Responding to a question referred to it by the EPO’s President, the Enlarged Board of Appeal of the European Patent Office has issued its opinion in relation to what was perhaps the most controversial referral of 2019. In a complete reversal of its opinion of just five years ago, the EPO has held that plants and animal products produced by essentially biological (natural) processes are not patentable.
In 2015, the Enlarged Board of Appeal of the EPO held that although non-microbiological processes for the production of plants which are “essentially biological” cannot be patented (Art 53 EPC), the products derived from using essentially biological processes could be patentable (G2/12; G2/13, also referred to as Broccoli/ Tomatoes II).
Following these decisions, the European Parliament asked the European Commission to review the patentability of plants and animals derived from essentially biological processes. This resulted in a European Commission Notice dated 8 November 2016 clarifying that the EU legislator had intended to exclude such plants and animals (either in whole or in part) from patentability when adopting the EU Directive on biotechnological inventions (Directive 98/44/EC). The Administrative Council of the EPO therefore amended Rule 28(2) EPC to state that, from 1 July 2017, the EPO will no longer grant patents for plants and animals exclusively obtained by means of an “essentially biological process”. Further background and the legal framework regarding patents for plants and animals exclusively obtained by means of an “essentially biological process” is set out in our previous update, here.
Following this rule change, Case T 1063/18 (Pepper), concerning the patentability of Syngenta’s application for a pepper plant, came before the Technical Board of Appeal, who found that amended Rule 28(2) EPC was in conflict with Article 53(b) EPC, as interpreted by the EBA in G 2/12 (Broccoli/Tomato II). Since Article 164(2) EPC states that the Articles shall prevail over the Rules, the TBA concluded that it had to apply G 2/12 (Broccoli/Tomato II) and that the change to the Rules was void. This decision was not referred to the EBA since, the TBA stated that the “EBA has given an interpretation of Article 53(b) EPC from which the board sees no reason to deviate”.
Nonetheless, following a meeting with the Administrative Council, the EPO’s President (António Campinos) referred the question of the patentability of plants produced by essential biological processes to the EBA.
Opinion of the EBA
Having found the referral from the President admissible, the EBA abandoned its earlier interpretation of Article 53(b) EPC in decisions G 2/12 (Broccoli/Tomato II), instead endorsing the interpretation that, after the introduction of new Rule 28(2) EPC, Article 53(b) EPC was to be interpreted to exclude from patentability plants, plant material or animals, if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process features define an essentially biological process. The EBA referred to this change of position as being as a result of a “dynamic interpretation” of Article 53(b) EPC, explaining in its press release:
“On the merits of the referral, the Enlarged Board endorsed its earlier findings on the scope of Article 53(b) EPC, which were based on the classical (i.e. the grammatical, systematic, teleological and historical) methods of interpretation. However, the Enlarged Board found that a particular interpretation which has been given to a legal provision can never be taken as carved in stone, because the meaning of the provision may change or evolve over time. This meant that decisions G 2/12 and G 2/13 did not settle the meaning of Article 53(b) EPC once and for all.
Taking account of the Administrative Council’s decision to introduce Rule 28(2) EPC, the preparatory work on this provision and the circumstances of its adoption, as well as legislative developments in the EPC contracting states, the Enlarged Board concluded that new Rule 28(2) EPC allowed and indeed called for a dynamic interpretation of Article 53(b) EPC.”
This opinion will not have a retroactive effect on patents or patent applications granted or filed before Rule 28(2) EPC came into effect (1 July 2017).
This volte-face by the EBA has come as something of a surprise to practitioners, a number of whom has thought that the EBA would find the President’s referral inadmissible, since there was no divergent case law on which to base it. Some will fear that there has been a strong amount of political interference in considering and amending the questions raised and finding, despite past case decisions, an outcome in alignment with the Commission’s viewpoint. This fails to recognise that the EPO is not an EU Community institution, but an intergovernmental organisation, with many, but not exclusively EU Member States (including Switzerland, Turkey and now the UK).
Many stakeholders in the agribio sphere, as well as other holders of patent applications stayed during prosecution pending outcome of this referral, will be disappointed by this outcome. However, those who say that improving seed quality using conventional breeding techniques should not be patentable as a matter of principle will welcome this decision. The decision will impact potentially investment in R&D, in particular, in the agri sector and again reopen the debate over the hostility of parts of Europe towards biotech crops.