The College of American Pathologists today expressed its support for a key government advisory group's recommendation to create an exemption from liability for infringement of gene patent claims when used for patient care purposes.
Last week, the Secretary's Advisory Committee on Genetics, Health and Society, (SACGHS) agreed on recommendations for the Secretary of Health and Human Services which, if adopted, would allow medical researchers to study, and pathologists to provide, genetic tests based on already-patented human genes without the threat of a patent infringement lawsuit.
"The CAP has had a clear policy in opposition of gene patents since 2000," said CAP President Stephen N. Bauer, M.D., FCAP. "This recommendation by the SACGHS is a significant step forward for patients and the advancement of medicine."
The CAP opposes the issuance of human health-related gene patents because genes are naturally occurring phenomena and patenting them limits access to medical care, jeopardizes the ability to practice medicine in the best interest of patients and raises the cost of care.
In May 2009, the CAP joined as a plaintiff in a lawsuit challenging the patents held by Myriad Genetics for the genes known as BRCA1 and BRCA2, which are indicators for hereditary predisposition to breast and ovarian cancer.
History has shown that when patents are granted, subsequent exclusive license agreements and excessive licensing fees related to the patents prevent physicians and laboratories from providing DNA and RNA-based diagnostic services. Patients suffer because diagnostic test services are less readily and affordably accessible; medical education and clinical research are also threatened.
Under patent protection, the understanding of the utility of the test, as well as the underlying disease processes, also becomes proprietary, thereby imposing a profound change in how the profession and the public acquire knowledge about these test and their applications. As a consequence, costs are higher, patient access to care is limited, quality is jeopardized, and training of health care providers is restricted.
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