LEGAL REGULATION OF THE PROTECTION OF RIGHTS TO BIOTECHNOLOGICAL INVENTIONS: UKRAINIAN AND EUROPEAN EXPERIENCE

Abstract

The article examines the specific features of the legal regulation of the protection of rights to biotechnological inventions in Ukraine and the European Union. The relevance of the topic is determined by the rapid development of biotechnology and its growing importance for medicine, pharmaceuticals, agriculture and other socially significant areas. Biotechnological inventions combine the features of technical solutions with the specific properties of biological material capable of self-reproduction, modification and functioning within biological systems. This complicates the determination of the scope of patent protection, the establishment of infringement, and the application of traditional judicial remedies. The purpose of the article is to identify the specific features of the protection of rights to biotechnological inventions by analyzing the legal nature of such objects, the provisions of Ukrainian and European Union legislation, as well as the case law of the Court of Justice of the European Union. The article substantiates that the specificity of protecting rights to biotechnological inventions is determined not by the need to create a separate legal regime, but by the characteristics of the object of patent protection itself. Unlike most traditional technical objects, biological material is not static and therefore requires an adapted approach to determining the scope of the patent holder’s exclusive rights and the conditions for their exercise. Particular attention is paid to Directive 98/44/EC on the legal protection of biotechnological inventions, which establishes special approaches to determining the scope of patent protection for biological material. The article also analyses the case law of the Court of Justice of the European Union, in particular Monsanto Technology LLC v. Cefetra BV and Others, in which a functional approach to the protection of genetic information was formulated. It is established that the mere physical presence of a genetic sequence in the relevant material is not sufficient to conclude that patent rights have been infringed; the decisive factor is whether such sequence performs the function for which it was patented. The article demonstrates that the specificity of protecting rights to biotechnological inventions is manifested primarily not in the list of substantive legal remedies, but in the mechanism of their implementation. General remedies for the protection of intellectual property rights may be applied to biotechnological inventions; however, their effectiveness depends on proper evidentiary procedures, the use of specialized knowledge, forensic examination and the preservation of biological evidence. It is concluded that Ukrainian legislation provides a general legal framework for the protection of such rights, but requires further development taking into account European approaches to determining the scope of patent protection, proving infringement and forming consistent judicial practice.