Bayer Intellectual Property GmbH & ors (appellants) v Sandoz AG & ors (respondents)

Thursday 16 May 2024

This is an appeal against the Order of HHJ Hacon (sitting as a HCJ) dated 12 April 2024 that declared that the Patent is and has at all material times been invalid and ordered that it be revoked.

Rivaroxaban is the generic name of a pharmaceutical used for the prevention or treatment of thromboembolic disorders. It was developed by the Bayer group of which the defendant forms part.

The active ingredient of rivaroxaban is protected by product claims of a patent owned by Bayer. Consequently Bayer has had a monopoly of the rivaroxaban market, selling the product under its brand name Xarelto. That protection was extended by an SPC but expired on 1 April 2024. This provides an opportunity for those who wish to market generic rivaroxaban, not least the claimants and third parties in these proceedings, save that Bayer also owns European Patent (UK) No. 1 845 961 (“the Patent”).

The claimants allege that the Patent is invalid and that it constitutes an attempt by Bayer to evergreen its lucrative monopoly in the manufacture and marketing of rivaroxaban, in other words to extend the monopoly through unjustified means.

Bayer has counterclaimed, alleging a threat on the part of the claimants and the third parties to infringe the Patent by the marketing of rivaroxaban products.

View hearing:

Part 1

Part 2