The Enlarged Board of Appeal (EBA) has decided in G 3/19 that the term “essentially biological processes for the production of plants or animals” in Article 53(b) EPC is to be understood and applied as extending to products exclusively obtained by means of an essentially biological process or if the claimed process feature defines an essentially biological process, i.e., that European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.
G3/19 is the EBA’s sixth decision which addresses the interpretation of Art. 53(b) EPC:
“European patents shall not be granted in respect of:
(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;”
Article 4 of the Biotech Directive (Directive 98/44/EC) mirrors the wording of Art. 53(b) EPC and addresses the patentability of plants and animals, specifically excluding plant and animal varieties from the scope of patentable subject matter. It also establishes that ‘essentially biological processes for the production of plants and animals’ are not patentable. However, similar to Art. 53(b) EPC, the Biotech Directive does not state whether plants or plant material (fruits, seeds, etc.), or animals/animal material obtained through essentially biological processes, can be patented.
In G 2/12 (Tomatoes II) and G 2/13 (Broccoli II), issued in 2015, the EBA held that the exception to patentability of essentially biological processes for the production of plants in Article 53(b) EPC did not have a negative effect on the allowability of a product claim directed to plants or plant material such as a fruit or plant parts. The fact that the process features of a product-by-process claim directed to plants or plant material other than a plant variety defined an essentially biological process for the production of plants did not render the claim unallowable. Hence, product inventions where the claimed subject-matter is directed to plants or plant material such as a fruit or plant parts other than a plant variety, as such, are not excluded from being patented (see Reasons, point IX.(1)).
In light of these EBA’s decisions, in November 3, 2016, the European Commission adopted a notice clarifying certain articles of Directive 98/44 on the protection of biotechnical inventions (“the EU Commission’s notice”). The Commission took the view that the EU legislator's intention when adopting Directive 98/44/EC was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes. Of note, the EU Commission’s notice is not legally binding but is intended as an internal document aimed at reducing the risk of divergent legal interpretations and promoting the harmonised application and implementation of the law of the EU. Only the Court of Justice of the EU (CJEU) is competent to interpret Union law. To date, no decision concerning the exception to patentability in respect of animals, plants or plant materials obtained by an essentially biological process and the interpretation of Art. 4 of the Biotech Directive has been handed down by the CJEU. Independent of this, the EPO is not directly bound by Union law.
In document CA/56/17, addressed to the Administrative Council of the European Patent Organisation, the President of the EPO proposed that the Implementing Regulations to the EPC be amended to the effect that – in accordance with the interpretation of the Biotech Directive developed in the EU Commission’s notice – plants and animals produced by essentially biological processes be excluded from patentability. In a decision of the Administrative Council of 29 June 2017 (CA/D 6/17), taken on the basis of Art. 33(1)(c) EPC, a new paragraph 2 was added to R. 28 EPC reading:
"(2) Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process."
G3/19 arises from the EPO president’s referral following the Board of Appeal (BoA) decision in T 1063/18 (Pepper). In T 1063/18 the BoA ruled that R. 28(2) EPC is in conflict with Article 53(b) EPC, as interpreted by the Enlarged Board of Appeal in decisions G 2/12 and G 2/13. The BoA argued that the only interpretation of Art. 53(b) EPC from G2/12 and G2/13 is that plants are not excluded from patentability, even if they can only be obtained by an essentially biological process (point 23 of the reasons). In addition, the BoA stated that the Administrative Council is not, in the light of Articles 33(1)(b)and 35(3) EPC, competent to amend the Convention, here Art. 53(b) EPC, by amendment of the Implementing Regulations, here R. 28(2) EPC (point 34 of the reasons), and the BoA considered that it is not necessary to deviate from the interpretation of Art. 53(b) given by the EBA in decision G2/12 and G2/13 (item 38 of the reasons). In accordance with Art. 164(2) EPC, the provisions of the Convention prevail.
In G3/19, the EBA endorses both the conclusions and reasoning of G2/12. However, this is not to say that, with decision G 2/12, the meaning of the exception to patentability under Article 53(b) EPC has been settled once and for all, for it may emerge at a later point that there are aspects or developments which were unknown at the time the decision was issued or irrelevant to the case, or were otherwise not taken into consideration (item XVIII). The EBA argues 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 (item XX). Taking account of the Administrative Council's decision to introduce R. 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 R. 28(2) EPC allowed and indeed called for a dynamic interpretation of Article 53(b) EPC (see EPO’s press communication). The EBA concludes that the understanding of the scope of the exception to patentability under Article 53(b) EPC which the Enlarged Board came to in decision G 2/12 (supra) may still be subject to later developments (item XXI).
In adopting this dynamic interpretation, the Enlarged Board abandoned its earlier interpretation of Art. 53(b) EPC in decisions G 2/12 and G 2/13. It held that, after the introduction of new R. 28(2) EPC, Art. 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.
Of note, the new interpretation of Article 53(b) EPC has no retroactive effect on European patents containing such claims which were granted before 1 July 2017, when Rule 28(2) EPC entered into force, or on pending European patent applications seeking protection for such claims which were filed before that date. For applications, the relevant date is their date of filing or, if priority has been claimed, their priority date (G3/19, item XXIX).