The Biotechnology Industry Organization (BIO) of Washington, D.C., and several other organizations have released a letter sent to U.S. Department of Health and Human Services Secretary Kathleen Sebelius, in which the organizations state strong concerns regarding recommendations of the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) in its Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests.

Other organizations joining BIO include the Association of University Technology Managers (AUTM), Genetic Alliance, the Wisconsin Alumni Research Foundation (WARF), and more than 20 other entities. The letter asks Secretary Sebelius to reject the Committee's recommendations and to keep the system implemented by the Bayh-Dole Act. The Bayh-Dole Act (the Patent and Trademark Act Amendments of 1980) concerns technology transfer and allows universities, small businesses and nonprofits to retain title to inventions developed under federally-funded research and to license such inventions.

In part the letter states, "We welcome efforts to improve patient access to genetic tests, and stand ready to work with you and other interested parties to do so. But 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. This would do more harm to patients than good, by impairing the research, development and commercialization of the medicines and diagnostic tests of tomorrow....We ask you 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."

The letter points out the impact upon research and technology since the implementation of the Act, including approximately 6,000 new U.S. companies formed from university inventions and around 4,350 new products on the market because of university patent licensing.

The organizations say the recommendations are "based on limited anecdotal experiences and an internally contradictory evidentiary record," and would hamper public/private collaborations and the commercialization of publicly-funded research. The SACGHS recommendations include creating an exemption from liability for infringement of patent claims on genes for anyone developing and commercializing tests under the patent for patient care purposes, and creating regulations to limit exclusive licensing of federally-funded inventions for genetic diagnostic purposes.

Read more:
The BIO letter may be accessed at: http://bio.org/ip/genepat/documents/SACGHSsign-onletter2-4-2010final_000.pdf

The SACGHS report may be accessed at: http://oba.od.nih.gov/oba/SACGHS/SACGHS%20Patents%20Report%20Approved%202-5-20010.pdf

More Industry Headlines