Why Bayer is fighting so hard for Xarelto

The need for German pharmaceutical company Bayer to restructure is discussed almost daily in the press. In these reports, the name of one blockbuster always comes up: Xarelto. Its substance patent expires today, but a second patent could continue to secure Bayer's market exclusivity if the courts do not rule as Paris recently did.

Patent protection secures Bayer millions in additional revenue every day. According toStatista, sales of Xarelto alone amounted to around €4 billion in 2023. Today, the basic patentEP 1 261 606for active ingredient rivaroxaban expires in Europe, but the company still has a dosage patent with which it can monopolise the market until January 2026 – so long as patent courts continue to rule in its favour, of course.

Currently, these hearings have one key question at their core: can the fact that patients must only take this medicine once a day be classed as an invention? At first glance, this might seem trivial. But to understand its complexity, one must delve deeper into the world of pharmaceutical inventions, how drug approvals work, and eventually how patent court proceedings impact its distribution.

The search for answers becomes a lesson in the interplay of regulations and procedures. It also clarifies why Bayer’s middle management must have greeted each of the recent and numerous court decisions from Munich and The Hague with jubilation. In the group’s current economic situation, jobs – and therefore livelihoods – depend on these patent court judgments.

Bayer sails through

Why is a large global pharmaceutical company such as Bayer, which has 99,723 employees and a turnover of €47.6 billion, so heavily financially dependent on a single drug? To answer this question, it must be understood that despite highly structured research, bringing a blockbuster drug onto the market is also a question of luck.

When, in 2000, the company filed substance patent EP 606 for active ingredient rivaroxaban, no-one could predict that it would eventually be such a stroke of luck for Bayer’s research, or that the fate of many employees would depend on it in 2024.

Instead, as is usual with substance patents, the patent is relatively comprehensive, was filed relatively quickly and was completely uncontroversial. According to the EPO database, no oppositions were filed. When it expired at the end of 2020, a supplementary protection certificate (SPC) extended its validity until today.

Once or twice a day?

When the company filed the European dosage patentEP 1 845 961in 2006, research was already much further along: it had access to results from the first clinical trials. Such results are decisive for a drug’s approval. For example, if a drug is approved for a single dose per day, a medical professional cannot prescribe it in a lower dose to be taken twice a day. Human clinical trials test a drug’s safety through both a specific dosage and a specific area of application.

Furthermore, if patients experience severe side effects, clinicians do not approve drugs after the clinical trial phase. This means the development of drugs is very expensive. Through long-running patents and SPCs, original manufacturers can secure monopoly profits during the protection period, making research lucrative.

Initially, similar to competitor product apixaban, it seemed as though medical professionals should administer rivaroxaban twice per day. But the inventors around Frank Misselwitz then discovered that a single dosage made sense, bringing the development into the clinical trial phase. The inventors also filed a patent application for this dosage.

The correct dosage is important for drugs such as Xarelto. If a doctor administers the anticoagulant too infrequently, blood clots can form in patients who, for example, must lie down for long periods following orthopaedic surgery. If the anticoagulant is given too often, internal bleeding can occur. In the worst-case scenario, both decisions can be fatal.

Surprise from Boards of Appeal

At the first instance, the European Patent Office revoked patent EP 961 in its entirety. Then, in October 2021,the EPO Boards of Appeal surprisingly reinstated the dosage patent in full.

The decision was hugely economically significant for Bayer, enabling the company to again monopolise the European market until January 2026. But if this will actually be the case has been the subject of much debate since the EPO decision.

Over the past two weeks, the dispute has flared up again. Courts in Munich, Paris and The Hague have handed down decisions.

The German and Dutch courts agreed with Bayer on the essential points, thus preventing generic manufacturers from entering the market with patent-infringing products. However, two national courts saw things differently.

South Africa diverges

Prior to this, only a court in South Africa had declared the patent invalid. An academic conference poster by Sebastian Harder, now professor emeritus at the University of Frankfurt, that presented research results 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.

Now, the Paris Judicial Court around presiding judge Anne-Claire Le Bras rejected the patent last Thursday. The French Court declared the French part of the patent invalid. At the same time, the court also rejected a preliminary injunction. This means that Sandoz can enter the French market with its generic version.

French boutique firmSchertenleibrepresented Sandoz in proceedings. A team around Ombeline Degreze-Pechade achieved this success for the regular client. The decision is a ray of hope for European generics manufacturers. The question now is whether other courts will follow suit.

Difference in Europe

The day before, the District Court of The Hague had prohibited pharmaceutical company Teva from launching a generic version of rivaroxaban in the Netherlands.

The first-instance court considers the sale of the drug to infringe a valid dosage patent for Bayer’s original product, Xarelto. In November 2023,the court had already ruled against Sandoz.

AVondstteam, led by Ricardo Dijkstra, represented Teva in the Netherlands. Sandoz worked with its trusted lawyers around Daan de Lange fromBrinkhof.

Munich prohibits generics listing

The German 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 the week before, in which the companies were acting as co-defendants.

In this case, Bayer had sued the Informationsstelle für Arzneispezifitäten (IFA, an information service provider for the pharmaceutical market), which is responsible for listing drugs in Germany. Only medicines that are listed may be sold on the German market, meaning that all listed drugs are in the system for a short time. This is the case even if a party obtains a PI against them.

To prevent this, Bayer took direct action against the IFA. The action was successful, with the court ordering the IFA to cease and desist, and to provide information. Furthermore, the court considered capsules to be an equivalent patent infringement, even though the patent itself only mentions tablets.

But, despite Bayer’s success, companies rarely choose this approach. Historically, JUVE Patent is only aware of such a lawsuitin the wide-ranging case over cancer drug, pemetrexed.