How two law firms secured Bayer millions for Xarelto in Germany

The anitcoagulant Xarelto with the active ingredient rivaroxaban is one of the Bayer Group’s most important blockbusters. Currently, the German pharmaceutical company lacks new active ingredients with blockbuster potential. As a result, older drugs are an important source of income.

Every day that generic rivaroxaban products cannot be sold is worth several hundred thousand euros for Bayer. Accordingly, the group is fighting hard to prevent various generic drug manufacturers from entering the market throughout Europe — with varying degrees of success.

In Germany, at least, Bayer is on the path to victory. Stada and Aliud Pharma are not allowed to enter the German market until 29 July. The Federal Patent Court will then decide on the revocation actions of various generics companies against the patent-in-suit EP 1 845 961.

If the court finds the patent invalid, the PIs against Stada, Aliud and other generics manufacturers would be null and void. Bayer would presumably have to pay damages for the enforcement of the injunctions and the generics manufacturers would be allowed to enter the German market.

Validity likely

Lars Meinhardt

However, the appeal judges of the Higher Regional Court Munich, led by presiding judge Lars Meinhard, do not believe that the patent was wrongly granted. According to statements from parties involved, they considered it very likely valid during the hearing yesterday. Like the Regional Court, the judges thus set a high standard for the examination of validity in the PI proceedings.

Meinhard and his colleagues thus confirmed the PIs of the first instance (case IDs: 6 U 2277/24 (Stada) and 6 U 2278/24 (Aliud)). These apply to the administration of rivaroxaban in both tablet and capsule form. Written judgments are not yet available. However, the court’s press spokesperson confirmed the outcome of the hearing to JUVE Patent.

Showdown in Munich

Before the big showdown at the German Federal Patent Court in July, the Higher Regional Court will hear further appeals against PI orders.

Bayer sells its product under the brand name Xarelto. The dosage patent EP 961 is important in protecting the drug throughout Europe, as the basis patent EP 1 261 606 expired in December 2020. Subsequently, an SPC protected Xarelto until 1 April 2024.

EP 961 is now intended to secure market exclusivity for Xarelto on behalf of Bayer. The patent has ‘Swiss form’ claims covering the use of rivaroxaban for the manufacture of a medication used in the treatment of thromboembolic disorders. The claims cover the use of a rapid-release tablet, which a patient can adminster once daily for at least five days.

In summer 2024, Bayer obtained PIs against several generics manufacturers at Munich Regional Court. Many have appealed. The Higher Regional Court Munich will hear the appeals of Zentiva and Glenmark on 20 March 2025 and the appeals of Betapharm and 089 Pharma seven days later.

Mixed outcome in the Alps

Bayer scored an additional success in Austria. On 30 January, the Higher Regional Court Vienna confirmed a PI of the first instance against Stada (case ID: 33 R 119/24y). Stada may therefore still not sell rivaroxaban tablets in Austria.

In Switzerland, however, Bayer was not so lucky. The Federal Patent Court in Zurich revoked the Swiss part of EP 961 at the request of Sandoz. Bayer can appeal this decision.

Bayer’s advocates

In the German proceedings, Bayer relied extensively on its regular patent attorneys led by partners Arwed Burrichter and Natalie Kirchhofer from Cohausz & Florack in Düsseldorf. They have managed the patents since the initial filing and have also coordinated the technical parts of the proceedings.

On the legal side, Bayer is working with A&O Shearman led by Stephan Neuhaus. The firm has a coordinating role and is also conducting the proceedings in France. In Austria, Bayer relied on market-leading IP boutique Gassauer-Fleissner. In Swizerland, the company works with a Zurich-based team from MLL Meyerlustenberger Lachenal Froriep.

Jan Phillip Rektorschek, Munich-based partner of Taylor Wessing, is the main representative for Stada and Aliud in Germany. Associate Julia Fischer assisted. Patent attorney Thomas Kernebeck from the law firm of the same name took over the technical part. He represents both firms as straw man in a dispute against Biogen over multiple sclerosis drug Tecfidera.

In the Swiss proceedings over Xarelto, claimant Sandoz retained Zurich-based firm Homberger. In Austria, Stada relied on Vienna-based IP boutique Geistwert Kletzer Messner Mosing Schnider Schultes.