UK courts revoke Bayer rivaroxaban patent in new win for generics

Mutiple pharmaceutical companies have succeeded in revoking a blockbuster Bayer patent in the latest round of proceedings, which have this time taken place in London. The ruling paves the way for generics to bring their anti-coagulant drugs to European market and counter the monopoly of Bayer's Xarelto medication.

The UK High Court has dealt Bayer a blow in its wide-ranging battle against generic drug companies in Europe, after finding the pharmaceutical company’s patent for active ingredient rivaroxaban invalid for lack of inventive step.

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

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

Xarelto top seller

Thereafter, following EP 606’s expiry, EP 961 is 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 can be administered once daily for at least five days.

Throughout Europe, generic companies are trying to destroy the patent in order to open up the market for generic products. In the UK, six claimants alleged that Bayer’s EP 961 is invalid and that the company is attempting to extend its market monopoly ‘through unjustified means’. In all six actions, Bayer counterclaimed for infringement, although the trial focused solely on the patent’s validity.

Posters for prior art

The UK High Court, led by presiding judge Richard Hacon, thus found EP 961 invalid for inventive step over the priort art named Harder, as well as another piece of prior art, the ‘Kubitza posters.’ Researcher Dagmar Kubitza had previously presented two posters which contained the work summarised in the two abstracts of ‘Blood 3004 and 3010’ in expanded form.

Furthermore, an academic conference poster by Sebastian Harder, currently professor emeritus at the University of Frankfurt, presented research results which played a decisive role. The researcher investigated the functioning of biomarkers using the example of rivaroxaban, among others.

In this and other proceedings, generics companies argued that Harder’s studies showed, at an early stage, that the once-daily dosage of Xarelto was already appropriate. The court in South Africa was the first to follow this view, followed by France in March 2024. The UK has clearly follow suit.

Movement in Europe

But this is by no means an isolated case. Over the past few months, Xarelto has been on the lips of pharmaceutical patent experts across Europe. In February 2024, the Stockholm Patent and Market Court upheld EP 961 in its entirety, meaning claimant Sandoz failed to destroy the Swedish part of the patent (case ID: PMT 16592-22).

At the EPO alone, 15 companies have filed oppositions against EP 961. There are also lawsuits in the US concerning the blockbuster drug. In November 2023, the District Court of The Hague ruled thatSandoz may not sell its generic version of rivaroxaban in the Netherlands, even after the expiry of an SPC. Sandoz had argued that the patent is not inventive, because the claimed dosage regimen for the subject is obvious from the prior art.

In Germany, the country’s Federal Patent Court recently considered the patent to be valid in a preliminary opinion. As a result, the Munich Regional Court issued PI orders against Zentiva, Stadapharm and Aliud. The decisions followed a lengthy hearing in which the companies were acting as co-defendants.

UK follows France

According to JUVE Patent information, Bayer also obtained a favourable ruling against Sandoz in Belgium, after the Enterprise Court of Brussels confirmed EP 961 (case ID: A/22/02947). Sandoz may appeal the judgment, which is considered very likely.

Conversely, however, judges in both South Africa and France found EP 961 invalid. On 28 March, the Paris Judicial Court around presiding judge Anne-Claire Le Bras rejected the patent. At the request of Sandoz, the French court declared the French part of the patent invalid.

JUVE Patent is not aware whether Bayer will appeal the UK ruling, although this is considered likely. Observers consider 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.

The great and good

Multiple leading law firms are involved in the action over rivaroxaban, many of whom have patent teams well-regarded for pharmaceutical litigation.

Pinsent Masons has long acted for several generic drug manufacturers in the UK, with the current proceedings seeing the firm fielding two teams across three clients. For Sandoz and Accord, partner Catherine Drew led the charge; James Marshall,who arrived at the firm last year after 26 years at Taylor Wessing, acted for Stada. Originally, partner Nicole Jadeja had acted for the client, but she deferred the work to Marshall whenshe departed Pinsent Masons for Bird & Birdin late 2023.

Teva is a core client for IP boutique Bristows, with the firm having acted for the company in various previous disputes including against Bayer overlow-testosterone treatment drug sorafenib, marketed as Nexavar. For the rivaroxaban proceedings, partner Andrew Bowler led the team.

Penningtons Manches Cooper, led by partner Duncan Curley, represents Cipla. Two years ago,Curley and his entire team from previous firm Innovate Legal moved to the UK firm, with Curley and senior associate Amanda Easey setting up its IP practice. For more than 14 years, Innovate Legal had represented generic drug companies in the life sciences sector in patent disputes in the UK.

HGF law represented Amarox and Hetero Labs, while a team from the London office of international firm Taylor Wessing acted for regular client Viatris. The firm represents Aliud Pharma, Stadapharm and Hexal in Germany.

No room in court

Partners Arwed Burrichter and Natalie Kirchhofer fromCohausz & Florackin Düsseldorf filed the original patent for Bayer, which is a German company. They have managed the patents since the company first filed them and also coordinate the technical aspects of proceedings.

In the UK, the London team of international firm Allen & Overy act for Bayer, led by partnerRafi Allos. The firm also represents the German pharmaceutical company in Germany and France, although it instructs Simmons & Simmons in the Netherlands.