The U.S. Supreme Court Hears Arguments Challenging Patents on Breast and Ovarian Cancer Genes
The U.S. Supreme Court heard arguments Monday in a case seeking to invalidate patents on two genes associated with hereditary breast and ovarian cancer. The American College of Medical Genetics and Genomics (ACMG) was one of the first plaintiffs to sign onto this historic legal case.
ACMG was also the first professional medical association to establish a position against gene patenting. In its 1999 ACMG Position Statement on Gene Patents and Accessibility of Gene Testing, which was reaffirmed in 2005, ACMG stated that: "It is the American College of Medical Genetics' position that genes and their mutations are naturally occurring substances that should not be patented."
Wayne Grody, MD, PhD, Immediate Past President of the ACMG was in the courtroom during the hearing and said that he was “guardedly optimistic” that the majority of Justices understood ACMG’s long-held policy. “Though the first half of the discussion got a little bogged down in parsing the difference between particular forms of natural and extracted DNA, toward the end the focus was clearly on human gene sequences, in whatever form, as products of nature and no more patentable than any other part of the body,” he said.
Lawsuit History
The lawsuit was filed by the American Civil Liberties Union and the Public Patent Foundation on behalf of researchers, genetic counselors, patients, breast cancer and women's health groups, and medical professional associations representing 150,000 geneticists, pathologists, and laboratory professionals. The patents allow Myriad Genetics to control access to the genes, thereby enabling them to limit others from doing research or diagnostic testing, which can be crucial for individuals making important medical decisions.
A federal district court invalidated all of the challenged patents in 2010. In 2012, a federal appeals court ruled for the second time that the patents on the genes were valid. Its 2-1 decision followed a Supreme Court order directing the appeals court to reconsider its initial decision in light of a related patent case decided by the Supreme Court last spring.
Challenges Monopoly on BRCA Genes
The patents granted to Myriad Genetics and the University of Utah Research Foundation give the company the exclusive right to perform and develop diagnostic tests on the BRCA1 and BRCA2 genes and thus to control the medical care provided to patients with hereditary breast and ovarian cancer and people at high risk for these diseases.
The case is the first challenge brought to human gene patents in the United States.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
