Federal Antimonopoly Service ordered Russian pharmaceutical companies to return revenue from the turnover of generics to the budget

Due to competition law violations, the Federal Antimonopoly Service issued instructions on the return to the budget of funds received from the sale of generic drugs under patent protection at state trade unions. Axelpharm must return 960.8 million rubles, proceeds from the supply of antitumor ruxolitinib (the original drug is "Jakavi" from Swiss Novartis), and Akrikhin — 577.7 million rubles for antidiabetic dapagliflozin ("Forsiga" from British—Swedish AstraZeneca). Companies have also been ordered to stop the turnover of generics.

The order was the second for Axelpharm: in early October, the FAS ordered the company to pay 513.7 million rubles to the budget from the sale of antitumor axitinib ("Inlita" from Pfizer). Two more proceedings on the refund of funds received for Russian generics are under consideration.

Akrikhin reminds us that no judicial act has established a violation of AstraZeneca's exclusive right when introducing the generic dapagliflozin into circulation. The company, like other manufacturers of dapagliflozin analogs, disputed the legality of extending AstraZeneca's rights to the drug, believing that the inventions had passed into the public domain.

The original ruxolitinib and dapagliflozin are protected by patents until 2028, and axitinib — until June 2025.

Until now, the Federal Antimonopoly Service has practically not considered patent infringement disputes: arbitration courts usually dealt with this.

Sergey Zuykov, Managing Partner of Zuykov and partners, calls the new decisions of the regulator precedent-setting for the pharmaceutical market.

The support of the FAS strengthens the position of the originators, says Konstantin Suvorov, partner of Kosenkov and Suvorov. According to him, they could follow the path of antitrust proceedings because of the possibility of causing significant financial damage to violators.

Akrikhin plans to appeal the decision of the Federal Antimonopoly Service. But it will not be easy, Sergey Zuykov warns. Konstantin Suvorov notes that the fact of using an invention without the consent of the patent holder in the framework of an antimonopoly case has already been established, therefore, contesting usually does not make sense.

Source: Kommersant