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 The Comptroller was wrong in one important respect, however, in that one cannot formally challenge after grant the decision of the patent office, whether the UK office or the EPO, on the ground that the breadth of the claims is not supported by the description. I have already commented on this; and it is obviously relevant to some of the Committee’s considerations. 10. (From Dr Jeremy Bray) A scientist cannot afford to challenge a patent This follows on from the Comptroller’s comment above. The Comptroller said that a scientist would be funded by eg MRC, who would be able to mount the challenge. However, I think that this is misconceived. Apart from the fact that most scientists are employed in industry; even if one takes those who are not, most are funded by grants or by their universities, and neither of these sources provide the funds for challenging patents; nor should they have to do so (which is why non-commercial research does not constitute infringement of a patent). MRC is one such funding body, and I am not aware of their ever having challenged a patent in the courts, and I would be surprised if they were to do so. It is of course true that an individual scientist could not afford the thousands of pounds that it would cost to mount an effective challenge to a patent. I do not think that it could be made much cheaper, since it is necessarily a difficult, complex an time-consuming process; nor indeed do I think it would make much difference even if it were much cheaper. Dr Bray’s point surely is that people should not have to challenge patents if the Patent Offices got it right during examination (and, by implication, did not so readily err on the side of the patent). This is at first sight an attractive argument; but from my experience I doubt whether it does in fact have much force. It gives the impression that there are hosts of invalid patents out there waiting to be challenged; that they are causing great inconvenience, which is not being alleviated because people cannot afford to challenge them. This is assuredly not the case. Most patents are probably immune to effective challenge; and most patents that cause serious inconvenience are challenged by industrial entities who can afford it. As I pointed out above, research scientists, and non-profit research organisations, generally do not even have to consider challenging patents, since non-commercial research on the patented invention does not constitute an infringement. It is when one wants to exploit commercially the results of that “downstream” research that the question of infringement of other peoples’ patents becomes important. From one point of view, it could be said that this then becomes a matter for the commercial partner (eg the pharmaceutical company) with whom the scientists collaborate to achieve the commercial exploitation. However, the assessment of commercial viability of exploitation of the research results, and in some cases the setting up of a new company to exploit the results, can be adversely affected by the risk of patent infringement. The problem may sometimes be acute at the individual level, but is small in relation to the whole picture. This may be changing, however, if broad patents are granted for the determination of gene sequences; so that in the foreseeable future, it would become very common to have to try and obtain, and of course pay for, a licence under someone else’s patent in order to utilise commercially a (human) gene. Dr Bray commented that it did not seem to be a requirement that such a patent had to describe the practical utility of the gene. I think that there is some force in this. In USA there is a more stringent requirement that the patent show the “utility” of the invention; and that may suffice to inhibit the patenting of these genes. We do not have such a strict requirement in the European patent laws, and DNA, being a chemical substance capable of manufacture, is regarded as “industrially applicable” irrespective of whether it has any known - practical use. While one might wish for a change in the European law in this respect. I think that the existing law could be more effectively used by the Patent Offices; notably by applying appropriately the requirements of inventive step, claim support and sufficiency of disclosure. The patent offices would doubtless say that they are already applying those principles “appropriately”, and from the perspective of the patent lawyer this is probably true. However, from the wider perspective of the patent system serving the community, and providing a balance between the public and commercial interests, the patent offices cannot be relied on to establish the ground rules themselves. In my view, they need guidance from those whose job it is to take this broader view. The proposed Directive could have been such an instrument, but unfortunately it seems to have tried to do too much in one go, and has got bogged down as a result. Better, in my view, to have gone for a series of short Directives on individual points; or even some lesser form of pronouncement which would nonetheless be noted by the patent offices in Europe (especially the EPO). 11. (From Sir Trevor Skeet) Should the UK Patent Office be concerned with ethical issues? No. Others have written cogently to the same effect; see for example the Letter and Memorandum by Professor Gerald Dworkin to the House of Lords Select Committee on the European Communities, Patent Protection for Biotechnological Inventions, Session 1993-94, 4th Report, pages 65-69.