On March 04, 2025, the Arbitration Court of Moscow (case No. A40-264483/24) considered the application of AKSELFARM LLC to challenge the decision and order of the FAS Russia (dated October 04, 2024, in case No. 08/01/14.5-51/2024) and came to the conclusion that the Applicant's claims are justified and subject to satisfaction in full.
«A.Zalesov & Partners» lawyers while representing the interests of the Applicant were able to prove that the antimonopoly law has not been violated by the Applicant, and that the FAS erroneously applied the provisions of Article 14.5 of the Law on the Protection of Competition in this case, due to:
- Lack of competitive relations. The case materials do not establish the existence of competitive relations between AKSELFARM LLC and Aguron Pharmaceuticals LLC, the holder of the patent right to the invention «Indazole compounds, pharmaceutical preparations for inhibiting protein kinases and methods of using them» under Eurasian patent No. 004460. This condition is mandatory for qualifying the actions of the Applicant as an act of unfair competition.
- Insufficiency and inadmissibility of evidence. The FAS made a 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» introduced into civil circulation by the Applicant. References to such documents as letters from the Eurasian Patent Office, offer from the Applicant to the patent holder, the Applicant's statement of claim for a compulsory license, the opinion of one expert on the part of the patent holder per se are not evidence of violation of the exclusive right to the invention under Eurasian Patent No. 004460.
- Lack of evidence of illegal use. The Court agreed with the Applicant's opinion that the decision of the FAS Russia lacks an analysis of the features of the invention and the medicinal product of the Applicant to substantiate the conclusions about the illegal use of the invention. To conduct such an analysis, the FAS has the right to appoint an expert examination on its own initiative. However, such an examination was not appointed by the antimonopoly authority, and the conclusions about the violation of the requirements of the current antimonopoly legislation committed by the Applicant, made even in the absence of an analysis of the features of the medicinal product and the claims of the invention under the Eurasian patent, are premature, not based on the provisions of the law and have no documentary evidence in the case materials.
The court concluded that the decision and order of the FAS Russia in this case are illegal.
This decision is of fundamental importance for law enforcement practice in the field of protecting intellectual property and antitrust regulation in the pharmaceutical industry.
There is a tendency of increased number of applications to the FAS Russia from patent holders to protect their rights, presumably as FAS is capable of solving disputes faster than the courts. We emphasize that in this case, disputes must be of an antitrust nature (compliance with several conditions to fall under the scope of antimonopoly regulation), and it is also necessary to prove the existence of IP rights infringement in accordance with the procedure established by law (to determine the presence or absence of use of an invention, the features of the invention under the patent and the contested product must be analyzed).
The client's interests were represented by the Managing Partner Aleksey Zalesov and Senior Associate Darya Kushnarenko.