Biogen fails against multiple generics over MS drug Tecfidera

The Regional Court Düsseldorf and the Judicial Court of Paris have both rejected Biogen's preliminary injunction applications against generic drug manufacturers over multiple sclerosis drug, Tecfidera. The decisions should clear the way for Neuraxpharm, Hexal and Viatris to launch their imitation products.

11 October 2022 by Konstanze Richter

Biogen Following decisions against Biogen in France and Germany, generic drugs companies Neuraxpharm, Hexal and Viatris could soon launch their competing products on the market ©I Viewfinder/ADOBE STOCK

Biogen owns EP 26 53 873, which protects a pharmaceutical composition comprising active ingredient dimethyl fumarate or monomethyl fumarate, plus one or more pharmaceutically acceptable excipients. Administered in a dose of 480 mg per day, the formulation is the basis of the drug Tecfidera, which doctors use to treat multiple sclerosis.

Biogen believes that generic drugs manufactured by Neuraxpharm, Hexal and Viatris (formerly Mylan) infringe EP 873, with the company applying for injunctions against the three companies at the Regional Court Düsseldorf (case IDs: 4b O 50/22, 4b O 54/22 and 4b O 5r/22). In filing the cases, Biogen hoped to prevent the sale of the competing products.

In parallel, Biogen also filed injunction proceedings against Viatris in France (case ID: 22/5579).

Biogen stumbles at EPO

However, Neuraxpharm and Hexal are among five parties that filed an objection against EP 873 at the European Patent Office. The patent-in-suit arose from a divisional application of parent patent EP 21 37 537, which the first instance EPO Opposition Division revoked due to lack of inventive step. In January 2022, Biogen appealed to the Boards of Appeal. However, the boards also revoked the patent due to added matter.

Thomas Musmann

In view of the EPO’s decision on the parent patent, Düsseldorf Regional Court also considered the validity of divisional patent EP 873 insufficiently secured to justify handing down a preliminary injunction. Biogen appealed against the decision.

Furthermore, the Judicial Court Paris also saw reasonable doubt as to the validity of the patent and refused to grant a preliminary injunction. In parallel, Biogen is fighting over the patent in Sweden, Ireland and the Czech Republic.

Tried and tested

Biogen relies on its regular advisor Rospatt Osten Pross. A team led by partner Thomas Musmann advises the client on numerous patent disputes. The patent attorneys at df-mp also have a long-standing client relationship with the originator company.

Name partner Sandra Pohlman was not only responsible for filing the patent-in-suit, but also represents Biogen in various opposition proceedings, most recently against Polpharma in the dispute over another MS drug, natalizumab.

Matthias Meyer

In France, the pharmaceutical company relies on Hoyng ROKH Monegier. Paris-based partner Benoît Strowel regularly acts in cross-border pharma cases.

He has already cooperated with Rospatt Osten Pross in the past, for example for Ceva in the dispute against Bayer/Elanco over a veterinary drug.

Herbert Smith Freehills is coordinating the international proceedings for Biogen, with Milan-based partner Sebastian Moore leading.

Bird & Bird has already advised and litigated for Neuraxpharm in the past. For the technical issues, the pharmaceutical company retained a team of patent attorneys from Ter Meer Steinmeister & Partner, which also represents the client in the opposition proceedings concerning EP 873.

Generics in Europe

Matthias Sonntag

Gleiss Lutz acted for Hexal, marking the first time the firm has represented the company in a patent dispute. The generics producer also regularly retains Bird & Bird for patent litigation.

Viatris, which emerged in 2020 from the merger of Dutch company Mylan with the then-Pfizer subsidiary Upjohn, is a regular client of Taylor Wessing.

For example, the German practice was recently active in proceedings against Bayer over Nexavar. In addition, the UK practice represented the generics company in a dispute with Flynn over an insomnia drug.

In France, Viatris’ predecessor Mylan has long relied on IP boutique Schertenleib. Here, name partner Denis Schertenleib represented the company in the French part of the cross-border proceedings against Novartis over fingolimod.

For Biogen
Rospatt Osten Pross (Düsseldorf): Thomas Musmann, Hetti Hilge (partners); associate: Tabea Schäfer
df-mp Dörries Frank-Molnia & Pohlman (Munich): Sandra Pohlman, Ulrich Dörries (both partners); Manuel Reiter (all patent attorneys)
Hoyng ROKH Monegier (Paris): Benoît Strowel, Florence Jacquand (both partners); associates: Laura Romestant, Charlotte Cuny
In-house (Cambridge, US): Brian Larivee (litigation counsel)

For Neuraxpharm (case ID: 4b O 54/22)
Bird & Bird (Düsseldorf): Matthias Meyer (partner); counsel: Daniel Misch
Ter Meer Steinmeister & Partner (Munich): Bernd Aechter (partner); Ingo Ortel (both patent attorneys)
In-house (Barcelona): María Gonzalez Fuentes (IP manager)

For Hexal (case ID: 4b O 50/22)
Gleiss Lutz (Düsseldorf): Matthias Sonntag, Mischa Krumm (both partners); of counsel: Thomas Bopp
Lederer & Keller (Munich): Michael Best (partner, patent attorney)
In-house (Munich): Michael Rein (lead IP litigation counsel), Kristina Herzberg (senior IP counsel)

For Viatris/Mylan (case ID: 4b O 55/22 and 22/5579)
Taylor Wessing (Munich): Jan Phillip Rektorschek, Julius Zacharias (both partners)
Schertenleib (Paris): Denis Schertenleib (partner); associate: Yasmine Azzaoui

Regional Court Düsseldorf, 4b Chamber
Daniel Voß (presiding judge)

Judicial Court Paris, 3rd Chamber
Nathalie Sabotier (presiding judge)


Update 02.03.2023: In the German appeal proceedings, the Higher Regional Court Düsseldorf has now confirmed the first-instance decisions. In the oral hearing, judge Thomas Kühnen followed the decision of the Regional Court’s 4b Chamber and dismissed Biogen’s application for a preliminary injunction. There is currently no proceedings on the merits pending in Germany. However, the opposition against EP 873 is still pending at the EPO.

For Biogen
Rospatt Osten Pross (Düsseldorf): Thomas Musmann, Hetti Hilge (partners); associate: Tabea Schäfer
df-mp Dörries Frank-Molnia & Pohlman (Munich): Sandra Pohlman, Ulrich Dörries (both partners, both patent attorneys)

For Viatris (case ID: I-2 U 121/22)
Taylor Wessing (Munich): Jan Phillip Rektorschek, Julius Zacharias (both partners)
Ter Meer Steinmeister & Partner (Munich): Luigi Rumi, Christian Hollatz (both partners, both patent attorneys)

For Hexal (case ID: I-2 U 116/22)
Gleiss Lutz (Düsseldorf): Matthias Sonntag, Mischa Krumm (both partners)
Lederer & Keller (Munich): Michael Best (partner, patent attorney)

For Neuraxpharm (case ID: I-2 U 117/22)
Bird & Bird (Düsseldorf): Matthias Meyer (partner); counsel: Daniel Misch
Ter Meer Steinmeister & Partner (Munich): Bernd Aechter (partner); Ingo Ortel (both patent attorneys)

Higher Regional Court Düsseldorf, 2nd Senate
Thomas Kühnen (presiding judge)

JUVE Patent updated this article on 02.03.2023 to reflect the latest decision in the ongoing case between Biogen and generic drug companies concerning Tecfidera.