Biogen defends adalimumab biosimilar Imraldi with international team

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 of EP 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.

International field

Although the proceedings took place in Düsseldorf, an international team was involved for Biogen and Samsung Bioepis. The team included German IP firm Rospatt Osten Pross, which is often involved in the German suits within pan-European litigation. This includes intensive work for a roster of innovator clients such as Biogen.

From the UK, London-based IP boutique Powell Gilbert is European coordinating counsel for Biogen. As well as acting in UK litigation, the firm has also worked with Biogen’s foreign counsel in national proceedings, and with patent attorney firm Patent Boutique in the EPO proceedings. The London office of Simmons & Simmons is acting as European coordinating counsel for regular client Samsung Bioepis, and as such were also involved in the proceedings against Fresenius.

In Germany, Düsseldorf-based Krieger Mes & Graf v. der Groeben leads for core client Fresenius. According to JUVE Patent information, Fresenius is also asserting EP 488 in France. Here, partner Sabine Agé of the Paris office of Hoyng ROKH Monegier is instructing Biogen, while the claimant Fresenius instructs August Debouzy. The team is led by partner Francois Pochart.

For Biogen
Rospatt Osten Pross (Düsseldorf): Thomas Musmann, Max von Rospatt, Simon Klopschinski (all partners)
Powell Gilbert (London): Penny Gilbert, Zoe Butler, Bryce Matthewson (all partners)
Simmons & Simmons (London): Scott Parker, Amy Crouch (both partners)
Patent Boutique (London): Jon Broughton (partner)

For Fresenius Kabi
Krieger Mes & Graf v. der Groeben (Düsseldorf): Jochen Bühling (partner): associate: Daniel Graetsch
Müller-Boré & Partner (Munich): Ulrich Hoffmanns (partner)

Regional Court Düsseldorf (Chamber 4a)
Berenice Thom (presiding judge); Dr. Bongartz, Maren Knappke (both judges)