Axelfarm through the court lifted the ban on the release of the drug for the treatment of lung cancer
The Russian company « Akselfarm » managed to achieve a ban on the withdrawal of Osimertiniba, used in the treatment of lung cancer, through the arbitration court. This drug is a generic of the original Tagrissso from the British-Swedish Astrazeneca. The implementation of the analogue was suspended by the Federal Antimonopoly Service, which considered this a violation of the rights of the patent. Tagrissso sales in four months of 2025 almost reached 3 billion rubles.
The Moscow Arbitration Court at the end of May 2025, at the request of Akselfarma, canceled the ban on the input of Osimertinib, which was imposed on the entry of lung cancer, imposed by the Federal Antimonopoly Service (FAS). The decision of the FAS was preceded by an appeal to the department of Astrazeneck AB, who considered that its rights as the winner of the patent for the original drug Tagrissso are violated in this way. The release of this tool is localized in the Kaluga region at the Astrazeneca production site in Russia LLC Astrazenka Industiz. The FAS in the fall of 2024 agreed with the arguments of Astrazeneck AB, considering the actions of Axelfarma a violation of competition and ordered the manufacturer to pay 567 million rubles to the budget. The company could receive such an amount from the implementation of its drug.
The arbitration court found that the FAS incorrectly interpreted the law on the protection of competition: the very fact of violation of the rights to the result of intellectual activity when introducing into circulation of goods is not yet unfair competition.
The court also canceled the order of payment to the budget.
The FAS told Kommersant that they would consider the issue of filing an appeal for a court decision. Also ready to enter Astrazeneca. The court decision, as Kommersant was informed in the company, “exacerbates legal uncertainty for all copyright holders of Russian patents.” The company also recalled that the FAS letter of January 24, 2025 was still not canceled, in which the preparations of the drugs notified that the acquisition of Osimertinib from Axelfarma violates the antimonopoly legislation. The Axelfarm, in turn, is considered the decision of the first instance of the court « strategic for the implementation of national interests. »
Mikhail Murashko, head of the Ministry of Health of the Russian Federation, in September 2023:
Domestic pharmaceutical producers today produce a large line of drugs for people with cancer.
Osimertinib -based preparations are implemented mainly as part of public procurement. According to the DSM Group, the original Tagrissso is purchased more often than a generic: in January -April of 2025, 10.7 thousand of its packages for 2.9 billion rubles were sold in Russia, and Osimertiniba – 1.2 thousand packages of 199.1 million rubles.
Probably, during the purchases of Osimertinib, there was a violation of the prohibition of the FAS. An analogue is cheaper than the original, and in March 2025, Akselfarm announced an additional reduction in the price of its own drug. “Thus, with an identical therapeutic effect, the Russian drug is less than 50% more than 50% compared to a foreign drug,” the company said.
The dispute around the drugs with the active substance Osimertinib is not the first such trial of the Axelfarma with the FAS.
In March of this year, according to Kommersant, the company won the lawsuit against the FAS regarding the claims of the service regarding the output of the Axitinib, used in the treatment of kidney cancer. This tool is based on the molecule of the original drug « Inlita » by the American Pfizer. The FAS noted that they had already appealed to this decision. At the same time, the service recalled that in a similar case on Dapagliflosin with the participation of Astrazeneca, the owner of the original drug for Diabetes “Forcig”, and “Akrikhina”, which produces Generic “Fordglyph”, the court took the opposite position, canceling the FAS acts only in terms of the revenue budget from the implementation of the analogue. At the same time, the court upheld the ban on the FAS to introduce medicines into circulation.
In the case of Axelfarm, the FAS did not establish the direct presence of competition between the holder of the patent and the manufacturer of Generic, and also did not conduct a detailed examination of the method of producing two drugs, says the senior partner of the lawyer Bureau, Timofeev, Gusev and partners ”Irina Ozolina. According to the managing partner of the Castalsky and Partners, Vitaly of Kastalsky, the copyright holders appeal in such cases to the FAS, and not to the courts, since this is easier. Konstantin Suvorov, a partner of the Kosenkov and Suvorov, says that if the position of the Axelfarm ships will resist higher instances, this can significantly affect the mechanism of intellectual property protection in the pharmaceutical industry.
