Commission Notice on products of essentially biological processes

January 2017

On 3 November 2016, the European Commission adopted Notice 2016/C 411/03, on certain articles of the Biotech Directive 98/44/EC, stating its view that animals and plants derived from essentially biological processes (EBP) should not be patentable.

Previously, there has been differing views between the EPO and the EU on the interpretation of Articles 53(b) and 54(3) of the EPC and Art 4(2) of the Biotech Directive, regards the patentability of EBP and the products thereof. The EU stating both the processes and products are not patentable and the Enlarged Board of the EPO, in the cases G2/12 and G2/13, concluding that the resultant animal or plants of an EBP may be patentable despite the process not being so.

On 12 December 2016, the EPO announced that it had stayed all examination and opposition proceedings relating to plants and animals obtained by an EBP, pending the Commission's Notice. The Notice makes plain that it is only providing guidance as to the application of the Directive and, in any event, its decision is not binding upon the EPO or the EU. Nevertheless, in practice the EPO does apply the Biotech Directive and, as seen in Case C-34/10, decisions of the CJEU are certainly persuasive, and although the Commission's Notice does not have the same force as a CJEU decision, it clearly warrants consideration.

Following the Notice, the EPO has stated that its contracting states are currently discussing what effect the decision should have. This is presumably in the forum of the Administrative Council, which has the power to amend the Implementing Regulations of the EPC and thereby effectively override the decisions in G2/12 and G3/12. No timescale has been given for a decision, however, the EPO has, with immediate effect, suspended all examination and opposition proceedings relating to the subject; searches will continue unaffected.

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The EPO agrees with the Commission to exclude products of essentially biological processes from patentability

Jemma Emmerson


Jemma is a paralegal in the Patents group based in London.

"contracting states are currently discussing what effect the decision should have"