Second medical use

Surprise success for Bayer blockbuster Xarelto at EPO

The EPO Boards of Appeal have reinstated the dosing patent for Bayer's thrombosis blockbuster drug, Xarelto. In the first instance, the patent was revoked completely. This time, however, inventive step was the sticking point.

28 October 2021 by Christina Schulze

Xarelto, Bayer The EPO Boards of Appeal has reinstated the dosing patent for Bayer thrombosis blockbuster drug, Xarelto ©Aleksey Khripunkov/ADOBE STOCK

On the evening of the second day of the trial, in a surprise move the EPO Boards of Appeal have reinstated the dosing patent for Bayer’s thrombosis blockbuster drug, Xarelto. Until shortly before the decision in the evening, it was still unclear which way the trial would go.

This surprise decision is a major economic success for the German pharmaceutical company. The high-selling and high-value drug will have market exclusivity for another year and a half.

Xarelto steps up

The EPO first instance had revoked EP 18 45 961 due to lack of inventive step. It describes a dosage for Bayer’s thrombosis drug, with active ingredient rivaroxaban.

For Bayer, the first day of hearings on Tuesday went largely as expected. For example, as in the first instance, the EPO’s internal appeal body did not consider the first three grounds for opposition to be convincing.

The main hearing took place in the largest courtroom at the EPO’s Munich headquarters. However, the judges allowed no spectators or parties via video. Due to Bayer’s request for a face-to-face hearing, the EPO had postponed the date for about a year.

Invention on dosage

On Wednesday morning, Bayer and the 15 opponents came to the heart of the dispute. The dosing patent says, in essence, that taking a single tablet per day is sufficient. Before the patent was granted 15 years ago, patients tended to take two tablets per day.

Natalie Kirchhofer

However, Bayer argued that taking only one tablet was both more convenient for the patient, and had a sufficient effect. At the trial, Bayer detailed why a medical expert could not have foreseen this.

Three-pronged attack

Bayer regularly works with patent attorney firms Cohausz & Florack, Hoffmann Eitle and König Szynka in Germany for important oppositions and appeals. In this case, the company relied in the first instance on Cohausz & Florack.

The firm has been involved in the patent from the filing stage.

However, after the retirement of patent attorney Ralph Minderop last year, the pharmaceutical company called in Hoffmann Eitle partner Joseph Taormino for the proceedings before the Boards of Appeal.

All opponents worked with their core advisors from the first instance.

For Bayer
In-house (Leverkusen): Jochen Nowak, Gabriele Handke-Ergüden
Cohausz & Florack (Düsseldorf): Arwed Burrichter, Natalie Kirchhofer (both lead); associates: Tobias Hoheisel, Lauren Schweizer (all patent attorneys)
Hoffmann Eitle (Munich): Joseph Taormino (partner); associate: Claudia Unsin (both patent attorneys)

For Actavis, Polpharma, Teva
Elkington Fife (London): Richard Gillard (patent attorney)

For Stada
In-house (Bad Vilbel): Şenay Has
Kernebeck (Frankfurt): Thomas Kernebeck (patent attorney)

For Generics
Venner Shipley (Cambridge): Anwar Gilani (patent attorney)

For Abdi Ibrahim
Breuer & Partner (Munich): Markus Breuer (patent attorney)

Anonymous opponent
Hamm Wittkopp (Hamburg): Alexander Wittkopp (patent attorney)

Anonymous opponent
ABG Intellectual Property Law (Barcelona): Enric Carbonell, Sofia Pettersson Höpfner (both patent attorneys)

Anonymous opponent
Stolmar (Munich): Matthias Stolmár, Denise Nestle-Nguyen (both patent attorney)

For Hexal
In-house (Munich): Maike Höpfner
Lederer Keller (Munich): Michael Best (patent attorney)

Anonymous opponent
Kraus & Weisert (Munich): Marc Gerauer, Sophia Ringler (both patent attorneys)

For Zentiva
In-house (Praque): Samuel Woodley
Reddie & Grose (Munich): Robin Ellis; Francesca Piana (patent attorney)

For Krka
In-house (Novo mesto): Mija Pelko
Hoefer & Partner (Munich): Michael Westendorp (patent attorney)

EPO Board of Appeal (3.3.01)
Albert Lindner (chair), Regina Hauss (rapporteur), Paul de Heij (legal member)