In our Spring 2011 edition of this newsletter, we reported on the referral to the EPO Enlarged Board of Appeal (EBA) of the cases that have become known as the Broccoli and Tomatoes cases (G2/07 and G1/08). The EBA ruled in those cases that methods of breeding and selecting of plants are only patentable if they involve "a technical step that by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced" and sent them back to the referring Technical Board of Appeal (TBA).
Having dismissed the method claims, the TBA bizarrely finds itself unable to dispose of the product claims to the plants themselves and the product-of-process claims, and it has made new referrals with more questions for the EBA. Can there be so much uncertainty in the law of patenting plants?
It seems the EPO has got itself into a quandary because:
A claim to a plant is only excluded under the "plant varieties" exclusion of Article 53(b) EPC if the clam is to a particular variety.The exclusion is interpreted very narrowly (see box), meaning that novel and inventive plant groupings that span different varieties are still patentable.
Nor is a plant excluded under the biological processes exclusion merely because the process of producing it is excluded.
So we have the incongruous result that a plant can be patentable (so long as it is not a specific plant variety) even though the process of producing it is not. Moreover, exclusivity in the plant is absolute and confers exclusivity in breeding new plants from it, thereby frustrating the legislative intention of not granting patents to the process.
"Surely this cannot be?" is the question (more or less) posed by the Board of Appeal to the Enlarged Board.
Originally, the broccoli case described methods of producing brassicas with increased concentrations of anticarcinogenic glucosinolates, and the tomatoes case described methods of breeding tomato plants that produce tomatoes with reduced fruit water content.
In each case, normal steps of crossing, back-crossing and selecting were employed.
There are at least two Elephants in the Courtroom
The first elephant-in-the-room is the question of whether the claimed plant is even new and inventive. Clearly in each case it passed the test to the satisfaction of the Examining Division, because the patent was granted and maintained by the Opposition Division, but novelty of the claims has yet to be considered by the Board of Appeal. Taking the tomato case, for example, this is particularly strange given that there is no suggestion that the claimed dehydrated tomato results from anything other than cross-breeding and pollinating. The reason given by the Board of Appeal for not addressing this fundamental question is that the issue of whether the claimed subject matter is excluded from patentability is "normally determined first" because there is "no point" in assessing whether excluded subject matter fulfils the requirements for patentability.
This approach for assessment of inventions that are not patentable under Article 53 EPC is in stark contrast to the EPO's approach to subject matter that is not to be regarded as an invention under Article 52(2) - mental acts, computer software etc. In the latter case, the debate has moved on from per se exclusion to an assessment of inventive step and whether the problem solved is "technical".
The second elephant-in-the-room is this absence of technicality. What technical effect is there in a new cross-breed of dehydrated tomato?
Article 53(2) Exclusions to patentability
European patents shall not be granted in respect of 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;
Narrow definition of a plant variety exclusion (from Decision G1/98)
A plant grouping within a single taxon of the lowest known rank, which grouping can be (a) defined by the expression of the characteristics that result from a given genotype or combination of genotypes and (b) distinguished from other plant grouping by the expression of at least one of those characteristics and (c) considered as a unit with regard to its suitability for being propagated unchanged.
A few hundred patent applications are filed at the EPO each year in class A01H, the class for new plants and processes for obtaining them. Most are for plants that have been genetically engineered, but a few have claims that encompass plants that could be derived from the sorts of non-technical breeding and selection processes deemed unpatentable in the Enlarged Board's first decision in these cases. The outcome of this decision is not going to have a major impact on patenting in the agro business (after all, the first elephant-in-the-room is that, in the absence of genetic engineering, the traits to be selected already exist in nature).
Of wider interest is how the EBA will plug the gap between Article 52(2) that focuses on what is an "invention" and Article 53(2) that focuses on public policy exclusions to patentability. These provisions have been given different treatment to date, the former being narrow and requiring "technicality" and the latter being a broad per se exclusion. Any element of technicality will satisfy Article 52, but any element of, e.g. surgery or diagnosis, will be captured by the exclusion of Article 53.
Since the referral to the EBA, the Tomatoes appeal has been withdrawn. The Applicants in the Broccoli case (Plant Bioscience Ltd.) asked for their case to be deferred pending the EBA decision in the Tomatoes case, so the cases were combined. The issue remains pending and we will update readers in due course.