The major advances in the identification of the human genome that took place from the early 1990s onwards triggered a significant increase in the number of patent applications concerning newly discovered human gene sequences that nevertheless failed to disclose the function of the isolated material, and thus did not meet the patent law requirement of industrial application. In order to address this issue the 1998 Directive on the legal protection of biotechnological inventions (Biotech Directive) 1 required patent applicants to disclose the industrial applicability of inventions covering human gene sequences and related proteins at the time of the patent application. Furthermore, the Biotech Directive established functionality-related protection for all types of genetic inventions, thus restricting the scope of protection granted to human genetic inventions to their ability to perform the industrial application disclosed by the applicant. This thesis analyses the implications of the Biotech Directive's approach towards the industrial application of human genes and fragments thereof in respect of three issues: the assessment of the industrial applicability of inventions concerning sequences or partial sequences of human genes; the distinction between discoveries and patentable inventions when the claimed subject matter is human genetic material; and the determination of the scope of protection awarded to patents over genetic information. The thesis argues that the requirement of industrial application can act as an efficient checkpoint for preventing the grant of patents over human genetic discoveries of no practical benefit to society, but also for impeding the issuance of overly broad patents in this field. At the same time, a strict interpretation of this requirement does not imply that patent authorities will systematically overlook the interests of private firms, but it is intended to set a realistic standard that serves to avoid the rise of undue barriers in the pursuit of research and innovation in this industry.

The accumulated importance of the patent law morality exclusion over the recent decades has been prompted by the increased protection sought for biotechnological inventions. This raises specific ethical concerns such as the respect for human dignity. The morality exclusion is regarded as an indispensable safeguard in the patent system of the 21st century, but its application and scope remains unclear, not least due to a division of competence between the European Union (EU), the European Patent Organisation and national Member States. In addition, the international Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) under the auspices of the World Trade Organization (WTO) sets minimum standards for the operation of the morality exclusion. In this study the scope, interpretation and application of the morality exclusion in European and international patent law is described and analysed by applying the legal dogmatic method. The object of study is the European patent law morality exclusion in terms of Article 53(a) and Rule 28 of the European Patent Convention and Article 6 of Directive 98/44/EC on the legal protection of biotechnological inventions. A connected purpose of this study is to describe, problematize and analyse the compliance by the regional rules (EU, European Patent Organisation) with the international framework provided by Article 27.2 of the TRIPS Agreement. Although this study is not limited to specific technologies, the majority of issues raised are done so in relation to the morality exclusion concerning biotechnological inventions, which is reflected in this work. Furthermore, the theoretical framework is dependent on the functioning of the morality exclusion in the respective systems, both regional (EU, European Patent Organisation) and international (WTO). This approach necessitates a consideration of the characteristics of each legal system. This thesis uncovers the differences in the interpretation of the morality exclusion (both within as well as between the legal systems), which causes legal uncertainty in this particularly complex field where patent law and ethics interact. The effects of such variations on the scope and application of the morality exclusion are clarified and critically reviewed. According to the wording of the morality exclusion, the commercial exploitation of an invention with regard to morality or ordre public is a central prerequisite in the assessment of excluded subject matter. Consequently, the interpretation of this particular requirement is subject to critical review, since its implications are decisive for the scope of application of the morality exclusion. It is furthermore questioned whether the European morality exclusions are TRIPS-compliant, and the possible effects (and available remedies) of non-compliance for the EU legal order are analysed. This in turn involves issues of norm conflicts in international and EU law. The author presents a critical analysis, investigates the interaction between legal systems and suggests clarifications in order to attain the optimal functioning of the morality exclusion.