Biological processes for breeding plants are only patentable under the EPC if they comprise steps which materially alter the breeding procedure such that the resulting plants are not obtained by simple recombination of the parent genomes.
In 1990, President Bush notoriously banned broccoli from his plate on Air Force One and in the White House. His logic was simple; he didn’t like broccoli, and as he was the President of the United States, he wasn’t going to eat it.
The Enlarged Board of Appeal of the EPO applied a more complicated set of arguments to decide on whether two European patents directed to processes for breeding broccoli and tomatoes were capable of patent protection under the European Patent Convention (EPC).
Article 53(b) EPC excludes essentially biological processes for the production of plants and animals from patent protection. However, the scope of the term “essentially biological” remained unclear. Whilst the decision of the Enlarged Board answers some questions, it introduces an imprecise meter for judging patentability of similar approaches in the future.
The patents in question
European patent No. 1 069 819 concerns a method for deriving broccoli with enhanced glucosinolate levels.
European patent No. 1 211 926 concerns a method for breeding tomatoes with reduced water content.
Both patents were maintained in amended form during opposition proceedings.
At subsequent appeal proceedings, both patents were referred to the Enlarged Board on account of comprising method claims which contain steps of classical plant breeding, including crossing and selection, to obtain new plants.
In the broccoli case, features were included which were argued by the proprietor to be technical. These included the use of molecular markers, which assisted in the selection of plants comprising the desired traits, and the use of double haploid breeding lines, which are the product of a technical process.
In the tomato case, a step was included which required leaving the tomatoes on the vine past normal ripening, to assess which plants had the desired characteristics. It was argued that this was a technical step, requiring deliberate human action.
The proprietors of the patents argued that technical features present in the claims allowed the same to escape the provisions of Art 53(b) EPC.
Article 53(b) EPC reads as follows:
“European patents shall not be granted in respect of:
- plant or animal varieties or essentially biological processes for the production of plant or animals; this provision shall not apply to microbiological processes or the products thereof;
Of the interpretations which had been made of the term “essentially biological,” one of the key positions was that taken in T320/86, in which a Technical Board of Appeal had concluded that if the claim was to escape the exclusion, invention seen in its totality had to be an invention other than a classical breeding process.
Since T320/86 had been decided, new Rule 26(5) EPC had been enacted, as a result of the incorporation of the provisions of the Biotechnology Directive of the EU into the EPC. This Rule reads as follows:
“(5) A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.”
This rule serves to define the terms of Art 53(b) EPC, but is somewhat ambiguous; as was made clear during the proceedings, crossing and selection are not natural phenomena, but processes which involve human intervention.
According to the proprietors, the inclusion of the phrase “consists entirely” meant that the provision of steps which were other than crossing and selection steps made the process as a whole patentable.
The Enlarged Board considered, and rejected, a number of approaches which have been taken to dealing with exclusions under the EPC.
It rejected an approach similar to that taken with methods of medical treatment, under Art. 52(4) EPC 1973. Under this approach, a single step which relates to a method of treatment is sufficient to invalidate an claim as a whole. This is clearly inapplicable, in view of the reference to “consists entirely” in Rule 26(5) EPC.
It also rejected the approach taken in respect to computer-implemented inventions, in which a single step which imparts technical character to the invention is considered sufficient to lend patentability. In the case of breeding processes, it was not contested that they are technical; they are excluded despite being technical.
It moreover rejected the approach taken in T320/87. This decision requires that the invention in totality be other than a breeding process, which means that the features of the invention which contribute to inventive step would be very important in determining the exclusion or otherwise of the method. This was felt to be inappropriate, since patentability would vary with changes in the state of the art, and exclusions should not be dependent on the state of the art.
Considering that crossing and selection necessarily involve technical steps, the Enlarged Board took the position that essentially biological processes were excluded even if technical. As stated on page 69 of the decision:
Hence, in more general terms, the conclusion to be drawn is that a process for the production of plants which is based on the sexual crossing of whole genomes and on the subsequent selection of plants, in which human intervention, including the provision of a technical means, serves to enable or assist the performance of the process steps, remains excluded from patentability as being essentially biological within the meaning of Article 53(b) EPC.
On this basis, if the claimed process is a process for obtaining plants based on sexual crossing and selection, then it is not patentable irrespective of what other steps may be included in the claim. However, the Enlarged Board left one opening for patentability:
However, if a process of sexual crossing and selection includes within it an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then that process leaves the realm of the plant breeding, which the legislator wanted to exclude from patentability. Therefore, such a process is not excluded from patentability under Article 53(b) EPC but qualifies as a potentially patentable technical teaching.
The Board pointed out that this additional step was to be part of the crossing and selection procedure; it could not be a step carried out before or after the crossing and selection, since otherwise it would be too easy to circumvent the exclusion. In any event, according to the Board, such steps can be claimed independently, without mentioning crossing and selection.
What does “by itself” mean?
The Board has left us with the idea that a step, which is part of a crossing and selection procedure, may make a process patentable if it “by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing”.
The most helpful clue to what was on the mind of the Enlarged Board is in its reference to the drafting of the Strasbourg Patent Convention (SPC), which was used as the basis for the EPC. In particular, the explanations given in the memorandum of the Secretariat of the Committee of Experts when addressing this topic differentiates between the use of a novel glasshouse for plant breeding, and the irradiation of seeds during plant breeding. The former is a technical step that does not render the breeding process patentable, since it does not alter it; the plant produced is a result of the mixing of plant genomes, however this may be facilitated by the glasshouse. However, the glasshouse may be patentable per se.
The use of irradiation, on the other hand, is a step which may render the breeding process patentable.
Here, we can see that irradiating seeds does indeed alter the breeding procedure, by modifying traits in the plants, in a manner which is not dependent (merely) on mixing of parent plant genomes. Arguably, therefore, it alters a trait in the plant “by itself” and not as a result of the mixing of plant genes.
Moreover, unlike the introduction of transgenes by recombinant DNA techniques, the irradiation step is contained within the process of crossing and selection and cannot independently give rise to a plant, so is properly claimed as part of the breeding process.
Tomatoes and broccoli?
Where does this leave the referring cases? The decision of the Enlarged Board concerns only the questions put to it; it is up to the referring Technical Boards to determine the fate of individual patent applications, by applying the reasoning of the Enlarged Board. It is too early for those decisions to be available, but in our view the tomato claims are unlikely to survive, since it has been held that technical crossing and selection steps are also excluded.
In the broccoli case, the reference to double haploid breeding strains will not be helpful, since this procedure is carried out before crossing. The use of molecular markers is more interesting. It could be argued that without the use of molecular markers the desired cross is so rare that it would take an unreasonably long time to isolate the desired strain. Here the Enlarged Board appears to be at pains to argue that the step should lead to an effect which is not the result of the mixing of plant genes. Again we might expect the process claims to fall.
However, the patent also comprises product claims, which claim the broccoli produced by the process. Product claims, of course, are not affected by this decision.
The position taken by the Technical Boards in both the Broccoli and Tomato cases will be very important for practice. From the reasoning of the Enlarged Board, it seems that biological processes for breeding plants will only be patentable if they include a step which genetically influences the offspring.