On 29 June 2017, the EPO amended Rules 27-b) and 28(2) of the European Patent Convention (EPC) with respect to patentable biotechnological inventions and their exceptions. The EPO thus follows the earlier opinion of the European Commission (EC) expressed in Notice 2016/C 411/03 regarding the patentability of plants or animals obtained by essentially biological processes, and now specifically excludes products obtained by essentially biological processes from patentability.
Essentially biological processes for the production of plants or animals are defined by Article 2(2) of Directive 98/44/EC on the legal protection of biotechnological inventions (the Biotech Directive) as processes that “consist entirely of natural phenomena such as crossing or selection” and are excluded from patentability under Article 4 of the Biotech Directive and Article 53(b) EPC.
With respect to products obtained by such processes, however, in March 2015, the EPO’s Enlarged Board of Appeal ruled that such products are not excluded from patentability (see G2/12 and G2/13). Briefly, the Board considered that there was no evidence in the preliminary works of the EPC that the meaning of “essentially biological processes for the production of plants” should be extended to encompass products defined or obtained by such processes. The Board also considered that extending the exclusion to plants or their parts would introduce an inconsistency in the EPC as such products (other than plant varieties which should be protected by a plant variety certificate) are generally patentable subject-matter. Further, for both product or product-by-process claims, the relevant point of law, in the Board’s opinion, was whether subject-matter is excluded from patentability and not the protection conferred by the claims. Following these decisions, some countries such as France have modified their legislation to specify that products obtained by essentially biological processes were not patentable subject-matter.
These decisions drew the attention of the European Parliament, which in December 2015 asked the European Commission to draft an opinion on the patentability of such products. In the meantime, all the pending examination and opposition proceedings regarding plants or animals obtained by essentially biological processes have been stayed by the EPO.
In its Notice of November 2016, the EC took a position opposite to the view of the EPO. In a nutshell, the EC considered that the EU legislator’s intention underlying the adoption of the Biotech Directive was to exclude products (plants, animals or their parts) obtained by means of essentially biological processes from patentability as well. More specifically, the EC considered that, despite the fact that products obtained by essentially biological processes were not explicitly excluded in the Biotech Directive, such exclusion could logically be derived from the fact that products obtained by a non-technical process could not be considered as technical in themselves and hence could not be considered as an invention (i.e. a technical solution to a technical problem). In addition, recital 32 of the Biotech Directive explicitly excludes the patentability of a new plant variety obtained by genetic modification – hence a technical process – of a particular plant variety. Following this reasoning, the EC drew the conclusion that the legislator’s intention was indeed to exclude products obtained by non-technical methods from patentability.
Despite the EPO being independent from the EU and therefore not bound by the opinions of the EC, the Administrative Council decided to amend Rules 27 and 28 EPC accordingly. Consequently, the EPC now explicitly excludes products (plants, animals or their parts) obtained by essentially biological processes from patentability.
What may change for you: The new rules entered into force on 1 July 2017. The previously stayed proceedings will be resumed and the new rules will apply to pending cases. It is quite difficult to foresee how these new provisions will be applied in practice by the Examiners or the technical Boards of Appeal.
However, patents or patent applications covering plants obtained by breeding and selection, even with the help of a genetic marker, should now be rejected by the EPO. This concerns a large part of vegetable seeds and to a lesser extent, field seeds. To the contrary, GMOs should still be considered as patentable subject-matter. Regarding future patent applications, the description and drafting of the claims should make clear that the products are not obtained by such processes. In case of litigation, the fate of granted patents remains uncertain…