The Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) for the Department of Health and Human Services (HHS) convened again on Friday for a snow-shortened session. One of several items on the Committee’s agenda was a report that the GLR has covered several times (see here and here): Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. With the threat of a blizzard looming, the meeting was unexpectedly short, with only a pair of public comments followed by the Committee’s vote to approve the report.
The report itself will not be available for several weeks, but the six recommendations on gene patenting and licensing approved by the Committee this past October continue to provoke a heated response. The Biotechnology Industry Organization (BIO), along with former Senator Birch Bayh (of Bayh-Dole Act fame) and others, held a Friday press conference to denounce – again – the report’s recommendations.
The SACGHS Recommendations. Most of the recommendations are uncontroversial, urging the Secretary of HHS to convene stakeholders to “explore” and “encourage” strategies to improve access to genetic testing, enhance patent licensing and ensure that the USPTO is “kept current with the latest scientific and technological developments related to genetic testing and technology.”
So what prompted Bayh’s charge that the recommendations represent “an attempt to send us back to a time when it appeared that American innovation was on its last legs and our economy was in deep distress”?
The sole controversial recommendation involves the Committee’s proposal to exempt healthcare practitioners and researchers from infringement of gene patents. The recommendation, in its entirety:
1. Supporting the Creation of Exemptions from Infringement Liability
The Secretary of Health and Human Services should support and work with the Secretary of Commerce to promote the following statutory changes:
A. The creation of an exemption from liability for infringement of patent claims on genes for anyone making, using, ordering, offering for sale, or selling a test developed under the patent for patient care purposes.
B. The creation of an exemption from patent infringement liability for those who use patent-protected genes in the pursuit of research.
BIO’s President and CEO Jim Greenwood looks at this particular SACGHS recommendation and sees doom and gloom. According to Greenwood, exempting patient care and research activities from infringement “would discourage investment in biotech innovation, hobble the transfer of federally-funded research, undermine university research programs, and harm patients who are waiting for life-saving therapies and diagnostics yet to be developed.”
Is the sky really falling, or would the SACGHS recommendation instead work as the Committee intends, increasing patient and researcher access to otherwise off-limits genetic information and tests? One of the most striking features of the proposed recommendation is the tremendous apparent breadth of its dual infringement exemptions. As written, the use and sale of a patented test for “patient care purposes” would be exempt, as would all uses of patent-protected genes for “research.” Patient care and research are broad, nebulous categories that, if interpreted generously, could cover every reasonably likely use for many patent-protected genes and related tests. We look forward to seeing how the final report elaborates on this issue, but it is not surprising that this recommendation would be the focus of controversy.
How a Bill Becomes Law. Still, the controversy may be somewhat academic, because it is hard to imagine it becoming law any time soon. As Schoolhouse Rock! taught us, it’s not easy to move from bill to law. No surprise, then, that the trip from a Departmental Secretary’s Advisory Committee recommendation to a law was too tortuous to ever find its way into a three minute educational animation.
Moving the proposal through HHS and, ultimately, Congress would require substantial elaboration. It’s nearly inconceivable that such elaboration would not involve narrowing the situations in which otherwise infringing activities would be considered exempt. Any Congressional action would be followed by further refinement as courts begin to apply the new infringement exemption (which would presumably show up in Section 271 of the U.S. Patent Act, near the Hatch-Waxman patent exemption that successfully accelerated the development of generic pharmaceuticals).
While the SACGHS recommendation will likely be years in producing any actual changes in patent law, if indeed it ever does, there are several pieces of ongoing litigation that bear directly on the future – and legality – of gene patents, as well as biotechnology patents more broadly. The oft-discussed Myriad litigation, as well as the less-familiar-to-mainstream-media but arguably more important Bilski and Prometheus cases that may define the contours of permissible personalized medicine patents, will almost certainly yield important developments far sooner than anything arising out of the SACGHS report or recommendations.
Of course, the SACGHS report and recommendations still matter, which is why BIO and others have been so quick to object. The SACGHS findings represent an important statement from a diverse and non-partisan advisory body that the current scope of gene patents interferes with both research and patient care. Although we should not expect to see this specific SACGHS recommendation become law in anything resembling the near future, it may play in an important role in the ongoing review of the appropriateness and limitations of gene patents.