Features of Patent Protection in the Pharmaceutical Sphere: Russian and Foreign Experience

The pharmaceutical sector, in the context of the peculiarities of intellectual property protection, is most in demand by patent holders and is well‑developed from a legal perspective, holding significant social importance for innovative drug provision. In patent law in Russia and abroad, special exceptions have been made for inventions used in medicinal products. At the same time, patent law and legal regulation of the circulation of medicinal products mainly exist in parallel, addressing different tasks, which raises many questions. This issue is global in nature and has been reflected in many foreign regulatory acts, which deserve attention when considering the modernization of domestic legislation. The article discusses aspects of the pharmaceutical market that need to be taken into account in the legal regulation of patent protection. Moreover, it specifies the main features of exclusive rights related to medicines. Special attention is paid to the introduction expediency of various variations of patent linkage in the Russian legal system. According to the author, the most appropriate and sufficient option is the “soft” patient linkage. The application of the Bolar’s Provision has been considered and it has been concluded that it is available to supplement the Civil Code of the Russian Federation with appropriate specific norms. It is also proposed to introduce in the Russian legal system the legal institute of state regulation of generics with the deferred introduction of them into civil circulation.