A&O Shearman’s first UK patent outing for Bayer in Xarelto appeal

Today, the UK Court of Appeal will hear Bayer’s pleading against a first-instance decision, in which the high court found the pharmaceutical company’s patent for active ingredient rivaroxaban invalid for lack of inventive step. However, all hope is not lost for Bayer, which in late April was awarded an interim injunction against the respondents, pending the outcome of the appeal. Today also marks the first patent case for Bayer’s representatives under the new A&O Shearman brand.

Xarelto hot topic

Bayer sells its product under the brand name Xarelto: dosage patent EP 1 845 961 is important for the further protection of the drug throughout Europe, as the basis patent EP 1 261 606, which expired in December 2020. From then onwards, an SPC protected Xarelto until it expired on 1 April 2024.

Following EP 606’s expiry, EP 961 was 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.

On 12 April the UK High Court, led by presiding judge Richard Hacon, found EP 961 invalid for inventive step over the prior art (case IDs: HP-2022-000029; HP-2022-000032; HP-2022-000034; HP-2023-000005; HP-2023-000006; HP-2023-000017). In all six actions, Bayer counterclaimed for infringement, although the trial focused solely on the patent’s validity.

On 22 April, the parties were also subject to a consquentials hearing, with Hacon granting Bayer injunctive relief. This restrains the six respondents, plus other parties not involved in the proceedings, from selling their generic versions of rivaroxaban with a once-daily indication in 10 mg, 15 mg and/or 20 mg measurements.

Bayer fights back

Initially the judge granted relief until 29 April 2024, but Bayer sought an extension of the interim injunction until the court of appeal decided whether or not to allow Bayer’s application for permission to appeal. On 29 April, the court granted Bayer’s request, meaning the interim injunction now extended further pending the outcome of the appeal. Today Bayer seeks to reverse the first-instance finding of lack of inventive step. The innovator pharma company will commence with its arguments in the morning, with the respondents addressing the judge in the afternoon.

While the European Patent Office also 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. The EPO decision was hugely economically significant for Bayer, enabling the company to again monopolise the European market until the expiry. That was until multiple generic drug companies began their battle to enter the market.

Rafi Allos

Aside from the UK, so far France is the only other European jurisdiction to find EP 961 invalid. On 28 March 2024, the Paris Judicial Court around presiding judge Anne-Claire Le Bras rejected the patent. At the request of claimant Sandoz, the court declared the French part of the patent invalid.

Thus, observers had considered the UK’s decision significant, as it lends credence to the previous decision handed down in France. Prior to this, the only country court to rule in favour of the generic drug companies was South Africa. In Sweden, Belgium, Germany and the Netherlands, Bayer has had more successful outcomes.

Outing for A&O Shearman

The current appeal action of Xarelto involves multiple leading law firms, all of which have patent teams that the market holds in high regard for pharmaceutical litigation. In the UK, a London team from international firm A&O Shearman, which until 1 May was known as Allen & Overy, acts for Bayer. Here partner Rafi Allos is leading the charge. It is the first time the London-based A&O Shearman patent team will appear in court.

For more information concerning advisors for the various generics companies, read our previous article ‘UK courts revoke Bayer rivaroxaban patent in new win for generics.’