The Supreme Court of the Russian Federation has accepted for review one of the most significant pharmaceutical market cases in recent years, details of which were reported by the publication “Civil Control of Public Procurement”. The Economic Collegium is set to address a fundamental question: whether the Federal Antimonopoly Service (FAS) has the authority to penalize generic manufacturers for patent infringement, or if this remains the exclusive jurisdiction of the Intellectual Property Court.
The dispute centers on the anti-tumor drug “Axitinib”. A Justice of the Supreme Court has referred cassation appeals from FAS Russia, Pfizer entities, and the company Pharmstandard for consideration. These appeals challenge lower court rulings that had favored the generic manufacturer, Axelfarm LLC.
The Core Conflict: 513 Million Rubles and Article 14.5
The history of the case dates back to the fall of 2024, when the FAS recognized Axelfarm’s actions as an act of unfair competition under Article 14.5 of the Law “On Protection of Competition”.
- According to the agency, the company launched a generic drug by unlawfully utilizing an invention protected by Eurasian patent No. 004460 without the patent holder’s consent.
- FAS demanded that sales cease and that all income derived from the violation—an amount exceeding 513 million rubles—be transferred to the federal budget.
Court Rulings: “FAS Failed to Prove Formula Usage”
Three judicial instances previously overturned the antimonopoly regulator’s decision. The courts pointed to procedural gaps in the FAS investigation, noting that the actual use of the patent had not been proven and it had not been established whether the drug contained every feature of the invention’s formula. Furthermore, the courts held that the agency failed to substantiate the existence of a competitive relationship at the time of the dispute and did not apply the norms of the Eurasian Patent Convention.
Arguments for Review
FAS and Pfizer maintain that the evidence base is sufficient. They point out that Axelfarm’s drug is officially registered as a “reproduced” (generic) version of the original drug “Inlyta”. Additionally, the appellants highlight that Axelfarm had previously attempted to obtain a compulsory license, which they argue indirectly confirms the company’s awareness that patent authorization was required.
“The Supreme Court must determine where a patent dispute ends and unfair competition begins. If the FAS’s approach is upheld, the antimonopoly tool will effectively become an additional mechanism for protecting exclusive rights in the pharmaceutical market.”
— Dmitry Dobroshtan, Expert in Procurement and Antimonopoly Regulation
The hearing will determine whether it is permissible to apply unfair competition statutes in situations requiring complex technical expertise regarding patent utilization.
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