BSHG Statement on
PATENTING AND CLINICAL GENETICS

Feb 1998

We recognise the importance of patent protection, in allowing the development of diagnostic and therapeutic products, for the benefit of health care. We distinguish a number of different situations:

Novel techniques, apparatus or procedures for use in clinical genetics

We view these as inventions in the conventional sense of the word, which ought to have the protection of patent law, subject to the normal restrictions on monopoly abuse.

Patents on fragmentary sequences from human DNA, of no known function or utility

We do not believe that such sequences should be patentable, partly because of the lack of demonstrable utility and partly because of the inevitable and unnecessary confusion which would arise when several groups were found to hold patents on parts of the same overall functioning sequence.

Human gene sequences of known function and utility

(i) A natural gene sequence is not an invention, but is a discovered product of nature.

(ii) A natural human gene sequence is part of the human body, and as such should not be patentable. The suggestion that such a sequence might be patentable if it is "isolated in a pure form" or "isolated outside of the body" seems to us a sophistry, and should not be allowed.

(iii) There is only one consensus of normal human sequence. If the sequence as such is patentable, it will not be possible for anyone at any time to devise a better or different way of genetic diagnosis; this is inequitable.

(iv) Cloning a novel gene using one of the limited number of generally applicable cloning procedures requires skill and application, but not originality. If anybody has a claim to a patentable invention it is the originators of the procedures, not the laboratory which happened to come out ahead of the competition in applying the method

For these reasons, the Society is, in principle, against the granting of patents on human gene sequences.

The utilitarian argument against this stance, that lack of patent protection would discourage commercial enterprises from engaging in gene isolation, does not persuade us. First, any such discouragement is probably inevitable. There are a very large number of human genes which will be cloned over the next several years. On the test of novelty, patents may be granted on some of the first to be cloned but refused on others, just as useful or important, which are cloned later using the same methods. Allowing some patents will only produce arbitariness and inequity. Second, most gene isolation to date has been done by public sector institutions, using government and charity funds, and greatly helped by the free interchange of materials and information which has up to now been the norm in the non-commercial section, but which is threatened by the rise of gene patenting.

Our opposition does not extend to the patenting of specific constructs containing human gene sequences which have particular utility. For example, a human gene sequence in a particular vector with a particular promoter might have utility for therapy; or an artificial construct might have specific value as a diagnostic reagent. These would be inventions, designed by human ingenuity, and in our view would be properly patentable if novel, non-obvious and useful. But we note that attempts at defensive patenting of natural gene sequences are already involving academic and commercial organisations in considerable work and expense, to the detriment of wider interest of society. There is an urgent need to send a clear signal that such patents will not be allowed.