In 2024, the Federal Antimonopoly Service (the “FAS”) issued several decisions in favour of originator companies in response to their complaints on unlawful circulation of generic products before expiration of patent protection for the brand-name drugs. Initially, this seemed to be a new and effective strategy for protecting the originators’ interests.
However, in 2025 the trend shifted. Generic companies succeeded in challenging the FAS’s decisions. Courts consistently overturned orders against companies marketing generic “Axitinib”, “Osimertinib”, “Ruxolitinib”, and “Bosutinib”. As a result, by the end of the year the industry concluded that a pro-generic approach had already become a stable judicial practice*.
However, the situation changed again in this March, when the dispute on “Axitinib” was examined** by the Russian Supreme Court. In its decision, the Supreme Court upheld the antimonopoly authority, which had previously initiated proceedings against “Axelpharm” under the complaint of the originator, and ordered “Axelpharm” to transfer approximately RUB514m (approx. EUR 5,5m) to the state budget.
The Supreme Court’s ruling formulates legal positions that sharply contrast with the pro-generic approach previously formed in the lower courts. The comparison of the positions on the most significant issues is set out in the table below.
Issue
Positions of Lower Courts
Position of the
Supreme Court
Whether the existence of competitive relations between a patent holder and an infringer is a mandatory condition for qualifying the latter’s actions as unfair competition?
Yes
For the application of Article 14.5 of the Federal Law “On Protection of Competition” the existence of competitive relations directly between an infringer and a patent holder must be established (Decision of the 9th Appeal Arbitrazh Court as of 16.12.2025*, and as of 15.12.2025*).
No
An infringement of IP rights may be recognized as unfair competition not only in cases where a patent holder directly competes with an infringer, but also in other cases of causing harm to rightsholder’s interests.
Is it possible to ascertain the use of an invention on the basis of indirect evidence?
No
Patent expertise is mandatory for ascertaining the use of an invention (Decision of the Arbitrazh Court of Moscow as of 27.11.2025*).
An administrative authority’s decision based on assumptions or conjecture is unlawful (Decision of the 9th Appeal Arbitrazh Court as of 15.12.2025*).
Yes
Obligation to conduct patent expertise leads to an unreasonably high standard of proof.
A finding of infringement of IP rights may be made by the FAS based on cumulative evidence: specialists’ reports, facts ascertaining the circulation, extracts from the Eurasian Pharmaceutical Register, etc.
Can preliminary actions aimed at the lawful use of an invention (for example, applying for a compulsory license) prove the use of an invention?
No
The choice of legal remedies cannot prove an infringement (Decision of the 9th Appeal Arbitrazh Court as of 16.12.2025*).
Yes
Obligation to conduct patent expertise leads to an unreasonably high standard of proof.
A finding of infringement of IP rights may be made by the FAS based on cumulative evidence: specialists’ reports, facts ascertaining the circulation, extracts from the Eurasian Pharmaceutical Register, etc.
Is the FAS competent to independently examine unfair competition cases related to the unlawful use of intellectual property?
No
Some courts noted that the antimonopoly authority is not competent to resolve the cases involving patent infringement (Decision of the 9th Appeal Arbitrazh Court as of 17.07.2025*).
Yes
The Supreme Court has not commented on this issue directly, but the FAS’s decision would hardly have been upheld if the service had not originally had the competence.
The Supreme Court’s position can change the pro-generic approach established in judicial practice. Following the Supreme Court’s decision, in the dispute concerning “Osimertinib” the cassation instance has already overturned the lower courts’ decisions, ruling in favour of the FAS. In April, there will also be appeal hearings regarding the disputes on “Ruxolitinib” and “Bosutinib”.
The Supreme Court’s position may encourage patent holders to more actively use the antimonopoly track of protecting their interests. Considering the balance of outcomes, speed, and costs, this mechanism may be more efficient than traditional court litigation.
* We have previously overviewed the history of unfair competition disputes between originator and generic companies. Our materials on this are available at the following links: [1], [2; p. 10]*. ** All links to judicial documents are in Russian.