The EPO has clarified its approach to the patentability of plants and animals by making changes to its rules.
Article 53(b) EPC derives from an EU Directive (Article 4(1) of Directive 98/44 EC) and excludes from patentability “essentially biological processes for the production of plants or animals”. According to the EPO’s Enlarged Board of Appeal, this excludes from patentability any process that contains the steps of sexually crossing the whole genomes of plants and then selecting the desired progeny plants. However, the Enlarged Board concluded in decisions G 2/12 and G 2/13 that the exclusion only applies to process claims, and not to the plants that are produced by those processes. Until recently, the EPO had followed this practice during examination and in post-grant oppositions.
In November 2016, the EU Commission adopted a notice stating that the legislator’s intention when drafting the EU Directive was to exclude from patentability the products (including plants, animals and parts of plants and animals such as seeds) that have been produced by the essentially biological processes, as well as the processes themselves.
Although the EPO is not bound by the findings of the EU, and the EU Commission notice is not legally binding on EU member states, the President of the EPO decided to stay proceedings on all pending EPO cases in this area until this issue had been clarified.
After much discussion, the EPO has decided to change its rules to align with the interpretation of the EU Commission, rather than that of the EPO’s Enlarged Board of Appeal. New Rule 28(2) EPC states that “under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process”. This new Rule entered into force on 1 July 2017. It is described by the EPO as a clarifying interpretation of the existing law. As such, the new Rule applies to pending European applications and European patents, as well as to applications filed on or after that date.
The EPO is expected to issue further guidance on the scope and meaning of this Rule in the next revision to its Guidelines for Examination later this year. If the EPO follows the reasoning of the EU Commission notice, then it is likely that transgenic plants and animals, and plants or animals obtained by technical mutagenesis (e.g. CRISPR, TALEN, ZFN) will still be patentable in Europe, but that plants or animals that are produced by natural crossing, and selected on the basis of particular markers, traits or characteristics, will no longer be patentable.