The Impact of Broccoli II & Tomato II on European Patents in Conventional Breeding, GMO's and Synthetic Biology: The Grand Finale of a Juicy Patents Tale?
Biotechnology Law Report, Vol. 34, No. 3 (2015), pp. 81-98
24 Pages Posted: 19 May 2015 Last revised: 30 Jul 2017
Date Written: May 19, 2015
On 25 March 2015, the Enlarged Board of Appeal of the European Patent Office (EBA) finally delivered its’ much awaited decisions on the consolidated referrals G2/12 (“Tomato II”) and G2/13 (“Broccoli II”). The EBA affirmed that products, namely plants or parts thereof, obtained by essentially biological processes are – unlike individual plant varieties – principally patentable under the European Patent Convention (EPC). This decision leaves considerable leeway for patenting novel and inventive plants and products thereof, which have been produced by “conventional” methods including breeding steps. The EBA has also clarified that this applies irrespective of if such claims are formulated in a product-by-process format or as a per se product . Moreover, the combined effect of Broccoli & Tomato I & II opens new opportunities for patenting GMOs - provided that all other patent criteria are also met. This generally appears to be "good news" for innovative plant breeders and agrochemical companies. However, caveat needs to be added: Major industry players had challenged the relevant patent-claims and the EBA's decision(s) remain very controversial. It is, for example, very uncertain how the CJEU would decide if confronted with similar issues in the context of national implementations of the Biotech Directive, which have taken a very different view than the EBA. Moreover, the fierce European opposition against genetically modified organisms (GMOs) and Synthetic Biology remains a major challenge to the industry, research and innovation in an increasingly significant area of science and debate.
Post scriptum (!) : After completion of this paper, the European Commission expressed that it did not share the opinion of the EPO’s Enlarged Board of Appeal (cf. the Interpretative Notice from November 2016). Like several EU member states, such as France, Germany, Italy and Netherlands, the Commission found that under the EU Biotech Directive products obtained by essentially biological processes should not receive patent protection. This intervention by the Commission, the divergences between the interpretation of the EPC and the Biotech Directive, and the need for legal certainty and harmonization, led the EPO to stay ex officio all the proceedings in which the decision depended entirely on the patentability of a plant or animal obtained by an essentially biological process. Then, on June 29, 2017, the Administrative Council of the EPO decided to amend Rules 27 and 28 of the Implementing Regulation. According to these amendments products (animals or plants) obtained exclusively from essentially biological process are now effectively excluded from patentability. Notwithstanding that this contradicts the earlier decisions by the Enlarged Board of Appeal, these amendments apply to European patent applications filed on or after July 1, 2017, as well as to European patent applications and European patents pending at that time.
Keywords: Biotechnology, Patents, Plant Science, European Patent Office, GMOs, Synthetic Biology, Conventional breeding methods, essentially biological processes, agricultural industry, CRISPR, unitary patent
Suggested Citation: Suggested Citation