Düsseldorf Higher Regional Court overturns ruling on Biogen’s Imraldi

Biogen may not use a specific composition with the monoclonal antibody adalimumab in its anti-rheumatic drug Imraldi, marketed in Germany. Düsseldorf Higher Regional Court found Biogen's biosimilar infringes a patent held by Fresenius Kabi, thus overturning a first-instance decision.

Fresenius Kabi alleges that Biogen’s Imraldi has infringed its EP 3 145 488 B1 for a ‘liquid pharmaceutical composition’. The patent covers a formulation containing the active ingredient adalimumab, used in the treatment of  rheumatoid arthritis.

Imraldi is an adalimulab biosimilar. Its reference drug is anti-rheumatic drug Humira, which is the trade name of adalimumab. After the SPC for Humira expired in late 2018, Biogen launched Imraldi. The drug is the result of a collaboration between the Biogen group and Samsung Biologics. In 2011, the two companies founded the joint venture Samsung Bioepis, which focuses on developing and commercialising biosimilars.

Formulation patent

In Fresenius Kabi’s view, however, certain compositions of Imraldi still infringe the formulation patent EP 488. Therefore, the company sued Biogen. Last spring, Düsseldorf Regional Court dismissed the claim. The 4a Chamber judges found that Biogen’s Imraldi did not infringe EP 488 on the grounds that it does not realise all features of the asserted patent claim (case ID: 4a O 70/22).

Fresenius Kabi appealed the decision. Now the Düsseldorf Higher Regional Court has overturned the first-instance judgment. The second-instance court found that the disputed composition of Imraldi does in fact realise all features of the patent-in-suit.

The Higher Regional Court also denied Biogen a prior user right, which could have allowed the company to market Imraldi in Germany despite Fresenius Kabi’s patent protection.

Upheld in opposition

The judges, led by presiding judge Stephan Fricke, granted Fresenius Kabi injunctive relief, as well as ordering information, rendering of accounts, recall and destruction. The court also declared Biogen liable to pay damages to Fresenius for past sales of Imraldi (case ID: I-2 U 48/24).

The court has not allowed a further appeal to the Federal Court of Justice, meaning the ruling is enforcable. Biogen can still file an appeal against denial of leave to appeal.

EP 488 was subject to EPO opposition appeal proceedings but was maintained without amendment by both the Opposition Division and the Board of Appeal.

The case is part of a wider international dispute, with a parallel action pending in France.