Bayer and Simmons & Simmons Repel Sandoz Nullity Suit over Xarelto

The current dispute between Bayer and Sandoz revolves around EP 1 845 961, which describes a dosage for Bayer’s thrombosis drug Xarelto using the active ingredient rivaroxaban. While the European Patent Office revoked EP 961 in the first instance in 2018 due to lack of inventive step, the EPO Boards of Appeal reinstated the patent in autumn 2021. The patent remains valid until January 2026.

SPC valid until April

The current patent-in-suit protects the dosage. However, EP 1 261 606, which protects the active ingredient, already expired in December 2020. Dutch SPC 300370 based on EP 606 expires on 1 April 2024.

Sandoz plans to market a generic medicine based on the substance rivaroxaban in the Netherlands after the SPC expires, obtaining several marketing authorisations for this purpose. In Bayer’s opinion, however, the generics manufacturer would also be infringing the rivaroxaban dosage patent EP 961, which does not expire until January 2026.

As such, the innovator drug company asked Sandoz to confirm that it will not market any rivaroxaban product in the Netherlands that infringes several patent rights, including EP 961, nor publish it in the G-Staandard. This is an online drug database which lists all products dispensed or used by Dutch pharmacies.

Sandoz attacks rivaroxaban patent

Sandoz confirmed to Bayer that it respects EP 606 and does not intend to market its generic product before the patent’s and associated SPC’s expiry in the Netherlands. At the same time, the generics manufacturer filed a nullity action against EP 961, arguing that the patent is not inventive because the claimed dosage regimen for the subject is obvious from the prior art.

Bayer responded with a counterclaim for infringement. The innovator believes that there is a risk of infringement of the dosage patent if Sandoz launches its copycat product on the market after the expiry of the Dutch SPC of the active ingredient patent.

However, the District Court of The Hague rejected Sandoz’s nullity suit. At the same time, the judges agreed with Bayer’s view that the market entry of a generic version of rivaroxaban from April 2024 constitutes an infringement of EP 961.

The court therefore prohibits Sandoz from infringement of the Dutch part of EP 961 (case ID: C/09/637811 / HA ZA 22-934). An appeal against this decision is possible, although JUVE Patent is not yet aware if Sandoz will take this step.