IP Information & News

​Patentability of plants or animals — the Boards of Appeal of the EPO Boards of Appeal assert authority

A decision of the Boards of Appeal of the European Patent Office (EPO) has overruled an Implementing Regulation of the European Patent Convention (EPC) relating to patentability of plants or animals exclusively obtained by means of an essentially biological process. The Implementing Regulation had previously been amended in view of an opinion of the European Union on interpretation of the Biotechnology Directive. The decision clarifies the correct current EPO interpretation of the EPC, and asserts the responsibility and authority of the Boards of Appeal for interpreting the EPC. So, inventions in respect of plants or animals exclusively obtained by means of an essentially biological process are (again) not excluded from patentability.

Protection of plants or animals

The development of new plants, animals and methods for producing plants or animals is useful for enhancing quality of life, for example, through enhanced environmental aesthetics and by tackling the challenges of food security. It is possible to protect novel plants via plant variety rights, and to protect both plant and animal innovations via patents. However, there are limits to what can be protected in view of the fact that the inventions to a greater or lesser extent relate to naturally-occurring organisms. The present decision relates to how the EPC should be applied to a plant-related invention.

The patent application

The present decision (T 1063/18) follows an appeal against the refusal of a patent application relating to a new pepper with improved nutritional value defined in respect of qualitative trait loci (QTLs) and physicochemical characteristics of the pepper fruits (EP 12756468.0; Syngenta Participations AG). The EPO’s Examining Division held that the claimed invention fell within the scope of an exception to the patentability of plants derived from essentially biological processes.

Exception to patentability

Article 53(b) EPC provides that “European patents shall not be granted in respect of: […] (b) plant or animal varieties or essentially biological processes for the production of plants or animals […]”.

Previous Enlarged Board of Appeal decisions have considered the meaning of an “essentially biological process” under Article 53(b) EPC (G 1/08 “Tomatoes I” and G 1/07 “Broccoli I”). Other decisions have held that patent claims to plant products per se are not excluded, as the prohibition at issue relates to processes only (G 2/12 “Tomatoes II” and G 3/12 “Broccoli II”).

In parallel, the EU produced the 1998 “Biotech Directive” (Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions). This set out to harmonise the national law on patentability of inventions relating to biological material. Article 4(1) of the Biotech Directive made clear that plant and animal varieties, and “essentially biological processes for the production of plants or animals”, shall not be patentable. Thus, the Biotech Directive and Article 53(b) EPC contain the same wording.

The interpretation of Article 4(1) of the Biotech Directive, however, has been noted to diverge from the Boards of Appeal’s interpretation of Article 53(b) EPC. In particular, the Commission Notice on certain articles of the Biotech Directive dated 8 November 2016 asserted that Article 4(2) of the Biotech Directive not only explicitly barred from patentability essentially biological processes for the production of plants or animals, but also implicitly excluded patenting plants or animals that are exclusively produced by these processes.

Although the EPC is not EU law, the Biotech Directive has informed the drafting of the EPC as well as other European national patent law. Thus, the Implementing Regulations of the EPC were amended by the EPO’s Administrative Council to try to bring them into conformity with the Commission Notice, and current Rule 28(2) EPC specifies 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”.

Accordingly, the present patent application was refused pursuant to new Rule 28(2) EPC, which had come into force during the final stages of application’s examination.

The appeal

The prima facie contradiction created by the Boards of Appeal’s decisions on Tomato II and Broccoli II on the one hand, and Rule 28(2) EPC on the other, perhaps made it inevitable that an appeal would be filed on the present case.

Among other things, the Appellant argued that the Commission Notice was not legally binding on the Biotech Directive, since only the Court of Justice of the European Union (CJEU) was competent to issue a binding interpretation. Therefore, the Notice certainly cannot overrule the interpretation of Article 53(b) EPC by the Enlarged Board of Appeal. The Appellant argued that new Rule 28(2) EPC was in conflict with the EBA’s previous decision in interpretation of Article 53(b) EPC. It was argued that this conflict was to be resolved by operation of Article 164(2) EPC, which provides that where an Article and a Rule of the EPC are in conflict, the Article shall prevail.

Separately, the Appellant thought that the scope of the term “essentially biological processes” being used by the EPO was not aligned with the narrow scope of the term as used in the Biotech Directive.

The decision

The Board of Appeal agreed that the Commission Notice had no legal authority and that there was no reason to deviate from the Board’s previous interpretation of Article 53(b) EPC to relate to methods only and not products. It was held that the Administrative Council’s amendment of Rule 28(2) EPC had put the EPC’s Implementing Regulations into conflict with the Convention itself, and so Article 53(b) EPC and its prior interpretation by the EBA is the correct law.

Accordingly, the decision to exclude the claimed plant pursuant to Article 53(b) EPC was set aside, and the application was remitted to the Examining Division to deal with clarity and inventive step matters that had arisen during the course of the appeal.

Having decided in the Appellant’s favour, the Board of Appeal did not see the need to consider the scope of the term “essentially biological processes”. This is a lost opportunity to further clarify what may fall within this much-debated legal exception to patentability, which would have been a disappointment to the Appellant and the third parties who made submissions on the Appeal.

Conclusion

The EPO has (again) clarified aspects of its position on product claims to plants, animals and related materials where the product is inevitably made by an essentially biological process by stating that, on the EBA’s interpretation, the EPC does not exclude such product claims.

However, the decision leaves many questions unanswered, such as the scope of the term “essentially biological process”. As a result, a meeting between the EPO and the representatives of the 38 EPO Contracting States, together with the European Commission as observer, has discussed different options in light of the need to provide legal certainty in the interest of the users of the European patent system and the general public in the short term. There is support to obtain an opinion from the EBA of the EPO. In any case, the debate will continue, and we will report developments on this important matter.

If you need advice on obtaining patent or plant variety protection for your plant product, or patent protection for your animal product, get in touch with me at sjm@udl.co.uk.

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