Merz and Uexküll prevail as Federal Court of Justice upholds fampridine patents

Merz is owner of EP 2 377 536 and EP 1 732 548. Both cover “methods of using sustained release aminopyridine compositions” and relate to a dosing regimen for fampridine. This forms the basis of Fampyra, a drug which aims to improve walking ability in multiple sclerosis patients.

Acorda originally filed both patents. Merz Therapeutics took them over after Acorda filed for bankruptcy in 2024. Both patents have since expired. When regulatory exclusivity for Fampyra expired in summer 2021, generics companies launched their own fampridine products in Germany and France.

However, Merz claims the drug is still protected through national SPCs of dosing patent EP 536, which will expire in July this year.

Dismissed, revoked, upheld

Initial nullity suits by Ratiopharm against both patents were dismissed by the German Federal Patent Court because parallel EPO oppositions were still pending at the time (case IDs: 3 Ni 22/20 and 3 Ni 23/20). In the case of EP 536, Ratiopharm appealed to the Federal Court of Justice against this dismissal. Germany’s highest court ruled that the nullity suit was admissible and referred the case back to the patent court.

Meanwhile, in 2020, the EPO Boards of Appeal upheld both EP 536 and EP 548 in opposition proceedings launched by Actavis, Neuraxpharm and Synthon. Acorda then applied for a preliminary injunction against Teva in Germany based on EP 548. The patent holder’s application failed at both the Regional and Higher Regional Court in Munich (case IDs: 7 O 3162/22 and 6 U 3044/22).

While the nullity suit by Ratiopharm against EP 536 was still pending at the Federal Patent Court, Teva filed a new nullity claim against EP 548. The Federal Patent Court revoked the national parts of both patents in 2023 and 2024 respectively due to lack of inventive step (case IDs: 3 Ni 19/22 and 3 Ni 2/22).

The patent holder Merz appealed the decisions. Now the Federal Court of Justice has overturned both revocations by the first-instance court and dismissed the nullity suits (case IDs: X ZR 165/23 and X ZR 72/24), thus upholding the national parts of both patents. Consequently, the German SPC based on EP 536 retains its validity.

Generic drug companies that have launched their products in Germany are now at risk of damages claims by Merz.

In recent PI proceedings at the UPC’s Paris local division over the French SPC 13C0033 based on EP 536, the judges decided that Merz’s PI request came too late to justify an injunction.

Success for Uexküll

Merz relied on Hamburg patent law firm Uexküll & Stolberg. Partner Albrecht von Menges led the nullity proceedings, with support from patent attorney Fabian Müller. They worked closely with the in-house team of Merz Therapeutics consisting of Head of Global IP Nikolai Graf v. Keyserlingk, Vice President and General Counsel Cornelia Keller and Head of Legal Corporate Maike Bermüller.

In the PI proceedings at the Regional and Higher Regional Court, a team from Rospatt acted for the then-patent-owner Acorda and its distribution partner Biogen. In the recent UPC PI proceedings in Paris, the French team of A&O Shearman and UK-based Carpmaels & Ransford represented Merz. The latter had also represented Acorda in the opposition proceedings at the EPO.

Patent attorney Michael Best of Munich firm Kraus & Lederer represented Teva with litigators Oliver Jüngst and Lucas Brons of Bird & Bird. They co-operated with Executive Counsel, European IP and Regulatory Litigation at Teva, Thomas Hendicott. The team of Bird & Bird had also represented Teva in the PI proceedings in Munich.

Stada instructed two teams of patent attorneys for the different nullity proceedings. Thomas Kernebeck took the lead in the EP 548 case. For EP 536 and the associated SPC, the pharmaceutical company relied on a team from Hamm&Wittkopp. Name partner Alexander Wittkopp led the nullity case, with assistance from Nils Kahlcke.

Litigators Daniel Hoppe and Sarah Salaschek of Bonabry provided legal support in both cases. The team also included Head of Patent Litigation Florian Pertenbreiter, and Patent Manager Sebastian Barthel from Stada’s in-house department.

The litigators from Bonabry and patent attorneys of Hamm&Wittkopp are a well-established team in pharmaceutical proceedings. They jointly represented Abdi Pharma and Polpharma in the Xarelto case and Formycon in the dispute over Eylea.