Supreme Court of the United States to Hear Isolated DNA Patent Case

Posted: December 3, 2012 at 9:43 am

SALT LAKE CITY, Nov. 30, 2012 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN) reported today that the Supreme Court of the United States granted certiorari agreeing to hear the case of The Association for Molecular Pathology, et al., v. Myriad Genetics, Inc., et al (Docket No. 12-398). The Supreme Court will review the earlier decision by the U.S. Court of Appeals for the Federal Circuit, which declared that Myriad's composition of matter claims covering isolated DNA of the BRCA 1 and BRCA 2 genes are patent-eligible under Section 101 of the United States Patent Act.

"Two previous decisions by the Federal Circuit Court of Appeals confirmed the patentability of our groundbreaking diagnostic test that has helped close to one million people learn about their hereditary cancer risk," said Peter Meldrum, President and CEO of Myriad Genetics. "Myriad devoted more than 17 years and $500 million to develop its BRACAnalysis(R) test. The discovery and development of pioneering diagnostics and therapeutics require a huge investment and our U.S. patent system is the engine that drives this innovation. This case has great importance for the hundreds of millions of patients whose lives are saved and enhanced by the life science industry's products."

About Genetic Patents and Genetic Testing

The BRACAnalysis test detects the presence of the BRCA1 and BRCA2 genetic mutations that can help determine a patient's risk of breast and ovarian cancer and inform treatment options. Women who test positive using Myriad's BRACAnalysis have an 82 percent higher risk of developing breast cancer and a 44 percent higher risk of ovarian cancer in their lifetimes. The test is widely available for all women with a family history of cancer and is cost effective for both patients and the healthcare system. Approximately one million women have already benefited from taking the BRACAnalysis test.

Myriad supports research studies on BRCA1, BRCA2 and other genes. More than 18,000 scientists have studied the BRCAgenes and published more than 9,000 research papers, making these genes among the most widely researched genes in history. In addition, Myriad has facilitated research through a partnership with the National Institutes of Health and provided at-cost testing for nearly 6,000 researchers receiving NIH grants.

Health economic studies conclude that Myriad's genetic tests are fairly priced. Excerpts supporting this conclusion include the following:

Additionally, Myriad has also established a Financial Assistance Program, which provides coverage at no charge to low-income patients who lack insurance. Over the past three years alone, more than 5,000 people have received free BRACAnalysis testing from Myriad. Approximately 95% of all patients in the United States have access to BRACAnalysis either through private insurance, Medicare or Medicaid. The average out-of-pocket cost to a patient is less than $100.

Even though Myriad automatically retests all positive results to confirm the findings at no additional charge to the patient, second-opinion testing is also available for all patients. Since 1999, many laboratories have performed confirmatory and second-opinion testing. The NCBI Genetic Testing Registry lists seven laboratories in the United States that conduct second-opinion testing on the BRCA 1 gene and six laboratories that test the BRCA 2 gene.

About Myriad's Patent Landscape

Myriad's intellectual property for its BRACAnalysis(R) test is strong, with 24 issued patents and more than 500 claims. This provides Myriad with extensive patent protection through 2018.

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Supreme Court of the United States to Hear Isolated DNA Patent Case

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