Taking into account developments after decisions G 2/12 and G 2/13 of the Enlarged Board of Appeal, the exception to patentability of essentially biological processes for the production of plants or animals in Article 53(b) EPC has a negative effect on the allowability of product claims and product-by-process claims directed to 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. This negative effect does not apply to European patents granted before 1 July 2017 and European patent applications which were filed before that date and are still pending.

 In G 3/19, under Art. 112(1)(b) EPC the President of the EPO referred the following points of law to the Enlarged Board of Appeal: 1. Having regard to Art. 164(2) EPC, can the meaning and scope of Art. 53 EPC be clarified in the Implementing Regulations to the EPC without this clarification being a priori limited by the interpretation of said Article given in an earlier decision of the Boards of Appeal or the Enlarged Board of Appeal? 2. If the answer to question 1 is yes, is the exclusion from patentability of plants and animals exclusively obtained by means of an essentially biological process pursuant to R. 28(2) EPC in conformity with Art. 53(b) EPC which neither explicitly excludes nor explicitly allows said subject-matter? On the admissibility of the referral, the President stated that there is conflicting case law with regard to the way boards of appeal have assessed the EPC rules which implement Art. 53 EPC under Art. 164(2) EPC. In particular, decision T 1063/18, where the board found that R. 28(2) EPC is in conflict with the meaning of Art. 53(b) EPC "as interpreted by the Enlarged Board of Appeal", differed from earlier case law. The President stated that in decision T 1063/18 the board assessed the conformity of R. 28(2) EPC, which implements Art. 53(b) EPC, in relation to an interpretation of said article in an earlier decision of the Enlarged Board of Appeal. The board thus equated law, i.e. "provisions of this Convention" within the meaning of Art. 164(2) EPC, with case law, i.e. the interpretation of Art. 53(b) EPC in an earlier decision of the Enlarged Board of Appeal. This approach differs from other decisions, such as T 315/03 (OJ EPO 2006, 15), T 272/95 (OJ EPO 1999, 590), G 2/07 (OJ EPO 2012, 130). The President argued that question 1 should be answered in the affirmative, since pursuant to Art. 33(1)(c) EPC the Administrative Council is competent to amend the Implementing Regulations to the EPC. This competence covers the possibility to implement the articles of the Convention – including those related to substantive patentability requirements – by interpreting and clarifying their meaning and scope. Furthermore, Art. 164(2) EPC does not provide a basis to a priori exclude the Administrative Council's interpretation and implementation of Art. 53 EPC, because it deviates from an earlier interpretation of the Enlarged Board of Appeal. The Administrative Council is limited only by the hierarchy of laws laid down in Art. 164(2) EPC. In other words, the applicability of a rule adopted by the Administrative Council is limited to the extent that it conflicts with an article of the Convention. However, under Art. 164(2) EPC the Administrative Council's power is not limited by an interpretation of the article in question in an earlier decision of the Enlarged Board of Appeal. This approach finds confirmation in decisions T 315/03, T 272/95, T 666/05 and T 1213/05. The President argued that question 2 should also be answered in the affirmative, since having regard to Art. 164(2) EPC, R. 28(2) EPC is in conformity with Art. 53(b) EPC. In decisions G 2/12 (OJ EPO 2016, 27) and G 2/13 (OJ EPO 2016, 28) the Enlarged Board did not conclude or even imply that Art. 53(b) EPC itself explicitly acknowledges the patentability of plants (or plant material such as fruit) exclusively generated by an essentially biological process. It was only by reference to R. 27 EPC that the Enlarged Board considered that Art. 53(b) EPC was to be interpreted on account of a "rather wide notion of the patentability of biotechnological inventions concerning plant-related processes and products other than plant varieties". As concerns Art. 53(b) EPC itself, the Enlarged Board acknowledged that it is open to different interpretations. R. 28(2) EPC is a permissible clarification of the meaning and scope of Art. 53(b) EPC. It is also in conformity with Art. 53(b) EPC which neither explicitly, nor when interpreted in accordance with established principles, precludes its application to plants and animals exclusively obtained by means of an essentially biological process via an implementing rule. Furthermore, legislative intent is one element to be taken into account in the interpretation of a provision and the EPC legislator's intention was to interpret Art. 53(b) EPC in line with the EU Biotechnology Directive. It should also be taken into account that since the European Commission Notice was published in November 2016, all 38 contracting states of the European Patent Convention have declared that under their national law and practice the products (plants and animals) of essentially biological processes are excluded from patentability. These considerations further support the conclusion that, having regard to Art. 164(2) EPC, R. 28(2) EPC is in conformity with Art. 53(b) EPC. Opinion G 3/19 was issued on 14 May 2020, see Annex 3.