RELATION BETWEEN THE PATENT LAW SYSTEM AND THE REGULATORY LEGISLATION WITH REGARD TO STEM CELL RESEARCH

Abstract: The focus of this thesis is the analysis of the relation of the patent law legislation and the regulatory law covering all types of stem cells. In the first part all types of stem cells are identified and a variety of issues connected to several types of stem cell is addressed in subsequent parts. Nevertheless, due to the controversy of the ES cells and in particular the human ones, the major part of the thesis discuses and analyses a regulation and case law relating to human ES stem cells. In order to analyse the relationship, the thesis focuses on the prerequisites in the morality clause of the patent law and identifies basic types of regulatory systems. Other conditions of the patentability are therefore not discussed by the thesis and the third part covering patent law focuses exclusively on the role of morality clause and the question of a scope of subject matter to be evaluated in respect to inventions relating to stem cells. In order to cover and analyse the relationship, the author finds crucial to analyse the morality clause in Article 53 (a) EPC, Rule 28 EPC and Article 6 Biotech Directive to get a more comprehensive understanding of the topic and therefore the harmonized legislation of patent law morality exclusions in Europe is the key part of the thesis. Conversely, as the regulatory legislation is harmonized at neither international level nor European one, a brief overview of national regulatory systems is presented in the part 4 of the thesis. However, due to wide range of approaches differing significantly among the countries only common characteristics of basic approaches are presented without the necessity to cover national legislations in details. An exception is made in respect to the regulatory legislation of the Czech Republic which is presented as a model example of one the approaches in order to provide a practical example of the relation of the patent law and the regulatory law.