Saturday, April 17, 2010

Are Gene Patents a Good Thing??

Report finds gene patents prevent competition, don’t promote advancement


A report published Wednesday by Duke University researchers concluded that gene patents and exclusive licensing do more to deter competition in the gene testing market than they do to further the development of new technologies for measuring the risk of disease.

Dr. Robert Cook-Deegan, director of Duke University's Center for Genome Ethics, Law & Policy in Durham, N.C., said, “It's notable that a gene linked to cystic fibrosis is not subject to an exclusive license, yet there is now a vibrant market for tests to identify carriers of the cystic fibrosis gene. This suggests the problem is not patents, per se, but how they are being licensed, particularly by universities.”

Published in the journal Genetics in Medicine, the study’s results are the product of eight case studies on 10 clinical conditions, including cystic fibrosis, hearing loss, breast cancer, colon cancer, Tay-Sachs disease and Alzheimer’s disease. Researchers from the Duke Institute of Genome Sciences and Policy and Duke's Center for Public Genomics conducted the research.

The question of patening genes has been in the news. Last month, a federal judge in New York ruled that patents should never have been granted genes to test for break cancer.

More than 20 percent of the human genome has already been patented by various scientists, academics, and companies. This translates into about 4,000 genes, the Anmerican Civil Liberties Union noted in its case against Myriad Genetics and Laboratories in Salt Lake City, Utah.

Duke researchers found that most of the scientists and researchers they interviewed, specifically pertaining to Alzheimer’s disease, were ambivalent when it came to patenting, and none attributed the races to trace the genetic origins of the disease to patents.

“The races were driven by wanting priority of scientific discovery, prestige, and scientific credit, and the ability to secure funding for additional research based on scientific achievement,” the researchers reported.

While this was reported for Alzheimer’s, the study outlines that the same is primarily true for the other diseases researched. Gene patents did nothing to promote innovation in terms of new technologies or methods for determining disease risk, the Duke researchers reported.

“If patents added ‘the fuel of interest to the fire of genius,’ in Abraham Lincoln’s famous phrase, it was here at best a tiny pile of kindling at the outer margin of a large conflagration,” the researchers wrote.

There are additional problems with exclusivity according to Dr. James P. Evans, a clinical professor in the genetics department at the University of North Carolina – Chapel Hill (N.C.), who wrote “Putting patients before patents,” a commentary on the case studies.

A patent holder exclusively licensing a laboratory to conduct the tests for a certain disease risk results in an “inability to obtain second-opinion testing and concerns over quality, given that the most robust means of quality assurance are not available in the context of a single provider,” he said.

When it comes to retesting, an exclusive license could make a difference, said Kevin Noonan, a patent attorney at Chicago-based McDonnel Boehnen Hulbert & Berghoff. “If I’m the exclusive licensee I can’t quibble with the person who says that yes, there is a cost that is incurred by having a patent,” he said. “There is a cost however, in not having the test in the first place.”

Evans also has another concern with exclusive licensing: Clinicians who are concerned about a certain laboratory have no alternative to choose from. This, he said, allows the laboratory, rather than the patients, to define the terms of testing.

“That’s a hypothetical,” Noonan said. If the exclusive licensee is doing the test in a certain lab and not doing it very well there is a good chance that people will sue over the incorrect test results and the lab won’t stay in business for very long, he said.

“There are provisions in the law, for tests coming from university labs, where the government can step in and grant a non-exclusive license to another lab. If there is evidence that the lab is doing their job poorly then patients can report this and the exclusive licensee would have to accept a sublicense to another lab,” he said.

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