Directive 98/44/EC and the European Patent Convention: challenges to the harmonization of biotechnology patenting in Europe

Abstract Biotechnology patenting in Europe is governed by two separate legal bodies. The European Union (EU), by means of Directive 98/44/EC, has set the rules for the patentability of biotechnological subject matter, while the European Patent Convention (EPC) regulates the actual grant of European patents. The EU has no control over the intergovernmental EPC, since the Convention is outside of the EU legal order. In practice, the two systems are not always aligned and interactions between the systems can be unpredictable. EU rules pertaining to biotechnology patenting were taken over verbatim in subordinate secondary legislation to the EPC, not primary legislation. It may be questioned whether this step was helpful in attempting to harmonize biotechnology patenting in Europe. In practice, the rules in this secondary legislation can be completely ignored—or they can be duly taken into account. It is also possible that secondary legislation to the EPC is used to overrule a decision in the field of biotechnology patenting by the highest judiciary in the EPC system. The introduction of the Unitary Patent and Unified Patent Court is an important new initiative by the EU. However, it does not fundamentally change the relationship between the EU and the EPC legal systems. Consequently, it does not change the existing situation regarding biotechnology patenting, since the actual granting procedure of European patents remains outside of the competence of the EU.