The Biotech Directive - Recent Developments
Since the Biotech Directive came into force in July, 2000, the European Commission has produced two reports covering the developments and implications of patent law in the field of biotechnology and genetic engineering, relating to the Directive. The first report was published in October, 2002. The Commission has recently produced a second report focussing on the following complex and sensitive topics, discussed below:
Scope of patents on sequences of genes which have been isolated from the human body
The question considered by the Commission was whether patents on gene sequences should be allowed according to the classical model of a patent claim, whereby a first inventor can claim an invention which covers possible future uses of that sequence, or whether the patent should be restricted so that only the specific use disclosed in the patent application can be claimed (referred to as “purpose-bound protection”). It is to be noted that “purpose-bound protection” is already allowed by the EPO in the form of second medical use claims, also called “Swiss claims”, if the new use of a known substance is patentable. A typical form of such a claim is: “Use of X in the manufacture of a medicament for the treatment of disease Y”.
EU Members States have differed by providing either a broad or a limited scope of protection. Most States provide “absolute” patent protection according to the classical model of a claim. However, two countries, France and Germany, have chosen a more restricted route of protection. France has banned the patenting of human gene sequences, and Germany has chosen to limit patent protection to only the specific use disclosed in the application, i.e. “purpose-bound protection”. While the Commission concludes that there are no objective grounds for limiting the protection relating to sequences or partial sequences of human genes, it has decided to withhold judgement on whether these Member States have correctly or incorrectly implemented the Directive. Instead, the Commission has decided to simply monitor whether there are any economic consequences arising from such divergences. No doubt a number of biotechnological companies will be disappointed that the Commission has not taken a firmer stand on the differences in implementation of the Directive for the patenting of human gene sequences.
Patentability of human stem cells and cell lines
In relation to the complex issue of stem cells, the Commission makes a differentiation between embryonic totipotent stem cells, which can develop into a human being, and embryonic pluripotent stem cells, which do not have this ability. The Commission confirms that the Biotech Directive is clear regarding totipotent cells, arguing that such cells cannot be patented as each cell could develop into a human being. In the words of the Commission, totipotent stem cells should not be patentable “on grounds of human dignity”.
With regard to the patentability of inventions relating to pluripotent stem cells (those which can develop into other types of cell but are not capable of developing into a human being), the Commission finds the situation more complex. The Directive allows Member States to refuse patents on ethical grounds. Given that there are differences between Member States on the issue of embryonic stem cells, the Commission has decided not to take a position on harmonising rules on the use of pluripotent stem cells, and the Commission therefore proposes to monitor developments in this area.
For a general overview of the Biotech Directive, click here
