The Presidium of the IPC has recognized the extension of AstraZeneca's patent on dapagliflozin until 2028 as legal

Initially, Akrikhin filed a complaint against Rospatent's decision in February 2024. The Federal Service adopted the contested act in 2023 - the regulator extended the term of AstraZeneca's patent for the group of inventions "C-aryl glucoside SGLT2 inhibitors and the method of using them" until 2028. According to the case materials, Akrikhin believes that the patent uses, in particular, dapagliflozin as the active ingredient of the pharmaceutical composition. At the same time, Forsiga itself, on the basis of the permission for the use of which the patent term was extended, uses dapagliflozin propanediol monohydrate. The plaintiff noted that the substance specified in the patent is not identical to the active ingredient of Forsiga, therefore, according to the applicant, the conditions for the patent extension were not met. Rospatent, in turn, opposed satisfying the complaint.

The IPPC considered Rospatent's conclusion that the product specified in the patent and the active substance of Forsiga were identical to be justified. The service ruled that "dapagliflozin propanediol monohydrate is a solvate of dapagliflozin", and the court supported this position. Thus, in April 2025, the court refused to satisfy Akrikhin's claim.

In July of this year, the company filed a cassation appeal to the Presidium of the SIP in order to challenge the decision of the lower court, but on September 15, 2025, it also rejected Akrikhin and recognized the actions of Rospatent as lawful.

AstraZeneca believes that such decisions "underline the illegality of introducing generics into civil circulation bypassing patent protection for original drugs." They also noted that the practice that has developed in recent years on the Russian market has a negative impact on the development of the pharmaceutical industry and the availability of innovative drugs.

The patent dispute between AstraZeneca and generic companies for dapagliflozin has been ongoing since 2022. The British-Swedish company received repeated patents for dapagliflozin. Slovenian KRKA, which received a registration certificate for its analogue Forsiga in 2022, tried to challenge Rospatent's decision to issue repeated patents to AstraZeneca first through direct appeals and then through the IPC. The latter rejected the plaintiff's claim, 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. However, 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.

In June 2024, AstraZeneca and Rospatent managed to appeal the decision of the Presidium of the IPC to the Supreme Court of the Russian Federation. 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.

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.”

Thus, in the fall of 2024, the regulator fined Akrikhin 577.7 million rubles for violating AstraZeneca's patent for dapagliflozin. The sanction, however, was challenged and canceled . In June 2025, the Supreme Court of the Russian Federation rejected Akrikhin's other claim against the antimonopoly service. At that time, the applicant tried to challenge the regulator's information letter regarding the recognition of Akrikhin's introduction of Fordiglif, a generic of Forsiga, into circulation without the consent of the owner of the patent for the active substance, AstraZeneca, as a violation of antimonopoly legislation.