On November 12, 2025, Russian IP Court held a hearing in case A40-264483/2024. Appeals of the FAS Russia and third parties: Agurone Pharmaceuticals LLC, Pfizer Inc., Pfizer Innovations LLC, and Pharmstandard - were considered against the decision of the Moscow Arbitration Court of March 12, 2025, and the ruling of the Ninth Arbitration Court of Appeal of July 17, 2025.
Previously, the courts of first instance and appellate instance found the Applicant's claims justified and fully satisfied them, and declared the FAS Russia's decision and order of October 04, 2024, in case No. 08/01/14.5-51/2024 regarding the infringement of Article 14.5 of Federal Law No. 135-FZ «On Protection of Competition» of July 26, 2006, to be completely unlawful.
Associates of «A.Zalesov & Partners» Patent & Law Firm, representing the Applicant, proved that actions of «AkselPharm» in introducing the medicinal product Axitinib (INN: Axitinib) into civil circulation under the registration certificate No. LP-No. (003110)-(PG-RU) dated August 31, 2023, do not constitute unfair competition under Article 14.5 of the Law on Protection of Competition, in particular due to the following:
Insufficient and inadmissible evidence. The Federal Antimonopoly Service made its decision in the absence of relevant, admissible and reliable evidence of the use of the invention under Eurasian Patent No. 004460 in the medicinal product «Axitinib», which the Applicant introduces into civil circulation. References to documents such as letters from the Eurasian Patent Office, the Applicant's offers to the patent owner, the statement of claim for a compulsory license, and the opinion of a single expert on the part of the patent owner do not, in and of themselves, constitute evidence of an infringement of the Eurasian Patent No. 004460.
Failure to prove the fact of illegal use. The courts agreed with the Applicant that the FAS decision lacked an analysis of the features of the Applicant's invention and medicinal product to substantiate its conclusions regarding the illegal use of the invention. To conduct such an analysis, the FAS has the right, on its own initiative, to commission an expert examination. However, the antimonopoly authority did not commission such an expert examination, and the conclusions regarding the Applicant's infringement of current antimonopoly legislation, made without analyzing the features of the medicinal product and the claims under the Eurasian patent, are premature, not based on legal provisions, and lack documentary support in the case file.
Failure to apply applicable law. The FAS Commission's decision not only failed to apply Eurasian patent legislation, but, contrary to established requirements, failed to establish whether each feature of the independent claim of the Eurasian patent was used in the Applicant's medicinal product «Axitinib» —the existence of a patent infringement must be proven in accordance with the established procedure.
The IP Court, having reviewed the cassation appeals, upheld the conclusions of the courts of the first and appellate instances: it upheld the judicial decisions and dismissed the cassation appeals.
The cassation court ruling is of fundamental importance for law enforcement practices in the area of intellectual property protection and antitrust regulation in the pharmaceutical industry. Currently, there is a growing trend of patent owners filing appeals to the Federal Antimonopoly Service (FAS) seeking protection of their rights, citing, among other things, faster review times and the possibility of banning products from circulation pending a ruling on an infringement case. It stands to mention that appeals to the FAS must meet the conditions for such cases to be considered by antitrust authorities: the actions of the alleged infringer must show signs of infringing antitrust laws.
It is also worth noting that «Axitinib» is included in the list of vital and essential drugs (VED).
The client's interests in the case were represented by Managing Partner Aleksey Zalesov and Senior Associate Darya Kushnarenko.