Should companies be allowed to patent genes? They are right now, and an HHS-advisory committee has warned that such practices threaten medical progress and could drive critical bio-medical research overseas in search of friendlier legal environments.
The HHS Advisory Committee on Genetics, Health, and Society also said in a report dated February 5 that the cost of genetic analysis has plummeted recently to a point where there is substantial potential to improve health using gene-based technologies.
But existing patent laws pose serious obstacles to “the promise of these developments,” according to the report. As evidence for this assertion, the report cites several labs that run multiplex gene testing but do not report the results regarding patent-protected genes to patients or clinicians, because they worry about being sued.
The Committee recommended that the US should create broad exemptions from liability for infringement of patent claims on genes used in diagnostic testing for patients, as well as in the use of patent-protected genes in research.
The Committee also recommended that guidelines be established to promote non-exclusive licensing for genomic and diagnostic genetic technologies, improved transparency in licensing, and creation of an advisory board focused on gene patenting and licensing practices and their impact on health.
The report was ordered by HHS Secretary Sebelius at a time when a bevy of lawsuits have put judges in the position of deciding whether gene patents are enforceable.
“Patenting has moved upstream; instead of covering only commercial products, patents can now control foundational research discoveries, claiming the purified form of genes. Fragmented ownership of these patents on genes by multiple competing entities substantially threatens clinical and research use,” according to the report. “Fragmented ownership may create problems such as patent thickets, blocking patents, high transaction costs, royalty stacking, and holdouts.”
The Biotechnology Industry Organization, the Association of University Technology Managers, and several biotech and diagnostics executives responded to the report with a letter urging Sebelius to reject the recommendations. “We believe that the recommendations, if implemented, would unravel two sets of laws that are the foundation of life science innovation in this country – the patent system and the Bayh-Dole Act,” they wrote. “This would do more harm to patients than good, by impairing the research, development and commercialization of the medicines and diagnostic tests of tomorrow.”