AxelPharm

History

2025

The Ninth Arbitration Court of Appeal confirmed the legality of actions to release Osimertinib

The Ninth Arbitration Court of Appeal confirmed the legality of the actions of AxelPharm LLC to produce Osimertinib. The company announced this on December 9, 2025.

The Ninth Arbitration Court of Appeal upheld the decision of the Moscow Arbitration Court of May 30, 2025, which invalidated the decision and order of the Federal Antimonopoly Service (FAS Russia) in relation to AxelPharm LLC.

Earlier, the FAS Russia, in its decision of November 20, 2024, banned the company from introducing into civil circulation the generic drug Osimertinib (INN Osimertinib) and obliged to transfer to the federal budget income from its sale in the amount of more than 566 million rubles. The basis was the conclusions of the department about the alleged act of unfair competition in connection with the illegal use of patent rights of third parties.

The Arbitration Court of the city of Moscow, and then the Ninth Arbitration Court of Appeal, comprehensively studied the case materials and came to an unambiguous conclusion: the actions of AxelPharm LLC do not contain the composition of unfair competition. The courts pointed to a number of fundamental violations committed by the FAS Russia in making the contested decision, including:

• Lack of competitive relations between AxelPharm LLC and the patent holder - AstraZeneca AB.
• Unspecified use patent in Osimertinib. The FAS Russia issued a conclusion without conducting the necessary analysis and comparison of the features of the invention on the patent and the features of a specific drug, as well as refusing the company to appoint a patent and technical examination.
• Unlawful interpretation of antimonopoly laws without taking into account special features of the composition of the offense established by Article 14.5 of the Law "On Protection of Competition" and clarifications of the Supreme Court of the Russian Federation.

Osimertinib is a targeted drug for the treatment of non-small cell lung cancer. Its inclusion in civilian circulation in the available generic version is of strategic importance for the Russian health care system:

1. Increase the availability of innovative therapies. The court decision makes it possible to ensure uninterrupted supplies of a vital drug within the framework of state programs of preferential drug provision (LO). This directly affects the quality and life expectancy of thousands of Russian patients.
2. Reducing the financial burden on the health care system. Competition in the generic drugs market helps to optimize government procurement spending, allowing the allocation of released resources to other priority needs.
3. Supporting pharmaceutical sovereignty. Confirmation of the legality of the production and sale of a domestic generic drug strengthens the stability of the national drug supply system in the face of global challenges.

{{quote 'We are satisfied with the decision of the Ninth Arbitration Court of Appeal which affirmed the legality and good faith of our activities. This judicial victory is an important precedent that strengthens the legal framework for the development of competition in the pharmaceutical market in the interests of patients and the state. Our company has always acted and intends to act strictly within the framework of the law, guided by the principles of fair business practice. The main priority for us is to provide Russian patients with affordable and high-quality medicines, which is fully consistent with the tasks of state health policy. We will continue to work on expanding the portfolio of socially significant medicines, contributing to increasing the availability of modern treatment for Russian citizens, the company said. }}

Confirmation of the validity of the Eurasian patent for the method of obtaining the domestic drug Axitinib

On July 24, 2025, the Board of the Chamber of Patent Disputes of Rospatent refused a foreign person "Agouron Pharmaceuticals," which is part of the Pfizer concern, in a patent dispute with the Russian society "Axelfarm." The objection of a foreign person to the action on the territory of Russia of the Eurasian patent No. 041487 for the invention was received by the Federal Intellectual Property Service on September 26, 2024. AxelPharm announced this on August 1, 2025.

The disputed patent protects the method for producing axitinib developed by specialists of the Russian company, which allows synthesizing this substance without using an expensive catalyst. The technology is currently used at the production site of Axelfarm, where the domestic drug Axitinib is produced in a full cycle (from the synthesis of the pharmaceutical substance to the manufacture of the final dosage form).

The introduction of this synthesis technology made it possible to maintain the therapeutic effectiveness of the Russian drug (in comparison with an imported drug), while significantly reducing its cost, which is more than 40% lower than the cost of a foreign drug.

The development of new approaches to the synthesis of pharmaceutical substances is a reflection of the development of our own, domestic technologies in pharmaceuticals, which contribute to the formation of conditions for achieving drug independence in Russia. In addition, reducing the cost of a domestic drug increases its accessibility to the population and increases the effectiveness of preferential drug provision for citizens in key nosologies, the company noted.

The domestic drug "Axitinib" is a tyrosine kinase inhibitor and is used to treat renal cell carcinoma. It blocks a protein that promotes the growth and proliferation of tumor cells, thereby slowing or stopping the spread of the tumor. The drug is included in the List of vital and essential drugs approved by the Russian government.

The conclusion of the collegium of the chamber on patent disputes in the case will enter into force after approval by the head of Rospatent until September 24, 2025.

2024

A fine of 566 million rubles for the sale of the generic drug AstraZeneca bypassing the patent

The Commission of the Federal Antimonopoly Service of Russia (FAS), having considered the complaint of AstraZeneca, made a decision on unfair competition by Axelfarm, which released Osimertinib (inn osimertinib) in July 2024 into civil circulation, bypassing AstraZeneca's patent for osimertinib, valid until 2032. AstraZeneca announced this on November 11, 2024.

The reason for AstraZeneca's appeal to the FAS was the participation in public procurement in a number of regions of the Russian Federation of distributors offering generic osimertinib with registration certificate LP- No. (002439) - (RG-RU) -310523 (RU holder - Axelfarm LLC).

Based on the results of the consideration of the case against Axelfarm, an order was issued, according to which the introduction of a generic drug into circulation before the end of the patent protection of AstraZeneca is prohibited. In addition, the FAS obliged Axelfarm to transfer income received from illegal actions in the amount of 566 million rubles to the state budget of the Russian Federation.

The original drug osimertinib, which is used cancer therapy in the lung, is produced in a full cycle in Russia at AstraZeneca's own plant in the Vorsino industrial park as part of a special investment contract Ministry of Industry and Trade Russia Kaluga region with and in volumes that fully meet the needs of the Russian market. There was no shortage of this drug and no deficiency. AstraZeneca is taking all necessary measures to ensure uninterrupted supply of medicines, as well as continuous production at the company's plant in the Kaluga region.

The issue of intellectual property protection is fundamental for AstraZeneca, the company intends to defend its interests by all legal means, including in court.

AstraZeneca also believes that the current situation with a systematic violation of intellectual property rights in the Russian pharmaceutical market requires discussion with the participation of regulators and legislative consolidation of mechanisms for ensuring the protection of patent rights. The company notes the serious risks that patent violations can carry in the long term: in the absence of strong patent protection, investments in the development and creation of new drugs can be significantly reduced, which will limit the access of Russians to medical and drug developments in the future. 

A fine of ₽513 million for the sale of 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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Фото: Freepik

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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