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.

The American College of Medical Genetics and Genomics was also the first professional medical association to establish a position against gene patenting. In an 1999 position statement they 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.”

They ‘get it’
“While it is always dangerous to try to predict the eventual ruling of the U.S. Supreme Court from listening to an hour of oral argument, I came away from today’s hearing guardedly optimistic that the Justices, or most of them, do ‘get it’ and may see the issue largely along the lines of ACMG’s long-held policy, noted Wayne Grody, MD, PhD, immediate past-president of the ACMG. “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.”

Lawsuit
The lawsuit was filed by the American Civil Liberties Union and the Public Patent Foundation (PUBPAT) 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 a Utah company, 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.

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?Nobody ?invents? genes, so no one should be able to claim ownership of them,? said Daniel B. Ravicher, executive director of PUBPAT. ?We are not talking about a new drug or a new tool to fight cancer. We are talking about a genetic marker that occurs naturally in the human body. That cannot, and should not, be patented.?

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Importance of intellectual property
However, Myriad Genetics has asked the United States Supreme Court to uphold the patents that have been vital for the development of innovative, live-saving genetic-based diagnostic tools to help patients and doctors assess the risks of breast cancer and ovarian cancer. In its brief with the Supreme Court, Myriad said that without adequate intellectual property protection, companies would face significant obstacles conducting pioneering research and bringing new products to market that save lives.

?This case has potentially broad implications for the biotech, animal health and agricultural industries and the development of products and services of enormous benefit to society,?? said Peter D. Meldrum, president and CEO of Myriad. ?Countless companies and investors have risked billions of dollars to research and develop scientific advances under the promise of strong patent protection.?

Multiple Rulings
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 [1] decided by the Supreme Court last spring.

In their opposition against the patents, the ACMG states that patents granted to Myriad Geneticsand the University of Utah Research Foundation give the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and thus to control the medical care provided to hereditary breast and ovarian cancer patients and people at high risk for these diseases. Myriad’s monopoly on the BRCA genes allows it to set the terms and cost of testing and makes it impossible for women to access alternate tests or get a comprehensive second opinion about their results. It also allows Myriad to prevent researchers from even looking at the genes without first getting permission from Myriad.

Synthetic molecules
But Myriad, on the other hand, counters that genes included in the lawsuitwere never available to the world until their scientists applied their inventive faculties to a previously undistinguished mass of genetic matter and created a new chemical entity. These scientistscreated synthetic molecules of DNA in the laboratory that are used to test patients for increased risk of breast cancer and ovarian cancer. Those synthetic molecules are different from what is found in nature or the human body. Mutations in two genes, known asBRCA1andBRCA2, have been found to signal that patients are at increased risk for hereditary breast and ovarian cancer.

?This was the product of creative, human ingenuity, resulting in significant new applications for human health that were previously unavailable,? notedRichard Marsh, executive vice president and general counsel of Myriad.?We invest heavily in the research and development that is needed to discover and provide high-quality molecular diagnostic products that save and improve patients? lives. Strong intellectual property and patent rights in the United States are critical to fulfilling our mission.?

This case is the first challenge brought to human gene patents in the United States.[2]

For more information:
[1] Mayo Collaborative Services v. Prometheus.
[2]Association for Molecular Pathology v. Myriad Genetics

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