by Jake Meyer

This week, the scientific journal, Nature published a commentary about gene patents.  In their article, “The Dangers of Diagnostic Monopolies,” Robert Cook-Deegan, Subhashini, Chandraskharan, and Misha Angrist, state that “patents have not caused irreparable harm in genetic diagnostics, but neither have they proven greatly advantageous.”  458 Nature 405-406 (26 March 2009).  The commentary recognizes that gene patents do cause a problem through the monopoly provided by a patent or exclusive license.  Exclusive licenses are difficult to invent around and the reality is that exclusive rights to testing for multiple common genes or variants associated with a disease ends up in the hands of one provider, even if they’ve only patented one or two of the genes.  The authors, concerned with the effect of exclusively licensed gene patents on the patient’s rights, propose that patient’s rights should have priority over patent rights when the patent holder interferes with the purpose of patent law – “to promote public good through advancing science and technology.”  The authors state that the rights of the patient should trump the rights of the patent holder if the patent holder does not permit:

1) basic research and clinical research, including genetic testing in clinical trials or health services research; 2) performing a test in a form that the patent holder doesn’t offer; 3) testing in a territory where the company does not test, but has exclusive rights; 4) getting second opinions or verification testing; 5) testing those not covered by its payment agreements with insurers and health plans; and 6) research and development to make testing more comprehensive, more accurate, or less expensive.

These policies that target many of the ills that gene patents have been suggested to cause, such as: impeding basic research, limiting access to tests even if one isn’t available (this happened with a test for Long QT, a fatal disease in children, where a test was not offered for 2 year and the patent holder would not let a willing and able laboratory offer the testing during that period), the inability to get second opinions or verify testing, and lack of improvement in accuracy of testing through a lack of competition and research.  Under this approach, patent holders would only be able to sue for patent infringement against another lab offering an initial genetic test, in the same form the holder offers it, in the same geographic territory the holder offers it, and the test must be covered by the testee’s health insurance.  These policies should be implemented to counter the harm to the public caused by a patent holder that impedes research and denies adequate access to affordable accurate testing.