Russia: the Antimonopoly Service’s role in pharma patent disputes. Part II

This post is a continuation of the previous post published on July 25, 2025 and available here. Said post mentions case No. А40-315385/24 relating to osimertinib, in which the Russian pharmaceutical company “Axelpharm” contested the unfavorable ruling of the Federal Antimonopoly Service (FAS) of Russia by filing a lawsuit with the Arbitration Court of Moscow. This court made a decision in favor of Axelpharm. However, the cassation instance court came to the opposite opinion. In another case relating to axitinib (No. A40-264483/2024), the lawsuit has even come to the Russian Supreme Court – its ruling was also issued in favor of the FAS and the originator company.

Details of the cases are discussed below.

Case No. A40-264483/2024 - Axitinib

This case became one of the most significant Russian pharmaceutical and antitrust disputes in recent years because it addressed the intersection of patent law, generic medicines, and unfair competition regulation. The case involved Axelpharm, the FAS, and patent holders connected with the cancer drug Axitinib, originally associated with Pfizer.

The central issue in the case concerned whether Axelpharm unlawfully introduced a generic version of the anti-cancer medicine Axitinib into the Russian market before the expiration of patent protection. Axitinib is used primarily for the treatment of renal cell carcinoma, a serious form of kidney cancer. The original patented product was protected by Eurasian Patent No. 004460. According to the patent holders and the FAS, Axelpharm’s generic product used the patented invention without permission and therefore constituted unfair competition under Article 14.5 of the Russian Law on Protection of Competition.

In October 2024, the FAS issued a decision against Axelpharm. The antimonopoly authority concluded that the company had violated competition law by placing the generic medicine into civil circulation before patent expiration. The FAS also ordered the company to transfer approximately 513 million rubles (approximately US$ 7 M) of revenue to the state budget. The authority treated the conduct not merely as a patent infringement issue, but as an act of unfair competition affecting the pharmaceutical market.

Axelpharm challenged the FAS’s decision before the Arbitration Court of Moscow. The company argued that the antimonopoly authority lacked sufficient evidence proving that the generic medicine actually used the patented invention. Lawyers representing Axelpharm also claimed that the FAS had incorrectly interpreted Article 14.5 of the competition law and exceeded its authority by considering a patent dispute without a proper examination.

In March 2025, the court sided with Axelpharm and invalidated the FAS’s decision entirely. The court found that the evidence presented by the antimonopoly authority was insufficient. In particular, the court criticized the lack of a forensic examination confirming the use of the patented invention in the generic product. The Ninth Arbitration Court of Appeal later upheld this decision in July 2025. The Russian Intellectual Property Rights Court (IP Court) as the first cassation instance also upheld the decision in November 2025.

However, the legal landscape changed dramatically in 2026 when the Supreme Court of the Russian Federation reviewed the case. On 11 March 2026, the Supreme Court overturned the earlier decisions and ruled in favor of the FAS. The Court held that the antimonopoly authority had acted lawfully and that the available evidence was sufficient to establish infringement of patent rights and unfair competition.

First, the Court stated that Russian law does not require the FAS to conduct a formal forensic examination in every case involving patented inventions. According to the Court, expert reports and other documentary evidence can be sufficient if the accused company fails to provide convincing counter-evidence. The Court specifically noted that Axelpharm did not seriously dispute the substance of the expert conclusions or provide alternative technical evidence disproving the patent use.

Second, the Supreme Court emphasized that the finding of unfair competition under Article 14.5 does not necessarily require proof of direct market competition between the infringer and the patent holder. This was a notable clarification because traditional competition law often depends on demonstrating competitive relations between parties. The Court instead focused on the unlawful commercial advantage obtained through premature market entry.

Third, the Court considered Axelpharm’s broader conduct relevant to the dispute. It was noted that the company had attempted several legal strategies connected to the patent, including applications for compulsory licensing and challenges to the validity of the patent before the Patent Office. The Supreme Court interpreted these actions as indirect confirmation that the company recognized the existence and relevance of the patent rights.

The final outcome was a complete reversal of the lower court decisions. Axelpharm’s claims were rejected, and the FAS’s order was reinstated.

Case No. А40-315385/24 – Osimertinib

This dispute concerned the generic version of the oncology drug “Osimertinib” marketed in Russia by Axelpharm, while the original patented product belongs to AstraZeneca AB and is covered by Eurasian Patent No. 024421.

The case originated after the FAS issued a decision in November 2024 finding that Axelpharm had engaged in unfair competition by introducing a generic version of Osimertinib into the market while a Eurasian patent protecting the active substance was still in force. The antimonopoly authority ordered the company to stop introducing the drug into civil circulation and demanded recovery of more than 566 million rubles (approximately US$ 8 M) allegedly earned from the sales.

Axelpharm challenged the FAS’s decision before the Arbitration Court of Moscow. In May 2025, the Court ruled in favor of the company and declared both the FAS decision and its prescription unlawful. The Court concluded that the antimonopoly authority had exceeded its competence and had not properly established the factual basis necessary to prove unfair competition. The judgement emphasized several key points. First, the Court found that the FAS failed to establish actual competitive relations between Axelpharm and AstraZeneca AB, which is a necessary element for liability under Russian unfair competition rules. Second, the Court noted that the FAS had not conducted a proper patent analysis comparing the patent claims with the characteristics of the generic product. Importantly, the FAS also refused to appoint a patent-technical examination, which the court viewed as a serious procedural flaw.

The Ninth Arbitration Court of Appeal later upheld this decision in December 2025.

The most significant aspect, however, was the later involvement of the IP Court as the first cassation instance.

In its ruling dated 7 April 2026, the IP Court reversed the previous judicial acts and concluded that the lower courts incorrectly interpreted the relationship between patent law and competition law. Thus, the use of a patented technical solution without the consent of the patent holder may constitute not only patent infringement but also an act of unfair competition where such conduct is aimed at obtaining advantages in the pharmaceutical market. A key conclusion of the ruling was that the FAS acted within its competence when assessing whether Axelpharm’s conduct created unlawful competitive advantages. The Court emphasized that the antimonopoly authority is entitled to evaluate market behavior connected with the unlawful use of intellectual property rights, especially in sectors with high commercial and social significance such as pharmaceuticals.

The IP Court also held that the previous courts had improperly evaluated the evidence collected by the FAS. In particular, the cassation instance considered that the available patent documentation, pharmaceutical registration materials, and information regarding the circulation of the generic drug sufficiently confirmed the use of AstraZeneca’s patented invention in Axelpharm’s product.

Another important conclusion concerned the economic nature of the violation. The Court stated that entering the market before the expiration of patent protection allowed the generic manufacturer to gain competitive benefits derived from another company’s research and development investments. Such conduct, according to the Court, contradicted the principles of good faith and fair competition established under Russian antimonopoly legislation.

Thus, the IP Court’s reasoning was aligned with the Supreme Court’s position set down in the judgement of 11 March 2026 in case No. A40-264483/2024. As a result, the IP Court cancelled the earlier judgements that had invalidated the FAS’s decision and adopted a new ruling recognizing the FAS’s findings as lawful.

Conclusion

Both above cases, but especially A40-264483/2024, are now widely regarded as a landmark precedent in Russian pharmaceutical law. They strengthened the authority of the FAS in disputes involving patented medicines and clarified evidentiary standards for unfair competition cases connected to intellectual property. The case law also signaled stronger judicial support for patent holders in the pharmaceutical industry at a time when Russia continues to debate import substitution, domestic generic manufacturing, and access to medicines. For legal practitioners and pharmaceutical companies, the cases became a defining example of how patent enforcement and competition law increasingly overlap in Russia’s healthcare sector.