On May 14th, 2020, the Enlarged Board of Appeal (EBoA) at the European Patent Office issued its decision G3/19 clarifying the controverted question around the patentability of plants and animals obtained exclusively by essentially biological processes.
In its decision, the EBoA held that plants and animals exclusively obtained by essentially biological processes are not patentable.
Thus, the EBoA corrects its previously adopted position in decisions G2/12 and G2/13 (“Broccoli / Tomatoes II”) and rules that Article 53(b) of the European Patent Convention (EPC) is to be interpreted, pursuant to new Rule 28(2) of EPC Implementing Regulations, in the sense that it excludes from patentability not only essentially biological processes for the obtention of plants and animals, mentioned in Article 53(b), but also plants and animals obtained exclusively by such processes.
In the above-mentioned decisions G2/12 and G2/13, the EBoA had interpreted that the exclusion of patentability of essentially biological processes for the obtention of plants and animals according to Article 53(b) EPC did not extend to products exclusively obtained by such processes.
This change of interpretation of Article 53(b) has been caused by a series of regulatory and case-law issues:
- In its decisions G2/12 and G2/13 (“Broccoli / Tomatoes II”), dated 25.03.2020, the EBoA interpreted that under Article 53(b) EPC, essentially biological processes for the obtention of plants and animals were excluded from patentability, but plants and animals obtained by such processes were not. According to this interpretation, plants and animals obtained exclusively by essentially biological processes could be claimed in a European patent under the EPC.
- This interpretation of the EBoA was criticized in the political spheres of the European Union and led to a non-binding statement from the European Commission (EC) at the request of the European Parliament. In a note published on the 08.11.2016, the EC stated that the intention of the legislator in adopting Directive 98/44/EC (from which Article 4 has an equivalent content to Article 53(b) EPC) was to exclude from patentability plants and animals, as well as parts thereof, exclusively obtained by essentially biological processes.
- The Administrative Council of the EPO introduced then a new Rule 28(2) in the EPC Implementing Regulations. Rule 28(2) is an interpretation of Article 53(b) EPC and establishes that 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. The new Rule 28(2) entered into force on the 01.07.2017. The introduction of this new rule was criticized in some legal spheres, as it implied indeed a modification of the EPC, by interpretative means and through the Implementing Regulations, when it should have been carried out as an EPC modification by the member States.
- Following that, on the 15.12.2018, a Technical Board of Appeals of the EPO (decision T 1063/18; “Pepper”) held that the new Rule 28(2) conflicted with Article 53(b) EPC and, therefore, the interpretation of said Article held by the EBoA in its decisions G2/12 and G2/13 (“Broccoli”; “Tomatoes II”) should prevail.
- This situation led the President of the EPO to refer again the matter to the EBoA, originating the recently announced decision G3/19. As previously mentioned, in its opinion the EBoA modifies the interpretation of Article 53(b) EPC previously held in decisions G2/12 and G2/13 (“Broccoli”; “Tomatoes II”) and, with the new interpretation held in G3/19, excludes from patentability plants and animals exclusively obtained by essentially biological processes, in line with the EC statement about the Directive 98/44/E.
The EBoA decision in G3/19 establishes that the new interpretation of Article 53(b) has no retroactive effects on European patents granted before 07.01.2017 and that contain claims referring to plants or animals exclusively obtained by essentially biological processes, nor on European patent applications filed before said date. Therefore, these European patents granted or filed before that date will be valid and it will not be possible to revoke them before the EPO on the basis of the new interpretation of Article 53(b) EPC.
However, the question whether granted European patents could be invalidated by national Courts of the European Union member States that have incorporated in their legislation the provisions of the Directive 99/44/EC, including the exclusion from patentability of plant and animal varieties and of essentially biological processes for the production of plants and animals, remains.
In Spain, this exclusion is included in Article 5, points 2 and 3 of the National Patent Law, and can be a ground for patent invalidity. In addition, the Court of Justice of the European Union could as well take a stand on this matter, in the event that a request for a preliminary ruling on the interpretation of the Directive 98/44/EC was formulated.
Links of interest:
- Press communiqué of the EPO dated 14.05.2020:
- EBoA Opinion G3/19: