A decision by a federal judge in New York means a potentially historic lawsuit will continue that challenges patents controlled by the University of Utah and Myriad Genetics on two human genes that can signal an increased risk of breast and ovarian cancer.
In an 85-page ruling, Judge Robert W. Sweet this week turned backed efforts by the two Utah defendants and the U.S. Patent and Trademark Office to dismiss the lawsuit filed in May by the American Civil Liberties Union on behalf of researchers, scientific research groups, women's health advocates and a number of women.
The lawsuit seeks to overturn the patents for the genes called BRCA1 and BRCA2, arguing they were illegally granted because genes are part of nature and should not be the subject of patents. The suit also argues the patents unconstitutionally restrict knowledge that could lead to research and the development of tests or treatments for those two cancers.
Sweet ruled that the groups and individuals who filed the suit have been directly affected by the restrictions imposed by the patents granted to the U. and Myriad and, therefore, have the legal right to sue.
"I think the decision is important in rejecting the U.S. Patent and Trademark Office's argument that plaintiff's can't bring constitutional claims against them because of the way the patent law is structured," said Sandra Park, an attorney at the ACLU's Women's Rights Project in New York.
University spokesman referred questions to Myriad, saying it controlled the patents. Myriad Genetics President and CEO Peter Meldrum reiterated the company's policy of not commenting on pending lawsuits.
The ACLU said about 20 percent of the estimated 20,000 to 25,000 human genes are patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer and asthma.
"We hope this challenge is the beginning of the end to patents on genes, which limit scientific research, learning and the free flow of information," ACLU attorney Chris Hansen said in a statement. "No one should be able to patent a part of the human body."
About 15 years ago, the BRCA1 and BRCA2 genes were licensed by the university to Myriad Genetics, a company formed by a former University of Utah researcher and others to create products from gene research. Myriad argues that the patents are necessary because they enable it to earn profits that allow for the creation of tests and treatments that otherwise might not be available.
Myriad sells test kits for the gene that doctors use to advise patients on whether they are at risk for breast or ovarian cancer and to help guide treatments.
The judge also ruled that members of the board of the University of Utah Research Foundation, which include President Michael Young, would remain as defendants in the lawsuit.
"The claims in this suit directly relate to the license agreement between the defendants and their efforts to enforce the patents," Judge Sweet wrote.
The judge said he would consider a motion by the ACLU and those it represents to decide the case in their favor. If he turns down that motion, the lawsuit could go to trial.
