Supplementary protection of intellectual property rights for medicines

Abstract

The article discusses the issue of extending the legal protection of intellectual property rights for medicines. The research aims to provide a comprehensive overview of the problems related to the implementation of Supplementary Protection Certificates (SPCs) in national legislation and possible solutions. The study also seeks to draw conclusions and make proposals for improving the regulatory framework for the SPCs of medicines. The work utilizes general scientific and specialized methods of scientific cognition, including dialectical, formal-logical, systemic-structural, comparative legal, as well as modeling, analysis, and synthesis methods, which collectively contributed to the organization, planning, and conduct of the research. The study is based on scientific publications from databases and search systems (PubMed, JAMA, Scopus, Springer, BMC, Oxford Academic), international and national regulatory acts, statistical studies by international organizations (Precedence Research), patents for inventions related to medicines, recommendations by national government bodies, as well as prescriptions and guidelines from international and national experts. Considering the analysis of statistical data on the development and implementation of medicines, it has been determined that original biological medicines are a major factor in the rising prices of treating conditions such as diabetes, oncological diseases, and others. Examples of patents for medicines owned by global pharmaceutical companies (Gilead, Bayer Intellectual Property Gmbh, etc.) that have ensured their commercial success and competitive advantages are examined. It has been established that patent protection provides the right holder with the opportunity to maintain a monopoly in the market, thereby compensating for the time spent on the development and research of original medicinal products. Legislative approaches to regulating relationships concerning the supplementary protection of inventions related to medicines in the form of SPCs in Ukraine and the EU are identified. The exclusivity periods for regulatory data protection for medicines in the EU are outlined. Based on the conducted research, it is concluded that the application of the SPC mechanism is a tool to achieve a balance between the protection of intellectual property rights and access to original medicines. Timely entry of generics and biosimilars to the market contributes to reducing market prices but negatively impacts the profitability of manufacturers of original medicines. Attention is drawn to problematic aspects of the legislative implementation of the SPC mechanism in Ukraine, which leads to incorrect interpretation and implementation of relevant provisions and necessitates updating. In light of the aforementioned, there is an urgent need in Ukraine to implement, update, and improve the legislative mechanism for regulating SPCs.