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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    a SS SS SSS 8 February 1995] [Continued The question is why should the gene (or more properly the DNA which makes up the gene) per se be patentable? The answer is that patents are granted for things as well as for processes. DNA is a chemical substance, and chemical substances are a category of “things” which can be patented. Even naturally occurring substances can be patented, if their existence was previously unknown or not accessible to the skilled person in an obvious or routine manner. That is part of the patent practice in almost all countries, and it is not going to change in the foreseeable future. It works well enough in most cases. If it is thought not to work well enough in the case of gene-derived DNA, then it is for those who think that to show clearly, and not be mere slogans and other waffle (I am not referring here to the members of the Committee), precisely what is the overwhelming harm that is being done, that would justify and be remedied by making an ad hoc exception to the general rule of patentability in the case of gene-derived DNA, whether human or otherwise. 6. (From Dr Lynne Jones) It is reasonable that other later workers should be obliged to pay royalties for their inventions relating to the use of a patented gene, even though it owes nothing to the earlier patent disclosure? The general assumption is that the initial “discovery” of the gene (the cloning and isolation of its DNA and the elucidation of its sequence) is seminal to the later work; that the later workers could not obviously have made their developments without that information. On that basis, therefore, the later invention would owe an essential element to the original patented invention. The problem in practice is usually, not that royalty payments are demanded, but whether the patentee is willing to grant a licence at all. Then one can worry about the size of the royalty and other conditions demanded by the patentee. However, the latter worry is largely a commercial concern; and pure research is probably only inhibited to the extent that a commercial source of research funding may be denied if the sponsor considers it unlikely that a licence under reasonable terms will be obtainable from the earlier patentee. 7. (From Dr Alan Williams) Is the assessment of inventive activity much less than it used to be? (presumably implying a fall in the standard of patent office examination of patent applications) I do not think so. Certainly, with the 1977 Patents Act the UK Patent Office has, for the first time, been empowered to assess patent applications for “inventive step” during the examination procedure. There is a problem in biotechnology that the protocols for doing the research often look simple, but their execution can be horribly difficult. Questions such as these were addressed by the Court of Appeal in this country in connection with the case of Genentech vs Wellcome in 1987, and they held that Genetech’s work in that case was not inventive. I think that the Court took too abstract a view of the matter; failing to relate the granting and maintaining of patents to their commercial function in protecting and rewarding investment in research and innovation. However, I would hardly have expected the British courts to consider such matters; it goes totally against the British legal tradition. In contrast, the European Patent Office, perhaps encouraged by the express concerns of the EU Commission that the patent system should have this function and not disadvantage European industry in relation to eg USA, has taken a much more pragmatic line in assessing inventive step in this new and difficult terrain. 8. (From Anne Campbell) Does the patenting of gene sequences inhibit the funding of scientific research into developments based on something that has been patented? There is some evidence that it does (from my own experience). “Blue skies” research funding of course has no strings (or shouldn’t have), but the prospect of not being able to exploit commercially research results because of an existing patent can inhibit commercial funding of a research project, or the chances of the research results being taken up by a commercial partner, or the setting up of a new enterprise to exploit the research results. I believe that there are instances in all those categories, but I also suspect that they form a very small part of the whole spectrum of commercial activity. Nevertheless, I do feel quite strongly that one should nurture these small seedling projects, as they are a source of many exciting enterprises (who often go on to adopt just the sort of defensive and exclusive patent policies themselves in turn!). 9. (Comment from the Comptroller-General) During examination of patent applications we err on the side of granting the patent because all our decisions are challengeable in the courts It is probably true that the UK Patent Office gives the benefit of the doubt to the patent applicant. This is probably true to a lesser extent also of the European Patent Office, although I doubt whether the officials of the EPO would so readily admit it.