3. Patentability of biological inventions

In its opinion G 3/19 (OJ 2020, A119), the Enlarged Board began by analysing the scope and focus of the referral and held that the two issues underlying it were interlinked and could be combined in the following single question: "Taking into account developments that occurred after a decision by the Enlarged Board of Appeal giving an interpretation of the scope of the exception to patentability of essentially biological processes for the production of plants or animals in Article 53(b) EPC, could this exception have a negative effect on the allowability of product claims or 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 feature define an essentially biological process?" Considering Art. 53(b) EPC on its own, i.e. without reference to R. 28(2) EPC, the Enlarged Board confirmed its earlier decisions in cases G 1/98 (OJ 2000, 111), G 2/07 (OJ 2012, 130) and G 1/08 (OJ 2012, 206), and G 2/12 (OJ 2016, 27) and G 2/13 (OJ 2016, 28). Furthermore, the Enlarged Board did not find any subsequent agreement or practice within the meaning of Art. 31(3)(a) and (b) Vienna Convention regarding its earlier interpretation. The Enlarged Board held that the application of the various methods of interpretation provided for in Art. 31 and 32 Vienna Convention, also taking into account the subsequent developments in the Contracting States, did not lead to the finding that the term "essentially biological processes for the production of plants" in Art. 53(b) EPC was to be read clearly and unambiguously as extending to products defined or obtained by such processes. It therefore endorsed the respective conclusions that it had come to in G 2/12. At the same time, however, the Enlarged Board acknowledged that Art. 53(b) EPC did not prohibit this broader understanding of the process exclusion either. Furthermore, the Enlarged Board recognised that, with the introduction of R. 28(2) EPC, the legal and factual situation underlying decision G 2/12 had substantially changed. This amendment constituted a new aspect that had arisen since the EPC was signed which could give reason to believe that a grammatical, and restrictive, interpretation of the wording of Art. 53(b) EPC conflicted with the legislator's aims, whereas a dynamic interpretation could bring a result that diverged from the wording of the law. The Enlarged Board held that the exclusion of products exclusively obtained by means of an essentially biological process was not incompatible with the wording of Art. 53(b) EPC, which did not rule out this broader construction of the term "essentially biological processes for the production of plants or animals". The Enlarged Board concluded that, in view of the clear legislative intent of the Contracting States as represented in the Administrative Council and having regard to Art. 31(4) Vienna Convention, the introduction of R. 28(2) EPC allowed and indeed called for a dynamic interpretation of Art. 53(b) EPC. Accordingly, the Enlarged Board abandoned the interpretation of Art. 53(b) EPC given in decision G 2/12 and, in the light of R. 28(2) EPC, held that the term "essentially biological processes for the production of plants or animals" in Art. 53(b) EPC was to be understood and applied as extending to products exclusively obtained by means of an essentially biological process or if the claimed process feature defined an essentially biological process. In conclusion, the Enlarged Board of Appeal answered the referral as follows: "Taking into account developments after decisions G 2/12 (OJ 2016, 27) and G 2/13 (OJ 2016, 28) 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.

In T 1063/18 the board decided that R. 28(2) EPC was in conflict with Art. 53(b) EPC, as interpreted by the Enlarged Board of Appeal in decisions G 2/12 (OJ EPO 2016, 27) and G 2/13 (OJ EPO 2016, 28). In accordance with Art. 164(2) EPC, the provisions of the Convention prevailed. The Enlarged Board in G 2/12 and G 2/13 had stated that applying the various methodical lines of interpretation to Art. 53(b) EPC pointed towards not extending the scope of the process exclusion to a product claim or product-by-process claim directed to plants or plant material. As secondary considerations, the Enlarged Board had also considered whether a dynamic interpretation of Art. 53(b) EPC was warranted and whether allowing the patentability of such a product claim rendered the exception to patentability of essentially biological processes for the production of plants meaningless. The Enlarged Board concluded that there was no legal justification for altering the understanding of Art. 53(b) EPC achieved by applying traditional means of interpretation. In the light of G 2/12 and G 2/13, the board did not agree with the reasoning of the examining division in the decision under appeal that R. 28(2) EPC constituted a "clarification of the scope of Article 53(b) EPC". Rather the meaning of this rule was in conflict with the meaning of Art. 53(b) EPC as interpreted by the EBA. While recognising the Administrative Council's power to lay down provisions concerning substantive law in the Implementing Regulations, the board also agreed with the finding in G 2/07 (OJ EPO 2012, 130) that the limits to the Administrative Council's law-making powers by means of the Implementing Regulations can be inferred from Art. 164(2) EPC. Moreover, the board concurred with the finding in T 39/93 (OJ EPO 1997, 134) that the meaning of an article of the EPC, on its true interpretation as established by a ruling of the Enlarged Board of Appeal, cannot be overturned by a newly drafted rule of the Implementing Regulations, the effect of which is to conflict with this interpretation. The interpretation of the Biotech Directive as put forward in the Notice of the European Commission on certain articles of Directive 98/44/EC was not seen as a relevant development because it had not been confirmed in a legally binding way. Considering whether an interpretation of Art. 53(b) EPC, different from that given in decisions G 2/12 and G 2/13, was necessary in view of Art. 31(3)(a) of the Vienna Convention on the Law of Treaties, the board concluded that neither the decision of the Administrative Council to adopt R. 28(2) EPC nor the Notice of the European Commission could be regarded as a subsequent agreement between the parties in the sense of the Vienna Convention.