NEW YORK — A judge on Tuesday weighed whether a lawsuit should proceed that seeks to invalidate a company's patents on two genes linked to an increased risk of breast and ovarian cancer.
The case challenging whether anyone can hold patents on human genes has broad implications for the biotechnology industry and genetics-based medical research.
Last March, the American Civil Liberties Union and the Public Patent Foundation sued Myriad Genetics Inc., the University of Utah Research Foundation and the U.S. Patent and Trademark Office in U.S. District Court in Manhattan.
The ACLU and the patent foundation say Myriad's refusal to license the patents broadly has meant that women who fear they may be at risk of breast or ovarian cancer are prevented from having anyone but Myriad look at the genes in question.
During a lengthy hearing in a packed courtroom, U.S. District Judge Robert Sweet was asked by lawyers for the plaintiffs to strike down the validity of the patents, while a lawyer for the defendants called for the lawsuit to be tossed toss out. The judge did not immediately rule.
Christopher Hansen, an ACLU lawyer, told Sweet that researchers deserved praise but not patents for winning the race to isolate an important part of the body.
He said important medical research was being hampered because the patents for "BRCA1" and "BRCA2" genes prohibit the study of the genes by others.
"New forms and testing and new ways of using the gene have been inhibited," Hansen said. "That's not good for womens' health."
Hansen argued that the patents were awarded for the discovery of an "ancient secret of nature."
He added: "A patent is not a reward for effort."
Attorney Brian Poissant said Myriad Genetics, based in Salt Lake City, and the University of Utah Research Foundation have a right to the patents, especially since they pertain to the process that was developed to isolate chemical composition.
He said to disallow the patents would wreck the foundation of the entire biotechnology industry. Court precedent, he added, is on their side.
"But the information is not new?" the judge asked at one point.
Poissant responded that every invention in the history of man involves something to do with nature.
Poissant said a ruling against the company could lead to the invalidity of thousands of gene patents.
"This would unravel the foundation of the entire biotechnology industry," he said.
U.S. government attorneys have defended the patents, saying the groups do not have the right to even challenge them.