No claim to damages for Millenium and Cilag in dispute over bortezomib

Millenium Pharmaceuticals and Cilag accuse several generic 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 Millenium’s drug Velcade with the active ingredient bortezomib. It is an anti-cancer medication used for the treatment of multiple myeloma and mantle cell lymphoma. Since the patents have since expired, the dispute revolves around damages.

Owner of the patents is the United States of America. Millennium Pharmaceuticals, a daughter company of Takeda operating as Takeda Oncology since 2008, is the licensee and claims to have an exclusive licence for the use of the patents. Johnson & Johnson subsidiary Janssen-Cilag is Millennium’s distribution partner in Germany.

Both sued Betapharm, Ratiopharm, Hikma Pharma and Zentiva alongside its manufacturer Synthon at the Regional Court Düsseldorf. Claiming the generic companies infringed the patents, they asked the court for a declaratory judgement along with requests for information and accounting so that the damages can be calculated. The lawsuits were first assigned to the Civil Chamber 4c, which was dissolved at the end of last year due to declining case numbers. They have since been transferred to the Civil Chamber 4a, headed by presiding judge Tilmann Büttner (case IDs: 4a O 38/25 – 4a O 45/25).

No exclusivity proven

The court dismissed the claims due to the claimants’ lack of the right to sue, them not being the patent holders. The judges did not follow the claimants’ argument that they had an exclusive licence, since the US as patentee had reserved the right to issue further exclusive licences. According to German law, this is incompatible with an exclusive licence. Thus the court did not see a right to sue. Since the second claimant, Cilag, only based its right to sue on Millennium as a sublicensee, the court dismissed their claim. JUVE Patent does not yet know whether the claimants will appeal the decision.

Tilmann Büttner

In parallel disputes over validity, the Federal Patent Court upheld EP 344 in 2024 (case IDs: 3 Ni 24/22, 3 Ni 26/22 and 3 Ni 9/23). An appeal against this decision is pending (case ID: X ZR 78/24). In the case of EP 667, the EPO Boards of Appeal also upheld the patent, albeit in limited form, in mid-2024.

Parallel proceedings over damages involving the claimed infringement of the same two patents are pending in France. Here, a judgment is expected to be handed down in late March. At the Paris court, Millennium sued Stragen, Zentiva and Dr. Reddy’s for damages amounting to €50 million each. Further parallel proceedings against Zentiva and Dr. Reddy’s are pending in Italy and against the latter in Spain.

Teams well versed in pharma

Claimants Millennium Pharmaceuticals and its distribution partner Janssen-Cilag instructed a German team of Herbert Smith Freehills Kramer. Associates Maximilian Martini and Julia Nguyen assisted Düsseldorf based partner Ina vom Feld. Patent attorneys of IP firm Cohausz & Florack advised on technical questions. Partners Arwed Burrichter and Natalie Kirchhofer are renowned for their expertise in pharma. The team also included young partner Tobias Hoheisel.

Most defendants relied on litigation teams from Bird & Bird. These teams worked either with their own patent attorneys or with various external patent attorney firms. The international law firm has extensive experience in patent disputes in life sciences and often acts for generic companies.

Bird & Bird for three defendants

Munich-based partner Christopher Maierhöfer and counsel Roksana Hosseini acted for Betapharm (case IDs 4a O 40/25 & 4a O 41/25). In technical matters, they relied on the pharma expertise of Sebastian Höpfner of patent attorney firm Zwicker Schnappauf & Partner (ZSP).

Ratiopharm (case IDs 4a O 42/25 & 4a O 43/25) instructed a team around Düsseldorf-based partner Oliver Jüngst, including counsel Lucas Brons and associate Natalie Ackermann-Blome. Patent attorney Sandra Lepthien, counsel at Graf von Stosch, provided advice on technical matters.

Another Düsseldorf-based Bird & Bird team around partner Christian Harmsen represented Zentiva (case IDs 4a O 44/25 & 4a O 45/25). He was assisted by counsel Bastian Selck and patent attorney Anne Halbach, also counsel at Bird & Bird.

Bonabry represented Synthon Pharma, who was involved in the dispute alongside Zentiva. Partner Carl Alexander Dinges, who left Preu Bohlig with a team to form Bonabry a year ago, represented the client. They worked together with patent attorney Alexander Wittkopp, who led the technical part of the case. The name partner of Hamm & Wittkopp often cooperates with the litigators of Bonabry, for example most recently for Stada in the UPC proceedings against Sanofi over cabazitaxel.

Hikma Pharma instructed Pinsent Masons (case IDs 4a O 38/25 & 4a O 39/25). Though not among the prominent German practices in patent litigation, the team around Munich based partner Marc Holtorf occasionally represents clients – often pharma companies – in patent disputes. For example, the team acted for Formycon in the first instance of the dispute against Janssen over Stelara.

Many teams for validity

Several patent attorneys involved in the infringement also led the nullity case against EP 344 in Germany and the opposition against EP 667 at the EPO.

At the German Federal Patent Court as well as in the EPO opposition, Bird & Bird partner and patent attorney Daniela Kinkeldey together with Anne Halbach acted for Zentiva. Meanwhile, Sebastian Höpfner of ZSP pleaded the nullity case for Betapharm and Sandra Lepthien of Graf von Stosch for Ratiopharm. At the EPO, Höpfner led the opposition for Betapharm and Dr. Reddy’s, while Graf von Stosch acted for opponent Teva.

Christina Kanz of Hoyng ROKH Monegier represented the US as patent owner at the Federal Patent Court with the assistance of Lisa-Marie Rauschendorfer. Intervener Millennium Pharma banked again on Arwed Burrichter and Natalie Kirchhofer of Cohausz & Florack. At the EPO, British mixed firm Carpmaels & Ransford acted for the patent holder.

French-German axis

In the French proceedings, the claimants as well as defendants rely on the French practices of their German representatives. Alexandra Neri from the Paris office of Herbert Smith Freehills Kramer represents Millennium Pharma and Cilag.

Bird & Bird acted for Dr. Reddy’s, whose subsidiary Betapharm the German team also represented in the Düsseldorf proceedings. Anne-Charlotte Le Bihan led the case for the client, working with associates Marylis Clerc, Audrey Naturel and patent attorney Margaux Beretta. The law firm also acts for the client in the parallel proceedings in Italy.

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