The Supreme Court upheld the FAS ban on the sale of generics of dapagliflozin

The court file on the case indicates that the claim from Akrikhin was first filed on April 24, 2025, but was then left without action. The application was accepted for proceedings at the end of May.

The contested letter of the FAS was published at the end of February 2025. In it, the regulator indicated that "the presence in the bid of the procurement participant of an offer to supply a medicinal product using the active substance dapagliflozin, the manufacturer of which is JSC Pharmaceutical Plant Polfarm, violates the current legislation of the Russian Federation and forms the basis for rejecting the application." In the registration certificate for the drug "Akrikhin" Fordiglif indicates that the company purchases dapagliflozin from the Russian "Active Component", the Polish "Polfarma" and the Indian Honour Lab Limited.

The patent dispute between AstraZeneca and generic companies over dapagliflozin has been ongoing since 2022. The original drug Forxiga is used to treat type II diabetes. In 2021, the British-Swedish manufacturer received repeated patents for dapagliflozin, which will be valid until 2028. Slovenian KRKA, which received a registration certificate for its analogue of Forxiga in 2022, tried to challenge Rospatent's decision to issue repeated patents to AstraZeneca, first through direct appeals and then through the Intellectual Property Court (IPC). It rejected the plaintiff's claims, but KRKA filed an appeal, and in October 2023, the IPC Presidium ordered Rospatent to consider the Slovenian pharmaceutical company's objection.

Akrikhin registered its generic in 2023. Referring to the IPSC decision, the company began introducing the analogue into civil circulation in April 2024. AstraZeneca considered such actions illegal and sent corresponding requests to the Investigative Committee of the Russian Federation and the Federal Antimonopoly Service. Later, the British-Swedish company announced Akrikhin's participation in government procurement.

Rospatent and AstraZeneca managed to appeal the decision of the Presidium of the IPC to the Supreme Court in June 2024. However, as noted by the British-Swedish pharmaceutical company, at the end of June 2024, Akrikhin introduced six more series of the generic into circulation. AstraZeneca believes that "the actions of Akrikhin, ignoring the acts of the Supreme Court, destabilize the Russian pharmaceutical market and significantly reduce its investment attractiveness."

As Alexey Darkov, advisor and head of the intellectual property practice at the law firm Verba Legal, explained to Vademecum at the beginning of 2025, “in patent disputes, the FAS previously took a reserved position, but now the practice has changed and it looks like the FAS is ready to make a decision in fairly obvious cases.”

In the fall of 2024, the regulator fined Akselpharm and Akrikhin for patent infringement. The regulator ordered Akselpharm to transfer 607.5 million rubles to the budget due to the sale of generics of the antitumor drugs Tagrisso (osimertinib) and Bosulif (bosutinib) from AstraZeneca and Pfizer. FAS made similar decisions due to the operator's sale of generics Inlita (axitinib) from Pfizer, Jakavi (ruxolitinib) from the Swiss Novartis. In total, the amount of FAS fines for Akselpharm exceeded 2 billion rubles. The antimonopoly service fined Akrikhin 577.7 million rubles for violating AstraZeneca's patent for the drug Forsiga (dapagliflozin).

Later, in January-February 2024, the FAS published four letters stating that the sale of patented drugs with the INN dapagliflozin, osimertinib, ruxolitinib and axitinib without the consent of the copyright holder is recognized as a violation of antimonopoly legislation.

The fines are currently being contested in the Moscow arbitration court. Thus, in mid-May, the first instance overturned the regulator's decision regarding Akrikhin, but the court agreed that the company had violated the rights of the originator. Akselpharm managed to cancel two fines totaling almost 1.1 billion rubles. Nevertheless, in these disputes, the court refused to recognize Akselpharm as having violated the patents of AstraZeneca and the Pfizer subsidiary, on the basis of which the latter manufacturers appealed to the appellate courts.