The European Patent Office (EPO) has stayed all examination and opposition proceedings relating to plants and animals obtained by essentially biological processes. This pause will give the EPO time to consider a Notice of the European Commission relating to the relevant provisions of Biotech Directive (98/44/EC). Search proceedings are not affected.
The Enlarged Board of Appeal (EBA) has previously held in the Broccoli II (G2/13) and Tomatoes II (G2/12) decisions of March 2015 that Article 53(b) EPC excludes from patentability essentially biological processes for the production of a plant or animal but that the plant or animal produced by this process may be patentable. It was decided, in effect, that the exclusion was directed to the process, not the products of that process as exclusions under the EPC must be interpreted narrowly. Our previous article discusses this in more detail.
On 3 November 2016, the European Commission adopted a Notice on the corresponding articles of the Biotech Directive which correspond to these exclusions and how it considers the Directive should be applied. The Commission disagrees with the EBA’s position on this subject matter and believes that the preparatory work by the EU Parliament should be taken into account. In particular, the Notice quotes the Parliament’s report:
‘Essentially biological procedures’, i.e. crossing and selection of the whole genome […] do not meet the general conditions for patentability, as they are neither inventive nor reproducible. Breeding is a reiterative process, in which a genetically stable end-product with the required characteristics is attained only after much crossing and selection. This process is so strongly marked by the individuality of the initial and intermediate material that an identical result will not be obtained upon its repetition. Patent protection is not appropriate for such procedures and their products.
(Explanatory statement to the ROTHLEY report, 25 June 1997 (A4-0222/97), p. 38, footnote 5)(emphasis added)
The Notice raises a further argument that certain provisions of the Directive are only consistent if the products of essentially biological processes are excluded from patentability, in particular Articles 3(2) and 4 of the Directive. These articles of the Directive dictate the patentability of biological material, and plant and animal varieties under EU law.
As such, the Commission concludes that it was the legislator’s intent when adopting the Biotech Directive to exclude from patentability products of essentially biological processes. However, this Notice has no binding effect. “Only the Court of Justice of the European Union is competent to interpret EU law” and the Notice is officially intended only to assist in the application of the Directive. In any case, the EPO is not an EU institution and is not subject to the Commission.
Nonetheless, it is evident that the EPO is taking the time to consider the Commission’s position carefully. The EPO notice confirming the stay of proceedings, states that EPO examination practice is under discussion with the representatives of the member states of the European Patent Organisation, presumably via the Administrative Council.
For now, on applications relating to this subject matter, the Examining and Opposition divisions will withdraw communications setting deadlines for applicants to respond. No further communications will issue for these applications until proceedings are permitted to resume.
The full release from the EPO can be read at www.epo.org/news-issues/news/2016/20161212.html.