grossing annual sales in excess of 20 Billion US Dollars), which is marketed under the name Imraldi®. Imraldi® is marketed in a collaboration between Samsung Bioepis and Biogen, and manufacturing activities in relation to Imraldi® are carried out in Denmark.
In 2018, Fresenius Kabi initiated preliminary injunction proceedings against Biogen before the Danish Maritime and Commercial High Court in an attempt to stop manufacturing and marketing of Imraldi® in Denmark. Samsung Biogen intervened in the matter in order to assist in defeating the application for a preliminary injunction.
Fresenius Kabi argued that the formulation for Imraldi® infringes upon certain Danish utility models taken out by Fresenius Kabi. However, the formulation for Imraldi® was actually developed and even advanced to clinical trials before the priority date for Fresenius Kabi’s utility models.
By an order published today, the Maritime and Commercial High Court has rejected Fresenius Kabi’s application for a preliminary injunction against Biogen.
In a landmark decision, the Court finds that the defendants have a right of prior use under the relevant provisions of the Danish Utility Model Act. This is the first published decision from a Danish court in which it is held that there is a right of prior use. Furthermore, the Court finds that Fresenius Kabi’s utility models are invalid for lack of basis. It is also the first time on record that a Danish PI court rejects an application for the grant of a preliminary injunction because the contested intellectual property right is invalid for added matter.
Bech-Bruun represented Samsung Bioepis, and the case was argued before the Maritime and Commercial High Court by Partner Klaus Ewald Madsen and Senior Associate Søren Christian Søborg Andersen.