BIO Sends Letter on SACGHS Report to HHS Secretary Sebelius

    By Donald Zuhn --

Last week, the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) issued its long-awaited report on gene patents.  While the report, entitled "Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests," indicates that gene patents and licensing practices concerning such patents have not had an adverse impact on patient access to genetic tests, it nevertheless includes a number of controversial recommendations.  The most controversial of these recommendations is a proposal to exempt gene patents from infringement liability.

On Thursday, the day before the report was issued, the Biotechnology Industry Organization (BIO) held a press conference to express concern about the report's recommendations (see "BIO Comes out Swinging against SACGHS Report").  Appearing at the press conference with BIO President and CEO Jim Greenwood were former Senator Birch Bayh, co-author of the Bayh-Dole Act; Dr. Brian Stanton, a member of the SACGHS Task Force on Intellectual Property and Access to Genetic Testing; Dr. Jim Davis, Executive Vice President, General Counsel and Secretary of Human Genome Sciences, Inc.; and Dr. Jon Soderstrom, the Managing Director of the Office of Cooperative Research at Yale University.

On Friday, BIO issued a press release noting that it had sent a letter to Health and Human Services Secretary Kathleen Sebelius (at right) regarding the "potentially harmful" recommendations of the SACGHS Report.  Joining Mr. Greenwood on the letter were representatives from the Association of University Technology Managers (AUTM); BayBio; Genetic Alliance; the Fox Chase Cancer Center; the Wisconsin Alumni Research Foundation (WARF); the WiSys Technology Foundation; Alkermes; Alnylam Pharmaceuticals; Bavarian Nordic Inc.; Bayer Corp.; Celera Corp.; Ceregene, Inc.; Clinical Data, Inc.; Fluidigm Corp.; Genzyme Corp.; GlobeImmune, Inc.; Human Genome Sciences, Inc.; Isis Pharmaceuticals, Inc.; Monsanto Co.; Novartis Oncology; Oncolytics Biotech Inc.; PsychoGenics Inc.; Regulus Therapeutics Inc.; Target Discovery, Inc.; and XDx.

The letter begins by expressing the group's "grave concerns about certain recommendations" in the SACGHS Report and urging Secretary Sebelius to "to reject these recommendations and ensure that the fundamentals of the innovation system put in place nearly 30 years ago through the Bayh-Dole Act are preserved."  The signatories contend that "collaboration fostered by the Bayh-Dole Act -- and fueled by massive amounts of private investment" has yielded "tangible medicines, diagnostic tests, and other healthcare-related products that are saving lives, improving diagnoses, and alleviating suffering for millions of people worldwide."  The group states that "[t]he critical links in this chain are the availability and enforceability of patents to protect these investments, and a flexible system of technology transfer to foster commercialization."

Declaring that "[i]t is not the time to undertake or recommend policy changes that would undermine the foundations of American life sciences innovation," the letter contends that the SACGHS report "contains certain recommendations that we believe would seriously hamper public/private collaborations and the commercialization of publicly-funded research."  The letter states that "[t]hese unprecedented recommendations -- based on limited anecdotal experiences and an internally contradictory evidentiary record -- include exempting from infringement liability the use of gene patents for the purpose of developing and commercializing diagnostic tests, and promulgating regulations that would limit exclusive licensing of federally-funded inventions for genetic diagnostic purposes."  The signatories argue that the report's recommendations "would chill future investment and innovation in this area, and would unfairly upset the investment-backed expectations of current patent owners and licensees," adding that the report's recommendations are "based on claims of a crisis in the current system that does not exist, supported by selective assertions that do not hold up under scrutiny."

The group of concerned organizations and companies states that "[i]n light of the risks of going back to the pre-Bayh-Dole era, no compelling case has been made to warrant the Committee’s recommendations," and concludes the letter by asking Secretary Sebelius to "carefully consider the views and experiences of those who actually bring biomedical innovation to suffering patients, and to look closely at the case studies themselves, before making any decisions with respect to the Committee's recommendations."

Comments

[EG]

"The most controversial of these recommendations is a proposal to exempt gene patents from infringement liability."

Wonderful, the SACGHS makes a recommendation unsupported by its own facts. So how does SACGHS propose to implement this recommendation. By legislation (e.g., a new Becerra bill) or by regulatory fiat? Does SACGHS realize that this is tantamount to a "compulsory license" but even worse, without any compensation for the patent owner? Did SACGHS bother to consider the impact of this recommendation on TRIPS? What about the impact on our domestic biotech industry and the jobs that may be sacrificed by implementing this recommendation?

[JD]

Oh, I thought cigarettes caused cancer.