The University of Utah and Myriad Genetics have asked a federal judge in New York to dismiss a high-profile lawsuit from gene research groups and others who are seeking to overturn the U.S. practice of granting patents on human genes.
The university and Myriad, which were sued in May over seven patents related to two human genes linked to breast and ovarian cancer, said the parties that filed the lawsuit cannot prove they were harmed by the patents granted to the university and licensed to Myriad about 15 years ago.
"This case is a thinly veiled attempt to challenge the validity of patents where, other than an overall policy disagreement concerning the legitimacy of gene patents, the plaintiffs have no actual dispute with the defendants over patent infringement," the university and Myriad said in their motion to dismiss. "If the plaintiffs in this case have standing, then virtually anyone can challenge any patent at any time."
The lawsuit poses legal and public policy questions about the patenting of a natural part of the human body and about women's access to health care because the diseases in question are nearly exclusive to women. If the lawsuit is ultimately successful, it could overturn the thousands of U.S. patents on human genes.
The practice of patenting genes has been controversial since the 1980s, when researchers began to discover and map them in humans and animals. Some researchers and institutions argued that their discoveries
and isolation of specific genes were the result of unique creative and research processes that went beyond what nature had created, and that they should be able to enjoy the benefits of their work as do others whose research leads to specific products and procedures.
The university and Myriad argue in their court motion that the patent process has worked as it was designed to do by fostering research and creating diagnostic tools for gene-related illnesses that are available to women through health-care providers.
"Using their synthetic tools and discoveries, the inventors engineered diagnostic tests for detecting these mutations in patients. The testing for these mutations has helped thousands of women get information that enabled them to make important choices and take steps to reduce their risk of breast and ovarian cancer," the motion said.
The American Civil Liberties Union, the leading organization in the lawsuit, declined comment, saying it was still studying the motion. The University of Utah referred questions to Myriad Genetics, which also declined to comment.
Among the plaintiffs are professional groups and universities associated with gene research, including the Association of Molecular Pathology, the American College of Medical Genetics, American Society of Clinical Pathology, College of American Pathologists, the University of Pennsylvania, Columbia University and New York University.
Such motions to dismiss are standard procedure in lawsuits. In addition to Myriad and the university, a third defendant, the U.S. Patent and Trademark Office, also has filed a motion asking to be dismissed from the suit.
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