TITLE: DNA patents: putting an end to "business as usual" AUTHOR: The Editors, The Lancet PUBLICATION: The Lancet, Vol 360, Number 9330 DATE: 3 August 2002 URL: http://www.thelancet.com/journal NOTE: The Nuffield Council on Bioethics is a British think tank of international repute. Their 109-page report, "The Ethics of Patenting DNA: A Discussion paper", can be downloaded from http://www.nuffieldbioethics.org/publications/pp_0000000014 .asp The below is a commentary from the editors of The Lancet, the UK's premier medical journal, on the report's findings. The Lancet Vol 360, No 9330, 3 August 2002 DNA PATENTS: PUTTING AN END TO "BUSINESS AS USUAL" Editorial "The patent system added the fuel of interest to the fire of genius". Abraham Lincoln, the only US President ever to hold a patent, might well be more sceptical today, in light of the more than 3 million genome-related patents that have been filed in recent years. The current patent system appears to add the fuel of greed and monopoly to a flicker of discovery. Concerns about the explosion of patents on DNA sequences led the Nuffield Council on Bioethics on July 23 to issue a discussion paper that calls for more rigorous standards for granting these patents ( http://www.nuffieldbioethics.org/home/ ). It also raises questions about the effectiveness of the current system, including the crucial ethical issue of whether it serves the public good. The report thoughtfully distinguishes among four uses of DNA sequences: diagnostic tests, research tools, gene therapy, and the production of therapeutic proteins. These distinctions are important because the incentive to develop commercial products may be less necessary for diagnostic tests and research tools than for therapeutics. Some patents, such as for the BRCA-1 gene, have created a monopoly by asserting rights over the gene sequence and its mutations, as well as for diagnostic tests. Although the report allows "use patents" for specific tests, it discourages exclusive rights for diagnostic tests, recommending compulsory licensing in such cases. The discussion paper rejects patents for DNA sequences used as research tools. It would allow research, usually in an academic setting, on patented inventions, provided it is not intended for commercial gain. (A research-exemption bill for gene patents is now pending in the US House of Representatives.) Gene therapy patents should rarely be granted; once the gene for the disease has been identified, the DNA sequences used to alleviate the effects of mutations are obvious. Instead, patent protection should focus on methods of gene delivery. The report accepts patent rights, narrowly defined, for gene products (therapeutic proteins) used to develop medicines. The reasoning behind the recommendations centres on the criteria that all patents must meet, which include novelty, usefulness, non-obviousness, and inventiveness. Usefulness and inventiveness have proved particularly problematic. Whereas isolation of the earliest DNA sequences required a great deal of inventiveness, much sequencing now takes place through computational techniques, weakening claims of inventiveness. And usefulness has been challenged on the grounds that many patents are awarded for uses that are only speculative. A historically overgenerous system should now raise the bar, such that patents on DNA sequences become the exception rather than the rule. The report suggests that many existing patents may be invalid. Empirical evidence for this conclusion is hard to come by; proving it would be time-consuming and prohibitively expensive. Nevertheless, examination of a sample of patents might provide useful data on a range of issues, including the nature and extent of invalidity and the number of overlapping patents. The Nuffield discussion paper is a pragmatic examination of an issue with profound legal, moral, and social implications. The document acknowledges a shift in focus, from whether DNA sequences ought to be patented at all -- an act many people find morally repugnant on its face -- to how such patents are used. Yet even if the public is willing to concede this point, other issues must be considered, enlarging and deepening the debate on whether the current system serves the public good. It has been argued that DNA patents often force the public to pay twice: first, in the form of tax dollars awarded as government research grants, and then to the patent holders for access to the inventions. Further, the role of patients, as donors of materials from which patents may arise, must be addressed. How do principles of justice and fairness apply here? What is the proper balance between altruism and reward? Finally, the report recommends that patent offices seek ethical guidance on these issues. A system of formal review by independent advisors, including lay people, ethicists, religious leaders, and scientists, may be advisable for addressing the often formidable implications of DNA patents. The Lancet