AlkorFarm challenges FAS decisions on participation in public procurement of essential medicines

The Moscow pharmaceutical company AlkorFarm is suing the Tatarstan office of the Federal Antimonopoly Service (FAS) over the rejection of its bids to participate in public procurement of the anticancer drug Ruxolitinib. In addition to Tatarstan, since September 2025, the company has filed similar lawsuits against FAS branches in dozens of other Russian regions.

According to the decision of the Tatarstan FAS, the bids were rejected due to a patent dispute. Contracting authorities stated that the company had offered to supply the drug Ruxolitinib, produced by OncoTarget LLC (the marketing authorization holder is AxelPharm LLC), which uses the active ingredient Ruxolitinib protected by Eurasian patents No. 019504 and No. 019784 held by the US company Incyte Holdings Corporation.

The patents expire in March and June 2028. The marketing authorization holder of the original drug Jakavi is Novartis Pharma AG. The medicine is included in the list of essential drugs and is used in the treatment of oncological diseases. At the same time, the manufacturer does not have permission from the patent holder to use the invention, the FAS noted.

“The decision of the Russian FAS recognizing AlkorFarm’s actions as an act of unfair competition is in force; it has not been overturned,” a representative of the Tatarstan FAS said. He added that the Russian FAS decision is currently being appealed in the Moscow Arbitration Court. A representative of the Tatarstan Ministry of Health indicated that the company had violated patent legislation requirements.

Representatives of AlkorFarm insist that procurement commissions do not have the authority to determine whether exclusive rights of patent holders have been violated. The company believes that establishing patent infringements falls solely within the jurisdiction of the IP Rights Court.

According to a source of Kommersant Volga-Ural, regional FAS branches have found themselves trapped: at present, there is no clear ruling from the IP Rights Court, and FAS decisions and court judgments contradict each other.

Patent attorney and managing partner of Zuykov and partners, Sergey Zuykov, believes that AlkorFarm has no chance of overturning the FAS decisions. “Current legislation does not allow infringement of patent holders’ rights. The provisions of the law granting preference to Russian manufacturers do not contain any authorization to violate the patent rights of others, even foreign right holders. FAS has the authority to establish violations of patent rights under Article 14.5 of the Competition Law,” Zuykov notes.

According to him, Russia has several legal mechanisms to use patents: obtaining a compulsory license in court in cases of significant shortage of a drug, or through the government in situations of state necessity. “Judging by the available information, AlkorFarm has not presented evidence of legal proceedings to obtain compulsory licenses. Therefore, the chances of challenging the FAS decisions are minimal,” the expert emphasizes.

Source: Kommersant