H. O. Androshchuk — PhD in Economics, Associate Professor
L. I. Rabotiahova — Leading Researcher
PROBLEMS OF PATENTING INVENTIONS IN THE PHARMACEUTICAL INDUSTRY: THE ECONOMIC AND LEGAL ASPECT (Part I)
Abstract. An economic and legal analysis of the state and development trends of patenting inventions in the pharmaceutical industry has been carried out. Analyzed the dynamics of investment in research and development in the pharmaceutical industry in the US and the EU, the cost of developing new drugs and their profitability. The innovative cycle of creating a medicinal product at the stages of preclinical and clinical trials, the effectiveness of inventive activity in the pharmaceutical industry has been investigated. The practice of introducing additional protection evidence in the EU has been studied. Considered in detail the regulatory framework and the practice of regulating the extension of the term of a patent in the United States. The growing importance of generic drugs is shown, ensuring a balance of competing interests between promoting medical innovation and providing access to them, which are the main focus of public policy makers, health activists and the private sector. It is emphasized that the foreign practice of extending the additional term of a patent for medicines to five years in developing countries leads to additional costs from national health budgets and adversely affects patients’ access to medicines.
Keywords: invention, generic, medicinal products, national security, patent, innovations, additional protection certificate, pharmaceuticals.