Myriad Applauds the Court of Appeals' Decision to Uphold Gene Patenting
U.S Court of Appeals for the Federal Circuit Rules Myriad's Composition of Matter Claims for BRCA1 and BRCA2 are Patent-Eligible
SALT LAKE CITY, July 29, 2011 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) reported today that the United States Court of Appeals for the Federal Circuit declared that the composition of matter claims covering isolated DNA and cDNA of the BRCA1 and BRCA2 genes are patent-eligible under Section 101 of the United States Patent Act. The Federal Circuit's ruling reverses the decision of the United States District Court for the Southern District of New York that the compositions of matter claims for the BRACAnalysis® product were invalid.
"We strongly support the Court's decision that isolated DNA and cDNA are patent-eligible material as both are new chemical matter with important utilities which can only exist as the product of human ingenuity," said Peter Meldrum, President and CEO of Myriad Genetics. "Furthermore, we believe this decision is in the best interests of the agriculture, biotechnology and pharmaceutical industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection."
The Federal Circuit also held that five of the Company's six method claims at issue did not satisfy Section 101. More importantly, with respect to the BRCA1 and BRCA2 genes, Myriad has 237 method claims for BRACAnalysis which were not affected by this ruling and remain in full force and effect providing Myriad with equally strong method of use patent protection.
Myriad is committed to researching and commercializing innovative molecular diagnostics products, such as the BRACAnalysis test, to assess a person's risk of developing disease, guide treatment decisions and help improve patient's quality of life. As such, the Company plans to continue its strong commitment to promoting women's health in the areas of hereditary breast and ovarian cancer, advancing and fostering research on the BRCA genes and providing excellent patient access to its test, including offering financial assistance programs to qualifying individuals.
Brian M. Poissant, Gregory A. Castanias, Laura A. Coruzzi, Eileen Falvey and Sasha Mayergoyz and other members of the law firm of Jones Day represented Myriad in this matter.
About BRACAnalysis® Testing
BRACAnalysis is a molecular diagnostic product developed by Myriad Genetics which analyzes the BRCA1 and BRCA2 genes to assess a woman's risk for hereditary breast and ovarian cancer. A woman who tests positive with the BRACAnalysis test has, on average, an 82% risk of developing breast cancer during her lifetime and a 44% risk of developing ovarian cancer. BRACAnalysis provides important information that the Company believes will help patients and their physicians make better informed lifestyle, surveillance, and preventive medication and treatment decisions. For more information about BRACAnalysis, please call 1-800-4-MYRIAD, or visit www.myriadtests.com.
About Myriad Genetics
Myriad Genetics, Inc. (Nasdaq:MYGN) is a leading molecular diagnostic company dedicated to developing and marketing novel predictive, personalized and prognostic medicine products to assess a person's risk of developing disease and guide treatment decisions. Myriad's portfolio of nine molecular diagnostic products are based on an understanding of the role genes play in human disease and were developed with a focus on improving an individual's decision making process for monitoring and treating disease. With fiscal year 2010 annual revenue of over $360 million and approximately 1,000 employees, Myriad is working on strategic initiatives, including new product introductions, companion diagnostics, and international expansion, to take advantage of significant growth opportunities. 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-G
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including the statements related to the Company's belief regarding the importance of the Court of Appeals' decision, and the impact of the Court of Appeals' decision on the Company's BRACAnalysis product and the Company's remaining method claims for BRACAnalysis. 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 products may decline or will not
continue to increase at historical rates; the risk that we may be unable to expand into new markets outside of the United States; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic products in a timely manner, or at all; the risk that licenses to the technology underlying our molecular diagnostic products 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 products 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 and acquire new technologies or businesses on satisfactory terms, if at all, and risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we acquire; the development of competing products and services; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our products; 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 Annual Report on Form 10-K for the year ended June 30, 2010,
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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