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.
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.
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.
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.
Links:
Authors
- Vsevolod Tyupa, Partner, Head of Life Sciences & Healthcare, vsevolod.tyupa@sl-legal.ru
- Ivan Zaraiskiy, Senior Associate, ivan.zaraiskiy@sl-legal.ru
- Violetta Gavrilova, Paralegal, violetta.gavrilova@sl-legal.ru