AMA meeting: Patents should not be issued for human genes
■ Delegates say such patenting may interfere with the availability of affordable genetic tests and inhibit the development of new ones.
By Victoria Stagg Elliott — Posted June 28, 2010
Chicago -- The American Medical Association opposes the patenting of human genes and related naturally occurring mutations, according to policy adopted June 15 at the organization's Annual Meeting.
"Genes are not legitimately patentable matter," said Raymond Lewandowski, MD, of Corpus Christi, Texas, who proposed the policy as a delegate from the American College of Medical Genetics.
The policy also states that patents that already have been issued should be licensed in a way that allows broad access by physicians and patients. The AMA will support legislation making those who use patented genes for medical diagnosis and research exempt from claims of infringement.
"Gene sequences are part of the practice of medicine and should be widely available," said Edmund Donoghue, MD, of Savannah, Ga., a delegate from the American Society for Clinical Pathology. "When patents are exclusive or prevent physicians and clinical laboratories from using certain tests, when [patents] limit access to medical care and raise costs, that is not in the public interest."
The patenting of genes has long been controversial, with those opposed saying that this practice limits medical research and prevents patients and physicians from accessing competitively priced genetic testing services.
On March 29, the U.S. District Court for the Southern District of New York invalidated patents on breast and ovarian cancer genes held by Myriad Genetics Inc. on the basis that they violated the prohibition of patenting natural phenomena. The American College of Medical Genetics was a plaintiff in that case. The Litigation Center of the American Medical Association and the State Medical Societies, along with a group of other medical organizations, filed a court brief challenging these gene patents. (See correction)
The ruling is expected to be appealed, and some of the delegates expressed concern that prohibiting these kinds of patents could hinder rather than help medical research.
"It takes a lot of time and money to develop genetic tests. Who is going to spend that money if they do not have some assurance of recouping their investment later?" said Kenneth Crabb, MD, an obstetrician-gynecologist and a delegate from the Minnesota Medical Assn., who was speaking personally.
In a related development, the AMA Council on Science and Public Health released a report on genomic-based personalized medicine. The AMA says it will continue to develop educational resources and point-of-care tools on the subject.