By Greg Lynch and Jared Scarlett, Wellington
Previously published in NZ BioScience vol. 9, no. 4, November 2001.
Under the European Patent Convention ("EPC") a single patent application can be submitted to the European Patent Office ("EPO"). This is the predominant mechanism for securing patent protection for an invention in most European countries. However, the biotechnology revolution has tested the EPC. It appears that insufficient consideration was given to potential advances in biotechnology at the time of signing the EPC in 1973.
Biotechnology and the EPCInventions having a commercial use that would be contrary to public policy are not patentable in Europe under Article 53(a) of the EPC. Additionally, Article 53(b) states that "plant and animal varieties" are excluded from patentability. Differences in interpretation of these two Articles have led to confusion. In particular, the EPO and various member states of the EPC have inconsistently applied the two Articles when considering whether to grant patents covering transgenic plants and animals.
Furthermore, the EPO itself has given confusing interpretations to Articles 53(a) and (b). For example, the "Oncomouse" patent application was initially rejected under Article 53(b) as covering an "animal variety". The rejection was appealed and the EPO Board of Appeals ("the Board") stated that the question under Article 53(b) was not whether the patent claims embraced an "animal" but whether the claims embraced an "animal variety". Eventually, the Oncomouse patent application was accepted and granted, laying the foundation for a recognised distinction between "animal" and "animal variety". The decision also appeared to pave the way for allowing of patents for transgenic animals and plants based on the incorporation of a novel gene.
Transgenic plantsA European patent covering a transgenic plant was subsequently sought by Plant Genetic Systems ("PGS"). The patent was initially granted, but then opposed by Greenpeace. The Board found nothing immoral in patenting a plant under Article 53(a), but rejected the patent under Article 53(b) because it interpreted the PGS plant as an unpatentable "plant variety."
However, the Board did accept PGS claims directed to transgenic plant cells and seeds under a second part of Article 53(b) that allowed the patenting of a product of a "microbiological process". The Board considered that the term "micro-organisms" included plant cells and seeds. That is, a single cell capable of reproduction was considered to come within the term of a "micro-organism."
These two cases led to considerable uncertainty in the European patent system for two reasons. Firstly, the apparent inconsistency in the definition given to "variety" between the Oncomouse and the PGS decisions of the board. Secondly, the EPO appeared to be willing to adopt definitions not entirely consistent with common scientific definitions.
The Biotechnology DirectiveIn an attempt to bring some consistency to the European patent system, a Directive was established to lay down the foundations for biotechnology patent applications. A proposal for the Directive began in 1988, but it was not until 1996, after substantial amendments, that agreement between the EPC members on the content of the Directive was finally reached. However, not everyone was happy. The Netherlands voted against the Directive and Italy and Belgium abstained. The Directive finally came into force on 30 July 2000.
The Directive is based on the following principles:
biotechnological inventions are of fundamental importance for the industrial development of the European Community, biotechnological advances require a considerable amount of high-risk investment and therefore only adequate legal protection can make them profitable, effective and harmonised protection is essential in order to maintain and encourage investment in the field of biotechnology, differences could create barriers to trade and hence impede the proper functioning of the internal market; and research aimed at obtaining and isolating such elements valuable to medical production should be encouraged by means of the patent system.The Directive provides that the following may not be patented:
i) plant and animal varieties;
ii) essential biological process for the production of plants and animals;
iii) the human body at various stages of formation and development and the simple discovery of one of its elements, including the sequence or partial sequence of a gene; and
iv) inventions of which the commercial exploitation of, would be contrary to ordre public or morality
However, the Directive does allow for the patenting of an invention based on an element isolated from the human body or otherwise produced by means of a technical process, which is industrially applicable, even where the structure of that element is identical to that of the natural element.
This means that an isolated gene or gene sequence, or other element isolated from an animal or plant, is patentable provided that its function is known and a suitable industrial application is derived from that product. However, no rights are given to that product when found in its natural environment.
The Directive also allows for the patenting of plants and animals provided that the application of the invention is not technically confined to a single plant or animal variety. This means that a patent for a novel gene sequence that confers a benefit to a plant will extend to any plant in which the gene has been artificially inserted.
Although the Directive came into force on 30 July 2000, the Netherlands sought an annulment of the directive under the EC Treaty. Italy and Norway also supported this action. However, earlier this year (2001) the arguments made by the Netherlands were rejected, and the validity of the Directive upheld by the European Court of Justice.
It is now hoped that the Directive will provide some certainty in the patenting of biotechnological inventions and bring the system more into line with the rest of the world. However, careful patent drafting will still be important for obtaining effective protection in Europe.
This is a general summary only and should not be taken as a substitute for specific advice.
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Baldwin Shelston WatersEmail: email@bsw.com
November 2001