Merz Wins Appeal to Block Generic MS Drug Sales in France

Pharmaceutical company Merz has secured a key legal victory in its ongoing dispute over its multiple sclerosis drug Fampyra. The Court of Appeal of the Unified Patent Court (UPC) has overturned an earlier decision and granted a preliminary injunction against Viatris. 

As a result, Viatris is now prohibited from selling its generic version, Fampridine Viatris, in France until the relevant protection expires on 25th July. The ruling takes immediate effect. 

The case centres on a patent and related supplementary protection certificate (SPC) covering fampridine, the active ingredient in Fampyra, which is used to improve walking ability in patients with multiple sclerosis. Merz had previously failed to obtain an injunction at first instance, with the court finding there was no urgency. However, the company appealed that decision. 

The Court of Appeal reached a different conclusion. It found that Merz could not reasonably have known that Viatris was about to launch its generic product based solely on earlier regulatory steps, such as pricing and reimbursement approvals. Instead, the court determined that the relevant point was when the actual market launch became public on 30 June. Since Merz filed its application shortly after, it acted within the required timeframe. 

The court also rejected arguments that blocking the generic drug would be disproportionate. It held that because the companies are direct competitors, allowing the generic product on the market could lead to lasting price reductions. 

This decision is one of the first UPC rulings to address SPC-related disputes and provides further guidance on how urgency is assessed in pharmaceutical cases.