Not Patentable – The end of the line for plants and animals produced by conventional breeding (G3/19)

Europe

The highest judicial authority at the EPO issued their opinion late last week in the controversial G3/19 (Pepper) case. Contrary to previous decisions in G2/12 and G2/13 (Tomato/Broccoli), the Enlarged Board of Appeal (EBA) has found that plant and animal products produced by essentially biological processes should NOT be patentable. This U-turn is the end result of significant political pressure from across Europe in favour of farmers and breeders who consider that patents on plants obtained from conventional breeding methods will hinder their activities.

Importantly, this new interpretation will not have retroactive effect on European patents granted before 1st July 2017, or pending European applications that were filed before this date.

Background

G3/19 relates to the interpretation of Article 53(b) EPC in conjunction with Rule 28(2) EPC, the latter of which was a relatively recent amendment to the EPC, coming into force in 1st July 2017. Both provisions relate to exceptions to patentability, and read as follows:

Article 53(b): 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; this provision shall not apply to microbiological processes or the products thereof.

Rule 28(2): 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 the Tomato/Broccoli decisions delivered in March 2015 (i.e. before the Rule 28(2) amendment), the EBA found that Article 53(b) excludes from patentability claims directed to an essentially biological process for the production of plants, and that this exclusion should be interpreted narrowly, i.e. should not prevent claims directed to plants or plant products produced by essentially biological processes.

However, this was not a popular position among farmers and breeders and the resulting political pressure led to the European Commission (EC) reviewing the Biotech Directive (Directive 98/44/EC), which deals with patenting of biotech inventions. The Commission concluded that the intention of the Directive was to exclude plant and animal products produced by essentially biological processes, not just the processes themselves, and this led to the introduction of Rule 28(2) EPC. This new rule though was not consistent with the previous Tomato/Broccoli EBA decisions, and it is this tension which led to a further referral to the EBA.

The present case relates to a Syngenta European patent application directed to pepper plants. The patentability of said claims was dealt with in 2018 by the EPO Technical Board of Appeal (TBA) (T1063/18), who considered that Rule 28(2) was in conflict with the prior interpretation of Article 53(b) from the Tomato/Broccoli decisions. The Rule 28(2) amendment was thus found to be void, and the claimed plant products considered patentable. Since the interpretation of Article 53(b) had already been the question of Enlarged Board referrals, the TBA did not refer the case to the EBA. However, the EPO President, in view of the aforementioned political pressure, took matters into his own hands and referred the case to the EBA for further scrutiny.

The Opinion

This is a lengthy opinion, which sets out the background to the case, details of the President’s referred questions, a review of statements from 41 third parties, and the EBA’s ultimate opinion. The key messages are summarised as follows:

  • Admissibility of the referral
  • The EBA confirmed that for a referral to be admissible to the Board, it must meet the following requirements:

    1. An answer by the Enlarged Board is needed in order to ensure uniform application of the law, or a point of law of fundamental importance has arisen, and
    2. Two Boards of Appeal have given different decisions on that question.

    The EBA considered these requirements met, although the reasoning for point (ii) is more convoluted. The EBA reasoned that the TBA decision for this case was in conflict with earlier TBA decisions, because earlier decisions had evaluated the impact of a later-adopted Rule when interpreting the European Patent Convention, whereas this decision did not when it dismissed new Rule 28(2) EPC.

  • Article 53(b) interpretation

The EBA confirmed the principles of interpretation, saying that it was necessary to establish the ‘authentic’ meaning of the relevant provision of the EPC, whilst taking into account decisions and opinions given by national courts.

In this regard, the EBA considered that an authentic/linguistic interpretation of Article 53(b) would not lead to the conclusion that the term ‘essentially biological processes for the production of ….’ clearly extends beyond processes to products defined or obtained by such processes. However, the EBA took note of the Biotech Directive and developments in some Contracting States that have resulted in national patent protection no longer extending to animals, plants or plant materials. The EBA also laid heavy emphasis on new Rule 28(2), and the intention of the Contracting States when this amendment was introduced.

Taking all aspects into account, in the Board’s opinion, Article 53(b) should be interpreted as excluding from patentability, animals, plants or plant materials exclusively obtained by means of an essentially biological process. The EBA thus abandoned the previous interpretation of Article 53(b) given in the Tomato/Broccoli decisions.

The EBA clarified that this new interpretation will not have retroactive effect on European patents granted before 1st July 2017, or pending European applications that were filed before this date.

EPO Press Communication

Interestingly, alongside the opinion, the EPO issued a press release providing a summary of the opinion and clarified when and why the EBA may be allowed to change its mind on interpretation of the EPC.

In this case, the introduction of Rule 28(2) and the circumstances of its adoption, as well as legislative developments in EPC Contracting States, called for a ‘dynamic interpretation’ of Article 53(b), and in adopting this approach, it was acceptable for the EBA to abandon its earlier interpretation in the Tomato/Broccoli decisions.

This communication gives patent proprietors and applicants some comfort that any change in the interpretation of the EPC cannot be undertaken without good reason.

Comment

This case provides a definitive answer on patentability of animal and plant products resulting from conventional breeding at the EPO. The position will not come as a surprise, in light of the amendment to the Biotech Directive and, subsequently, the EPC. However, it will still be a blow to the Agritech industry, who will now need to rely more on plant variety rights for protecting innovations in this area.

It is possible that the situation in the UK will diverge following Brexit, and that once the UK is not bound by the EU’s Biotech Directive it will still be possible obtain patents in this area before the UK IPO. Watch this space!

Please do not hesitate to contact us should you have any questions or require any advice about the issues raised in this article.