Biogen defends adalimumab biosimilar Imraldi with international team

The Regional Court Düsseldorf has dismissed an infringement claim brought by Fresenius Kabi against Biogen over a patent containing active ingredient adalimumab, which is used as an anti-rheumatic drug. The case is part of a larger battle involving the commercialisation of Biogen's biosimilar Imraldi, with previous proceedings also taking place in the UK and Denmark.

The Regional Court Düsseldorf has found in favour of defendant Biogen, after Fresenius Kabi filed a suit for the US biotechnology company’s alleged infringement ofEP 3 145 488 B1(case no. 4a O 70/22) for a ‘liquid pharmaceutical composition’. Fresenius had sought injunctive relief, information, rendering of accounts, recall, destruction and a declaration of liability for damages.

However, the judges found that Biogen’s Imraldi biosimilar does not infringe the patent, on the basis that it does not realise all features of the asserted patent claim. In parallel proceedings in the UK and Denmark, the defendant is Samsung Bioepis. The company is the marketing authorisation holder for the Imraldi product, while Biogen is the commercialisation partner. As such, an international team of patent-specialist firms acts across all proceedings.

Launching the biosimilar

Imraldi is an adalimulab biosimilar. Its reference drug is anti-rheumatic drug Humira, which is the trade name of adalimumab.

After the supplementary protection certificate for Humira expired at the end of 2018, Biogen launched the biosimilar, which is the result of a collaboration between the Biogen group of companies and Samsung Biologics. In 2011, they founded the joint venture company Samsung Bioepis. The latter is focused on the development and commercialisation of biosimilars.

EP 488 is also currently subject to EPO opposition appeal proceedings. On 22 December 2022, the EPO maintained the patent-in-suit, against which Biogen filed an appeal. The Technical Board of Appeal has scheduled oral proceedings for 20 June 2024.

Fresenius had previously asserted another patent against Biogen,EP 3 148 510. The plaintiff once again brought infringement proceedings at Düsseldorf Regional Court (case ID: 4a O 101/18), in which it asserted EP 510 against Imraldi. In June 2022, the EPO Technical Board of Appeal then confirmed the Opposition Division’s revocation of the patent. In November 2022, Fresenius withdrew the earlier action in Germany.

Similarly, two sets of Danish preliminary injunction proceedings have taken place concerning EP 488 and EP 510. In both instances, the court denied Fresenius its requested PIs. In UK proceedings, Fresenius consented to the revocation of the latter patent shortly before the scheduled trial in 2019. The companies have also gone head-to-head in the Netherlands in revocation and infringement proceedings, as well as carrying out proceedings in Italy.