Protection and ownership of research results

Abstract

Introduction. This article aims to present the rules concerning the protection and ownership of the results of scientific research and development works and related know-how, including those jointly generated in multicentre research projects. Material and methods. The analysis focuses on the identification of types of medical research results and the possibility of protecting them under intellectual property law, including copyright, patent and unfair competition law. It also con­siders regulations providing provisions on the ownership and commercialisation of R&D results acquired under research programmes, projects and sponsored research, including clinical trials. Results. The lack of protection of research results as such by intellectual property rights, the different nature of those results, as well as potential conflicts of interests that arise from the exploitation of data which has both scientific and market value, may in practice cause problems in regard to who is entitled to them and what are the rules for their use and publication. Situations of conflict may arise at the interface between the interests of the different actors involved in conducting and financing research (researchers, research centres, sponsors). Conclusion. Effective management of research and development results requires identification of the appropriate regime (statutory, project or contractual) under which they were obtained and are going to be exploited. Although the rules in force for the acquisition of rights can only be modified contractually to a certain extent, it is strongly recommended to supplement them with detailed contractual provisions specifying the rules for the co-ownership of results, the rights and obligations of the entities involved in the research, as well as ensuring confidentiality and restrictions on their disclosure with and/or without the consent of co-authors and sponsors financing research.