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TITLE:  Nuffield Council on Bioethics urges caution in patenting DNA
SOURCE: Nuffield Council on Bioethics, UK
        http://www.nuffieldbioethics.org/press/pr_0000000321.asp
DATE:   July 23, 2002

------------------ archive: http://www.gene.ch/genet.html ------------------


Nuffield Council on Bioethics urges caution in patenting DNA

Patents involving DNA sequences should be the exception rather than the 
rule, according to a paper published today (23 July) by the Nuffield 
Council on Bioethics. The Discussion Paper <http://
www.nuffieldbioethics.org/filelibrary/pdf/theethicsofpatentingdna.pdf>, The 
ethics of patenting DNA, recommends a number of significant changes to the 
way that patents are granted involving DNA sequences.



The Discussion Paper, prepared by an international group of experts, 
proposes an ethical framework for gene patenting with recommendations aimed 
at policy-makers, courts, patent lawyers and patent offices. 'We are 
concerned that, for patents involving DNA, the patent system is in danger 
of not achieving its main goal - to stimulate innovation for the public 
good. We believe that the Council's recommendations would safeguard against 
this situation,' comments Dr Sandy Thomas, Director of the Nuffield Council 
on Bioethics.

'It is important to question whether patents involving genes could 
adversely affect healthcare and research,' continues Dr Thomas. Diagnostic 
tests and medicines could become unaffordable or unavailable, the 
development of new ones might be slowed down, and research could be 
inhibited. The Paper aims to address these concerns. 'The Council calls on 
patent offices worldwide to work together to examine ways to ensure that 
the patent system is fairly, but rigorously applied in the case of DNA.'

Currently, the patent system considers DNA sequences as eligible for 
patenting, once isolated from their natural environment. 'But even if DNA 
is, in principle, eligible for patenting, it does not mean that each and 
every application for a patent should be granted' explains Dr. Thomas. At 
present each application must also satisfy three legal tests: it must be 
novel, inventive and useful. When applied to DNA sequences, the Nuffield 
Council argues that these three tests are increasingly problematic. 'It is 
vital that the tests of inventiveness and usefulness should be more 
rigorously applied,' insists Martin Bobrow, Professor of Medical Genetics 
and one of the authors of the paper. 'If this happens, it should 
substantially reduce the number of patents granted involving DNA sequences.'


- 'Inventiveness'

The process of isolating a gene has changed dramatically in the past ten 
years. It is now possible, for example, to identify a gene simply by using 
a database made by others. The Paper concludes that the identification of 
DNA sequences through the use of such computational techniques should not 
be regarded as 'inventive'.

Several types of patents involving DNA would be unlikely to be granted if 
the test of 'inventiveness' were stringently applied. When a gene is 
associated with a disease, the DNA sequence can be used as a diagnostic 
test, for example for breast cancer, or as a target for gene therapy, for 
example to treat haemophilia. But should that DNA sequence itself be 
patentable? 'We feel that once the link between gene and disease is 
identified, the use of the gene, for diagnosis or therapy is obvious. It 
therefore does not fulfil the inventive (or 'non-obvious') test. Patents 
involving a DNA sequence as a diagnostic test or for gene therapy should 
rarely be granted,' continues Professor Bobrow. 'In the case of a 
diagnostic test, a patent on the use of the sequence may be acceptable, but 
the patent should be restricted to the particular test specified'.


- 'Usefulness'

This test should also be rigorously applied. Some medicines, or therapeutic 
proteins, can be produced directly from a DNA sequence, for example 
insulin. 'In such cases, we accept that the test for usefulness is fully 
met, and a patent on the DNA sequence itself, to produce a specific 
protein, is justifiable,' says Professor Bobrow. However, some patents are 
filed for DNA sequences that do not have any immediate therapeutic use but 
which may be important for research. The Paper recommends that granting 
patents involving DNA sequences which are to be used as research tools 
should be discouraged.

The Paper recognises that the patent system should reward people for useful 
new ideas and inventions but argues that, in the case of DNA sequences, the 
balance is currently too firmly in favour of the claimant. 'One specific 
problem which we considered is the fact that one gene often gives rise to 
more than one product. This means that it is quite common to find an 
entirely new use for a DNA sequence after it has been patented. If a patent 
protects all the uses of a sequence, this can give extensive, and in our 
view unjustified, rewards to the original researcher,' comments Dr Thomas. 
The Paper notes that some patents that have already been granted are of 
doubtful validity and makes a number of recommendations to limit the 
possible adverse effects of these patents.

For further information

The paper will be launched at a press conference on Tuesday, 23 July, 
10.00am at One, Great George Street, Westminster. For further information 
please contact Nicola Perrin on +44-20 7681 9627 or e-mail: 
bioethics@nuffieldfoundation.org

Notes to Editor
1. Copies of the Paper are available to download from the Council website at
http://www.nuffieldbioethics.org
2.For a printed copy (costing 3 including p&p) please
e-mail: bioethics@nuffieldbioethics.org.
3. The Nuffield Council on Bioethics is an independent body which examines 
the ethical issues raisedby developments in medicine and biology. 
Established in 1991, it is funded by The Nuffield Foundation, the Medical 
Research Council and The Wellcome Trust.
www.nuffieldbioethics.org
4. Membership of the Round Table Meeting
Professor Tom Baldwin Head of Department of Philosophy, University of York 
and member of the Nuffield Council on Bioethics
Professor John Barton George E. Osborne Professor of Law, Stanford Law 
School, USA
Professor Martin Bobrow CBE Head of Department of Medical Genetics, 
University of Cambridge and Deputy Chairman of the Nuffield Council on 
Bioethics
Professor Sir Brian Heap CBE FRS Master, St Edmund's College, University of 
Cambridge and member of the Nuffield Council on Bioethics (until December 
2001)
Hon Mr Justice Jacob Judge of the High Court, Chancery Division
Professor Dame Marilyn Strathern Mistress of Girton College, Cambridge and 
William Wyse Professor of Social Anthropology and member of the Nuffield 
Council on Bioethics
Professor Michael Stratton Head of the Cancer Genome Project, The Sanger 
Centre, Cambridge
Professor Joseph Straus Managing Director, Max Planck Institute for Foreign 
and International Patent, Copyright and Competition Law, Germany
Dr Alan Williamson Consultant for biotechnology and member of the Nuffield 
Council on Bioethics

 

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