German Court Grants Sales Ban for Generic Fampridine Products Following Patent Victory for Merz
核心洞察
Munich Regional Court granted preliminary injunctions against seven generic manufacturers of fampridine products, effectively banning their sales in Germany until mid-July 2025.
The injunctions follow Germany's Federal Court of Justice upholding Merz's patents for Fampyra, a multiple sclerosis treatment that improves walking ability in patients.
Generic companies including Stada (搜索), Ratiopharm (搜索), and Hexal (搜索) can no longer distribute their fampridine products through German pharmacies due to removal from the Lauer Taxe database.
Munich Regional Court has granted preliminary injunctions against seven generic drug manufacturers, effectively banning the sale of their fampridine products in Germany following a major patent victory for Merz Therapeutics (搜索). The court ruled in favor of Merz in cases against Betapharm, Aliud Pharma, Stada (搜索), Puren Pharma, Ratiopharm (搜索), Hexal (搜索), and Heumann Pharma, with the injunctions remaining valid until mid-July 2025.
Patent Protection for Multiple Sclerosis Treatment
The dispute centers on Fampyra, a drug that aims to improve walking ability in multiple sclerosis patients. Merz holds two key patents - EP 2 377 536 and EP 1 732 548 - both covering "methods of using sustained release aminopyridine compositions" and relating to specific dosing regimens for fampridine. While these patents have expired, Merz maintains protection through German supplementary protection certificate DE 12 2013 000 046.5 based on EP 536.
The legal foundation for these injunctions was established when Germany's Federal Court of Justice recently upheld both patents, overturning earlier revocations by the Federal Patent Court. The higher court dismissed nullity suits and restored validity to the national parts of both patents, consequently maintaining the validity of the German SPC based on EP 536.
Market Impact and Distribution Consequences
The preliminary injunctions have immediate practical consequences for the German pharmaceutical market. Due to the court orders, the Informationsstelle für Arzneispezialitäten (IFA) will no longer list the affected generic drugs as available in the Lauer Taxe. This database provides pharmacies with information on the availability of approved medicines, and without a listing, medicines cannot be distributed in Germany.
Generic companies had launched their fampridine products in Germany and France after regulatory exclusivity for Fampyra expired in summer 2021. However, Merz successfully argued that the drug remained protected through national SPCs of the dosing patent, creating legal risk for generic manufacturers who entered the market.
Settlement and Submission Patterns
Not all generic manufacturers faced the same outcome. Merz settled disputes with Basic and Micro Labs, while other companies including Ascend Pharma, Zentiva, and Neuraxpharm previously submitted to the Federal Court of Justice decision in the nullity action. This pattern suggests varying strategies among generic manufacturers in responding to Merz's patent enforcement efforts.
Parallel European Proceedings
The German success contrasts with mixed results in other jurisdictions. In parallel preliminary injunction proceedings against Viatris at the Unified Patent Court's Paris local division over French SPC 13C0033 based on EP 536, judges decided that Merz's request came too late to justify an injunction. An appeal in that case is pending, with oral hearings having taken place recently.
Patent History and Ownership Transfer
The patents have a complex ownership history. Acorda (搜索) originally filed both patents, but Merz Therapeutics (搜索) acquired them after Acorda filed for bankruptcy in 2024. The European Patent Office Boards of Appeal had previously upheld both EP 536 and EP 548 in 2020 opposition proceedings launched by Actavis, Neuraxpharm and Synthon.
Initial nullity suits by Ratiopharm (搜索) against both patents were initially dismissed by the German Federal Patent Court due to pending EPO oppositions. The Federal Patent Court later revoked the national parts of both patents in 2023 and 2024 respectively due to lack of inventive step, but these decisions were ultimately overturned by the Federal Court of Justice.
Legal Representation
Merz relied on A&O Shearman for proceedings at both the UPC and Munich Regional Court, with Munich-based partner Stephan Neuhaus leading the pharmaceutical litigation. The team worked closely with Merz Therapeutics (搜索)' in-house legal department, including Head of Global IP Nikolai Graf v. Keyserlingk and Vice President and General Counsel Cornelia Keller.
Generic manufacturers employed various legal strategies, with Bonabry representing four defendants and Bird & Bird acting for Ratiopharm (搜索) and Basic. The complex multi-jurisdictional litigation involved coordination between patent attorneys and litigation counsel across different European venues.