Restricting Gene Patents: A Pro-Market Agenda
This commentary is contributed by James P. Evans, clinical professor genetics and medicine at the University of North Carolina and Editor-in-Chief of Genetics in Medicine.
Gene patents have been controversial since they were first granted in the US over two decades ago. The controversy is now reaching a fevered pitch after a surprising US District Court decision which held that human genes are not legitimately patentable and an amicus brief by the Department of Justice largely in support of this contention. How this case will be decided by the Court of Appeals for the Federal Circuit and the Supreme Court (should it accept the inevitable appeal) is anyone’s guess.
But in spite of what might be suggested by the rhetoric often accompanying this debate, the questions at hand are amenable to logical analysis and the application of evidence. Such an analysis argues strongly that if patents on naturally occurring genes are ultimately ruled out of bounds, the net effect on commerce would be positive.
“From Gulf Oil to Snake Oil”: Congress Takes Aim at DTC Genetic Testing
It has been a busy week in Washington for direct-to-consumer (DTC) genetic testing companies. Following public FDA meetings and a new round of FDA device notification letters earlier in the week, representatives from three major DTC genetic testing companies (23andMe, Navigenics and Pathway Genomics) were hauled in front of Congress today to defend their companies, their industry and the practice of DTC genetic testing.
The hearing on “Direct-To-Consumer Genetic Testing and the Consequences to Public Health” was conducted by the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations. The meeting was chaired by Representative Bart Stupak of Michigan. Materials from the hearing, including a briefing memorandum, opening statements from Stupak and Representative Henry Waxman of California and witness testimony are available on the Committee’s website. Also available are materials from the Government Accountability Office (GAO) investigation into DTC genetic tests. These materials include the report the GAO submitted to Congress – “Direct-to-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices” (pdf) – as well as a YouTube video featuring excerpts from undercover phone calls made by the GAO to DTC companies as part of their investigation (both of which are discussed in detail below).
SACGHS Chair: Put Patients Before Patents
This afternoon, the journal Genetics in Medicine released an online-only supplement analyzing the relationship between gene patents and genetic testing. The bulk of the issue is devoted to a series of 8 case studies surrounding 10 clinical conditions. The case studies were undertaken over the past several years by researchers at Duke University’s Center for Public Genomics, and were led by Robert Cook-Deegan.
The Case Studies. Those who have been following the gene patenting debate for the past few years may recognize the case studies. They were released in largely their current form in March 2009 as a lengthy appendix to the draft report on “Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests” (pdf) prepared by the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS).
The SACHGS report has since been finalized and, as we have discussed, was submitted to HHS Secretary Kathleen Sebelius with a series of recommendations, including exemptions to patent infringement liability for clinical care and research. If adopted, those recommendations would significantly reshape the gene patent and licensing landscape.
