Genes Not Eligible for Patents ############################## US supreme court’s final ruling on breast cancer gene patents should apply to all other gene patents, especially on deadly viruses such as the recent Middle Eastern Respiratory Syndrome virus Prof Peter Saunders Gene patents bad for science and bad for health Genes in humans and other organisms should not be patentable (see [1] Why Biotech Patents Are Patently Absurd, ISIS scientific publication). In the first place, they are discoveries, not inventions. The DNA sequences that people are claiming as their own existed in nature long before molecular biology was thought of. It’s as though Friedrich Wöhler, the first person to isolate aluminium, had been entitled to been able to patent not just the process by which he did it but the element itself. Patents are meant to be awarded only if there has been an inventive step that was not obvious to anyone ‘skilled in the art.’ This hardly applies to DNA sequencing, which has now become so routine that you can have your entire genome sequenced for $5000 [2]. Some claim that research will be hindered if laboratories cannot obtain patents on what they have found. On the contrary, it is patents and the pressure to obtain patents that can inhibit research. An important factor in the progress of science is that people and laboratories working in an area share their results and experience. That happens much less when there are patents and possibly large profits at stake. There is plenty of opportunity for patenting once the basic science has been done and the effort moves on to applications. To be sure, the boundary between pure and applied science is not always clear cut and there will be occasional border disputes, but we will have to cope with these, just as we cope with the many other grey areas of patent law. Two recent cases illustrate clearly how patenting can get in the way of science and health. One - concerning the breast cancer genes BRCA1 and BRCA2 - has been resolved by the recent decision of the US Supreme Court that naturally occurring genes cannot be patented. The other, involving a recently discovered virus that appeared in the Middle East about a year ago, is still to be resolved. BRCA1 and BRCA2 In 1990, a group at Berkley led by Mary-Claire King found that a gene associated with an increased risk of breast cancer was located on the long arm of chromosome 17. A number of laboratories set out to find the precise location of the gene and to sequence it; and to speed the work up they shared their results, as is usual in science – or used to be. In 1994, researchers at Myriad Genetics Inc. together with colleagues at the University of Utah, the US National Institutes of Health, and McGill University in Montreal, succeeded in determining the sequence of the gene. They immediately applied for and were awarded a patent. What exactly had the team done to deserve this patent and the monopoly that went with it? They had indeed been the first to sequence the gene. They had not been the first to suggest that such a gene exists. They had not worked out its approximate location in the genome, they had relied on results from other laboratories that were being freely shared in the manner that was then usual. In effect, they had put the last piece of a jigsaw into place and claimed ownership of the results of the whole project. The patents gave Myriad a monopoly and they took full advantage of it. Myriad offers diagnostic tests for BRCA1 and another similar gene BRCA2, and charges a high price for them. They also have not allowed other laboratories to produce tests for these genes. Not only has this almost certainly kept the price of the test high, it has also made it impossible to obtain a second opinion. In addition, it has had the perverse effect that where methods have been developed to test simultaneously for a range of possibly harmful mutations, the laboratories involved were forbidden to reveal the results for BRCA1 and BRCA2 to the woman who has undergone the test. Myriad’s patents were challenged, and the case went all the way to the US Supreme Court. On 13 June 2013 it ruled unanimously against Myriad. In the words of Justice Thomas, “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” He went on, “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.” Justice Breyer added that natural laws may not be patented either standing alone or in connection with processes that involve “well-understood, routine, conventional activity” [2]. The Supreme Court justices were unanimous, but it has taken a long time to get to this decision and some of the lower courts had taken a different view. Myriad reacted by pointing out that they still had “strong intellectual property protection” for their tests, and while their share price fell, it was only by about 5%. This clearly shows that that not being able to patent genes will inhibit neither the identification of genes nor the development of tests and treatments. Read the rest of this report here i-sis.org.uk/Genes_not_eligible_for_patents.php
Posted on: Fri, 23 Aug 2013 21:03:16 +0000
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