Federal District Court Rules Isolated DNA Claims are Not Patentable
SALT LAKE CITY, Mar 30, 2010 (GlobeNewswire via COMTEX News Network) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that Judge Robert W. Sweet of the Federal District Court for the Southern District of New York ruled that certain claims covering isolated DNA sequences in seven of the 23 patents covering BRACAnalysis(R) are invalid. Myriad will appeal the decision to the Court of Appeals for the Federal Circuit and will continue to vigorously defend this litigation.
"While we are disappointed that Judge Sweet did not follow prior judicial precedent or Congress's intent that the Patent Act be broadly construed and applied, we are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation," said Peter Meldrum, President and CEO of Myriad Genetics. "More importantly, we do not believe that the final outcome of this litigation will have a material impact on Myriad's operations due to the patent protection afforded Myriad by its remaining patents."
In this case, the ACLU Plaintiffs sought a declaratory ruling that 15 claims under seven BRCA patents owned or exclusively licensed to Myriad were invalid and unenforceable. However, there are 164 claims remaining under these seven patents which were not challenged, and Myriad holds an additional 16 patents covering BRACAnalysis(R) which also were not challenged.
"Notwithstanding today's decision, we are extremely proud of what Myriad has been able to accomplish over the years in promoting women's health in the area of hereditary breast and ovarian cancer," Meldrum said. "Countless lives have been saved as a result of our efforts in concert with the health care community."
BRACAnalysis is an analysis of the BRCA1 and BRCA2 genes developed by Myriad Genetics for assessing 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, preventive medication and treatment decisions. As published in the Journal of the National Cancer Institute, researchers have shown that pre-symptomatic individuals who have a high risk of developing breast cancer can reduce their risk by approximately 50% with appropriate preventive therapies. Additionally, as published in the New England Journal of Medicine, researchers have shown that pre-symptomatic individuals who carry gene mutations can lower their risk of developing ovarian cancer by approximately 60% with appropriate preventive therapies.
For more information about BRACAnalysis, please call 1-800-4-MYRIAD, or visit www.myriadtests.com.
About Myriad Genetics
Myriad Genetics, Inc. is a leading molecular diagnostic company focused on developing and marketing novel predictive medicine, personalized medicine and prognostic medicine products. Myriad's news and other information are available on the Company's Web site at www.myriad.com.
The Myriad Genetics, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6336
Myriad, the Myriad logo, BRACAnalysis, Colaris, Colaris AP, Melaris, TheraGuide, Prezeon, OnDose, and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Company's confidence and belief that the Court of Appeals for the Federal Circuit will reverse the decision of Federal District Court and uphold the patent claims being challenged in this litigation; and the Company's belief that the final outcome of this litigation will not have a material impact on the Company's operations due to the patent protection afforded the Company by its remaining patents. 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 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 our products; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of healthcare payment systems; uncertainties about our ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; 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 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, 2009,which has been 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.
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SOURCE: Myriad Genetics, Inc.
CONTACT: Myriad Genetics, Inc. Suzanne Barton, Director, Investor Relations (801) 584-1138 firstname.lastname@example.org
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