The Moscow Arbitration Court considered the case A40-301763/2024, based on the application of AkselPharm LLC to the Federal Antimonopoly Service of Russia (FAS Russia), seeking to invalidate the decision of the FAS of Russia and of the order of November 20, 2024, in case No. 08/01/14.5-67/2024, regarding infringement of Article 14.5 of Federal Law No. 135-FZ «On Protection of Competition» of July 26, 2006.
Lawyers of «A.Zalesov & Partners» Patent & Law Firm representing the Applicant proved that actions of AkselPharm LLC in introducing the medicinal product Ruxolitinib (INN Ruxolitinib) into civil circulation under the registration certificate No. LP-No. (003574)-(RG-RU) dated November 01, 2023, do not constitute unfair competition under Article 14.5 of the Law on Protection of Competition.
The court confirmed that the FAS decision was made in the absence of admissible and reliable evidence of the use of the patented invention in the Applicant's medicinal product. When making the contested decision, the antimonopoly authority failed to apply the provisions of Eurasian patent law, and, contrary to the requirements of this law, it failed to determine whether each feature of the independent claim of the invention was used in the disputed medicinal product.
The court also agreed with our arguments and stated that the mere fact of state registration of a generic medication does not constitute proof of patent infringement without an analysis and comparison of the patent claims and the medication's features to establish use in accordance with the requirements of current legislation.
Along with the decision, order of the FAS of Russia to transfer revenue in the amount of 960,791,122 rubles and 48 kopecks to the federal budget was declared unlawful and revoked.
It should be noted that Ruxolitinib is included in the list of vital and essential medicinal products.
The client's interests in the case were represented by Aleksey Zalesov, Head of Intellectual Property Practice, and Darya Kushnarenko, Senior Associate.
The case is being widely discussed in the media and the professional community, for example, on the website of the business magazine Vademecum (in Russian).