By its ruling of December 15, 2025, the Ninth Arbitration Court of Appeal upheld the appeal of AkselPharm LLC and overturned the decision of the Moscow Arbitration Court of July 07, 2025, which had denied the claim to invalidate the non-regulatory legal acts of the FAS Russia. The Federal Antimonopoly Service, at the request of several pharmaceutical companies, opened a case against AkselPharm LLC. After reviewing the case, the FAS concluded that the company's actions constituted illegal use of an invention protected by Eurasian Patent No. 004427 in the production and marketing of «Bosutinib» medicinal product without the consent of the patentholder. The court of the first instance upheld the FAS's arguments, dismissing AkselPharm's claims.
The appellate court found the findings of the court of the first instance erroneous and the applicant's contentions valid. In its reasoning, the appellate court detailed the following key legal arguments supporting the illegality of the contested acts of the FAS of Russia:
- Absence of competitive relations. A specific criterion for the application of Article 14.5 of the Law on Protection of Competition is the use of the result of intellectual activity owned by a competing business entity, i.e., the existence of a competitive relationship with the patent holder, and not with another party. In this case, the antimonopoly authority and the court of the first instance recognized Pfizer Innovations LLC, the distributor of the original drug, as a competitor of AkselPharm LLC, rather than the patent holder. The appellate court stated that the patent holder should be considered a competitor, as it holds the exclusive right to the intellectual property, which is protected from unlawful use by the Law on Protection of Competition.
- Failure to apply mandatory provisions of the Eurasian Patent Convention. The panel found that, when considering the case, the FAS and the court of the first instance failed to apply the provisions of the Eurasian Patent Convention and the Patent Regulations governing patent infringement when determining whether the Eurasian patent had been infringed in violation of Article 13 of the Eurasian Patent Convention. Specifically, they failed to establish whether each feature of the independent claim of the disputed invention was used in the disputed medicinal product.
- These findings are based on a combination of circumstantial evidence. Inclusion of a patent in the Eurasian Pharmaceutical Register does not constitute legal protection for a specific generic name, used for informational purposes only and does not confirm use of the invention in a specific product. References to documents such as the Applicant's offers to the patent holder, the Applicant's statement of claim for a compulsory license, the patent attorney's report prepared at the expense and in the interests of the applicants in the antitrust case, which contains a number of procedural deficiencies, and the registration of a generic medicinal product do not, in and of themselves, constitute evidence of Eurasian patent infringement.
- The fact of unlawful use has not been proven. The Court of appeal noted that, in accordance with current legislation, to establish a patent infringement, it is necessary to establish the invention use in a specific product by comparing the features characterizing the product and the features of the claims. That is, by examining and comparing the features of the invention under the Eurasian patent with the features of the medicinal product in which the invention is allegedly used, rather than between the two medicinal products. The court agreed with the Applicant's opinion that the decision of the FAS of Russia 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. The FAS commission has the right to order an expert examination to clarify issues requiring specialized knowledge, but failed to do so. A decision by an administrative body based on an assumption or presumption of a circumstance is neither lawful nor justified.
The court concluded that the first-instance court's decision and the order of the FAS of Russia in this case were unlawful.
The court's ruling sets an important precedent amid the growing practice of patent holders seeking protection of their rights from the FAS. The court confirmed that no grounds for classifying an infringement under Article 14.5 of the Law on Protection of Competition are required.
The client's interests in the case were represented by Aleksey Zalesov, Head of Intellectual Property Practice.