First published in AIPLA’s Biotech Buzz newsletter, Barbara Fleck explains the Enlarged Board of Appeal’s controversial decision.
The Enlarged Board of Appeal (EBA) has ruled that plants or animals produced by an essentially biological process are not patentable in Decision G3/19 of 20 May 2020, a conclusion that goes against earlier Decisions in G2/131 and G2/121.
The Decision does not apply to European patents granted before 1 July 2017 or European patent applications which were filed before that date and are still pending.
This matter was a referral by the President of the European Patent Office (EPO), based on earlier Decision T1063/18 by the Technical Board of Appeal on EP2753168 in the name of Syngenta Participations AG. EP2753168 included claims to cultivated pepper plants and was originally refused by the Examining Division in April 2018 as failing to comply with the exceptions to patentability set out in the European Patent Convention (EPC) under Article 53(b) and Rule 28(2).
To obtain a European Patent, inventions must satisfy the requirements of patentability set forth by the articles and rules of the EPC. Article 53(b) states that European patents shall not be granted in respect of “plant or animal varieties or essentially biological processes for the production of plants or animals”. Additionally, the Directive 98/44/EC on the legal protection of biotechnological inventions provides a supplementary means of interpretation when considering the EPO’s rules regarding biological inventions.
In the key decisions G2/13 and G2/12 of March 2015 (commonly referred to as Tomatoes II and Broccoli II), the EBA held that claims to products derived from an essentially biological process are allowable as long as the other criteria for patentability are fulfilled. The EBA held that this was the case even if the process used to obtain the products (i.e. selecting and crossing the plants) was essentially biological and thus in itself not patentable as set out under Art. 53(b). The main rationale for the decision was that exclusions from the general principle of patentability have to be narrowly interpreted in law. Therefore, the exclusion of claims directed to an essentially biological process for the production of plants did not extend to products derived therefrom.
However, the European Parliament viewed these decisions as potentially in conflict with the legal protection provided to plant varieties under EU plant variety right legislation. Thus, the European Commission was asked to look into the matter. The Commission concluded that the intention for Directive 98/44/EC had been to exclude products that are obtained by means of essentially biological processes from patentability, and that Tomatoes II and Broccoli II were contrary to this intention.
The Administrative Council of the European Patent Organisation (the “AC”) therefore amended Rules 27 and 28 EPC which entered into force on 1 July 2017. New paragraph 2 of Rule 28 stipulates 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”.
Notably, the exclusion as set out in amended Rule 28 reflects national law in some countries across Europe, including Germany and the Netherlands.
Given the amendment of Rule 28, the Examining Division refused application EP2753168 in April 2018. However, in the Appeal proceedings, the Board concluded that recently amended Rule 28(2) was in direct conflict with Article 53(b) as earlier interpreted by the EBA in G 2/12 and G 2/13, and thus de facto void. In view of this legal uncertaintly, the President of the EPO referred the following questions to the EBA:
- Having regard to Article 164(2) EPC, can the meaning and scope of Article 53 EPC be clarified in the Implementing Regulations to the EPC without this clarification being a priori limited by the interpretation of said Article given in an earlier decision of the Boards of Appeal or the Enlarged Board of Appeal?
- If the answer to question 1 is yes, is the exclusion from patentability of plants and animals exclusively obtained by means of an essentially biological process pursuant to Rule 28(2) EPC in conformity with Article 53(b) EPC which neither explicitly excludes nor explicitly allows said subject-matter?
There are two matters at the heart of the G3/19. The first concerns a general point, namely the competence of the AC to provide an interpretation of the EPC by introducing or amending implementing Rules which contradict the Articles of the EPC. The second relates to the proper interpretation of Article 53(b) EPC and whether plants or animals produced by an essentially biological process are patentable.
Unsurprisingly, the referral attracted significant interest. Third party observations were submitted by over 40 parties, including industry and trade organisations, the EU Commission, national governments, national Patent and Trademark Offices and the UK’s Chartered Institute of Patent Attorneys (CIPA).
The Board decided that wording of question 1 was “too general and unspecific in that it broaches an institutional topic which reaches well beyond the ultimate object of the referral. According to the Board, the scenario presented in the first question would, if followed to its logical conclusion, effectively give the AC 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 therefor rephrased both questions “to reflect the referral’s true object”, namely proper interpretation of Article 53(b) EPC. In doing so, the EBA effectively avoided having to fully consider whether it was appropriate for the AC to make the change to amend Rule 28.
Holding that that plants or animals produced by an essentially biological process are excluded from patentability, the EBA abandoned the interpretation of Article 53(b) EPC given in G2/12 and G2/13. The EBA argued that this change in position was in line with a “dynamic interpretation Article 53(b) EPC” in the sense that the meaning of Article 53(b) may change over time, depending on new developments – in this case, the introduction of Rule 28 (2) by the AC.
There is no doubt many will see this Decision as hugely controversial. However, the Decision should at least bring certainty for innovators in the agritech field. While farmers and breeders who consider that patents on plants obtained from conventional breeding methods will hinder their activities may welcome the Decision, many innovators will be disappointed by the U-turn of the EBA.
It is worth noting that whilst the EBA ruled that plants or animals produced by an essentially biological process are not patentable, it is also clear that not all plant related inventions will be affected by this Decision. Claims to transgenic plants as well as plants modified by genome editing should remain patentable.