The Supreme Court ruled that a generic drug launch can violate patent rights and competition law even without direct market rivalry.
Russia’s Supreme Court has issued a detailed 15-page ruling in a dispute between pharmaceutical company AxelPharm and the Federal Antimonopoly Service (FAS), clarifying how antitrust rules apply to generic drugs.
The court upheld the FAS decision that AxelPharm engaged in unfair competition by bringing to market a drug containing axitinib before the expiration of a Eurasian patent held by Agouron Pharmaceuticals (part of Pfizer). It overturned earlier rulings by three lower courts, which had sided with AxelPharm and found insufficient proof of patent use.
The dispute began in 2024 after complaints from Pfizer and other foreign drugmakers. The FAS concluded that AxelPharm’s product infringed patent protections, violating Russia’s competition law. Lower courts disagreed, arguing that regulators failed to prove the use of the patented invention or the existence of direct competition, noting that the patent holder had not marketed the drug in Russia.
However, the Supreme Court rejected these arguments. It found that the use of a patented substance in a generic drug may still constitute infringement, even if the product is registered as a generic. The court also ruled that direct competition between the parties is not required to establish unfair conduct, as harm to a patent holder’s economic interests can arise through other mechanisms.
Additionally, the court dismissed claims that an expert opinion used in the case was biased, noting that AxelPharm did not challenge the expert’s qualifications or findings.
The ruling ultimately confirms the legality of the FAS decision and requires AxelPharm to pay 514 million rubles in recovered income, reinforcing stricter enforcement of patent rights in Russia’s pharmaceutical market.
Source: Pravo.ru
