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UK Think-tank Urges Tougher Tests For Gene Patents

LONDON - On July 23, the UK-based Nuffield Council on Bioethics released a report entitled "The Ethics of Patenting DNA." The report sought to examine issues of genetics and intellectual property, particularly those that concern research related to human healthcare. It also sought to provide an ethical framework and recommendations that may be used by policy makers and others.


The report, which took more than two years to write, is a timely discussion of the ethical and public interest arguments against patents covering DNA. It says that patents are essential to stimulate and reward innovation, and states that the law covering the patentability of gene sequences is currently too lenient. 


The paper is based on the well-rehearsed arguments surrounding DNA patents: Supporters argue that IP on DNA is essential to stimulate investment in R&D in new health-care products and processes, while opponents contend that these patents hinder new-product development and limit access to health care by increasing costs and inhibiting the free exchange of information and materials.


The authors of the report examine and negate three arguments against patenting DNA: the special status or nature of DNA; the legal criteria for patents; and the potential deleterious consequences DNA patents can have on health care and research.


In the first case, they examine the classical argument that patenting an individual's DNA should be disallowed because DNA is part of man's common heritage. The authors rightly counter this argument by observing that DNA patents can only relate to isolated versions of such sequences, which are held to be patentable under Article 5 of the European Biotechnology Directive, since technical effort is required to isolate the sequence from its natural environment. In other words, the authors contend, sequences are not naturally occurring.


In the second case, the report, citing legal criteria enshrined in US and European patent laws, discusses the extent to which IP for DNA sequences is and should be eligible for patenting. The authors admit that the requirement of novelty is not a strong factor against the patenting of DNA. As they point out, the isolation of a gene from its natural environment is sufficient to show that a novel product has been created. 


They write, for example, that techniques used to clone and isolate genes today are very different from those previously employed; whereas researchers may have relied on positional cloning, they now employ a combination of computational and cloning techniques to identify novel sequences.


They also write that technological advances have made the process of isolating a gene commonplace rather than inventive, even if the resulting sequence codes for a novel product. As a result, they have called for patent offices to apply a stringent test for inventive step.


The authors agree with the European test for obviousness--whether isolating a gene would have been obvious to a person skilled in the science, with regard to the prevailing science at the time, irrespective of whether the sequence itself was structurally obvious or not. 

Finally, the report discusses certain issues relating to patents over DNA, such as diagnostic tests, research tools, gene therapy and therapeutic proteins. In general, the authors take the view that patents over genes have stifled innovation in all these areas. In this regard, it is also worth noting two recent bills put before the US House of Representatives by Rep. Lynn Rivers (D-Mich.).


The first requires that the White House conduct a study "that assesses the impact of Federal policies, including intellectual property policies, on the innovation process for genomic technologies." It has been said that the study could easily be biased against gene patents. 


The second bill, H.R. 3967, provides for an exception to patent infringement for non-commercial research, and for physicians who use certain diagnostic tests.  The bills have been met with scepticism. Furthermore, the need for such legislation is questioned given the existence of a research exemption in US law and the fact that diagnostic kits are generally reasonably priced and readily licensed by patentees.


To be sure, the report is nothing more that a discussion paper--lawmakers, policy makers, or patent offices are not bound by its recommendations. Nonetheless, the pre-eminence of many of those contributing has guaranteed it a level of respect.

Penny Gilbert is a partner and Antony Rumboll is an Assistant Solicitor in the Bio/Pharma group of the UK law firm Bristows.

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