« Axelfarma » canceled the ban on the FAS to the release of the drug « Axitinib »
Axelfarm has so far managed to fight off the claims of the Federal Antimonopoly Service (FAS), which prohibited the company to take the drug “Axitinib” used in the treatment of kidney cancer. The department considered that the farm producer violated the law on the protection of competition, since its tool was made on the basis of the molecule of the original drug « Inlita » by the American Pfizer. The FAS has already issued an Axelfarme order demanding to pay a fine of more than 500 million rubles: this is comparable to the entire amount of the drug under government procurement.
At the beginning of March 2025, the Moscow Arbitration Court abolished the PAS of the Axelfarm adopted in October last year to remove the Axitinib revolution – a drug used mainly in the treatment of kidney cancer. This was reported to Kommersant in the company itself. The motivating part of the court decision has not yet been published in the arbitration file. Only after its appearance, the FAS will consider the issue of filing an appeal, Kommersant was told in the department.
« Axitinib » is reproduced from the original drug « Inlita » produced by the American Pfizer. Both drugs have the active substance – axitinib. The FAS, imposing a ban, insisted that in this way the company violated the law on the protection of competition. The agency also ordered the company to pay more than 500 million rubles to the budget. The agency considered a violation the fact that the Russian side brought the drug on the market based on the same molecule as the Pfizer tool.
Pfizer was informed “Kommersant” that they would appeal the decision of the Arbitration Court, adding that they will always supply their drug to the Russian market.
Moreover, they emphasize in the company, Pfizer, together with Pharmstandart, is engaged in the localization of Inlita production at the factory in Ufa.
This is not the only dispute of the Axelfarm with Pfizer. Earlier, the Russian side through the court tried to get a forced license for an antitumor drug based on Bozutinib, produced by an American company (see “Kommersant” dated January 31, 2024).
Pfizer owns a patent for Inlita in the Russian Federation and the EAEU through one of his « daughters » – « Aguron Farmasyutikals Eleles. » Its validity period, taking into account the extension, expires in June 2025. Axelfarma also has an Eurasian patent for Axitinib issued in May 2024: its term expires in 2027.
According to the analytical company DSM Group, axitinib -based preparations are implemented mainly through public procurement. So, in 2023, Inlita was sold totaling 1.9 billion rubles, in 2024 – almost 1 billion rubles. Axitinib was not implemented in 2023, in 2024 the volumes of its public procurement amounted to 564.2 million rubles.
All last year, Pfizer filed lawsuits in arbitration courts, seeking the provision of interim measures for the supply of “Axitinib” as part of public procurement, the head of the de-Jure lawyer Bureau Nikita Filippov notes. “The courts refused to satisfy the statements, referring to the fact that the suspension of the execution of state contracts and the arrest (released parties. – « Kommersant ») drugs will lead to a violation of public interests, ”he explains.
How the Axelfarm has now managed to recapture claims about violation of patent rights, it is not clear, says Mr. Filippov.
According to him, the company has a registration certificate in the Ministry of Health, as well as the fact that the drug is attributed to critical products of the farm industry and is included in the list of vital drugs, « itself does not exempt from compliance with patent legislation. »
The dispute between the Axelfarma and the FAS confirms that in the Russian Farmotrasli, a unified judicial practice on compulsory licensing has not yet developed, the managing partner of the Castalis and Partners, Vitaly Kastalsky, states. “If the dependent invention, such as“ Axitinib ”, is patent exclusively to obtain a compulsory license, but at the same time it is ultimately used not as a dependent, but as a basic one, this should be considered a violation of the rights of the patent holder,” the expert believes.
Oncologist Evgeny Ladyin explains that Axitinib has an effect on the tumor, preventing her from building her own vascular network. According to him, about 7 thousand patients in Russia annually diagnosed metastatic kidney cancer. There are several different combinations of therapy. On average, it can be assumed that a third of patients receives a combination based on “Axitinib”, this is about 2 thousand patients per year.
