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Reporting on its project on the ethics of patenting DNA, the Nuffield Council on Bioethics has recommended that more stringent criteria for inventiveness and utility should be applied to applications for patent protection of DNA sequences. The Working Group that produced the report argues that now positional cloning to find genes has been largely superseded by computational techniques, it has become increasingly difficult to support the contention that an inventive step is involved in determining a gene sequence. The Group also takes the view that a credible use for a particular sequence should have to be shown in order for it to pass the test of “utility”; a theoretical use should not be sufficient.

The report then moves on to consider the four major types of patentable application of DNA sequence information: in diagnostic tests, as research tools, in gene therapy, and in the production of therapeutic proteins. It suggests that, rather than granting a product patent that covers all uses of the sequence, patent offices should instead grant a “use” patent that covers only a specific diagnostic test so that development of other (perhaps better) tests is not hindered. In cases where patents have already been granted, there may need to be more recourse to compulsory licensing if a patent holder refuses to grant licences on reasonable terms. Considering the granting of patent rights over DNA sequences as research tools, the report suggests that this should be the exception rather than the norm, and that this outcome can be achieved by stringent tests of the sequence’s claimed utility. The report warns in general against the granting of excessively broad patents (for example, patents on partial sequence information that also cover the entire sequence, or patents on a gene sequence that also cover all proteins encoded by it), and against the practice of exclusive licensing by patent holders, which can stifle research. In the area of gene replacement therapy for single-gene diseases, the opinion of the group is that the simple use of the gene itself in this context is obvious and not patentable, but that it should be possible to patent the technology needed to make gene replacement therapy work.

Finally, the Group recommends that, in view of the ethical and public-interest aspects of patenting DNA sequences, there should be clearer guidance as to the criteria for refusing a patent on the grounds that it is contrary to morality or “ordre public”. At several points throughout the report, the Working Group suggests a coordinated approach by joint working of the US Patent Office, the European Patent Office and the Japan Patent Office.