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.