The Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) has held that plants, plant material and animals will be excluded from patentability if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process features defines an essentially biological process.
The extent to which biotechnological inventions are patentable is set out in the Biotechnology Directive (98/44/EC) (the Directive) as implemented into national law. European patents can be granted for microbiological processes and products but not for plant or animal varieties or essentially biological processes for the production of plants or animals (Article 53(b), European Patent Convention) (EPC) (Article 53(b))).
In Tomatoes/Broccoli II, the EBA held that, in light of all appropriate considerations, including the Directive, the term "essentially biological processes for the production of plants" in Article 53(b) should not be interpreted as excluding plants or plant products from patentability (G 2/12 and G 2/13). In response, the European Commission issued a notice in 2016 (2016 notice) stating that the Directive was intended to exclude from patentability products obtained by means of essentially biological processes although the European Court of Justice had not yet ruled on the exception to patentability in respect of animals, plants or plant materials obtained by an essentially biological process. The 2016 notice was not legally binding but was intended to reduce the risk of divergent legal interpretations and promote the harmonised application and implementation of EU law.
In 2017, the Administrative Council of the EPO introduced a new Implementing Regulation stating that, under Article 53(b), European patents cannot be granted in respect of plants or animals exclusively obtained by means of an essentially biological process (Rule 28(2)).
In New pepper plants and fruits with improved nutritional value/Syngenta Participations AG, the EPO appeal board held that Rule 28(2) was inconsistent with the interpretation of Article 53(b) in Tomatoes/Broccoli II (T 1063/18).
S applied for a European patent for a pepper plant.
The Technical Board of Appeal (TBA) held that Rule 28(2) was void because of its incompatibility with Article 53(b) as interpreted in Tomatoes/Broccoli II.
The President of the EPO referred questions of interpretation of Article 53(b) to the EBA.
The EBA acknowledged that the meaning of Article 53(b) is unclear. Although accepting the decision reached