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NL – Sandoz v. Astellas / Appeal – Betmiga® (Mirabegron)

16 Jan 2025

Sandoz AG v. Astellas Pharma, Inc., Court of Appeal The Hague, The Netherlands, 14 January 2025, Case no. 200.325.249/01

Astellas successfully defended its Patent (EP 1 559 427) and associated SPC (300599) that form the basis of its top-selling drug Betmiga® (mirabegron) for the treatment of overactive bladder, against an invalidity attack brought by Sandoz in the Netherlands.

The Court of Appeal of The Hague this week confirmed a judgment rendered by the District Court of The Hague dismissing the revocation claim made by Sandoz.

The court rejected the arguments of Sandoz that the patent cannot invoke priority. In addition, the court dismissed the arguments of Sandoz that the patent lacks inventive step.

Like Sandoz, the court applied the problem-solution-approach. Sandoz had invoked two prior art publications as starting point for its inventive step attacks.

Regarding the first publication, the court decided that it did not qualify as closest prior art.

With respect to the second publication, the court decided that it was far from certain that the average skilled person would combine this with the teaching of the first publication with a reasonable expectation of success and investigate mirabegron as one of the six compounds disclosed therein.

In assessing the reasonable expectation of success, the court followed and expressly referred to the approach taken in the parallel case by the Federal Court of Justice in Germany in its judgment of 25 June 2024: when assessing whether a reasonable expectation of success exists, all relevant circumstances of the case must be considered, including the field of technology involved, the degree of research incentive, the effort required to formulate and pursue a research design, and what alternatives exist, with their respective advantages and disadvantages.

Courts in other jurisdictions have also upheld the patent. In the UK, the Court of Appeal decided in July 2023 to uphold the property rights (case IDs: CA-2022-001348, 001349), reported here on the EPLAW Patent Blog.

In Germany, the Federal Court of Justice also upheld the property rights in June 2024 (case ID: X ZR 92/23).

A copy of the judgment (in Dutch) can be read here.
A copy of the judgment (in an English machine translation) can be read here.