Astellas and Hoyng ROKH defend overactive bladder patent in The Hague

The use patent EP 1 559 427 and the associated SPC (300599) form the basis of Astellas’ drug Betmiga with the active ingredient mirabegron. It is one of the pharmaceutical company’s top-selling drugs. The patent has expired, but the SPC is in force until 6 January 2028.

The active ingredient mirabegron was previously considered for the treatment of diabetes mellitus, for example. It was also known that the substance class to which mirabegron belongs is suitable for the treatment of urinary urgency and incontinence — both symptoms of an overactive bladder.

Similar decisions

In the Netherlands, the District Court of The Hague dismissed the nullity action in the first instance in 2022 (case ID: C/09/625472 / HA ZA 22-183). Sandoz then appealed the decision. Now the Court of Appeal has confirmed the first-instance ruling. The bench comprised presiding judge Herman Speyart van Woerden and judges Michiel Bonneur and Freyke Bus. Applying the problem-solution approach, they dismissed Sandoz’ claim that Astellas’ patent and SPC lacked inventive step and failed to invoke priority.

Thus, Sandoz cannot launch its generic mirabegron product for another three years until Astellas’ SPC expires in 2028.

Courts in other jurisdictions have also upheld the patent. In a decision last summer the German Federal Court of Justice upheld the property rights and thus overturned a first-instance judgment of the Federal Patent Court. In the UK, the Court of Appeal decided in July 2023 to uphold Astellas’ property right (case IDs: CA-2022-001348, 001349).

Astellas retains mixed teams

Astellas relied on a mixed team from Hoyng ROKH Monegier. The law firm has a long-standing client relationship with the pharma originator and currently represents the client in another high-profile dispute over cancer drug Xtandi. Amsterdam-based partner Frank Eijsvogels led the case with partner Theo Blomme. Associate Nathalie Rodriguez Arigon assisted. Patent attorney Jeroen den Hartog of the Amsterdam office of Hoyng ROKH Monegier provided technical support.

Amsterdam IP boutique Vondst acted for the plaintiff Sandoz, with litigator Otto Swens taking the lead with associates Merel Hendriks and Carly van der Beek. The latter moved to Pinsent Masons in October. Patent attorneys Lilian Hesselink and Wouter Mooij from renowned patent attorney firm De Vries & Metman advised on technical questions.

In the German nullity action, a mixed team from Hoffmann Eitle led by patent attorney Peter Klusmann represented the pharmaceutical manufacturer Astellas. Teva/Ratiopharm relied on a mixed team from its go-to law firm Bird & Bird.

In the UK, Pinsent Masons represented Teva and Sandoz while Astellas relied on a team from Hogan Lovells.