On 12 March 2026, the Constitutional Court issued the corresponding rulingResolution No. 13-P “On the case of verifying the constitutionality of clause 2 of Article 1362 of the Civil Code of the Russian Federation in connection with complaints from Sanofi Russia JSC and Vertex Pharmaceuticals Incorporated” dated 12 March 2026.. This is another important protective measure following the legalisation of “parallel imports” without the consent of right holders who have exited the Russian market. Both of such steps prioritise overcoming market shortages of certain goods, work and services over protecting the intellectual property rights of those abusing their rights.
Furthermore, the Constitutional Court, in setting key guidelines for courts in resolving disputes over the issuance of compulsory licences, has repeatedly emphasised the inadmissibility of a negative bias, which could lead to the deprivation of right holders’ legal stability, and the use of this instrument for unfair competition.
The ruling places particular emphasis on such reservations, leaving no doubt that this instrument should be applied by courts only in exceptional cases, namely only in response to right holder’s bad faith or inactivity that results in legitimate public interests being infringed.
Background
Vertex is the right holder of the patents used in Trikafta medicine, which is used to treat the rare (orphan) hereditary disease cystic fibrosis. Sanofi Russia JSC is the official distributor of Vertex in Russia.On 29 August 2022, the Medical Research Company (a party to a contract with a distributor of a foreign manufacturer that produces an equivalent medicine — Trilexa) filed a lawsuit in the Moscow Arbitrazh Court, requesting a compulsory licence. The Moscow Arbitrazh Court dismissed the claim, which was dissented by the 9th Arbitrazh Court of Appeal. Its decision was subsequently upheld by the Intellectual Property Court and the Supreme Court. Vertex and its official distributor disagreed with the decisions and filed a complaint with the Constitutional Court.
Constitutional court’s position
The Constitutional Court of the Russian Federation upheld the constitutionality of clause 1 of Article 1362 of the Civil Code of the Russian Federation, stating that this regulation is itself aimed at achieving constitutionally significant goals and presupposes judicial, rather than administrative, intervention in the sphere of exclusive rights.The court emphasised that compulsory licensing is an exceptional measure aimed at satisfying the public interest and eliminating a public dysfunction resulting from an insufficient supply of goods on the Russian market. This instrument is intended to balance private and public interests, and therefore the following guidelines were formulated for resolving such disputes:
Licence issuance conditions
- a compulsory licence is permitted only for the purpose of relieving a shortage on the market with goods similar to the original, provided that such shortage is contrary to socially significant interests of society;
- non-use or insufficient use of the patent by the patent holder, which may be evidenced by a refusal to supply, avoidance of participation in tenders, or the supply of goods at prices significantly inflated in comparison to similar products;
- a compulsory licence is granted only after the expiry of the term established by Article 1362 of the Civil Code of the Russian Federation (four years from the date of issue of the patent for an invention).
The court cites the following as signs of such abuse of patent rights:
- creating an artificial supply shortage;
- establishing discriminatory conditions for introducing a product to the market;
- setting significant price differences for identical products in different jurisdictions.
Proof
The Constitutional Court stated that it is sufficient for the claimant to prove the intention and ability to use the invention under the right holder’s patent. The right holder, on the other hand, must prove the actual use of the invention and disprove the applicability of their patents to a scarce commodity.
Right holder’s fee
A compulsory licence is not granted free of charge, and the right holder is entitled to an appropriate fee, the amount of which is determined by the court. The calculation of such fee must be qualified and justified. Furthermore, the right holder has the right to demand an adjustment of the fee amount should circumstances change.
Significance of the case
This case resolves a long-debated issue in the field of intellectual property rights in the Russian Federation.Firstly, the Constitutional Court explicitly stated the exclusivity of a compulsory licence as a measure to combat the abuse of patent rights, and the inadmissibility of reverse abuses that violate the interests of right holders.
Secondly, it sets out the conditions for issuing compulsory licences, formulates criteria for good faith, and establishes restrictions applicable to the terms of the licence itself.
Thirdly, it allocates the burden of proof for various circumstances between the right holder and the licensee.
In the context of sanctions and restrictions on the use of intellectual property, this ruling plays an important role in judicial practice, as it establishes basic guidelines for resolving disputes over compulsory licensing.
