Invalidation of gene patents will benefit patients

Apr 3 2010

Dr. Jim Evans, an expert in gene patenting and genetics policy who has led a program to educate federal judges about the intricacies of genetics and genetic policy, says the ruling by United States District Court Judge Robert Sweet that invalidated seven patents related to the BRCA 1 and BRCA 2 genes "came as a surprise to everybody. It's really quite unusual for plaintiffs to get a summary judgment."

Evans chaired a Federal task force, part of the Secretary of Health and Human Services Advisory Committee on Genetics, Health and Society that recently made formal recommendations to the HHS secretary regarding the role of gene patents in medical diagnostics. Evans, a medical geneticist, is director of Clinical Cancer Genetics and is the Bryson Distinguished Chair of Human Genetics at the University of North Carolina at Chapel Hill and a member of the UNC Lineberger Comprehensive Cancer Center. He is available for comment about the March 29 ruling.

"I think that the judge showed an impressive understanding of genetics and some of the nuances involved," Evans says. "I agree with him."

"The essence of DNA is that it is an embodiment of biological information. As such it is distinct from other chemical compounds in nature. It is this informational content that makes it special and the act of isolating it therefore is less relevant to patent considerations than for other biological molecules. A gene still does the same thing (i.e. confer information) in the test tube as it does in the cell. Thus, Judge Sweet correctly noted that a gene is qualitatively different from other biological molecules such as adrenaline, which can be patented when isolated," Evans says.

"It's a very important case, but its immediate impact shouldn't be overestimated. It will be appealed to the Court of Appeals for the Federal Circuit, the court to which all patent cases are appealed. Then it will almost certainly be appealed to the Supreme Court, though who knows if they will agree to hear it" Evans says.

"There will be arguments about whether this ruling will be good for patients; I would say yes. The broad area of diagnostic testing is unduly hampered by gene patents and they are not necessary for the development of diagnostic genetic tests. This ruling, if upheld, will open the field of genetic diagnostics in time for the benefits of robust analytic techniques like whole genome sequencing to be applied for patient benefit," Evans says.

"While one can argue that the patent incentive may serve a more useful purpose in the realm of therapeutics, most useful therapeutic patents are considerably "downstream" of the genes themselves so I doubt that one will see any significant deleterious effect of such a ruling on therapeutics either. In broad terms I think this is a win for both patients and their providers," Evans says.

"The issue of gene patenting has been controversial since the United States Patent and Trademark Office first granted them. Such controversy and furor have arisen in part because people tend to perceive genes as different from other biological entities," Evans says. "They are something we all share and they encode information that is unique to each of us as individuals. Thus it is difficult at some basic level to defend the patenting of genes. The idea that we would be prevented from having considerable latitude in analyzing our own genes is something that strikes people as a bit absurd on the face of it."