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 in Tomatoes/Broccoli II, the EBA noted that the interpretation of the EPC is dynamic, and subject to change over time in light of developments to the legal and factual situation which were unknown at the time the decision was issued or irrelevant to the case, or were otherwise not taken into consideration.
Although Article 53(b) has in the past been properly construed as excluding only essentially biological processes from patentability, Article 53(b) is written in such a way that it is possible to interpret it more broadly as also excluding products of essentially biological processes from patentability. The introduction of Rule 28(2) substantially changed the legal and factual situation underlying Tomatoes/Broccoli II. By implementing Rule 28(2), it was clearly the intention of the contracting states to the EPC that Article 53(b) should be read as excluding products of essentially biological processes, and because Rule 28(2) was not fundamentally incompatible with Article 53(b), the interpretation reached in Tomatoes/Broccoli II should be abandoned in favour of a new, broader interpretation which aligns with Rule 28(2) and the 2016 notice.
The EBA rejected the argument that, under principles of the rule of law, legislative decisions on matters of fundamental or essential importance are reserved to the legislature and cannot be made by administrative bodies using regulations. A rule agreed to by the vast majority of the member states of the EPC which altered an EBA interpretation of the EPC was not contrary to the rule of law. By consenting to Rule 28(2), and the alignment of many contracting states' national provisions to the content of the rule, there was a clear indication of legislative intent to change the interpretation of Article 53(b) and to exclude from patentability plant and animal products obtained by an essentially biological process.
This changed approach by the EBA will only affect patent applications with a priority or application date on or after 1 July 2017, the date on which Rule 28(2) came into force. Patent applications for products derived from essentially biological processes with priority or application dates before 1 July 2017 will continue to be approved by the EPO, as they are in accordance with the law as it stood following the Tomatoes/Broccoli II opinion. As the exclusion will not be retrospective, it is unclear how many of the more than 250 pending cases mentioned in the reference will be adversely affected.
Case: Pepper G 0003/19.
First published in the July 2020 issue of PLC Magazine and reproduced with the kind permission of the publishers. Subscription enquiries 020 7202 1200.