Принудительное лицензирование фармацевтических изобретений при их неиспользовании (недостаточном использовании) правообладателем

https://doi.org/10.24031/1992-2043-2026-26-3-182-232 This article examines the conditions for granting a compulsory license in respect of pharmaceutical inventions under Article 1362(1) of the Civil Code of the Russian Federation, employing literal, systemic, and teleological interpretation. The impetus for this publication stems from the Constitutional Court’s Ruling No. 13‑P of 12 March 2026, which reviewed the constitutionality of Article 1362(1) in response to complaints brought by JSC “Sanofi Russia” and Vertex Pharmaceuticals Incorporated. The study identifies a range of theoretical and practical challenges arising from this ruling and proposes potential solutions. Particular attention is devoted to addressing key questions: what are the permissible conditions for compulsory licensing in the pharmaceutical sector? What risks and consequences must be evaluated in such cases? How should the concepts of insufficient use of an invention and the supply of relevant products be interpreted as prerequisites for a compulsory license? Whether the price differential between the originator and generic drug (where the latter is more affordable) may be considered when determining whether to grant a compulsory license? Whether the applicant seeking a compulsory license must demonstrate its capacity to exploit the invention more effectively than the patent holder, thereby advancing consumer interests. The analysis also places considerable emphasis on the comparative examination of foreign legal practices. Keywords: invention; pharmaceuticals; patent holder; compulsory licensing; non-use of invention; demand; supply.