The FAS of Russia recognized pharmaceutical companies Akrikhin and AxelPharm as violating Article 14.5 of the Law on Protection of Competition.
The Federal Antimonopoly Service (FAS) issued a ruling to recover more than 1.5 billion rubles from the pharmaceutical companies AxelPharm and Akrikhin for violation of antimonopoly legislation. The companies were found guilty of releasing generic drugs Ruxolitinib and Fordiglif before the expiration of patents for the original drugs.
AxelPharm was obliged to return to the budget about 960 million rubles, and Akrikhin — about 577 million rubles. FAS emphasized that patents for original drugs are valid until 2028.
Akrikhin disagreed with the FAS decision and announced its intention to appeal it in court. In its statement, the company claims that the compound dapagliflozin, which is part of Fordiglif, has passed into the public domain and can be freely used.
AstraZeneca, the patent holder for the original drug Forsiga (containing dapagliflozin), supported the FAS decision. AstraZeneca considers the decision to be fair and important for the entire pharmaceutical industry in Russia. The company noted an increase in patent infringement cases for drugs this year. As an example, AstraZeneca cited the situation with Akrikhin, which in late June released new batches of generic Fordiglif, despite the fact that the Supreme Court of the Russian Federation confirmed the validity of AstraZeneca's patent for dapagliflozin until May 2028.
AstraZeneca expressed hope that the FAS decision will set a precedent for the industry and help stem the tide of patent infringements. The company emphasized that the production volume of Forsiga at the plant in Kaluga Region is sufficient for the Russian market and there is no shortage of the drug.
Source: Pharmprom