G3/19: Are essentially biological processes patentable?
Posted in | Aug 27, 2019
This series of articles considers referrals pending before the Enlarged Board of Appeal of the European Patent Office (EPO). Whilst the outcome of these referrals may be some months or years away, the opinions issued by the Enlarged Board of Appeal may fundamentally change the way the law is interpreted. In this article, we look at referral G3/19.
G3/19, a referral to the Enlarged Board made in April 2019, deals with a long running issue regarding the patentability of inventions relating to plants and animals.
Article 53 of the European Patent Convention (EPC) provides exclusions to patentable subject matter. This Article explicitly excludes “plant or animal varieties or essentially biological processes for the production of plants or animals” in Art. 53(b) EPC.
Rule 28 (2) EPC (introduced in 2017) also deals with this, 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’. The new Rule has the effect of preventing patents claiming plants or animals per se, if the plant or animal is produced solely by means of an essentially biological process (e.g. conventional plant or animal breeding).
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.
Referrals were made to the Enlarged Board of Appeal regarding the apparent contradiction between Art 53(b) - which only specifically prevents claiming essentially biological processes, not plants or animals produced by those processes – and Rule 28(2).
Consequently, in G2/12 and G2/13, it was ruled that using essentially biological processes to create a plant, plants material or plant parts, “does not have a negative effect on allowability” of a claim to a plant made by an essentially biological process. The Enlarged Board decided that as ‘the only method available at the filing date’ of creating the claimed subject matter was an ‘essentially biological process’, the claim was allowable.
These decisions meant that when considering plant or animal related inventions in which plants or animals are claimed per se, Rule 28(2) EPC should be ignored in favour or Art 53(b) EPC, in line with the provisions of Art. 164 EPC.
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?
This question asks whether it is possible to clarify the exclusion to patentability in Art. 53 EPC in the Rules, without the taking into account the G decisions discussed above. If the Enlarged board decides this is possible, this means that there can exist a rule to clarify Art. 53 EPC which is not affected by the fact the Enlarged Board have already made a decision on this matter. This would allow the Administrative Council (the body who create the Rules) to implement a Rule/s to clarify Art. 53 EPC without contradicting G2/12 and G2/13. The second question deals with the scenario in relation to the current Rule 28 EPC.
If the Enlarged Board answers no, then the precedents set in G2/12 and G2/13 will stand as the tests for patentability where essentially biological process are concerned, as no Rules can be created which are not inherently bound to the interpretation of the law set out in these decisions.
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?
In other words, if the Enlarged Board decides it is possible to clarify Art. 53 EPC in the Rules without the limitations of the above G decisions, does current Rule 28 (2) EPC do this in conformity with Art. 53 EPC.
This question asks if Rule 28 (2) EPC is too strict, in excluding subject matter that is patentable under Art 53 EPC. If this is the case, the Rule must be changed, as Art. 164 EPC states that the Articles must take precedence over the Rules.
If the Enlarged Board decides this is the case, it remains to be seen how the Rules will be changed. It is possible to remove Rule 28 (2) EPC entirely, or try to replace it with a rule which is in conformity with Art. 53 EPC. If the Administrative Council try to replace Rule 28 (2) EPC, there may well be another referral to the Enlarged Board in the future on the same grounds as this one.
It seems unlikely that the Enlarged Board would want another referral on a similar point of law in the future, given that this referral is heavily linked to two previous referrals (G2/12 and G2/13), so they may try to decide these questions in a way that limits the chance of a future referral.
What this means
In light of the significant questions asked to the Enlarged Board regarding the patentability of essentially biological processes, the President of the EPO has stayed all relevant examination and opposition proceedings at the EPO, resulting in an ever-increasing number of patent applications and opposed patents which are dependent upon this decision.
If the Enlarged Board agrees with G2/12 and G2/13, it appears that the overly restrictive Rule 28 (2) EPC will be overturned, and inventions related to plants or animals obtained by essentially biological means will remain patentable at the EPO.
However, in the event that the Enlarged Board changes its opinion, then another exclusion will be added to the list of non-patentable inventions at the EPO.
If you have any questions about this decision or would like general advice on practice before the EPO, please get in touch to speak to of our attorneys.