The court upheld the cancellation of the FAS fine for Akselfarm in the amount of 513 million rubles for the sale of the generic drug Inlita

The FAS decision was made in early October 2024. In it, the regulator, in response to an appeal from Pharmstandard, Pfizer and its subsidiary Agouron Pharmaceuticals, which holds the Eurasian patent for axitinib until the end of June 2025, prohibited Akselpharm from selling a generic that violates the intellectual property rights of the originators. The antimonopoly service also ordered the Russian company to pay 513.7 million rubles to the state.

In response to the regulator's order, Akselpharm applied to the Moscow Arbitration Court in November 2024. The pharmaceutical manufacturer reported that the drug Axitinib has all the necessary permits - a registration certificate and a patent for an invention issued by the Eurasian Patent Office and expiring in November 2025. The first instance agreed with the applicant's arguments and recognized the FAS decision as illegal.

The regulator and third parties – Pharmstandard, Pfizer and Agouron Pharmaceuticals – did not agree with this position of the court. Appeals were filed in early April 2025. The parties wanted to reinstate the FAS decision of the autumn, but on June 3 the court refused to overturn the ruling of the first instance.

Pfizer stressed that “intellectual property is critical to driving innovation and economic growth in countries around the world.” The American company announced its intention to appeal to the cassation court.

Currently, four companies have state registration for drugs with axitinib in the Russian Federation: the American Pfizer, the Russian Akselpharm, Promomed and the Research Institute of Chemical Diversity. Akselpharm received a registration certificate for its generic earlier than other domestic manufacturers - on August 31, 2023.

In February 2024, the manufacturer of the original drug, through Agouron Pharmaceuticals, tried to suspend the execution of a state contract for the supply of a drug with the active ingredient axitinib to the Tyumen Region Department of Health for 170 thousand rubles as a security measure. The contractor for the purchase was the company "Medical Protection Products", which supplied 504 tablets of the drug from "Akselfarm". The Arbitration Court of the Tyumen Region refused to satisfy the plaintiff's claims.

In the summer of 2024, Vademecum wrote that in February-August 2024, Agouron Pharmaceuticals filed 53 claims with arbitration courts of the regions of Russia with similar demands. The plaintiff insisted that the implementation of state contracts would lead to the appearance on the market of a generic that violates the company's patent for the original drug Inlita. "Medical Protection Products" appeared as the executor of state orders in more than 35 petitions of the Pfizer subsidiary.

The FAS ban on the sale of the generic Inlita was the first in a series of similar orders from the regulator against the pharmaceutical manufacturer. Thus, in the same month, the antimonopoly service fined Akselpharm 960.8 million rubles for violating the patent of the American Incyte Corporation for the antitumor drug from Novartis - Jakavi (ruxolitinib), protected by patents until 2028. In November 2024, the FAS obliged Akselpharm to transfer another 607.5 million rubles to the federal budget for the introduction of two generics of patented drugs - the antitumor drug Bosulif (bosutinib) from Pfizer and the drug for the treatment of non-small cell lung cancer Tagrisso (osimertinib) from the British-Swedish AstraZeneca. Akselpharm also managed to appeal the latter order; the dispute is currently being considered by the appellate court.

The autumn decisions of the FAS marked a change in the regulator's position on patent disputes. What thematic confrontation will be remembered for in 2024 and what practice the courts adhere to when considering claims affecting intellectual property in the pharmaceutical industry – in the Vademecum review .