Essentially biological processes and their products – what is patentable?

The first half of Article 53(b) of the European Patent Convention (EPC) states that essentially biological processes (EBPs) for the production of plants or animals are an exception to patent protection.

This small provision (which implements Art 4 of the Biotechnology Directive) has been the surprising source of conflict between the EU Commission and the Enlarged Board of the EPO about whether the products of EBPs are themselves patentable, as explained below:

Essentially biological processes

A process is an EBP "if it consists entirely of natural phenomena such as crossing or selection" (Rule 26(5) EPC). EBPs do not, therefore, include genetic manipulation or the production of transgenic animals through chromosomal incorporation.

In consolidated cases Broccoli/PLANT BIOSCIENCE G 2/07 and Tomatoes/STATE OF ISRAEL G 1/08, the Enlarged Board holds EBPs within the meaning of Article 53(b) EPC to include a non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants.

Such a process does not escape exclusion merely because it contains a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants.

Products of essentially biological processes

On 3 November 2016, the European Commission adopted Notice 2016/C 411/03, relating to the Art 4 Biotechnology Directive, stating its view that animals and plants derived from EBPs should also not be patentable.

Previously, there had been differing views between the EPO and the EU on the interpretation of Articles 53(b) of the EPC, regarding the patentability of EBPs and their products. The EU had stated that both processes and products are not patentable and the Enlarged Board concluded in joined cases G2/12 (Tomatoes II, which concerned a method for breeding tomatoes having reduced water content, and the product of the method) and G2/13 (Broccoli II, which concerned a method for selective increase of the anticarcinogenic glucosinolates in brassica species), that the resultant animal or plants of an EBP may be patented even though the process may not.

Further to the Commission Notice, however, the EPO published its own notice on 29 June 2017 stating that, for patent applications filed on or after 1 July 2017, it would exclude from patentability applications for plants and animals exclusively obtained by an essentially biological breeding process. The EPO says in its notice that while the Biotechnology Directive excluded EBPs from patentability it did not provide for a clear exclusion for plants or animals obtained from such processes.

It was now clarified in the Commission Notice, the EPO explained, that the European legislator's intention is to exclude not only these processes but also the products obtained by them. As a result, Rule 28 EPC was amended by addition of paragraph (2) to clarify that the exclusion applies to plants or animals exclusively obtained by means of an essentially biological process.

A further twist

Subsequently, however, in a further twist, the Technical Board of Appeal has held in T 1063/18 that Rule 28(2) is incompatible with Articles 53(b) EPC as interpreted by the Enlarged Board. The board saw no reason to deviate from that interpretation. The Technical Board concluded that the provisions of the EPC would prevail.

It remains to be seen whether further decisions of the Technical Boards of Appeal will follow the authority of G2/12 and G2/13, or the amended Rule 28. A decision of the Enlarged Board is now needed to settle the matter at the EPO, but it is also possible that a national court could refer the issue to the Court of Justice of the European Union if the opportunity arises. A conflict between EPC and European Union law could, therefore, continue.

This is an extract from A Practitioner's Guide to European Patent Law, to be published later in 2019, by Paul England and with contributions from Sara Burghart, Judith Krens and François Pochart.