SIP agreed to cancel Akselpharm's patent on osimertinib

Patent No. 040996, as reported on the Eurasian publication server, was registered in August 2022. In September 2023, AstraZeneca applied to Rospatent with a request to terminate patent protection in Russia. The application, as stated in the service's decision, was motivated by the "non-compliance of the group of inventions described in the above formula of the contested patent with the patentability conditions of "industrial applicability" and "inventive step". The regulator satisfied the request in August 2024.

In early November 2024, Akselpharm filed a claim with the IPC. As third parties, the court involved AstraZeneca and the Eurasian Patent Organization in the consideration of the case. At the end of June 2025, the IPC denied the applicant's claims.

AstraZeneca Vademecum reported that the company "has repeatedly noted that the δ-crystalline form of osimertinib mesylate contained in the Eurasian patent does not have any unexpected advantages over known forms of osimertinib." The company's representatives also believe that at the moment, there are discrepancies in the practice of Russian and Eurasian pharmaceutical regulators regarding the assessment of the patentability of selective inventions, "that is, particular cases of a known class of compounds." "These discrepancies may lead to competition between the Russian and Eurasian patenting systems and provoke unnecessary disputes. Harmonization of patentability criteria between the two agencies will help to avoid this," AstraZeneca concluded.

Vademecum also requested Akselpharm’s position on the thematic dispute and clarification on how the cancellation of the Eurasian patent affected the company’s ability to sell its osimertinib product in Russia.

The original drug Tagrisso (osimertinib) from AstraZeneca is used to treat non-small cell lung cancer. The active substance of the drug is protected by a Eurasian patent until 2032. Akselpharm registered its own generic under the TN Osimertinib in mid-2023. In order to defend its rights to the invention, the foreign pharmaceutical manufacturer applied to the Arbitration Court of the Moscow Region back in October 2021, when Akselpharm had just submitted a dossier for registration of the generic, but the plaintiff was unable to interrupt this process.

AstraZeneca then filed a lawsuit against the Ministry of Health in the Moscow Arbitration Court. In November 2023, the lawsuit was dismissed. The Ministry of Health indicated that preparations for registration and the registration of the generic itself do not affect the rights of the foreign pharmaceutical company. AstraZeneca was unable to challenge the decision of the court of first instance.

In August 2024, the manufacturer of the original drug was able to challenge the patent for the Tagrisso analogue in the Chamber for Patent Disputes. At the same time, AstraZeneca filed a complaint with the Prosecutor General's Office of the Russian Federation against the actions of Akselpharm. As the patent holder company reported at the time, the generic manufacturer began selling its drug through government procurement.

In early September 2024, the Moscow Arbitration Court rejected another claim by a British-Swedish manufacturer, which demanded that the state registration of Osimertinib be cancelled and that Akselpharm be obliged to remove information about the drug from its website. The Ninth Arbitration Court of Appeal upheld the decision of the first instance.

In the fall of 2024, the FAS issued several thematic orders to the company "Axelpharm". In October, the antimonopoly service fined the manufacturer for introducing into civil circulation generics of the antitumor drugs Inlita (axitinib) from the American Pfizer and Jakavi (ruxolitinib) from the Swiss Novartis. In November, the regulator made a similar decision due to analogs of the antitumor drug Bozulif (bosutinib) from Pfizer and Tagrisso from AstraZeneca. In total, the amount of FAS fines for the manufacturer exceeded 2 billion rubles.

In early March 2025, Akselpharm managed to appeal the order issued due to the sale of the generic Inlita to the Moscow Arbitration Court. At that time, the plaintiff challenged the fine of 513.6 million rubles. Then the court also found the fine of 567 million rubles illegal due to the introduction of the generic Tagrisso to the market.