G3/19: Essentially biological processes excluded from patentability
Posted in | Jul 24, 2020
The EPO has announced a decision has been made by the Enlarged Board of Appeal in the G3/19 referral. Following our earlier article on the referral, we now take a look at the decision itself.
The G3/19 referral was the latest development in an ongoing saga regarding the patentability of inventions relating to plants and animals.
Article 53 of the European Patent Convention (EPC) explicitly excludes “plant or animal varieties or essentially biological processes for the production of plants or animals”.
Rule 28 (2) EPC (introduced in 2017) adds a further restriction, stating ‘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’.
This rule was introduced in response to the Enlarged Board decisions G2/12 and G2/13, which decided that the products obtained from essentially biological processes were, in principle, patentable.
Article 164 EPC provides for other documents, including the Implementing Regulations (i.e. the Rules) to create legislation to govern the EPO. Article 164 (2) EPC states that the text of the EPC (i.e. the Articles) take precedence in case there are conflicts between the pieces of legislation.
This referral was made by the President of the EPO, in order to clarify the EPO’s position on this matter. There referral asks two questions:
1. 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?
2. 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?
The Enlarged Board considered the first question above to be too broad, and that answering the question as referred may provide for the Administrative Council (who set the Rules) to circumvent the usual procedure for changing the interpretation of the Articles of the EPC itself, simply by changing and/or amending the Rules. The Enlarged Board thus considered that it would not be suitable to answer this question.
Accordingly, the Enlarged Board re-phrased the question as follows:
Taking into account developments that occurred after a decision by the EBA giving an interpretation of the scope of the exception to patentability of essentially biological processes for the production of plants or animals in Article 53(b) EPC, could this exception have a negative effect on the allowability of product claims or product-by-process claims directed to plants, plant material or animals, if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process feature define an essentially biological process?
The rephrased question narrows down into the issue at hand, in that there are two previous Enlarged Board decisions, and a Rule introduced after the decisions which seems to overrule the decisions, and exclude products and product-by-process claims directed to plants, plant material or animals, if the claimed product is exclusively obtained by means of an essentially biological process.
The Enlarged Board found that the rephrased referral was admissible (without commenting on the admissibility of the original referral), and gave a decision on this matter, as described below.
The opinion of the Enlarged Board, confirms that the introduction of the new Rule 28(2) EPC can serve to change the interpretation of Article 53(b) EPC, despite the fact the Article itself has not been amended - and so products exclusively obtained by essentially biological processes are deemed to be excluded from patentability.
This decision seemingly puts an end to the long running saga relating to essentially biological processes and their patentability, with the introduction of legal certainty that products exclusively obtained by essentially biological processes are not patentable at the EPO.
What this means
This decision appears to be the final nail in the coffin regarding the patentability of products obtained by essentially biological means. This may provide a significant blow to many companies involved in the agriculture sector.
Further, the Enlarged Board’s decision to reformulate the referral of its own volition and then subsequently give an opinion that sides with the Administrative Council, may be seen as bowing to internal pressure form the EPO itself. Given that many commentators outside the EPO expected the referral to be found inadmissible or for the Enlarged Board to side against the Administrative Council, this decision could raise some questions about the independence of the Enlarged Board.
In practice, this decision means any applications filed on or after 1 July 2017 (when the above-mentioned Rule 28(2) came into force) will no longer be allowable if they claim products obtained by essentially biological processes. Importantly, this does not apply to applications filed before the above date.
As always, we shall keep you informed of any further referrals to or decisions from the Enlarged Board of Appeals. If you have any questions regarding this referral, please contact us to speak to one of our patent attorneys.