The Moscow Arbitration Court rejected Swiss company Roche’s lawsuit against Russian biopharmaceutical company Promomed and its production site Biokhimik. The foreign manufacturer sought to prohibit the commercial circulation of the reproduced drug Risdiplam (risdiplam) — a generic version of the original spinal muscular atrophy (SMA) treatment Evrysdi, which is protected by a patent until November 26, 2035. According to the arbitration case file, Roche’s claim was denied.
The original Swiss drug Evrysdi (risdiplam) is protected by Eurasian patent No. 035068. In 2025, the Russian Ministry of Health approved the generic Risdiplam, developed by Promomed (the registration certificate is valid until May 2030).
Later, the Federal Antimonopoly Service (FAS) approved the maximum price for the generic. According to the agency’s press service at the time, the drug’s price will be 48% lower than the registered price of the original Evrysdi developed by the Swiss pharmaceutical giant.
Roche filed the lawsuit in mid-2025. The company demanded a ban on the circulation of the generic drug until the patent expires, citing a “threat of infringement of the exclusive right to the patented invention,” as the originator had not granted consent for the patent’s use.
According to the text of the ruling, a demand for a ban can only be granted if the plaintiff proves the existence of a real threat of rights infringement.
Promomed insisted that no substantiated threat existed. The court indicated that the registration of the drug and its maximum price, in and of itself, cannot be considered a threat — this requires a combination of additional factors (e.g., attempts at commercialization or the economic interests of the defendant).
“The burden of proving the threat of patent infringement for medicinal products lies with the plaintiff; the defendant’s registration of the drug and its price does not, by itself, create a threat; in conjunction with the registration of the drug and price, the plaintiff must also prove the existence of more than one factor mediating the threat. In the present case, the set of conditions for recognizing the threat as existing has not been met,” the court’s ruling states.
According to the court, the plaintiffs did not prove that by registering the drug and price 10 years before the patent expiration, the defendants had aimed specifically at the unlawful use of the invention. These actions could constitute formal preparation in case grounds provided for by law arise (for example, if the patent is invalidated or its term is prematurely terminated).