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2 July 2020BiotechnologyAnna Gregson

EPO’s G3/19: no turning back?

In its decision G3/19, issued in May, the European Patent Office’s (EPO) Enlarged Board of Appeal (EBA) held that plants, plant material, and animals exclusively obtained by an essentially biological process are not patentable.

G3/19 is the latest chapter in a 20-year history of the protection of plant-related innovation, beginning with the introduction of the EU Biotech Directive in 1998. Before G3/19, the EBA’s last contribution to this saga was the issuance of the consolidated G2/12 and G2/13 (Tomatoes II and Broccoli II) in March 2015.

In those decisions, the EBA concluded that the exclusion of essentially biological processes for the production of plants in article 53(b) of the European Patent Convention (EPC) did not have a negative effect on the allowability of a product claim directed to plants or plant material. These decisions were not popular in some EPC member states, which led to the EU Commission issuing a guidance notice in November 2016 to the effect that the Biotech Directive excluded such products from patentability.

Despite the non-binding nature of this guidance, in June 2017 the Administrative Council of the European Patent Organisation introduced rule 28(2) EPC, which excludes plants or animals exclusively obtained by means of an essentially biological process from patentability. New rule 28(2) EPC was therefore in direct conflict with the EBA’s interpretation of article 53(b) EPC in G2/12 and G2/13, setting the stage for the EBA’s recent G3/19.

The interplay between rule 28(2) EPC and article 53(b) EPC was first considered by the EPO Boards of Appeal in T1063/18 (Pepper). In this case, the board found that rule 28(2) EPC was in conflict with article 53(b) EPC as interpreted by the EBA in G2/12 and G2/13.

The board also found no reason to deviate from the EBA’s interpretation of article 53(b) EPC, as the provisions of the EPC (ie, the articles) prevail over those of the Implementing Regulations (ie, the rules) in the event of any conflict. The board in T1063/18 deemed it unnecessary to refer a question on the patentability of plants made by essentially biological processes to the EBA, concluding that the EBA had already decided on that point in G2/12 and G2/13.

Subsequently, under pressure from the EPO’s Administrative Council, the president of the EPO, António Campinos, in April 2019 referred a question on the patentability of plants made by essentially biological products to the EBA.

The president’s questions

Campinos referred two questions to the EBA, the first of which asked the EBA to rule on the appropriateness of the introduction of rule 28(2) EPC.

As noted by the EBA in G3/19: “The scenario presented in the first question would, if followed to its logical conclusion, effectively give the Administrative Council, as the authority empowered by the EPC to adopt the Implementing Regulations, a ‘carte blanche’ to deviate from established case law and give a particular meaning to any article of the EPC by means of the rules of the Implementing Regulations.”

The EBA also took issue with the second question, considering it to contain “in thinly disguised form, the answer it seeks”.

The EBA combined and rephrased both questions. This rephrasing of the president’s questions by the EBA is significant because, unlike the original questions, the EBA’s rephrased question does not address whether the introduction of rule 28(2) EPC by the Administrative Council was appropriate. Rather, it considers only whether, having been introduced, new rule 28(2) EPC changes the interpretation of article 53(b) EPC.

Admissibility of the referral

Before turning to consideration of the rephrased question, the EBA considered the admissibility of the president’s referral. The EBA concurred with Campinos that the point of law in question was of fundamental importance—one of the requirements for an admissible referral.

Regarding the second requirement for an admissible referral, the need for conflicting Board of Appeal decisions, the EBA cited T1063/18 (Pepper), where the board held that the Administrative Council could not amend article 53(b) EPC by means of rule 28(2) EPC.

It also cited 2002’s T272/95, in which the board acknowledged that the Administrative Council had amended the implementing regulations to take account of the Biotech Directive, and deemed that a change of interpretation of an article by amendment of these regulations was allowable.

The EBA, therefore, concluded that the president’s referral, in the form of the question as rephrased by the EBA, was admissible.

Interpretation of article 53(b)

The EBA then considered the grammatical, systematic and teleological interpretation of article 53(b) EPC. It concluded that the relevant analysis by the EBA in G2/12 and G2/13 was correct: none of these methods for interpretation leads to the conclusion that the term “essentially biological processes for the production of plants” clearly extends beyond processes to products defined or obtained by such processes.

The EBA also noted that similar legislation in ten of the 38 EPO member states (excluding plants or animals obtained by essentially biological processes from patentability) did not amount to a consensus on the correct interpretation of article 53(b).

So far, the EBA’s reasoning is in line with what interested observers expected, and consistent with its previous decisions. However, the EBA then proceeds to consider a “dynamic” interpretation of article 53(b) EPC in the light of rule 28(2) EPC.

The EBA reasons 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.”

It added: “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.”

The question remains as to whether it was appropriate for the Administrative Council to introduce rule 28(2) EPC in the first place. The EBA reasons that there is no general prohibition on amending the rules in such a way that interpretation of the articles is affected. Moreover, this question was considered irrelevant to the questions as rephrased by the EBA.

Instead, the EBA considers the introduction of rule 28(2) EPC to demonstrate clear legislative intent on the part of the member states to exclude plants produced by essentially biological processes from patentability, and requires the EBA to apply a dynamic interpretation to article 53(b) EPC.

The EBA accordingly abandoned the old interpretation of article 53(B), given in G2/12, and instead adopted a new interpretation in line with the latest rule changes. That means that “essentially biological processes” include products obtained exclusively by those processes.

Where do we go from here?

The EBA’s decision in G3/19 will come as a disappointment to innovators in the agri-tech space. When considered solely in the context of the EBA’s previous rulings on article 53(b) EPC, the latest decision is surprising. But the surprise is perhaps lessened when we consider the significant pressure from the Administrative Council, member states, the president and other political influences to reach this conclusion.

Following this decision, there are some who have questioned whether the EBA can be truly independent, given the immense amount of pressure that can be brought to bear on fundamental and politically sensitive points of law.

While the EBA deliberately rephrased the question in G3/19 to focus on rule 28(2) EPC and article 53(b) EPC, it remains to be seen whether in the future the Administrative Council will feel emboldened to force its preferred interpretation of other articles by amending the rules, without requiring unanimous agreement or a diplomatic conference.

Looking for silver linings, the new interpretation of article 53(b) EPC will apply only to European patents and applications with a filing or priority date before July 1, 2017. Also, the change in practice is not as significant as it may first appear: some member states already have legislation excluding plants made by essentially biological processes, meaning that some innovators already focus on plant variety rights to protect innovations of this type.

The exclusion applies only to plants, plant material and animals exclusively obtained by means of an essentially biological process, and therefore products made by a technical means are, and remain, patentable.

While the apparent inconsistency with the EBA’s final decision with its previous decisions is frustrating, the EBA did at least appear alive to the risk of the Administrative Council forcing through future revisions of the EPC by amendment of the implementing regulations, hence its rephrasing of the president’s questions.

It is to be hoped that, together with the unique political context surrounding the matter of the patentability of plants made by essentially biological processes, this means that the risk of similar “back door” amendments is not as great as first consideration of G3/19 may suggest.

Anna Gregson is a partner in the agri-tech and life sciences teams at Mathys & Squire. She can be contacted at:  algregson@mathys-squire.com

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