Insights: The patentability of plants and animals obtained by essentially biological processes – conflict or conformity of Article 53 EPC and the implementing regulations

A new Referral to the Enlarged Board of Appeal (EBA) has been submitted by the President of the EPO concerning the patentability of plants and animals obtained exclusively by essentially biological processes, G3/19. This Referral follows Technical Board of Appeal decision T1063/18, a case concerning the patentability of plants obtained by an essentially biological process. In this decision, the Board considered that Article 53(b) EPC, as previously interpreted by the EBA in decisions G2/12 and G2/13, was in conflict with Rule 28(2) EPC, which excludes from patentability the products of essentially biological processes. The Board concluded that in view of Article 164(2) EPC, the provisions of the Convention prevail and as such, products obtained through essentially biological processes are patentable.

In response to T1063/18 and in accordance with Article 112(b), the President of the EPO has referred the following two questions to the EBA:

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 background of patentablity in this field
T1063/18 follows several years of efforts to clarify the law in Europe concerning the patentability of products obtained by essentially biological processes.

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (“The Biotech Directive”) states that “essentially biological processes for the production of plants or animals” should not be patentable (Article 4(1)(b)). This is enshrined in the EPC in Article 53(b) EPC.

In March 2015, the EBA ruled in two decisions, G2/12 and G2/13, that Article 53(b) EPC does not exclude from patentability plants or plant materials obtained by essentially biological processes. These decisions supported a narrow interpretation of the exclusion.

However, in November 2016, the European Commission issued a Notice on the interpretation of certain articles of The Biotech Directive, directly conflicting with these EBA decisions. In 2017, the Administrative Council of the EPO implemented an amendment to Rule 28 EPC so as to follow this interpretation. New Rule 28(2) EPC states:

“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.”

In T1063/18, the Technical Board of Appeal was asked to reconsider the Examining division’s refusal of an application claiming a plant obtained by an essentially biological process. The refusal was overturned on the basis of a conflict between Article 53(b) EPC as previously interpreted by the EBA and new Rule 28(2) EPC. As noted above, it is this decision that has prompted the current Referral.

Interestingly, in the Referral the President has suggested that Rule 28(2) EPC is in conformity with Article 53(b) EPC, i.e. that the law is consistent with respect to the exclusion of plants and animals obtained by essentially biological processes. The President notes that such an interpretation of Article 53(b) EPC is consistent with the EU legislator’s intent behind The Biotech Directive. Furthermore, this interpretation is consistent with the agreement and practice of the EPC Contracting States. In this regard, the President notes that since the European Commission Notice was published in November 2016, all 38 Contracting States of the EPC have indicated and declared that under their national law and practice the products of essentially biological products are excluded from patentability. It is clearly the President’s view that the EU position should be followed.

The admissibility of the Referral to the EBA
Article 112(1)(b) EPC permits the President of the EPO to make a Referral to the EBA on a point of law when “two Boards of Appeal have given different decisions on that question”. In the Referral document, a detailed explanation is provided as to why it is appropriate for both questions to be considered

For the first question, the President concludes that the case law has differed. Notably, the President discusses the disparity between T1063/18 and the approach of the EBA set out in G2/07 suggesting that an earlier interpretation of Article 53 EPC (for example by the EBA) should not impose an absolute bar on its implementation by a newly drafted EPC Rule. Interestingly, the President has suggested that the correct approach to follow should be that of the earlier case law and not that of T1063/18.

The President reasons that the second question should be admissible on the same basis. However, the Referral goes on to provide further reasoning to support the admissibility of the second question. The President points out that validity of Rule 28(2) EPC, notably the issue of whether or not plants and animals produced by essentially biological processes, is a point of law of fundamental importance. It is suggested that there are currently about 18 appeals pending against decisions based on Rule 28(2) EPC and about 250 examination and about 7 opposition proceedings in which the application of Rule 28(2) EPC has or may become decisive. It is also noted that the legal developments since G2/12 and G2/13 have led to the position where all Contracting States consider the products of essentially biological processes to be excluded from patentability under harmonised European patent law.

It remains to be seen whether or not the EBA will admit this Referral. However, if the EBA confirms the admissibility of this Referral, it is likely that any pending cases affected by the outcome of this decision will be stayed.

If you wish to know more about this Referral or would like further advice, please contact Joanna Peak or your usual Boult Wade Tennant LLP advisor.