The following is a contribution from Verena Simpson PhD of Zacco Denmark A/S.
The core of the Decision
1. A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being “essentially biological” within the meaning of Article 53(b) EPC.
2. Such a process does not escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genome of plants or of subsequently selecting plants.
What triggered the Enlarged Board of Appeal [EBoA] Decision?
The Technical Board of Appeal [TBoA] were faced with the task of deciding whether an opposed patent EP1 069 816 should be maintained in amended form. The claims were directed to “a method of producing Brassica oleracea with elevated levels of glucosinolates” comprising steps of crossing selected wild Brassica oleracea species with broccoli breeding lines; selecting hybrids with elevated of glucosinolate levels; backcrossing the selected line; and finally selecting a broccoli line with elevated of glucosinolate levels, where molecular markers are employed to select the desired hybrids.
The sole question faced by the TBoA (T 83/05) was whether the claimed “method” was excluded from patentability under Art 53b EPC and Rule 26(5) EPC2000.
How do Art 53b EPC and Rule 26(5) EPC define non-patentable biological processes?
Art 53EPC states 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;”
Rule 26(5) EPC states that:
“A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomenon such as crossing and selection.”
Rule 26(5) EPC2000 (inserted as Rule 23b in EPC1973; coming into force in 01.09.1999) serves to implement the EU Biotechnology Directive, whose purpose is to harmonize the protection of biotechnology inventions throughout the EU. The implementing regulations (Rule 26 EPC) and supplementary guidance provided by the Bio Directive is also applicable to pending applications, filed before 01.09.1999 (G2/06).
What are “natural phenomena” in the context of Rule 26(5) EPC?
The wording of Rule 26(5) EPC has been a source of diverse opinion, because it seems to be a contradiction of terms to define an “entirely natural phenomenon” as one that involves “crossing and selection”. A process for producing plants that involves “crossing and selection” is traditionally an activity carried out by plant breeders. This suggests that the “natural phenomena” in Rule 26(5) EPC was intended to relate to classical breeding requiring human intervention, as against purely natural events occurring in nature. Accordingly, the “essentially biological processes for producing plants” that are excluded from patentability under Art 53b EPC should be understood to involve human activity. Classical breeding aims at producing new plant varieties, which are themselves also excluded for patentability, since they are protected by Breeder’s Rights under UPOV. Purely natural processes would, in any event, not need to be excluded, since their lack of technical teaching makes them inherently non-patentable.
What type of human intervention in a process for producing a plant escapes exclusion under Art 53(b) EPC?
So long as the characteristics of a plant resulting from a process of crossing and selection, are solely the result of an essentially biological process, then a process for its production is excluded from patentability. The use of technical steps to facilitate the crossing and selection process (such as the use of DNA markers) does not make the process patentable, so long as their use has no impact on the outcome of the biological process. Such technical steps or tools for plant breeding could, however, i n themselves qualify as patentable inventions*.
However, a process involving human intervention where the plant genome is modified by genetic engineering, where the GMO plant product is not solely the result of plant crossing and selection, is not excluded by Art 53(b) EPC.
How would this decision impact the allowability of the amended claims in the opposed patent (T 83/05)?
In light of this decision, the amended claims in the opposed EP1 069 816 would fall within the Art 53(b) EPC exclusion on the grounds that the claimed method for producing the “Brassica oleracea with elevated levels of glucosinolates” involves the steps of classical crossing and selection, and that the use of a technical step (using DNA markers for selection) does not exempt the claim from this exclusion.
*Note: Although DNA markers are valuable tools for breeding, their use can neither be protected in a process for breeding a plant, according to this Decision, nor are can they be protected as DNA sequences in a plant, if they are too short to be attributed any biological function.