Human genetics : minutes of evidence, Wednesday 8 February 1995 ... / Science and Technology Committee.

  • Great Britain. Parliament. House of Commons. Select Committee on Science and Technology
Date:
[1995], ©1995
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Licence: Open Government Licence

Credit: Human genetics : minutes of evidence, Wednesday 8 February 1995 ... / Science and Technology Committee. Source: Wellcome Collection.

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    8 February 1995] [Continued Memorandum from Mr Ian Armitage following oral evidence given on 8 February 1. What would count as a discovery, and so be unpatentable, and what as an invention? There is no doubt that the elucidation of the sequence (formula) of a naturally occuring gene or other DNA constitutes a “discovery”, and “as such” is specifically excluded from patentability in Europe at least. However, many patentable inventions are based on discoveries, and it is an integral aspect of the patent system, which is certainly not going to change in the foreseeable future. Such inventions arise in virtually all fields of technology, and biotechnology is not peculiar in that respect. The question, therefore, is the meaning of “as such”; and related to this, the nature and extent of the patent protection that is allowed based on such a discovery. One must distinguish between the DNA sequence and the DNA itself. The “sequence” is the chemical formula of the DNA, and is therefore mere “information”. One cannot therefore patent “the sequence”. As the opponents of patentability in this area would say: “the sequence is God-given” (or words to that effect). The DNA however is a chemical substance, of precisely known (or knowable) structure and formula. It can be manufactured on an industrial scale, whether by extraction from a natural source or by chemical or biochemical synthesis; it can be bought and sold, and held in the palm of your hand. It is therefore not information “as such”. It is now firmly established in patent law and practice in virtually all countries that one can patent a chemical substance per se, so long as it has the necessary qualities of “novelty” and “inventiveness”, and that its production can be carried out on the basis of the patent disclosure. One may debate whether there can be “novelty” in a chemical substance which already exists in nature, and whether there can be “inventiveness” in isolating and characterising the substance and describing how it can be made or obtained. Suffice it to say for the present purposes that under the principles of patent law and practice, the answer is “yes” to both questions. This is a genie that will not go back in the bottle. Therefore, provided that the specific circumstances of the individual case indicate that the requirements of novelty, inventiveness and sufficiency of patent disclosure are met, the DNA (the chemical substance per se) which represents a gene or a part of a gene is patentable, and will continue to be so, unless specific law is made to exclude it from patentability. The making of such ad hoc law should, in my view, only be undertaken when there is an overwhelming requirement for it. In general, ad hoc law tends to create more problems than it solves. I comment on this below. 2. Would other IP protection mechanisms, eg, copyright, be appropriate for protecting DNA sequences (not developments based on them)? No. Copyright is in principle intended to protect an author’s artistic creations. One can ignore the “artistic” bit, which is very loosely interpreted; but so far as natural DNA sequences are concerned, of course, these have not been “created” by the hand or mind of man, and so should not be regarded as the copyright of anyone. So far as artificially devised DNA sequences are concerned, these have been devised by the hand or mind of man, and can therefore constitute a patentable invention in the normal, and largely uncontroversial, manner. The contentious issue largely concerns natural DNA sequences; and copyright simply isn’t a suitable form of IP protection for the sequences (ie, the sequence “information” per se. There is however a possible area in which copyright might be applied; and that is in relation to the protection of the DNA sequence information which is stored on the databases (or in the lab notebooks etc) of the scientists who discover them. That would be to prevent others from copying the sequence information derived from that source. It would not prevent others from elucidating the sequence information independently. This kind of copyright protection, if it existed under the present copyright law or some special addition to that law (as was done for computer programmes), would however be primarily for the benefit of those who have such databases, and would create additional restrictions on the use of such research results, thereby only aggravating the concerns of those who want to see such results made more freely available. In short, I think it is a non-starter.