Construction of an efficient and balanced patent system: patentability and patent scope of isolated DNA sequences under US Patent Act and EU Biotech Directive

Abstract

European countries started their efforts to develop an efficient and balanced patent system in the 1970s. Regarding harmonization of procedural and substantive aspects of patent granting, the signing of the European Patent Convention (‘EPC’)1 in Munich in 1973 marked the beginning of these efforts, and the Convention entered into force in 1977. This process continued under the leadership of the European Patent Office (‘EPO’), in refinement of examination guidelines and its own case law. In parallel with these efforts, the European Union (‘EU’) expanded its interests in patent systems, and published green papers and proposals for furthering the harmonization of patentability and patent scope of inventions in particular technology fields through EU directives. Inventions in these technology fields include computer programs and biotechnology because patentability of these inventions is most controversial for important public policies competing with the patent public policy for promoting these inventions. The EU made an attempt to enact a directive for computer software inventions by publishing a proposal. This attempt failed because the EU was unable to find a compromise between different industry sectors representing competing interests after an extensive debate on whether patent protection promotes or hinders innovations. For biotechnological inventions, the EU was successful in enacting the Biotechnology Directive (‘Biotech Directive’). However, texts of the Biotech Directive represent compromises and thus include a lot of ambiguity in key terms defining the scope of protection. This led to different interpretations adopted by national courts in EU member states. Further, patent owners need to file multiple suits with national courts to enforce national patents resulting from the same European patent because the enforcement of European patents has not been uniform, which may lead to different results of patent validity and infringement for the same European patent against the same defendant. To remove the non-uniformity in interpretation and inefficient parallel litigations, the EU is working to develop a uniform patent enforcement system.