copyright 1995 Dr. Patricia A. Rae
Sim, Hughes Ashton & McKay / Sim & McBurney , Toronto, Canada
Earlier this year, the Technical Board of Appeal of the European Patent Office reached a decision on the interpretation of Article 53(b) of the European Patent Convention (EPC) which narrows the ambit of protection available for genetically engineered plants.
The decision arose from an appeal by Greenpeace Ltd. from a decision of the Opposition Division upholding the grant of a patent to Plant Genetic Systems N.V. for plant cells and plants which had been made herbicide resistant by genetic engineering and for processes for producing such plant cells and plants.
The plants and plant cells had been rendered resistant to a herbicidal glutamine synthetase inhibitor by transformation with a DNA sequence coding for an enzyme able to inactivate the glutamine synthetase inhibitor.
The Board of Appeal considered two main issues, namely, whether any of the claimed subject matter was unpatentable pursuant to Article 53(a), as "contrary to 'ordre public' or morality", and whether it was unpatentable pursuant to Article 53(b), as constituting a plant variety or essentially biological process for the production of plants, other than a microbiological process or a product thereof.
The Appellant argued that public survey evidence indicated that the public did not support the patenting of animals or plants and also that the creation of herbicide-resistant plants was a threat to the environment.
The Board rejected the survey evidence as not reflective of "ordre public" concerns or moral norms and with respect to the environmental question, held essentially that responsibility for ensuring the safety of introduction of genetically engineered plants into the environment is the responsibility of the relevant regulatory bodies and not of the Patent Office, which generally is dealing with an invention at an early stage before the relevant environmental data are available. The claims were found not to violate the prohibition of Article 53(a).
With respect to Article 53(b), the Board concluded that a "plant variety" is "any plant grouping within a single botanical taxon of the lowest known rank which. is characterised by at least one single transmissible characteristic distinguishing it from other plant groupings and which is sufficiently homogenous and stable in its relevant characteristics."
The Board concluded that plant cells, which can be cultured in a manner similar to the culture of bacteria and yeasts, cannot be considered to be within the definition of a plant or of a plant variety. The claims to genetically engineered plant cells were therefore upheld.
With respect to the genetically engineered plants, however, the Board noted that the patent itself stated that the characterising feature of the claimed plant (its herbicide resistance), is transmitted in a stable manner in the plants and seeds throughout succeeding generations. The Board held that the transformed plants or seeds disclosed in the patent comply with the definition of a "plant variety", being distinguishable, uniform and stable in their relevant characteristics. Claims to these plants or seeds were therefore not patentable in view of Article 53(b), unless they could be considered to fall within the exception for "microbiological processes or the products thereof".
In considering the nature of the process involved, the Board had to consider whether the process of producing the genetically engineered plant by first transforming plant cells or tissue with the desired DNA, followed by regenerating a plant from the plant cells or tissue, constituted "an essentially biological process for the production of plants" and whether it constituted a "microbiological process".
The Board concluded, on the basis of previous cases, that if a process for the production of plants includes at least one essential technical step which cannot be carried out without human intervention, and which has a decisive impact on the final result, the process is not an "essentially biological process". The step of inserting the resistance-conferring DNA sequence into the plant genome was found to be such a decisive, human-directed step and claims to the process of producing the genetically transformed plants were found patentable.
The Board then turned to the meaning of "microbiological processes or the products thereof". The Board considered that the term "microorganism" includes plant cells as manipulated in vitro in a laboratory. They therefore concluded that genetic engineering processes carried out on plant cells may be defined as "microbiological processes" and that the product, namely the genetically modified plant cells and cultures thereof may be defined as "the products thereof".
The claimed process for producing genetically modified plants, however, was a multi-step process in which only the initial transformation step could be considered to be a microbiological process.
The Board concluded that the concept of "a microbiological process" may not be extended to include a technical process which comprises a succession of steps, only one of which, albeit an essential step, is of a microbiological nature.
Considering the process by which the transformed plants had been obtained, the Board concluded that, regardless of the decisive impact that the microbiological process step had on the final result, the multi-step process whereby the whole plant was produced was not a microbiological process within the meaning of Article 53(b), such that the plant produced could escape the prohibition on patentability of plant varieties.
In summary, claims to genetically modified plant cells and to a process for producing genetically modified plants were held to be patentable, whereas claims to genetically modified plants themselves were held unpatentable.