Generics companies successfully challenge Biogen’s Dutch Tecfidera patent

Dimethyl fumarate, or DMF, treats multiple sclerosis. The dispute between Biogen and numerous generics manufacturers concerns the daily oral administration of 480 grams of the active ingredient.

Biogen’s EP 2 653 873 protects this low dosage administration. The company is trying to prevent various manufacturers across Europe from entering the market with generic products. In the Netherlands, the US biotech company has now failed.

Three claims, one case

Last week, the District Court The Hague declared the patent invalid in the Netherlands. Biogen had sued Polpharma (part of the Sandoz Group), Neuraxpharm and Mylan (part of the Viatris Group) for infringement of EP 873 (case IDs: C/09/639604 / HA ZA 22-1028; C/09/639606 / HA ZA 22-1029; C/09/639609 / HA ZA 22-1030).

The three generics manufacturers responded with counterclaims for revocation. Following the nullity decision, the infringement actions are no longer necessary. Biogen had originally sued the manufacturers individually. However, Edger Brinkman, Marije Knijff and presiding judge Margot Kokke consolidated the proceedings. All three judges are also judges at the Unified Patent Court.

The three judges considered the revocation attacks successful “because the patent is either sufficiently disclosed but not inventive or (potentially) inventive but not sufficiently disclosed”. Shortly before Christmas, the European Patent Office’s Opposition Division had confirmed EP 873. A total of 14 opponents had tried to prevent the granting of the patent, including Accord, Hexal, Neuraxpharm, Polpharma, Stada, Teva, and Zentiva.

Appeal likely, market entry unclear

Several of the opponents immediately filed an appeal against this decision with the Boards of Appeal.

An appeal is also likely in the Dutch proceedings, although Biogen has not indicated whether it will pursue this route. The decision of the District Court The Hague is one of the first in Europe. Biogen will certainly want to prevent it from having a signal effect for other countries.

In Germany, Biogen is using the patent to take action against several generics manufacturers with ex-parte PIs. Two years ago, Biogen failed to win PIs against Neuraxpharm, Viatris and Hexal at Düsseldorf Regional Court. Biogen is battling generics manufacturers in many other European countries, such as France and Sweden.

In principle, the way is now clear for Neuraxpharm, Polpharma and Mylan to launch their own products on the Dutch market. However, Biogen can still invoke market exclusivity under EU law until 3 February. Furthermore, if the generics manufacturers enter the Dutch market, they run the risk of the ruling being overturned on appeal.

Bird & Bird, BarentsKrans and Brinkhof

The generics companies relyied on regular advisors in the Dutch dispute. A Bird & Bird team around partner Marc van Wijngaarden represented Neuraxpharm. Emma Stokk and Sabrina Lodder provided support. Patent attorney Lilian Hesselink from De Vries & Metman took over the technical part.

A Düsseldorf-based Bird & Bird team is also advising neuraxpharm in the German proceedings. Patent attorney firm Ter Meer Steinmeister & Partner leads the EPO proceedings for the generics company.

Viatris subsidary Mylan relied on Jaap Bremer from Dutch national firm BarentsKrans, including Jarieke Timmerman and Jens Brugman. Rene Raggers from Dutch patent attorney firm AOMB took over the technical part. Litigation counsel Ben Clossick Thomson and senior patent attorney Joshua Cravigan were present in the court room on behalf of Viatris Global.

Brinkhof represented Sandoz. The company frequently retains the firm in the Netherlands. The team consisted of partner Daan de lange, Barbara Mooij, Charlotte Tiems and Isabelle Kleinveld. Sandoz IP litigation counsel Michael Rein has the lead in-house.

Interestingly, Bird & Bird associate Emma Stokk and BarentsKrans associate Jarieke Timmerman were among JUVE Patent’s Ones to Watch 2024 due to their work on in the case.

Hoyng ROKH for Biogen

An Amsterdam team from Hoyng ROKH Monegier represented Biogen. Partner Peter van Schijndel took the lead. The team also included partner Roeland Grijpink, Rosalie ten Wolde, Pien Hasse and Dirk Henderickx.

Sandra Pohlman, patent attorney from Munich-based IP firm df-mp represents Biogen in the EPO and German proceedings. She was also present in den Dutch court room.