Patenty na drugie medyczne zastosowanie – niekończąca się historia wątpliwości i kontrowersji

Abstract

The notion of “second or further medical use” encompasses inventions whose the subject-matter is new medical use of a known product (substance). It means that the product as such, as well as its other medical use, are a part of the state-of-the-art. In our times patent protection of this kind of inventions is common but the concept and model of this protection are differentiated. They mainly depend on whether it is allowed or banned to patent medical procedures (medical methods). The article concerns the patent protection of the second medical use under European patent system, i.e. the system based on EPC and on national patent systems of the countries which are the parties to this Convention. In all these systems, patenting medical methods is banned. The aim of the article is to present the process of establishing the model of patent protection of the second medical use in these systems, and to discuss some of the main hesitations and controversies resulting from this model. They mainly concern the question of compliance of this model with the rules and concepts of patent protection which until recently seemed indisputable.The subject matter and purpose of this kind of inventions evoked also additional questions and problems. In particular, the discrepancy between the patent protection of these inventions and the system of reimbursement of pharmaceuticals, which is common in the countries-EPC parties, is clearly visible. The analysis leads to the conclusion that the apparent difficulties in protecting such patents illustrate the negative consequences of treating legal instruments as tools for achieving specific objectives, but operating in a legal and economic vacuum.