German Federal Patent Court upholds Xtandi patent in win for Astellas

Astellas is defending several IP rights across multiple countries that protect its drug Xtandi. The current case concerns the basic patent EP 1 893 196 and its German SPC (12 2013 000 155.0). These protect the active ingredient enzalutamide, which forms the basis of Xtandi, a drug used for treating prostate cancer. The EP is in force until May 2026 and the respective SPC extends protection in Germany until 25 June 2028.

Astellas as intervenor

The Federal Patent Court recently dismissed a nullity suit brought by Hexal (case ID: 3 Ni 20/23). Accord Healthcare, Synthon and Stada had joined as plaintiffs. Astellas Pharma is the exclusive sub-licensee of the challenged IP rights. It had joined the proceedings as an intervening party alongside the defendant and holder of the patent and SPC, The Regents of the University of California.

EP 196 and the related SPCs are also subject to parallel proceedings in the UK and Netherlands. In October 2024, the UK High Court upheld the British part of EP 196 and the SPC in its entirety. An appeal against the decision is pending.

In the Netherlands, the District Court The Hague will soon hand down its first-instance decision on EP 196. Earlier this year, the court upheld EP 3 725 778, a patent protecting the formulation of enzalutamide.

Power in life sciences

The parties seeking invalidity relied on their long-standing representatives. The Munich patent attorney firm df-mp Dörries Frank-Molnia & Pohlmann represented Sandoz subsidiary Hexal, which filed the first nullity action. The team, led by partner Elisabeth Greiner, included counsel Holger Schimmel and associate Tom Schwarzer.

The firm is highly regarded for disputes over life sciences patents. It often appears in nullity proceedings and EPO oppositions, as well as alongside lawyers in infringement proceedings. Sandoz and its subsidiary Hexal are among the firm’s core clients.

Accord relied on patent attorneys Christian Hollatz and Veronika Müller of Ter Meer Steinmeister. Litigator Daniel Hoppe from IP boutique Bonabry provided support. Hoppe launched Bonabry early this year with partners from Preu Bohlig. Partners Konstantin Schallmoser and Sarah Salaschek are also working for Synthon in the nullity proceedings.

Patent attorney firm Hamm & Wittkopp represented Stada, with name partner Alexander Wittkopp in the lead. The firm also acts for the generics company in filing and oppositions.

The Regents of the University of California and intervenor Astellas Pharma relied on a Munich-based team from Hoffmann Eitle. The team consisted of patent attorney and partner Peter Klusmann and partner and litigator Dirk Schüßler-Langeheine. Patent attorney Jan Zillies and lawyer Melanie Schain assisted.

For the defence of its drug in the UK, the patent owner and licensee relied on Kirkland & Ellis. Claimants Accord, Sandoz and Teva instructed a London-based team from Pinsent Masons. In the parallel Dutch proceedings, Brinkhof is representing the generics companies, while Astellas relied on a mixed team from Hoyng ROKH Monegier.