On the issue of compounding drugs in pharmacies pursuant to physicians' prescriptions using a patented invention

Background. Identification of terminological and practical inconsistencies in the field of patent law in regulatory legal acts, including the Civil Code of the Russian Federation (CC RF) is important for lawmakers, regulators, stakeholders in the pharmaceutical market, and patent holders.

Objective: To conduct a comprehensive analysis of Clause 5 of Article 1359 of CC RF, which provides an exception to patent holders’ exclusive rights regarding the compounding of drugs in pharmacies pursuant to physicians’ prescriptions, in terms of its consistency with current pharmaceutical legislation and international legal standards.

Material and methods. The methods of historical-legal, semantic-linguistic, and comparative-legal analysis were applied. The Russian regulation was compared with that in the European Union (EU), the United States of America, Japan, Brazil, etc. Additionally, provisions of international agreements, including the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the EU Agreement on a Unified Patent Court, were analyzed.

Results. The current wording of Clause 5 of Article 1359 of CC RF was found to suffer from insufficient terminological clarity regarding the concepts of “individual compounding” and “medicinal product”, thus leading to legal uncertainty and potential conflicts with existing pharmaceutical legislation. The analysis of international practices revealed common regulatory approaches to this exception: the individual (personalized) nature of compounding (for a specific patient), mandatory medical prescription, exclusion of industrial-scale manufacturing, and the professional status of the performer (a pharmaceutical specialist). The Russian norm appears to have been borrowed from regulatory models of EU countries. However, in the absence of clear criteria for its application, risks of a broader interpretation arise, including the preparation of active pharmaceutical ingredients, which contradicts the objectives of patent regulation and the current structure of the pharmaceutical market.

Conclusion. Clause 5 of Article 1359 of CC RF is designed to protect pharmacy organizations and implements the principle of fair use of patented objects, provided that the medicinal products are lawfully obtained. It may serve as a negotiating tool in cases of drug shortages. To uphold constitutional obligations regarding public health protection and to eliminate legal uncertainty, the norm requires legislative clarification and refinement.

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