The work of compounding pharmacies and the possible risks of violating the exclusive rights to original medicines

The revival of production pharmacies in Russia began in 2022. To effectively use the capabilities of compounding pharmacies, it is necessary to take into account the importance of eliminating the risk of infringement of intellectual property rights. The aim. The study of the foreign practice of compounding pharmacies in terms of infringement of exclusive rights, as well as the position of foreign patent offices and the World Intellectual Property Organization (WIPO). Materials and methods. A key aspect of the research was the study of the foreign practice of violating the exclusive rights to original medicines. An information search was conducted for publications related to the activities of compounding pharmacies in the world, as well as issues related to the regulation of the relationship between their activities and legislation in the field of intellectual property. Results. The article analyzes foreign judicial practices and positions of patent offices, summarized by WIPO, on this issue. The results and discussion are based on the consideration of foreign court cases and legislative norms related to the production of patented drugs in compounding pharmacies. The examples of court cases that raise issues of violations of exclusive rights are given. Conclusion. In Russia, the possibility of one-time compounding of drugs using the invention in pharmacies according to doctors’ prescriptions is fixed at the legislative level. However, this permission only applies to a “specific recipe”. One possible way to reduce the severity of the problem may be to directly allow pharmacies to use contractors to fulfill a specific request. The concept of “one-time compounding” also requires disclosure, which may expand the capabilities of pharmacies. The results obtained can be used in the framework of legislative regulation of the compounding of medicines in a pharmacy.