Broccoli and Tomatoes – the Patentability of Biological Processes
21st June 2011
The Enlarged Board of Appeal of the European Patent Office has handed down its opinion in the combined referrals G2/07 and G1/08, which relate to the patentability of biological processes for the production of plants.
Referral G2/07 was made as a result of appeal proceedings relating to European Patent No 1069819, which claimed a method of deriving broccoli with enhanced glucosinolate levels. This method involved the use of molecular markers which assisted in the selection of plants containing desired traits.
Referral G1/08 was made as a result of appeal proceedings concerning European Patent No1211926, which related to a method for breeding tomatoes with reduced water content. The claimed method included a step of leaving the tomatoes on the vine past normal ripening.
Essentially biological processes for the production of plants are excluded from patentability under Article 53(b) EPC and Rule 26(5) EPC:
Article 53(b) EPC
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 26(5) EPC
A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.
Article 53(b) EPC clearly states that essentially biological processes for the production of plants or animals are not patentable. It had been argued by the patent proprietors that “essentially” should be interpreted to mean “purely”, that the claimed methods involved a technical step which required human intervention, and that this step therefore took the process outside the exclusion of Article 53(b) EPC.
In total, four questions were referred to the EBA. These were based around the correct interpretation of the phrase “essentially biological process for the production of plants or animals”, and whether the inclusion of a technical step takes a claim outside the exclusion of Article 53(b) EPC.
In making their decision, the EBA considered the meaning of Rule 26(5) EPC, which seeks to define the term “essentially biological”. The EBA acknowledged that, by giving “crossing or selection” – processes which necessarily involve human interference – as examples of “natural phenomena”, this rule is inconsistent and difficult to interpret. After reviewing the legislative history, the EBA ultimately concluded that “regrettably, Rule 26(5) EPC does not give any useful guidance on how to interpret the term ‘essentially biological process for the production of plants’”.
On considering Article 53(b) EPC, the EBA held that the term “essentially” should not be taken to mean “purely”, and that merely using a technical device in a breeding process which involves the sexual crossing of plants is not sufficient to give the whole process a technical character.
Thus, a process for the production of plants based on the sexual crossing of the whole genome, even if that process includes human intervention to enable or assist certain steps, remains excluded from patentability under Article 53(b) EPC.
However, the EBA went on to say that, where a technical step introduces or modifies a trait in the plant’s genome without being the result of merely mixing the genes of the plants chosen for selection, this technical step would take the method outside the exclusion. This step must be performed within the steps of crossing or selection – not as a precursor and not afterwards.
The EBA further considered that, in the context of determining patentability under Article 53(b) EPC, it is irrelevant whether the technical step is in itself novel or inventive. If this were to be the case, it would amount to making the exclusion from patentability under that Article dependent on the prior art, which could not have been the intention of the legislators.
This decision means that, for an invention directed to the production of plants through crossing or selection to be patentable, it is not enough for there simply to be human intervention in the process; that intervention must result in a product which cannot be obtained by merely mixing the entire genome of the selected plants.
21 June 2011
Compulsory licensing of pharmaceuticals
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