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 5. To what extent does the ability to patent genes distort companies’ research priorities? [Not really for me to comment.] 6. To what extent can patent offices detect claims that are too far removed from the patent to be easily achievable? It is well established that one patent monopoly can validly dominate later (patentable) inventions, eg for an unobvious improvement or development of the basic invention. However, sometimes a patent monopoly can be unacceptably broad, in the sense that it specifically monopolises that which the original inventors have not invented. In the case of the CF research, the original researchers who elucidated the CF gene would have foreseen the possibility that this could lead to some kind of therapy for CF, but it was most unlikely that they could at that time have predicted precisely what it would be, and have provided in their patent an enabling disclosure for such a therapy. Therefore, one might say that if their patent included a claim specifically to the therapeutic use of the DNA or the protein encoded thereby, that would have been unreasonably broad, since it was an invention yet to be made. Unfortunately (in my view, and the view of many others), there is a lacuna in the present European patent law which tends to exclude any effective challenge to the patent after grant on the ground of undue breadth of claim; so it depends very much on the patent office examiner getting it right before grant, and there have been some cases where people feel quite strongly that the examiner got it wrong. However, even with an amendment to the patent law in Europe to remedy this, I am not sure that it will really address the underlying question (problem) here. In the notional scenario indicated above (with reference to a CF-type of case), the claims to the DNA and the encoded protein would probably not be affected by such an amendment to the patent law, since they are not directed specifically to an invention yet to be made (such as CF therapy), but to an invention that clearly has been made, and described in the patent. What therefore could or should be done to alleviate the perceived problem of inhibition of “downstream” research? Indeed, is it a real and substantial problem at all? There are many aspects on which scientists have expressed concern to my knowledge. Some of these are better founded than others; some are based on misunderstandings of patent law, and are alleviated to some extent when the law is explained to them. I will just consider the aspect indicated above, of dominating patents (eg including claims to natural DNA and protein encoded thereby) inhibiting the commercial funding and exploitation of research by others based on the original patented disclosure. The main problem, as I see it, is uncertainty. Those funding the later research need to know that they can exploit the results and get a return on their investment. They need to know that they will not be held to ransom by the dominating patentee (ie the licence terms will be reasonable). There are compulsory licence provisions in the patent laws of most countries, but primarily to prevent abuses of monopoly, and to protect the public interest (eg if the exploitation of an important invention is being prevented by the dominating patent). However, the compulsory licence provisions are seldom used, and therefore there is very little body of law on which to base good advice to the later researchers and their backers. Also, it takes years before you can even start a legal action to obtain a compulsory licence. I do not need to go into detailed discussion of this question here. It would be a major subject in itself. Suffice it to say that, in my view, a modification of the compulsory licence laws, and their harmonisation throughout the patent laws of the major industrial countries, would be a much better way of addressing the most serious and legitimate concerns of science and industry, than any kind of ad hoc legislation to exclude certain specific types of subject matter from patentability. COMMENTS ARISING OUT OF THE MEETING OF THE COMMITTEE ON 8 JANUARY 1995 A. ARISING OUT OF THE QUESTIONS TO THE PATENT OFFICE REPRESENTATIVES 1. (From Dr Lynne Jones) Is there a value in national patent offices alongside the EPO? Limited value in the biotechnology field, in my experience. Inventions in that area are generally expected to be exploited on a very wide scale, so that very few will be interested in obtaining patents in just UK or one or two individual countries. The emphasis is increasingly in centralisation of patent application and grant procedures; and in principle that is generally beneficial.