Teva Santé and August Debouzy fend off Biogen’s PI request in Tecfidera case

The latest twist in the Tecfidera saga comes via a ruling from the Paris Judicial Court. On 5 February, presiding judge Irène Benac dismissed Biogen’s PI claim against Teva Santé (case ID: RG 24/58777). The judgment is now publicly available. Biogen had accused the generic drug company of infringing EP 2 653 873.

EP 873 is a formulation patent of the original basic patent for Tecfidera. EP 873 protects a pharmaceutical composition comprising active ingredient dimethyl fumarate or monomethyl fumarate, plus one or more pharmaceutically acceptable excipients. Administered in a dose of 480mg per day, the formulation now forms the basis of Tecfidera. It is also the subject of litigation in Germany, the Netherlands and other countries.

Doubts on validity

In December 2024, the European Patent Office’s Opposition Division confirmed EP 873 after a total of 14 opponents had tried to prevent the granting of the Tecfidera patent. Several opponents have since filed an appeal with the Boards of Appeal. The BoA will hear these at the end of November 2025.

In France, Biogen asked the Paris court to prevent Teva Santé from launching its own products on the market until February 2028. But the Paris judge had doubts as to whether the patent would survive a revocation action and did not grant the PI. Judge Benac declared that “there is no ground for preliminary injunction in view of the serious means alleging a lack of inventive step capable of challenging the apparent validity of the patent on which the claims are based”.

Biogen can appeal the ruling. It is not known whether the US company will take this step.

Win some, lose some

With market exclusivity for Tecfidera having expired in Europe on 1 February, the battle for market share here has since begun in earnest. Every day that generic versions are kept off the market is likely to flush hundreds of thousands of euros into Biogen’s coffers. Accordingly, Biogen is trying to keep generics off the market in various European countries.

In Germany, at least, Biogen has succeeded. In January, Düsseldorf Regional Court prohibited Hexal, Stada, Aliud Pharma, Glenmark and Ratiopharm as well as three other generics manufacturers from launching their own products on the German market.

The ruling was in stark contrast to that of Dutch courts. A few days earlier, the District Court The Hague nullified EP 873, concluding that Biogen’s infringement claims are moot. Biogen had sued Polpharma (part of the Sandoz Group), Neuraxpharm, and Mylan (part of the Viatris Group) for infringement of EP 873. The three generics companies are now in principle free to enter the Dutch market.

Teva Santé and others

According to JUVE Patent information, Biogen has also filed a main action against Viatris and its subsidiary Mylan as well as Neuraxpharm. The generics manufacturers likely responded with counterclaims for revocation. The Judicial Court Paris will hear the cases on the merits against the defendants on 6 March 2025. Biogen and Mylan/Viartis have battled it out in PI proceedings before.

JUVE Patent has not yet received confirmation that the US company has also filed a main action against Teva Santé.

Benoît Strowel and Florence Jacquand are handling the lawsuits against all three generics manufacturers. Both are partners at Hoyng ROKH Monegier. Additionally, the law firm is advising Biogen in the Dutch proceedings, while the French team is also active for the company in another dispute. Meanwhile, in Germany, Biogen is relying on the Düsseldorf IP firm Rospatt in the Tecfidera case.

A team from August Debouzy led by partner François Pochart represented Teva Santé in the PI proceedings. Pierre-Olivier Ally and Mayeul Ottaviani assisted. Teva Santé is a regular client of the patent team. It currently represents the generic company in many disputes with originators.

Viatris and Neuraxpharm rely on the Paris-based IP boutique Schertenleib. Name partner Denis Schertenleib and partner Ombeline Degrèze-Péchade have the lead.