Supreme Court Supported FAS in Drug Patent Dispute

21.04.26

With its landmark ruling No. 305-ES25-15716, the Supreme Court (SC) overturned the decisions of the arbitration courts in case No. A40-264483/2024, thereby upholding the order of the Federal Antimonopoly Service (FAS) protecting the position of the original drug rights holder.

Essence: Company "AxelFarm" launched the generic "Axitinib" on the market before the expiration of Eurasian patent No. 004460 (Agouron/Pfizer), without obtaining the patent holder's consent. The FAS deemed this unfair competition under Article 14.5 of the Competition Protection Law and ordered the transfer of ~513.7 million rubles of income to the budget. Three instances of arbitration courts overturned the FAS decision.

Outcome: The SC overturned the acts of the three instances. The claims of "AkcelFarm" are fully denied.

Key legal positions of the SC:
Standard of proof for patent use. The courts unreasonably demanded that the FAS appoint a forensic examination. In the presence of a patent attorney's opinion and the infringer's failure to provide counter-evidence — this is sufficient. The law does not establish a closed list of admissible evidence.

Estoppel. "AxelFarm" in one case (A40-168707/2024) itself recognized that the patent protects the substance axitinib, while in this case it simultaneously denied the fact of its use. The SC qualified this as impermissible contradictory behavior.

Competitive relations with the rights holder are not mandatory. For the composition of Article 14.5 of the Competition Law, direct competition between the infringer and the patent holder is not required. Causing harm to the economic interests of the rights holder is sufficient — including through its distributor model.

Absence of references to Eurasian legislation is not a defect of the decision. Paragraph 3 of Article 1358 of the Civil Code of the Russian Federation and Article 10 of the Eurasian Patent Convention are substantially identical, therefore a non-normative act of the FAS relying on the Civil Code does not become illegal due to the absence of a direct quote of the Convention.

The order to transfer income is lawful. Collection of ~513.7 million rubles to the federal budget is a legitimate measure under Part 3 of Article 51 of the Competition Law, aimed at restoring the balance of interests.

Significance for practice. This ruling sets a precedent: The FAS has the right to suppress "patent evergreening in reverse" — early market entry of a generic — using antitrust law instruments, without a standard infringement lawsuit from the patentee. The burden of disproving the fact of patent use is effectively shifted to the infringer.