U.S Court of Appeals Upholds Myriad's Gene Patents
Court Finds Composition of Matter Claims for BRCA 1 and BRCA 2 Patentable
SALT LAKE CITY, Aug. 16, 2012 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) reported today that the United States Court of Appeals for the Federal Circuit declared that the Company's composition of matter claims covering isolated DNA of the BRCA 1 and BRCA 2 genes are patent-eligible material under Section 101 of the United States Patent Act. This decision reinstates the prior decision by the Court on July 29, 2011.
"We are very pleased with the favorable decision the Court rendered today which again confirmed that isolated DNA is patentable," said Peter Meldrum, President and CEO of Myriad Genetics. "Importantly, the Court agreed with Myriad that isolated DNA is a new chemical matter with important utilities which can only exist as the product of human ingenuity."
It is important to correct some common misconceptions on the societal impact of "gene" patents; namely that such patents impede research, result in high-cost testing and takeaway a patient's option for second-opinion testing. Myriad believes that statements made to these points in the public press are incorrect. To set the record straight,
"Gene" patents have not hindered research on BRCA 1 and BRCA 2 and Myriad has never denied, opposed or impeded any research studies on these, or any other, genes. Further, more than 18,000 scientists have researched the BRCA genes, publishing more than 9,000 research papers.
The cost of the BRACAnalysis test is not prohibitive and patient access is extensive. Myriad has provided close to one million patients with BRACAnalysis test results. Approximately 95% of appropriate patients in the United States have access to BRACAnalysis either through private insurance, Medicare, Medicaid or Myriad's Financial Assistance Program, which provides coverage at no charge to low-income, uninsured patients. Over the past 3 years alone, more than 5,000 patients have benefitted from this assistance program.
Lastly, second opinion testing is available for patients with positive test results in a number of U.S. laboratories, including a large reference laboratory licensed by Myriad in 2001.
Brian M. Poissant, Gregory A. Castanias, Laura A. Coruzzi, Eileen Falvey, Jennifer L. Swize and Sasha Mayergoyz and other members of the law firm of Jones Day represented Myriad in this matter.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's portfolio of molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com
Myriad, the Myriad logo, BRACAnalysis, Colaris, Colaris AP, Melaris, TheraGuide, Prezeon, OnDose, Panexia and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-F, MYGN-G
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the scope and strength of the Company's patents and the Company's strategic directives under the caption "About Myriad Genetics". These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and companion diagnostic services may decline or will not continue to increase at historical rates; the risk that we may be unable to develop or achieve commercial success
for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and companion diagnostic services and any future products are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with manufacturing our products or operating our laboratory testing facilities; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United
States and foreign countries and changes in the structure of healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; the development of competing tests and services; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our tests; the risk of patent-infringement and invalidity claims or challenges of our patents; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A in our most
recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
CONTACT: Rebecca Chambers
Director, Investor Relations and Corporate Communications
Source: Myriad Genetics, Inc.
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