In the consolidated cases G 2/12 and G 2/13 (OJ 2016, A28 and OJ 2016, A29) the Enlarged Board was concerned with the question whether the exclusion of essentially biological processes for the production of plants in Art. 53(b) EPC had a negative effect on the allowability of product claims or product-by-process claims directed to plants or plant material (such as a fruit or plant parts) which are directly obtained and/or defined by an essentially biological process. It concluded that it did not.

The Enlarged Board applied the various methodical lines of interpretation set out in Art. 31 and 32 of the Vienna Convention on the Law of Treaties. None of these led the Enlarged Board to conclude that the term "essentially biological processes for the production of plants" extended beyond the processes to products defined or obtained by such processes. This result was confirmed when the preparatory work of the EPC was taken into account as a supplementary means of interpretation.

The Enlarged Board also examined whether considerations had arisen since the Convention was signed which might give reason to believe that a literal interpretation of the relevant provision would conflict with the legislator's aim. However, it could not see why the original intention of the legislator in drafting Art. 53(b) EPC was no longer justified, just because new plant breeding techniques were available today.

The Enlarged Board considered whether allowing patenting of a product claim or a product-by-process claim for a plant or plant material that is obtained by a means of an essentially biological process could be regarded as a circumvention of the process exclusion. It found that it could not, referring to the clear wording of Art. 53(b) EPC. It warned that broadening the scope of the process exclusion to the extent that it included products obtained by essentially biological processes for the production of plants would introduce an inconsistency in the system of the EPC, as plants and plant material other than plant varieties were generally eligible for patent protection.

On the question whether it was of relevance that the protection conferred by the product claim encompassed the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under Art. 53(b) EPC, the Enlarged Board highlighted the distinction between the requirements for patentability and the extent of protection. Whether a product claim or a product-by-process claim was patentable was to be examined irrespective of the extent of protection that is conferred by it after grant.

The Enlarged Board emphasised that its judicial decision-making powers did not extend to the ethical, social and economic aspects raised in the general debate, as it had no mandate to engage in legislative policy.

The questions of law referred to the Enlarged Board of Appeal were answered as follows:

1. The exclusion of essentially biological processes for the production of plants in Art. 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plant material such as a fruit (G 2/12) or plant parts (G 2/13).

2. The fact that the process features of a product-by-process claim directed to plants or plant material other than a plant variety define an essentially biological process for the production of plants does not render the claim unallowable (G 2/13). The fact that the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the production of plants disclosed in the patent application does not render a claim directed to plants or plant material other than a plant variety unallowable (G 2/12, G 2/13).

3. In the circumstances, it is of no relevance that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under Art. 53(b) EPC (G 2/12, G 2/13).

In its decision T 83/05 of 10 September 2015 date: 2015-09-10 the board applied G 2/13. Claim 1 of the main request was directed to an edible Brassica plant produced according to a method of crossing and selecting. Claims 2 and 3 were directed to an edible portion and to the seed of a broccoli plant produced by a method defined in the same manner as in claim 1. Claims 4 and 5 were directed to a broccoli plant and a broccoli inflorescence. The board remitted the case to the department of first instance with an order to maintain the patent on the basis of claims 1 to 5 of the main request.

In T 1242/06 of 8 December 2015 date: 2015-12-08 the board applied G 2/12. The newly submitted claims were restricted to claims for products and related to a (naturally) dehydrated tomato fruit of the species L. exculentum. The board held that the subject-matter in question was not excluded from patentability pursuant to Art. 53(b) EPC. The board remitted the case to the opposition division with the order to maintain the patent on the basis of these claims.

Following a Notice of the European Commission, clarifying that Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions intended to exclude products 'exclusively obtained by means of an essentially biological process', the Administrative Council amended R. 27 EPC and R. 28 EPC in 2017 (OJ 2017, A56) to exclude from patentability plants exclusively obtained by means of an essentially biological process.

In T 1063/18, the board, in an enlarged composition consisting of three technically and two legally qualified members, held that R. 28(2) EPC (see OJ 2017, A56) is in conflict with Art. 53(b) EPC as interpreted by the Enlarged Board of Appeal in decisions G 2/12 and G 2/13. The board referred to Art. 164(2) EPC, according to which the provisions of the Convention prevail in case of conflict with the Implementing Regulations, and decided to set the decision under appeal aside and to remit the case to the examining division for further prosecution.

The board did not see any reason to deviate from G 2/12 and G 2/13. The interpretation of the Biotech Directive as put forward in the Notice of the European Commission on certain articles of Directive 98/44/EC was not seen as a relevant development because it had not been confirmed in a legally binding way. Considering whether an interpretation of Art. 53(b) EPC, different from that given in decisions G 2/12 and G 2/13, was necessary in view of Art. 31(3)(a) of the Vienna Convention on the Law of Treaties, the board concluded that neither the decision of the Administrative Council to adopt R. 28(2) EPC nor the Notice of the European Commission could be regarded as a subsequent agreement between the parties in the sense of the Vienna Convention.

On 4 April 2019 the President of the European Patent Office referred to the Enlarged Board of Appeal points of law on the interpretation of Art. 164(2) EPC and the assessment of R. 28(2) EPC under said provision. Under Art. 112(1)b) EPC the following questions were referred to the Enlarged Board of Appeal:

1. Having regard to Art. 164(2) EPC, can the meaning and scope of Art. 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 R. 28(2) EPC in conformity with Art. 53(b) EPC which neither explicitly excludes nor explicitly allows said subject-matter?

This referral is now pending as G 3/19.