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 3. What might be the consequences of simply declaring naturally occurring sequences unpatentable? This would bea piece of ad hoc legislation of the type I referred to above. It would create a special exception to an established category of patentable subject matter (chemical substances per se). As I suggested, there ought to be overwhelming need for such legislation before it is introduced; and I do not see such a need at present, partly because the problems with the persent situation (insofar as there are any) are not shown to be sufficiently serious, and are not necessarily addressed adequately by such a move. Also, it would be a measure difficult to define and enforce. I indicated above that ad hoc legislation can introduce more problems than it solves. In particular, it creates a new and extended legal borderline, which then has to be interpreted by the courts in “borderline” cases, to the obvious benefit of lawyers, but few others. For example, would the exclusion apply to sub-fragments of naturally occurring sequences; and if so how small? As you get to DNA fragments which are below about 20 bases, you are entering the region where it becomes statistically likely that any DNA sequence you care to think of will in fact occur in nature. And does the exclusion apply if the natural DNA sequence is modified or has a different DNA sequence added to it? This is the normal situation in practice when one is utilising natural DNA sequence information. And would a patent on an apparently non-natural DNA sequence suddenly become invalid if it were discovered that the sequence does in fact occur in nature? These are just some of the joys that await the introduction of such a measure, and one could foresee many others. 4. What is or will be the effect of the patent system on research? One could perhaps look at the kind of patent claim which is produced at present, and which is presumably the target of such a proposal. The research team elucidates the DNA sequence of part of a natural gene; a result which is of some importance and potential benefit to mankind. (The “cystic fibrosis gene” is a case in point). Note that they would probably not elucidate, at that stage at least, the entire gene; and it is seldom that the entire gene would be required for any practical application of that discovery. Indeed, with human genes it is usually a very small (albeit very important) part of the natural gene that is required. Suppose the actual or potential practical applications include (as they did for CF) a diagnostic test, the therapeutic administration of the protein encoded by the “normal” gene (ie the gene not having the defect), and the therapeutic administration of a (usually non-natural) form of the normal gene suitable for generating the protein in situ in the patient. One of the monopoly claims which I would expect the inventors to include in the patent would be along the lines: A DNA isolate encoding a protein having the amino acid sequence depicted [in the patent] and having the property.....[eg of doing that which the normal gene does in non-CF individuals]. Another would be: A DNA sequence containing the [eg CF] defect depicted [in the patent] and capable of distinguishing by hybridisation between a gene carrying that defect and a gene not carrying that defect. Yet another would be: A protein having an amino acid sequence depicted [in the patent] and having the property . . . [eg of doing that which the normal protein does in non-CF individuals]. There would be other claims, eg to diagnostic kits and therapeutic formulations, but the above type of claims are probably the ones that would have the most restrictive effect on the activities of others who were seeking to build upon the original work. Other scientists may legitimately want to build upon that work, and it is certainly in the public interest that they should be able to do so. They may have been already involved in the same line of investigation when they were “beaten to it” by their rivals, or they may start on it after seeing the initial results. The foregoing type of patent claims do not prevent such research, since non-commercial research based on the patented invention is not an infringement of the patent. The problem is that they may not be able to get commercial funding or to develop commercial enterprises for the exploitation of their further work, eg because it is unclear whether licences will be available under the original patent, or the terms of such a licence are too onerous.