Partial success for Millenium Pharma in battle over Velcade in Paris

Millennium Pharmaceuticals and Cilag accuse several generic drug companies of infringing patents EP 2 251 344 B1 and EP 3 078 667 B1. Both protect a formulation of boronic acid compounds. They form the basis of Millennium’s drug Velcade with the active ingredient bortezomib. The drug treats multiple myeloma and mantle cell lymphoma. Since the patents expired in 2022, the dispute revolves around damages.

The owner of the patents is the United States of America. Millennium Pharmaceuticals, a subsidiary of Takeda (operating as Takeda Oncology since 2008), is the licensee and claims to have an exclusive licence for the patents. Johnson & Johnson subsidiaries Janssen and Cilag are sub-licensees of Millennium.

In February 2025, Millennium, Janssen, and Cilag sued Stragen, Dr Reddy’s, and Zentiva in France at the Judicial Court Paris for marketing their products before the patents had expired. The US as the patent owner joined as intervenor.

Stragen is the legal successor to Synthon, which had obtained marketing authorisation for its bortezomib drug in 2018. It transferred this authorisation first to Ohre Pharma. In the summer of 2022, following the expiry of the disputed patents, the marketing rights were then transferred to Stragen by universal succession.

Split proceedings

Due to its complexity regarding the ownership of the patent and the question of exclusive licences, the case was split to obtain a first judgment on the procedural aspects. The generic drug companies claimed the action was inadmissible, raising several preliminary objections on standing to sue and statutes of limitation.

In a partial judgment handed down yesterday, the court rejects the pleas of inadmissibility. Millennium, Janssen, und Cilag are entitled to bring legal proceedings, and the United States is entitled to intervene as a third party.

Entitled to sue

In this, the Paris judges differed from a recent German judgment. In February, the Regional Court Düsseldorf had dismissed Millennium’s claim to damages because the firm is not the patent owner and does not qualify as exclusive licensee under German law.

According to the French judgment however, the licence agreement expressly grants Millennium the right to bring an action for patent infringement in its own name – irrespective of the exclusivity of the licences. Although the licence expired on 25 January 2022 upon the expiry of the patents, the right to bring an action for acts of infringement committed prior to that date remains in force.

Furthermore, Janssen and Cilag are allowed to join Millenium’s claim as sub-licensees.

Focus on limitation period

Regarding the statute of limitations, according to French law, actions for infringement are time-barred within five years, calculated from the date on which the right holder became aware, or ought to have become aware, of the last fact enabling him to bring the action.

Stragen argued that the claim for compensation for non-pecuniary damage was time-barred, as the event giving rise to liability – namely the price reduction of the original product Velcade – had occurred in May 2019 and thus more than five years before the action was brought.

The court stated that the event giving rise to liability is the alleged act of infringement, namely the launch of the generic medicine — in Stragen’s case on 1 July 2020. The price reduction of the original product serves only for quantifying the damages.

Not earlier than 2020

In the current case, damages can be calculated for infringing acts dating back to early 2020, but not before. However, the three defendants had launched their products at different times. Zentiva, for example, started selling its generic in October 2019, but due to the limitation period cannot be held liable for damages before 10 February 2020. Stragen only launched their product in mid-2020, thus fully falling within the period of limitations.

The proceedings will continue on the merits in the autumn. The court will then have to decide not only on the infringement claim, but also on the question of damages against the backdrop of the first price reduction.

The plaintiffs are seeking compensation for the so-called springboard effect, that is the impact of the infringing acts on the sales level of the originator product and the resulting price competition. The calculation is based on the difference between the price of the originator before and after its 40% price reduction in 2019.

Same firms in France and Germany

In the French proceedings, the claimants as well as some of the defendants relied on the French practices of the law firms that represented them in the German proceedings.

Alexandra Neri from the Paris office of Herbert Smith Freehills Kramer represents Millennium Pharma and Cilag, while Hoyng ROKH Monegier acts for the US with a team led by Paris-based partner Amandine Métier.

Stragen instructed a team around young patent litigator Jules Fabre, who moved with two associates from Pinsent Masons to Taylor Wessing in 2025. Counsel Marina Jonon and associates Louise Millot and Clémence de Marassé-Enouf assisted in the case.

Zentiva once more relied on the Parisian IP boutique Schertenleib. Young partner Marc Lauzeral led the case, assisted by associates Maurane Cadinot and Stella Signoroni. The firm has acted for the generics manufacturer before, for example against Bayer in the dispute over sorafenib.

Bird & Bird acted for Dr Reddy’s. Anne-Charlotte Le Bihan led the case for the client. The law firm also acts for the client in parallel proceedings in Italy.