Sweet call on gene patents

Clinton Colmenares in our news office wrote this …

 Jim Evans is a self-proclaimed science geek whose intellect and wit move at warp speed. He rides a bike to work and wears neck ties fashioned with DNA patterns. In our popular Santa video he proclaimed that the jolly old elf is “clearly a mutant.” 

He’s also an expert in gene patenting and genetics policy. He led a program to educate federal judges about the intricacies of genetics and genetic policy. He 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.  

James P. Evans, MD, PhD

When news broke that United States District Court Judge Robert Sweet ruled on March 29 that seven patents related to the BRCA 1 and BRCA 2 genes were invalid — genes cannot be patented, basically — we contacted Jim. So did reporters from The New York Times, the Wall Street Journal and the CBS Evening News (they decided not to run a story). 

Jim had the last quote in The Times:  

James P. Evans, a professor of genetics at the University of North Carolina, said that would not necessarily be the case. There is thriving competition in areas like testing for mutations that cause cystic fibrosis or Huntington’s disease, even though no company has exclusivity.  

“It’s quite demonstrable that in the diagnostic area, one does not need gene patents in order to see robust development of these tests,” he said.  The ruling “came as a surprise to everybody. It’s really quite unusual for plaintiffs to get a summary judgment.”

In the WSJ he said:  

“If this decision is upheld, it in the end is a win for patients and providers,” said Dr. Evans, also a medical geneticist at the University of North Carolina, Chapel Hill. 

Here are some of the comments he shared with me yesterday: 

“I think that the judge showed an impressive understanding of genetics and some of the nuances involved. 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.  

“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. 

“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.  

“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. 

“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.  

“They are something we all share and they encode information that is unique to each of us as individuals. Thus it is difficult at one 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.”

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