Is it legal to patent a human gene?
That was the question facing a panel of three judges on the U.S. Court of Appeals for the District of Columbia Circuit in Washington on Monday. Their answer -- expected sometime in the coming months -- will have wide-ranging consequences for patients, researchers and companies, experts said.
Association of Molecular Pathology, et. al. vs. United States Patent and Trademark Office, et. al. pits a group including the American Civil Liberties Union, researchers, doctors and patients against the patent office and Salt Lake City-based Myriad Genetics, a company that holds seven patents covering two genes, known as BRCA1 and BRCA2.
Variants of the BRCA genes are associated with heightened risk of breast and ovarian cancer. Myriad makes tests that detect these genes -- indeed, because it holds patents on the genes it is the only company that makes such tests. The plaintiffs in Monday's hearing have argued that Myriad's corner on the market is bad for patients, among other reasons, because it makes it harder for a woman to get a second opinion or analysis on her test results.
The patent office and Myriad have countered that the protections offered by patents create incentives for researchers and companies to put in the effort it takes to come up with groundbreaking tests such as the BRCA screens in the first place. "But for the prospect of the patent exclusivity, Myriad Genetics would not have been established and funded by investors," the defendants argued, in a brief asking the court to dismiss the case.
The legal question before the judges boils down to whether a gene, once it is "isolated" from a person's entire genetic code, is a "product of nature," and therefore ineligible for patent. Does merely removing a bit of DNA from the rest of the genetic material around it make that DNA a new invention? Or, as attorney Courtenay Brinckerhoff, a partner with the law firm Foley and Lardner, posed the question in a statement: "Can Myriad explain the difference between patenting isolated DNA and patenting a leaf that has fallen off of a tree?"
Several thousand genes have already been patented, the Los Angeles Times has reported, so any decision that isolated DNA is the equivalent of a falling leaf will send shockwaves through the biotechnology industry. The Salt Lake Tribune, Myriad's hometown paper, reported Monday that the judges questioned attorneys on both sides for more than an hour in front of a gallery of several hundred spectators -- "an unusually long time for oral arguments and an unusually large crowd."
Many expect the case to eventually land before the Supreme Court.