Xarelto battle reaches Sweden with Bayer win against Sandoz

In February, the Stockholm Patent and Market Court upheld Bayer’s European patent EP 1 845 961 in its entirety, meaning Sandoz has failed to destroy the Swedish part of the patent (case ID: PMT 16592-22).

EP 961 protects a once-daily dosing regimen of rivaroxaban, the active pharmaceutical ingredient in anticoagulant Xarelto. The drug, which is one of the German pharmaceutical giant’s top-selling products, treats thromboembolic disorders.

Exclusivity for Xarelto

EP 961 is important for the further protection of Xarelto throughout Europe in the coming months, as the basis patent EP 1 261 606, which protects the active ingredient, already expired in December 2020. Since then, an SPC has protected Xarelto, but this expires on 1 April 2024.

Thereafter, EP 961 is intended to secure market exclusivity for Xarelto on behalf of Bayer. The patent covers the effect of taking Xarelto once a day. Generics companies throughout Europe, such as Sandoz, are therefore trying to destroy the patent in order to open up the market for generic products. There is currently no infringement suit pending in Sweden.

The Swedish judges also ruled that Sandoz now owes Bayer compensation for litigation costs. The company has appealed to the Patent and Market Court of Appeal in Stockholm.

Setback in Belgium

But the case in Sweden is not isolated; Bayer is fighting various generics manufacturers throughout Europe over Xarelto. JUVE Patent is aware of lawsuits in Germany, France, the Netherlands, Austria, Sweden and the UK. At the European Patent Office alone, 15 companies have filed oppositions against EP 961. There are also lawsuits in the US concerning the blockbuster drug.

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

In November, the District Court of The Hague also dismissed a nullity action brought by Sandoz against EP 961. The Dutch judges also ruled that a market entry of a generic version of rivaroxaban after April 2024 constitutes infringement of EP 961.

New developments in Germany

Although the Federal Patent Court has not yet ruled on the validity of EP 961 in Germany, it provisionally found the patent valid in January. However, the court can still change this provisional opinion, which the law requires, until the final judgment.

The court will hear the nullity case in June 2025 (case ID: 3 Ni 11/22). Hexal, Accord, Genepharm, Krka, Abdi Farma, Polpharma, STADA and ratiopharm have all taken legal action against Bayer on the basis of EP 961.

However, the positive preliminary opinion is important for Bayer given the upcoming expiry of the SPC regarding basic patent EP 660 in April. Bayer wants to use the subsequent patent EP 961 to prevent generic products from entering the market.

With the Federal Patent Court’s preliminary opinion, the generics manufacturers must now expect preliminary injunctions from Bayer. The probability that the German patent courts will also confirm these has now increased.

Cohausz & Florack backs Bayer

Cohausz & Florack is playing a central role on Bayer’s side in the European dispute over Xarelto. Patent attorneys Arwed Burrichter and Natalie Kirchhofer are not only conducting the German proceedings and the dispute at the EPO, but are also involved in the Belgian and Swedish proceedings.

In Sweden, the patent attorneys are assisting Mannheimer Swartling partner Oscar Björkman Possne. He has a relatively recent relationship with Bayer, first acting for the German pharmaceutical group in the dispute with Ceva over veterinary drug BayCox Iron. In Belgium, Bayer relies on Brussels-based partner Christophe Ronse from Altius. Sandoz challenged the Bayer patent with the help of Kristof Roox from Crowell.

Firms across Europe

Malmö-based law firm Setterwalls, led by partner Martin Levinsohn, is representing Sandoz. Levinsohn is known in Sweden for advising on life science cases.

Elsewhere, too, many litigators are involved in the battle for Xarelto. Amsterdam-based IP boutique Brinkhof acted for generic drug company Sandoz in the Dutch proceedings. In the Netherlands, Bayer has a long-standing relationship with Simmons & Simmons. It also regularly instructs the law firm in many countries, including Germany.

In Germany, Bayer not only relies on Cohausz & Florack but also on Hoffmann Eitle regarding the Xarelto battle. The German team of Allen & Overy acts as coordinator in the current case while, in the UK, proceedings have just begun. Many generics companies are challenging Bayer here, including Sandoz and Accord. Bayer is again relying on a London-based team from Allen & Overy.

For Bayer
Mannheimer Swartling (Stockholm): Oscar Björkman Possne; counsel: Emil Brengesjö; associates: Stina Eriksson, Johanna Jacobson
Cohausz & Florack (Düsseldorf): Arwed Burrichter, Natalie Kirchhofer (both partners, both patent attorneys)
In-house (Leverkusen): Elisabeth Haselhorst (litigation counsel), Stefan Beyreuther

For Sandoz
Setterwalls Advokatbyrå (Malmö): Martin Levinsohn (partner); associates: Adeline Fredriksson, Anja Siöstedt, Elin Sjörén

Stockholm District Court, the Patent and Market Court
Ulrika Persson (presiding judge), Tove Bodegård, Anna Hedberg