Ass'n of Molecular Pathology v. Myriad Genetics, U.S. Supreme Court's Legal Advocacy

U S Supreme Court' s Mixed Ruling Expected to Open Doors for Consumers

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The Court’s mixed ruling rejects patent giving Myriad the exclusive right to test and isolate breast and ovarian cancer genes while leaving unanswered questions.

Background

Myriad Genetics held exclusive patents on two human genes (BRCA1 and BRCA2) that relate to a person’s predisposition to developing breast and ovarian cancer. Because of its patents, Myriad was the only provider of BRCA genetic testing in the United States. A woman’s risk of developing breast and/or ovarian cancer is greatly increased if she inherits a BRCA1 or BRCA2 mutation. Individuals whose families have a history of cancer can benefit by a genetic blood test to determine if they have the mutation, and early detection opens several options including preemptive surgery. Because of its patents, Myriad has prohibited other labs and medical professionals from conducting tests on BRCA1 and BRCA2 genes, hindering the ability of patients to seek a second opinion. Myriad charges between $3,000 and $4,000 for its BRCA genetic test. A coalition of nonprofit organizations, scientists, professors, genetic counselors, and individuals at high risk for hereditary breast and ovarian cancer filed a lawsuit alleging that Myriad’s patents on genes violate the Constitution and patent laws. They argue that human genes and DNA molecules are natural phenomena that are not the kind of “discovery” covered by patent laws. AARP Foundation Litigation attorneys filed AARP’s friend-of-the-court briefs (five in all) pointing out that patent law did not envision patenting natural phenomena. Patents stifle scientific research for cures for genetic diseases, elevate the already high cost of genetic testing, and limit patient access to potentially life-saving tests. The Supreme Court ruled that discovering a human gene and removing (isolating) the gene from the human body was not patent eligible but that creating a synthetic version of the gene was patent eligible. Myriad will no longer be the sole option for patients desiring BRCA testing and other medical professionals are free to remove the genes for diagnostic testing. The Court’s ruling upholding synthetic DNA, or cDNA, leaves unanswered questions regarding the impact of patents on synthetic DNA or whether cDNA meets other standards of patentability. The Court also left unanswered which applications of new knowledge about the BRCA1 and BRCA2 genes are patent eligible.

What s At Stake

This case will impact the cost and availability of genetic tests. The ruling is expected to lower the cost of genetic testing and increase patient access to the test. Genetic diagnostic tests can determine how a patient will respond to a specific drug or a patient’s risk for developing a number of diseases.

Case Status

The Association for Molecular Pathology. v. Myriad Genetics was decided by the U.S. Supreme Court.

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