US Government Takes A Side In Gene Patent Debate

Dan Whalen is a JD Candidate at Osgoode Hall Law School

In a recent amicus brief, the US Department of Justice has suggested that patents for “isolated human genomic DNA” be invalidated, a significant change to the longstanding practice of gene patenting. The surprising proposition comes in response to an appeal by Myriad Genetics of an earlier court decision to quash the company’s patents on BRCA1 and BRCA2, genetic risk-indicators of breast cancer. Gene patents are common to many jurisdictions, notes Bob Cook-Deegan of Duke University, and go mostly uncontested where the genes themselves are used for a valuable purpose. The patent-holder’s grip becomes tenuous, however, for patents that simply describe the DNA sequence of a gene, as Myriad’s patents do. Such claims have been the target of many previous legal challenges. In 2004, the European Patent Office revoked the company’s patents surrounding the genes and later only returned rights for its proprietary diagnostic test.

The concerns over gene patenting are myriad, so to speak. The American College of Medical Genetics argues that one detriment of such monopolies is the limited accessibility of competitively priced genetic testing services. As Canadian provinces have found, the test’s licensing fees render it more expensive than others available, straining health care budgets and potentially forcing the provinces to stop offering such publicly insured genetic counselling. Another worry is that such monopolies limit the overall level of expertise on those particular genes and thus also the pace of research to benefit patients. This stunted rate of development may be especially troubling in Myriad’s case, given the reported test’s failure rates in detecting the genes’ presence. Proponents of gene patenting, like F. Scott Kieff, counter that innovators must be protected and incentivized, as in any other industry. The two arguments’ conflicting merits create a moral dilemma, which the government’s proposal does not address directly, though it does mark an important step towards greater legal certainty.

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