Patentability of products of biological processes
23 December 2016
In our December patent newsletter [see note 1 below] we reported the publication of a notice from the European Commission on its interpretation of certain aspects of the so-called 'Biotech Directive' (Directive 98/44/EC). A conclusion of the notice was inter alia that under Article 4 of the Biotech Directive, there should be an exclusion to patentability of both essentially biological processes and the products derived from such processes.
The notice ran contrary to the decisions by the Enlarged Board of Appeal at the European Patent Office (EPO), G 2/12 (Broccoli II) and G 2/13 (Tomatoes II). We had tentatively suggested that on the face of such a notice, there was no immediate reason for the EPO to change its stance. The EPO is independent from the European Union (EU) and is thus not under its direct jurisdiction (though decisions from the European Courts have sometimes been decisive in changing EPO practice, for example, in the Brüstle v Greenpeace decision [see note 2 below] relating to stem cells).
EPO stays "essentially biological process" case examination and oral proceedings
On 12 December 2016, the EPO announced [see note 3 below] that all examination and opposition proceedings in cases which related to a plant or animal obtained by an "essentially biological process" would be stayed. There does not appear to be any suggestion of how long the stay is expected to last, though there is a statement suggesting that the EPO will somehow implement the interpretation of the Biotech Directive given by the European Commission if the EPO member states follow said interpretation.
This announcement is possibly as surprising as the G 2/12 and G 2/13 decisions themselves, given that there is no provision in the European Patent Convention (EPC) for proceedings to be stayed in the event of any action from an EU body. What is clear is that the EPO is now reviewing, through the Administrative Council, changes to the EPC which could alter the Broccoli and Tomatoes decisions, perhaps by implementing limited breeder's exceptions to the law. What is clear is that the "legal certainty" for patentees and third parties provided by G 2/12 and G2/13 is now once again in doubt.