Insights: EPO Stays Cases Related to Products of Essentially Biological Processes

The EPO has announced that cases will be stayed if they depend entirely on the question of whether products of essentially biological processes are patentable. Relevant cases will be those in which the subject-matter of the invention is a plant or animal obtained by an essentially biological process.

The patentability in Europe of essentially biological processes and their products is governed in EU member states by the EU “Biotech Directive” (Directive 98/44/EC); the Biotech Directive is also applied by the EPO following its incorporation into the EPC. The stay follows a Notice from the European Commission holding that the Biotech Directive was drafted with the intention to exclude from patentability plants or animals obtained by an essentially biological process.

The Notice is not binding on EU member states but may be persuasive when the provisions of the Biotech Directive are interpreted at a national level. Whilst the EPO itself is not bound by EU legislation, it seeks to align its practice with that of the EPC contracting states, the majority of which are EU member states. However, the interpretation set out in the Notice is at odds with the interpretation of the same issue set out by the EPO in Enlarged Board decisions Broccoli II and Tomato II (reported here).

The stay has therefore been put in place to allow time to resolve this disparity and for discussions to take place on how the Notice should affect EPO examination practices. The outcome will likely depend on what approach, if any, is agreed by EPC contracting states.

If a case is to be stayed, the EPO will inform relevant parties to the examination/opposition proceedings and withdraw any pending time limits for reply or action.