AxelPharm

History

2024: Fine of ₽513 million for selling a copy of a cancer drug

The Federal Antimonopoly Service of Russia recognized the pharmaceutical company AxelPharm as a violator of the law on protection of competition in the release of the generic anticancer drug Axitinib. As a result of the consideration of the case on October 25, 2024, the company was ordered to transfer to the budget income in the amount of ₽513 million received from illegal sales.

According to Rossiyskaya Gazeta, the company brought to the market a copy of the drug and participated in regional tenders for its purchase, despite the patent in force until June 2025, owned by Aguron Pharmaceuticals Elsie.

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Vitaly Dianov, Chairman of the General Council of the Association of Antimonopoly Experts, partner of Alumni Partners, said that bringing the generic to the market before the expiration of the patent for the original drug is legitimate to consider as an act of unfair competition.

AxelPharm is also involved in the proceedings over another anti-cancer drug - Osimertinib, a patent for which is valid until 2032. The company has concluded more than 40 contracts for the supply of its version of the drug to various regions of Russia.

Elena Kuznetsova, head of the antimonopoly practice of the law firm Rustam Kurmaev and Partners, noted that in Russia there are legal mechanisms for obtaining rights to reproduce foreign drugs, including the possibility of obtaining a compulsory license from the government or challenging patents in court.

Over the past two years, the Russian government has issued only two permits for compulsory licensing - for the production of Semaglutide and Remdesivir drugs. Such permits are issued by a special subcommittee created under the Government Commission for Economic Development and Integration by presidential decree in February 2024.^[1]

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