Patent Disputes in Russia: AIPM Data

Patent litigation in the Russian pharmaceutical sector has nearly tripled over the past three years compared to the preceding five. Companies are now withdrawing generic drugs six to seven years before a patent expires, instead of the previous three-year window. The nature of these disputes has shifted from direct patent challenges to controversies over early generic launches and compulsory licensing.

The Association of International Pharmaceutical Manufacturers (AIPM) has analyzed patent disputes in Russia from 2017 to January 2026. This report is available at Право.ru.

Over the past nine years, courts have handled more than 150 intellectual property cases. The number of disputes has almost tripled, rising from over 30 cases in 2017-2021 to more than 90 in the last three years. The nature of the conflicts has also evolved. Companies now rarely challenge patents directly but increasingly withdraw generics before the original patent expires or seek compulsory licenses.

The disputes involve at least 45 international non-proprietary names (INNs), with more than 25 specifically related to early generic launches. The AIPM notes that the window for early generic withdrawals has expanded from three to six to seven years before patent expiration. This trend makes it less likely for patent holders and generic manufacturers to reach amicable agreements.

About 40% of the disputes concern drugs with varying degrees of localization, including five INNs with special investment contracts. The participants have also diversified: while previous conflicts mainly involved foreign originators and Russian manufacturers, now at least five disputes are between Russian companies.

Most cases take more than a year to resolve, with some lasting from three to six years. The exception is compulsory license cases, which are often decided by first-instance courts within three months to a year, sometimes in accelerated proceedings.

In 2022-2026, courts received about 30 cases related to compulsory licenses. Approximately 70% of these were filed under clause 1 of Article 1362 of the Civil Code, citing insufficient use of the invention. However, there is no legislative definition of "insufficient use," and judicial practice has not yet established clear criteria for determining it, the AIPM highlights.

In the absence of clear criteria, courts independently evaluate the adequacy of an invention's use. For instance, in a case where an applicant sought to cancel a previous license, the court applied the "market saturation" criterion. The manufacturer of the original drug needed to demonstrate its ability to supply the market with sufficient quantities to meet current needs, comparable to what was available when the compulsory license was granted.

Most of the cases received by the courts are now considered behind closed doors, not included in the generalizations from the Intellectual Property Rights Court or the Supreme Court. This hinders the expert community's ability to fully analyze the grounds for these decisions. Courts also frequently fail to involve local manufacturers as third parties to justify an invention's use in Russia.

A pivotal decision for practice will be the Constitutional Court's upcoming ruling on the constitutionality of paragraph 1 of Article 1362 of the Civil Code. Sanofi Russia and Vertex Pharmaceuticals have filed complaints, arguing that the norm allows for incorrect determination of the required proof and judicial assessment. Additionally, the norm does not clearly define the courts' powers and duties regarding the scope of opportunities granted to licensees.

The AIPM also highlights the lack of legal clarity in cases involving preclinical and clinical trial information. From 2022 to 2026, at least four such disputes arose, particularly among Russian manufacturers. There is no unified approach to legal protection for this information at the EAEU level.

The study's authors highlight a significant development: courts increasingly reject interim measures in patent disputes. Essentially, copyright holders can no longer rely on this legal tool to safeguard their rights.

Amidst these developments, the Federal Antimonopoly Service (FAS) has taken a firm stance: introducing a generic drug to market before the original patent expires is deemed unfair competition. The Courts of First Instance and Appeal have upheld the FAS's decision regarding the generic drug dapagliflozin (case no. A40-305697/2024), but in another case (no. A40-31162/2025), involving the drug bozutinib, the First Instance Court dismissed the FAS's ruling, only for the Appeal Court to overturn it, deeming the FAS's decision illegal.

These are just two instances of ongoing disputes. In other cases, the First Instance Courts have overturned FAS decisions on technical grounds. They found no competitive relationship with the original drug's copyright holder, rejected the EAEU Pharmaceutical Register extract due to its informational nature, and dismissed the patent attorney's conclusion, citing its preparation for third-party interests.

Both these cases are currently under review by higher authorities (cases no. A40-264483/2024 and no. A40-315385/2024). Meanwhile, in the first case concerning Axitinib, the Supreme Court has accepted the complaint for review, with the hearing scheduled for March 11. The Intellectual Property Rights Court is still adjudicating the Osimertinib case.