MSD Danmark

MSD wins Denmark's first biosimilar patent litigation


MSD wins Denmark’s first biosimilar patent litigation

MSD Danmark, Samsung Bioepis and Biogen (Denmark) Manufacturing were successful in a decision rendered on 8 March 2019 by the Maritime and Commercial High Court in Copenhagen. Denmark’s specialist IP court denied Roche and Genentech preliminary injunctions against MSD Danmark, Samsung Bioepis and Biogen. MSD Danmark was represented by Accura’s Morten Bruus, Partner and Head of IP & Life Science.

The issue in the case was whether MSD Danmark, Samsung Bioepis and Biogen by manufacturing and marketing a medicinal product in Denmark infringed Roche and Genentech’s rights according to the Danish part of a European product patent.

The medicinal product is a biosimilar version of a biological medicinal product, which is manufactured and marketed by Roche and Genentech.

A biosimilar medicinal product is a similar but not identical version of an existing biological medicinal products (i.e. the reference medicinal product) that must have been authorized in the EU for at least 10 years. A biosimilar medicinal product may have minor differences in the molecule compared to the reference medical product, but these differences must not influence the efficacy and safety, including adverse reactions, of the biosimilar version compared to the reference medicinal product.

MSD Danmark, Samsung Bioepis and Biogen argued in the case that Roche and Genentech had neither proved the validity of the patent nor that the medicinal product infringed Roche and Genentech’s rights under patent no. DK/EP 1308455.

Overall, the Maritime and Commercial High Court found it probable that the patent was valid, but rejected Roche and Genentech’s request for a preliminary injunction against the sale of the defendants’ medicinal product and recall from the market, as there was no likelihood of an infringement of their rights under the patent-in-suit. With the Maritime and Commercial High Court’s decision, MSD Danmark can continue the sale of its medicinal product to Danish hospitals.

Morten Bruus represented MSD Danmark before the Maritime and Commercial High Court.