Merz fails with PI request in first-ever SPC case against Viatris

Viatris can continue to sell its generic drug Fampridin Viatris in France for the time being. This is the result of a recent judgment by the Paris local division in PI proceedings between Merz and Viatris (case ID: UPC_CFI_697/2025).

The Paris judges decided that Merz’s PI request came too late to justify an injunction. The panel consisted of presiding judge Camille Lignières, French judge Carine Gillet and Belgian judge Samuel Granata. Technically qualified judge Rainer Friedrich completed the panel.

Merz’s request too late

On 31 July, Merz Therapeutics, the US subsidiary of German pharmaceutical company Merz, revoked the opt-out from the UPC system for its EP 2 377 536. EP 536 covers the multiple sclerosis drug fampridine, which Merz markets under the brand name Fampyra. The drug aims to improve walking ability in multiple sclerosis patients. Currently, the drug is covered by French SPC 13C0033, which is based on EP 536.

On the same day, Laëtitia Bénard, partner at A&O Shearman in Paris, filed the PI request to prevent Viatris from selling a generic fampridine product in France (case ID: ACT_33980/2025).

The expiry of SPC 033 in July next year likely prompted Viatris to launch a generic version in France under the brand name Fampridin Viatris on 10 June 2025.

Guidance for timing

Viatris defended itself against the PI application by arguing that the SPC is likely invalid and that the Merz application was filed too late. The judges did not deal with the revocation argument, but focused entirely on the lack of urgency aspect.

According to the judges, Merz could have known about the foreseeable market entry of Viatris in France from 22 November 2024 at the latest and could have taken action against it based on imminent infringement. The judges stated that the market authorisation by the French regulators was completed and publicly known on this date. At this time, the Viatris product was assigned a price and a reimbursement rate.

Merz, on the other hand, argued that it was not yet responsible for Fampyra at that time. The US company had only acquired the rights from Biogen in January.

Merz contended that the act of infringement only became fully known when Fampridin Viatris entered the market on 10 June 2025 and that a PI application was therefore filed in good time at the end of July. However, the judges ruled that this “cannot be considered as a new starting point that creates urgency and justifies a diligent filing of the application for PI”.

Merz now has 15 days to appeal the decision. The company has not yet decided whether to take this step, but it is considered likely. If the ruling is upheld, originators in the pharmaceutical sector will now have to keep a close eye on the national market authorisation proceedings if they want to launch a PI against the market entry of generic products in good time. Following this judgment, companies will not have a second chance at the UPC once a product has launched.

Schertenleib successful for Viatris

Paris IP firm Schertenleib defends Viatris in the UPC case. The firm recently represented the generics company in a national case against Bayer concerning cancer drug Nexavar.

The UPC case search names Marc Lauzeral as main representative for Viatris. Name partner Denis Schertenleib is also involved in the case.

A&O and Carpmaels for Merz

For A&O Shearman partner Laëtitia Bénard, the instruction by Merz marked her first UPC case. The firm’s German team has previously only handled mobile communications and streaming cases for Samsung and Dish Technologies. Partner Charles Tuffreau is also involved in the PI proceedings. Neither Tuffreau nor Bénard have previously worked for Merz.

London-based litigation partner Agathe Michel-de-Cazotte from Carpmaels & Ransford is also representing Merz. The UK firm previously handled the EPO proceedings. Partners Ed Oates and David Holland were responsible for the cases at the Opposition Division and Boards of Appeal. In 2022, the EPO upheld EP 536 in amended form.