The report published by the Nuffield Council on Bioethics, recommends a number of significant changes to the way that DNA patents are granted, and proposed that patents involving DNA sequences be allowed only in exceptional circumstances.
Professor Sheila McLean, Director of the Institute of Law and Ethics in Medicine at the University of Glasgow, said:
“This looks like an eminently sensible proposal, which will safeguard the interests of the inventor as well as the interests of the public.”
Professor Richard Gardner, Department of Zoology at Oxford University, said:
“The Nuffield Council recommendations seem both sensible and much needed to check the present patent mania regarding DNA sequences.”
Professor David Goldstein, Department of Biology, University College, London, said:
“I think the Nuffield Council on Bioethics gets the balance right in arguing that any patents for DNA sequences should be specific. I have for some time been troubled by the idea that someone could patent a DNA sequence without knowing anything about it, and then have some stake in any application that involves that sequence. This is not only contrary to the spirit of patent law, but it could easily constrain genetic research. The hard part is figuring out how to do something useful with a DNA sequence, and innovators might be discouraged if they had to share profits with someone who patented the sequence without any idea of what could be done with it.
“The Council’s focus on patenting the specific uses of sequences, including specific diagnostic applications, strikes a good balance between rewarding specific discoveries while allowing further innovation.”
Diana Sternfeld of the BioIndustry Association Intellectual Property Committee, said:
“The BIA is pleased to note that the Council does not suggest that genes should not be patentable, or that the statute law should be changed to make them unpatentable.
“The Council’s conclusion that the existing criteria for patentability – novelty, inventiveness and utility – make it ‘increasingly problematic’ for genes to be patented reflects the way patent law is supposed to work. As a technology develops, the level of skill in the field increases, and what may be regarded as inventive in the early days of a technology may become routine as the years pass. Applied genetics and recombinant DNA technology are no different from other technical fields in this respect.”
Dr Richard Marshall, Senior Research Fellow at the Centre for Respiratory Research, University College, London, said:
“As a clinician and researcher in the field of genetics, I feel that the principles of protecting patient interests and the potential for research are both strongly supported by the Nuffield report. I firmly believe that the fundamental information contained in the human genome is a resource that should be used for the benefit of mankind and should be universally available for non-commercial research purposes.
“Like many people, I am wary of the commercial influences that favour financial considerations over benefits to patients. However, I also appreciate that many of the potential benefits the genome offers us will not be realised without commercial development, and in this regard the document does allow for patenting where this knowledge is applied in a truly innovative manner. The Nuffield Council are to be commended for their excellent report in the difficult area of bioethics.”
Dr Robin Lovell-Badge, Head of Developmental Genetics at the National Institute for Medical Research, said:
“I think this report will be very useful. I agree that in most cases a simple DNA sequence should not be patentable. But it is not always so obvious that a particular DNA sequence causes a disease, and a considerable investment of time and resources may be involved in its discovery. In these cases it seems more reasonable that a company should be able to protect its investment and discovery with a patent.
“There will also be many cases where a perfectly novel and inventive genetic application does not rely on an exact DNA sequence. How will patent protection be guaranteed unless broad claims can be made?
“The Council recommends that granting patents involving DNA sequences which are to be used as research tools should be discouraged. However, the distinction between research and application is often blurred. Moreover, the applications themselves are often obvious or use a methodology that is already patented. Once the sequences are in the public domain it is then too late to obtain any patent protection.
“Finally, the rules would have to apply to all to be effective. How can this be achieved when there are already significant differences in the way that patents are applied for and granted between Europe, the USA and the rest of the world?”
Maggie Ponder, chair of the Genetic Interest Group, said:
“Families and individuals affected by genetic disorders wish to see the speediest development of new understanding and techniques. They also want to see the affordable application of this knowledge and technology. In the view of the Genetic Interest Group, the Nuffield Council have struck the right balance between what can be competing pressures in both research and applications.
“With ever-improving methods for isolating and characterising genes and their protein products, the presumption today must be that the mere isolation of a gene should not be sufficient grounds for a successful patent application. Companies should be encouraged to work at a higher level of innovation and understanding, in the development of novel targets and therapeutics which are deserving of patent protection.”
Dr Sandra Knapp, Botanist at the Natural History Museum, said:
“I think that the Nuffield Council are right to be cautious about granting patents for DNA sequences. Such sequences are useful for much more than just medicines – if a bit of DNA is patented it could stifle basic research of all kinds, not just medical research useful to humans.”
Dorothy Nelkin, Professor of Law and Sociology at New York University, said:
“The interests of the public may be compromised by current patent practices in three ways. First, patenting restricts data sharing among scientists, which may impede useful research. Second, patenting can restrict the information available to the public through open publication. Third, the rush to patent can influence the quality of medical care, because of licensing constraints and conflicts of interest. With this in mind, I think that the Nuffield Report makes some excellent recommendations.”
1) The BioIndustry Association is the trade association for innovative enterprises in the UK’s bioscience sector. (2) The Genetic Interest Group is a national alliance representing individuals and families affected by genetic disorders.