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On March 12, 2026, the Constitutional Court of the Russian Federation issued Resolution No. 13-P on the case of verifying the constitutionality of the provisions of paragraph 1 of Article 1362 of the Civil Code of the Russian Federation in connection with the complaints of Sanofi Russia Joint Stock Company and Vertex Pharmaceuticals Incorporated.

The Constitutional Court of the Russian Federation has identified the constitutional and legal meaning of paragraphs one and two of clause 1 of Article 1362 of the Civil Code of the Russian Federation, which is mandatory for law enforcement, and has recognized that the contested provisions of the law do not contradict the Constitution of the Russian Federation.

The Court pointed out the inadmissibility of encouraging the infringement of exclusive rights to the results of intellectual activity that goes beyond the reasonable limits of the protection of the rights holder's economic interests, and the inadmissibility of unfair and malicious behavior aimed at acquiring a monopoly position in the market that is not justified by the meaning and content of current legislation. 

Resolution No. 13-P indicates that patent infringement may also include unjustified failure to use a patent, failure to produce patented products when there are opportunities to do so and refusal to transfer technology under a license agreement when there are no such opportunities, maintaining obviously insufficient production volumes that are not due to objective reasons and refusal to increase production when there is stable demand for the product, or a noticeable excess of the price of products supplied to a given jurisdiction in which a patent related to these products was obtained over prices set by the patent holder for other jurisdictions that is not justified by compelling circumstances.

The court also confirmed that in the case of the granting of a compulsory license, no seizure of property occurs.

The institution of compulsory licensing is important for ensuring a balance of constitutionally significant values and their protection, correcting the imbalance of private and public interests in cases of non-use or insufficient use of a patent, and the acquisition of unjustified economic advantages by the patent holder.

The Constitutional Court of the Russian Federation paid more attention in this Resolution to proof and the establishment of circumstances that are significant for the case and the distribution of the burden of proof.

The clarifications of the Constitutional Court of the Russian Federation in the Resolution are of great importance for law enforcement practice in cases of issuing compulsory licenses, the formation of legal positions, and the adoption of lawful and reasoned judicial decisions.

«A.Zalesov & Partners» represents the interests of plaintiffs in many cases concerning the issuance of compulsory licenses and fully agrees with the Constitutional Court of the Russian Federation that the release of generic drugs should be considered a positive factor for the economy, capable of significantly increasing the availability of innovative products on national markets.

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