The Battle for Gene Ownership Reaches the U.S. Supreme Court
Thursday, December 06, 2012
With its decision on Nov. 30 to review an appellate court’s 2 to 1 ruling upholding patents on the BRCA1 and BRCA2 genes, the U.S. Supreme could alter the course of molecular pathology in the United States during 2013.
BRCA1 and BRCA2 are two of the 23,000 genes in the human genome, 20 percent of which have been patented. However, most of the other patented genes currently do not affect patients’ decisions about their health in the same way as BRCA1 and BRCA2, according to Wayne Grody, MD, PhD, FASCP. In the United States, about 0.5 to 2.5 percent of all women (depending on ethnic group) have these genetic mutations and are estimated to have a 50- to 90-percent lifetime risk for breast cancer and 25- to 50-percent lifetime risk for ovarian cancer. This compares to an average woman’s lifetime risk of 12.2 percent for breast cancer and 1.7 percent for ovarian cancer.
“Gene patents hinder advances for patient care and make the process slower and more expensive. The field of molecular diagnostics for pathologists will not move that fast if we are hindered by patents on key genes.”
—Wayne Grody, MD, PhD, FASCP
“It is anyone’s guess which side the U.S. Supreme Court will take on the gene patent issue, but it’s the last hurdle in a case that started four years ago,” said Dr. Grody, Professor of Pathology and Laboratory Medicine, Pediatrics, and Human Genetics at the University of California at Los Angeles School of Medicine. “However, I have more hope now because of the U.S. Supreme Court’s recent ruling to invalidate two patents that gave Prometheus Laboratories exclusive rights over correlating the body’s natural response to levels of a certain drug. That ruling ensured critical scientific data and clinical correlations derived from it remained available for responsible patient care and is somewhat similar to the issues of Myriad Genetics’ ownership of patents on BRCA1 and BRCA2 gene mutations.”
Joining the American Civil Liberties Union (ACLU) in 2009, ASCP is one of 20 plaintiffs that include geneticists, patients, and scientific organizations in this case, which is the first challenging whether human genes can be patented. Early on the ACLU asked Dr. Grody to serve as an expert consultant concerning the technical language and knowledge in the legal briefs and to persuade medical societies to join the case “to make the argument stronger with their support,” he said.
The battle over the legality of gene patents began when the ACLU and its plaintiffs sued Myriad Genetics and the U.S. Patient and Trademark Office over whether human genes can be patented. The plaintiffs argue that patents on human genes, which are “products of nature,” violate the First Amendment and patent law.
“Gene patents hinder advances for patient care and make the process slower and more expensive,” Dr. Grody said. “The field of molecular diagnostics for pathologists will not move that fast if we are hindered by patents on key genes.
“In my mind, this is a moral issue. A company’s ownership of human genes is outrageous.”
How would a U.S. Supreme Court ruling against human gene patents affect pathologists, laboratory professionals, and patients?*
Gene patent holders could not stop other laboratories from offering genetic testing. For example, Myriad sued the University of Pennsylvania laboratory run by plaintiffs Arupa Ganguly and Haig Kazazian, forcing them to stop testing the BRCA genes, even though their test was different from Myriad’s and cost less.
Gene patent holders could not prevent others from providing genetic testing that relies on new developments in genetic research. For instance, Myriad denied plaintiff Ellen Matloff’s request to allow Yale University to screen patients for BRCA genetic mutations that were excluded from Myriad’s standard test, but shown by the scientific community to be associated with cancer risk, leading to false negative test results.
Patients would not be forbidden from getting a second opinion or testing at a lower cost because a patent holder has a monopoly on a gene. For example, the case’s plaintiff Lisbeth Ceriani, a young breast cancer survivor who needed to determine her ovarian cancer risk, could not afford to pay $4,000 out of pocket for Myriad’s testing. The company refused to contract with her insurance company, which was willing to provide coverage.
Genetic testing could be offered that screens multiple genes for certain conditions, giving patients and doctors a better understanding of how genetic factors might affect diagnosis and treatment.
Universities, laboratories, and biotechnology companies could develop new tests, drugs, and other inventions based on genetic information and sequencing without reprisal for patent infringement.
“Without Myriad’s restrictive patents on BRCA1 and BRCA2 gene mutations that affect hundreds of thousands of women in the United States, any qualified and accredited molecular diagnostics laboratory could begin to test for these gene mutations,” Dr. Grody said. “This would improve patient care through increased access to the test, lower cost, and more transparent findings, and peer reviews across the field.”
* “Are Human Genes Patentable? Supreme Court Will Decide,” American Civil Liberties Union, Nov. 30, 2012, accessed on Dec. 6 at http://www.aclu.org/blog/womens-rights-free-speech/are-human-genes-patentable-supreme-court-will-decide