Published on June 28, 2006
Gene Patents Put America’s Health Care at Risk, says CAP
Washington, D.C.—The College of American Pathologists (CAP) this week asked the U.S. Department of Health and Human Services (HHS) Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) to reexamine the current practices in the patenting and licensing of genetic sequences to ensure that gene-based diagnostic tests are widely available and affordable for the greatest public benefit.
SACGHS moved to further study the issue of gene patents during the meeting. It first considered the issue during its March meeting for which CAP provided written testimony.
“We are facing the unprecedented situation in which a single patent owner can prevent physicians throughout the country from performing diagnostic procedures that use certain gene-based tests,” said Carol Ann Rauch, MD, PhD, FCAP, who testified before SACGHS. “The College believes that current practices of the patenting and licensing of genetic sequences must be reexamined to ensure that gene-based diagnostic tests are widely available and affordable for the greatest public benefit.”
Pathologists have a keen interest in ensuring that gene patents do not restrict the ability of physicians to provide quality diagnostic services to the patients they serve. Gene patents and subsequent licensing practices pose a serious threat to medical advancement, medical education and patient care. Information derived from mapping of the human genome represents a naturally occurring, fundamental level of knowledge that is not invented by man and should not be patented.
When patents are granted, subsequent exclusive license agreements, excessive licensing fees, and other restrictive licensing conditions prevent researchers, physicians, and laboratories from providing genetic based clinical testing services.
Last December, the College and five other organizations filed an amicus curie brief to the U.S. Supreme Court in a case for which the outcome could determine whether a basic scientific fact may be patented. The brief argued that test methods and scientific findings in the patent are part of a continuum of medical research and development aimed at the continual improvement of patient care. Unfortunately, the high court recently dismissed the case and patent holders will be able to continue to restrict access to and use of basic scientific principles. Justices Breyer, Souter, and Stevens, in their dissent, embraced some of the arguments presented in the CAP-signed brief.
The CAP’s testimony may be found on the Web site (Word, 66 K).
The College of American Pathologists (CAP) is a medical society serving about 16,000 physician members and the laboratory community throughout the world. It is the world’s largest association composed exclusively of pathologists and is widely considered the leader in laboratory quality assurance. The CAP is an advocate for high quality and cost-effective patient care.