Biotechnology patenting caught between Union law and EPC law: European bundle patents, unitary patents and intentional harmonization of decisions in the internal market

Although in the European Union (the Union) the substantive rules for the patenting of biotechnological inventions are governed by Directive 98/44, the actual examination and grant of patents in Europe is provided by the European Patent Office (EPO), which is not part of the Union legal order and acts according to a non-Union legal instrument, the European Patent Convention (EPC). This hybrid situation results in legal uncertainty and can lead to partly inconsistent applications of patentability requirements, since the EPO is not bound to Union law and cannot refer questions to the Court of Justice of the EU (CJEU). Thus, there is no guarantee that the Union and Unified Patent Court (UPC) judiciaries, on the one hand, and the EPO judiciaries, on the other hand, will come to comparable conclusions regarding the patenting of identical biotechnological subject-matter in the Union, irrespective of whether it concerns a classic European patent or a unitary patent. However, the unitary patent is introduced in the framework of fostering the functioning of the internal market and ensuring undistorted competition, and it provides uniform protection. The CJEU has given a very limited interpretation only to this concept of uniformity, leaving room for inconsistent decisions. Hence, it would appear that only intentional, determined harmonization efforts of the diverse judiciaries involved can increase consistency between decisions of the Union and the non-Union legal systems, although the judiciaries are unrelated. This call for coherency becomes even more pressing with the establishment of the unitary patent. Given this complex situation it may be questioned whether in the Union the law-makers of Directive 98/44 can fully achieve their aim in regulating and harmonizing biotechnology patenting.