The Enlarged Board of Appeal of the EPO has decided that products obtained exclusively by an essentially biological process are not patentable
The Enlarged Board of Appeal (EBoA) of the European Patent Office (EPO) has published the decision of case G3 / 19 (text here) on the patentability, under the European Patent Convention (EPC) of plants or animals obtained exclusively by means of an essentially biological process.
The conclusion is that such products are not patentable under the EPC. This decision harmonises the patentability requirements before the European Patent Office with the national legislation of several of the Contracting States in this technical field.
This resolves the controversy between:
- the previous decisions G2 / 12 and G2 / 13, in which the Enlarged Board of Appeal of the EPO accepted the patentability of the products,
- the initiatives of the European Union, the Administrative Council of the EPO and some EPC member states opposed to the patentability of such products.
What are the products obtained by an essentially biological process?
It must be remembered that an essentially biological process for the production of plants or animals is a method that involves the steps of crossing and selection without genetic manipulation, even in cases where these steps are supported by human intervention through technical means.
Two patents examples are:
- Broccoli: EP1069819. Describes a technical selection step using molecular genetic markers of broccoli plants with a high concentration of certain anticancer compounds.
- Tomato: EP1211926. Describes a technical step of tomato selection with a lower proportion of water by calculating the percentage of dry weight.
In relation to the methods described in these patents, the Enlarged Board of Appeal of the EPO interpreted that a procedure that includes the crossing and selection steps is considered to be an essentially biological method even though it includes a technical step, as occurs in the cases G 1/08 (tomato I) and G 2/07 (broccoli I).
Once it was decided that their methods were not patentable, the holders of the broccoli and tomato patents continued to litigate, so that at least the patentability of the products obtained by these methods were recognised because the exclusion of patentability (art 53 (b) EPC) refers to the methods, but it does not mention the products resulting from these methods. These actions were presented again before the EPO’s Enlarged Board of Appeal, with cases G2/12 (tomato II) and G2/13 (broccoli II). On 25 March 2015, in a consolidated decision of these cases, the EBoA concluded that, although essentially biological processes per se were excluded from patentability, the products obtained through these procedures could indeed be patented.
A situation of legal uncertainty
The decision adopted for cases G2/12 (tomato II) and G2/13 (broccoli II) implied an interpretation of Article 53(b) EPC that allowed the patentability of products obtained through essentially biological processes.
However, this position was not shared by several of the EPC Contracting States or by the institutions of the European Union. These actors forced the implementation from 1 July 2017 of the new Rule 28(2) EPC by the Administrative Council of the European Patent Organisation (EPOrg) to expressly exclude the patentability of plants or animals obtained exclusively by means of an essentially biological process. The new rule offered an interpretation of Article 53(b) EPC that was contrary to that of the EBoA and was intended to nullify the decisions of G2/12 (tomato II) and G2/13 (broccoli II).
The conflict was particularly evident in decision T1063/18 (peppers) of 5 December 2018, when the Board of Appeal interpreted that, in the event of a conflict between an Article and a Rule of the EPC, the Article should prevail as established in Article 164(2) EPC and declared Rule 28(2) EPC promoted by the Administrative Council of the EPO as null and void. This case clearly referred to the prevalence of the Article according to its interpretation by the EBoA.
This situation had raised doubts about which interpretation should prevail and an evident problem of legal uncertainty for users of the patent system in this technical area. It had also raised questions about the independence of the EPO’s Boards of Appeal, and their adaptation to political developments in the patent system.
Decision without retroactive effect
On 14 May 2020, decision G3/19 of the Enlarged Board of Appeal was published, where the Board reaffirms and validates its previous conclusions in cases G2/12 (tomato II) and G2/13 (broccoli II) in accordance with the means of interpretation available at the time of making those decisions.
However, it understands that legal developments subsequent to those decisions (for example, the adoption of Rule 28(2) EPC), which clarify the intention of the legislator, must be taken into account. Their consideration allows the adoption of a dynamic interpretation of Article 53(b) EPC, in the sense that its meaning may change over time. It is an important change in the jurisprudence of the EPO’s Boards of Appeal, which opens the door to changes in the jurisprudence based on political or social considerations and adaptation to a changing environment.
The EBoA has also decided that this new interpretation of Article 53(b) EPC in G3/19 has no retroactive effect. As a result European patents granted before 1 July 2017 (date of implementation of Rule 28(2) EPC) and patent applications with a filing date or priority date prior to 1 July 2017 will not be affected.
Protection of innovation
In view of this decision G3/19, inventors in this technical field will have to consider alternative strategies that allow them to obtain adequate protection for their innovation. In certain cases it may be appropriate to request protection titles for specific plant varieties, while in other situations the best strategy may be to implement appropriate measures to guarantee trade secrets.
Finally, it should not be forgotten that, although the methods considered to be essentially biological or the products derived from these methods cannot be patented, technologies associated with these methods or these products may be patentable.