A lawsuit naming the University of Utah and a Salt Lake City company has launched a major assault on the U.S. government's grants of patents for human genes, arguing the practice denies women with breast and ovarian cancer the benefit of new tests and possible treatments.
The federal lawsuit, filed Tuesday in New York by the American Civil Liberties Union, cites the case of a single mother, diagnosed with cancer in both breasts, who was denied a gene test because Myriad Genetics would not accept her insurance. Another cancer victim wanted a second opinion after a first test came back positive but Myriad's exclusive licensing agreement meant there were no other options for testing.
The lawsuit says the patents violate parts of the U.S. Constitution and asks the court to declare them invalid. The lawsuit, which also names the U.S. Patent and Trademark Office, has the potential of overturning the practice of granting patents related to human genes and could affect the thousands of current gene-related patents.
The controversy over patenting of genes has been seething for years, ever since the research community divided over the practice that began in the 1980s.
For the University of Utah -- which patented the genes labeled BRCA1 and BRCA2 -- the case raises questions about a public institution restricting gene research through an exclusive licensing agreement with a for-profit company, Myriad Genetics. The lawsuit also poses basic legal and public policy questions about the patenting of a natural part of the human body and about women's access to health care, since the diseases in question are nearly exclusive to women.
The lawsuit was filed on behalf of three professional organizations, eight medical researchers, two women's health groups and five women affected by cancer. Named as defendants are the University of Utah Research Foundation, the U.S. Patent and Trademark Office and Myriad Genetics, which markets tests that show whether a person has a risk of breast and/or ovarian cancer based on their genetic makeup.
"We do think the precedent in this lawsuit could potentially invalidate other patents held on human genes," said Sandra Park, a staff attorney for the ACLU's Women's Rights Project who helped prepare the lawsuit.
But Myriad Genetics General Counsel Richard Marsh said a 1980 U.S. Supreme Court decision upheld the legality of gene-related patents.
"Our initial reaction is we're very comfortable or confident as we respond to this lawsuit -- which we will do -- that the court will uphold our patents and find them valid and enforceable consistent with what's taken place in the last 30 years," he said.
Park, however, said the 1980 case involving researcher-created bacterium that ate oil, not a human gene. "We think it's completely different from what's at issue in our case," she said.
The University of Utah declined to respond to specific questions, issuing a written statement saying the patents that were licensed 15 years ago were granted in accord with the law.
"The university is contractually obligated under these licenses to permit Myriad to use them commercially," said the university.
The university did not say whether it has granted similar exclusive licenses.
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 that leads to specific products and procedures.
Plaintiff Genae Girard, 39, was diagnosed with breast cancer in 2006. Shortly after that she underwent a Myriad genetic test that found she had a mutation of the BRCA2 gene. She wanted a second opinion but was unable to obtain one because of Myriad's exclusive license.
Another plaintiff, Lisbeth Ceriani, 45, a single mother diagnosed with cancer in both breasts in May 2008, was denied testing because Myriad would not accept her insurance coverage for the test and she was unable to pay the $3,000 cost, according to the suit.
"Because of the patents and because Myriad chooses not to license the patents broadly, women who fear they may be at increased risk of breast and/or ovarian cancer are barred from having anyone look at the BRCA1 and BRCA2 genes or interpret them except for the patent holder," according to the lawsuit.
Marsh declined to address the specific complaints in the lawsuit but said about 90 percent of the $3,000 price per test is covered by insurance, leaving an average out-of-pocket expense of about $55.
Marsh also said Myriad had not restricted research into the genes by enforcing its patent license.
Plaintiff David Ledbetter, professor and director of medical genetics at the Emory University School of Medicine in Atlanta, specifically took aim at the University of Utah and the issues of exclusively licensing of human genes in a way that restricts research and development of treatments.
"Personally I have less criticism of a for-profit company making a business decision about how it thinks it will achieve its revenue goals, versus a university and university investigators who are so dependent on the cooperation and participation of patients and families, who then have a moral obligation to make the clinical utility of their discoveries available to those same patients and families," he said Wednesday.
"I actually have a strong critical attitude and comments toward universities who are significant contributors to the problems that we have with genetic testing monopolies," Ledbetter said.
He pointed out that groups such as the Association of University Technology Managers and the National Institutes of Health oppose exclusive licensing.
The ACLU also raises the First Amendment's guarantee of free speech, claiming the exclusivity of the license to Myriad amounts to restrictions on knowledge about the relationship between gene mutations and the risk of cancer.
"So the patent is really on that thought," Park said.
Myriad Genetics is a publicly traded company that made a profit of $47 million in its fiscal year 2008. The company's stock on Wednesday closed down 41 cents, or 1.25 percent, to finish at $32.39 a share on the Nasdaq stock market.
Association of Molecular Pathology
American College of Medical Genetics
American Society of Clinical Pathology
College of American Pathologists
Haig Kazazian, genetic researcher, University of Pennsylvania
Arupa Ganguly, genetic researcher, University of Pennsylvania
Wendy Chung, genetic researcher, Columbia University
Harry Ostrer, genetic researcher, New York University
David Ledbetter, genetic researcher, Emory University
Stephen T. Warren, chair Department of Human Genetics, Emory University
Ellen Matloff, director, Yale Cancer Genetic Counseling Program
Elsa W. Reich, genetic counselor, New York University
Breast Cancer Action, a support group
Boston Women's Health Book Collective, also known as Our Bodies, Ourselves, women's health advocacy group
Lisabeth Ceriani, breast cancer victim
Runi Limary, breast cancer victim
Genae Girard, breast cancer victim
Patrice Fortune, breast cancer victim
Vicky Thomason, ovarian cancer victim
Kathleen Baker, whose mother and grandmother died from breast cancer
U.S. Patent and Trademark Office
Directors of the University of Utah Research Foundation
Genes are part of a body's cells and they instruct the body to create the proteins and gene products that allow the body to function.