Author: James Legg
30 June, 2017
The EPO has announced that its Administrative Council has taken the decision to amend the relevant Regulations in order to exclude from patentability “plants and animals exclusively obtained by an essentially biological breeding process”. The new provisions will apply from 1 July 2017.
By way of background, in November 2016 the European Commission issued a Notice relating to certain articles of the EU “Biotech Directive” (Directive 98/44/EC). The Biotech Directive, which is incorporated into the EPC, excludes from patentability essentially biological processes for the production of plants or animals but does not exclude products obtained by such processes. Moreover, in 2015 the EPO’s Enlarged Board of Appeal in G2/13 and G2/12 (Broccoli II and Tomato II) held that plant products produced by “essentially biological processes” (for example, sexual crossing) are patent eligible even if the only method available at the filing date for generating the plant product is such a process (reported here).
Notwithstanding the guidance provided by the EPO’s Enlarged Board of Appeal, the Notice issued by the European Commission indicated that the Biotech Directive was drafted with the intention to exclude from patentability plants and animals obtained by “essentially biological processes”. Following the issuance of the Notice, the EPO announced in December 2016 the decision to stay all proceedings in which the invention is a plant or animal obtained by “essentially biological processes” (reported here).
During the period of the stay many third parties provided submissions to the EPO on the legality of the stay itself and on whether the European Commission’s Notice should influence the law applied by the EPO. These included position papers submitted by the Chartered Institute of Patent Attorneys (CIPA) and the UK BioIndustry Association (BIA). These parties and others submitted that the stay in proceedings was inappropriate and that the EPO should continue to follow the guidance provided by the Enlarged Board of Appeal in Broccoli II and Tomato II.
The third party submissions also highlighted the importance of patents for genetically-modified plants and animals. It is difficult to know how broadly the term “essentially biological breeding process” will be applied. For example, consider knock-out mice that provide valuable cancer models for testing candidate therapeutics. These mice are often generated by using a well-established knock-out method on a cell or embryo, followed by a series of breeding steps to generate a chimera, then a heterozygote and finally a homozygote. Will the knock-out step be sufficient to avoid the new exception to patentability?
Despite these submissions, the decision announced by the EPO indicates that “plants and animals exclusively obtained by an essentially biological breeding process” will be excluded from patentability from 1 July. In addition, the cases that have been stayed will be resumed and examined according to the new practice. The reference in the announcement to “the relevant Regulations” suggests that a change will be made to the Implementing Regulations of the EPC. However, as noted in the position paper submitted by CIPA, this would arguably be in conflict with Article 52(1) EPC and, in the case of such a conflict, the EPC makes it clear that the relevant article takes precedence. Therefore, far from “providing more clarity and legal certainty for users of the European patent system” as suggested by the EPO, it seems that this latest decision will cause considerable uncertainty for both patent proprietors and third parties. Accordingly, this is unlikely to be the end of the story. We will provide further updates as and when available.