AstraZeneca demands review of FAS order cancellation against Akselpharm due to patent infringement on Tagrisso

AstraZeneca explained that they do not agree with the decision of the Moscow Arbitration Court, since it “limits the possibilities for protecting intellectual property” and “calls into question the powers” ​​of the FAS. The originator believes that the first instance did not take into account the position of the Constitutional Court of the Russian Federation and “a whole range of evidence in the case.”

AstraZeneca also referred to the decision of the Moscow Arbitration Court from mid-May 2025. At that time, the court agreed that Akrikhin had violated the rights of the British-Swedish company to the drug Forsiga (dapagliflozin), but still overturned the decision of the antimonopoly service to collect 577.7 million rubles from the generic manufacturer.

Generic Tagrisso under the TN Osimertinib was registered by Akselpharm in mid-2023. The active substance of the drug is protected by the Eurasian patent of AstraZeneca until 2032. When Akselpharm first submitted a dossier for registration of the generic in 2021, the originator applied to the Moscow Region Arbitration Court, but the plaintiff was unable to interrupt the process.

Later, AstraZeneca filed a lawsuit against the Russian Ministry of Health in the Moscow Arbitration Court. In November 2023, the lawsuit was dismissed: the court agreed with the ministry's position that preparations for registration and the registration of the generic itself did not affect the rights of a foreign pharmaceutical company. In August 2024, the manufacturer of the original drug was able to challenge the patent for the Tagrisso analogue in the Patent Dispute Chamber. 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 2024, AstraZeneca again failed to cancel the state registration of the reproduced drug through the courts and force Akselpharm to remove information about the drug from its website.

In the fall of 2024, the FAS made its own decision on the patent dispute: the regulator recognized the introduction of generics Tagrisso and the antitumor drug Bozulif (bosutinib) from the American Pfizer by Akselpharm as cases of unfair competition, on the basis of which it obliged the manufacturer to transfer 607.5 million rubles to the budget. The FAS made similar decisions due to the sale of generics of Inlita (axitinib) from Pfizer, Jakavi (ruxolitinib) from the Swiss Novartis. In total, the amount of FAS fines for Akselpharm exceeded 2 billion rubles.

In early March 2025, Axelpharm 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. The case is currently being heard by the Ninth Arbitration Court of Appeal on the complaint of the Pfizer subsidiary.

At the end of May, Akselpharm challenged the FAS decision on the generic Tagrisso. According to Akselpharm, the court found the FAS order illegal due to "the non-compliance of the calculation method for this amount (567 million rubles) with current legislation."