Individual prescription drug production: an analysis of foreign law enforcement practice and development prospects
Abstract
This article addresses contemporary issues concerning regulatory requirements and intellectual property rights in the context of pharmaceutical manufacturing conducted abroad. In view of the increased interest within the Russian Federation in the application of the legal “exception” provided under article 1359 of the Civil Code of the Russian Federation – which establishes that the one-time preparation of medicinal products in pharmacies pursuant to a physician’s prescription does not constitute an infringement of the exclusive right to an invention – the article undertakes a comparative examination of how this exception is implemented in other jurisdictions. It analyzes prevailing interpretations of the “one-time” criterion in the sphere of pharmaceutical compounding, as well as the observable trend toward relaxing constraints on both the timeframe and volume of such preparation. Furthermore, the article considers international experience with risk-based regulatory approaches designed to ensure the safe and compliant use of individually prepared medicinal products.
About the Authors
N. D. Denisenko
Sirius University of Science and Technology
Russian Federation
Russian Federation
Natalia. D. Denisenko, Head of the Center for Intellectual Property and Technology Transfer
Krasnodar region, Sirius Federal Territory, Olympic Ave., 1
T. N. Erivantseva
Eurasian Patent Office
Russian Federation
Russian Federation
Tatiana N. Erivantseva, Cand. Sci. (Medical sciences) Head of the Center for the Promotion of Patents
Moscow, Cherkassky Lane, 2
R. A. Ivanov
Sirius University of Science and Technology
Russian Federation
Russian Federation
Roman A. Ivanov, PhD in Molecular Immunology, Director of the Translational Medicine Research Center, Chairman of the Academic Council
Krasnodar region, Sirius Federal Territory, Olympic Ave., 1
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Review
For citations:
Denisenko N.D., Erivantseva T.N., Ivanov R.A. Individual prescription drug production: an analysis of foreign law enforcement practice and development prospects. Bulletin of Federal institute of industrial property. 2025;4(4):286–297. (In Russ.)
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