Supreme Court of the United States Remands Gene Patenting Case
Federal Circuit Court of Appeals to Re-Consider the Case
SALT LAKE CITY, March 26, 2012 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) reported today that the Supreme Court of the United States remanded the case of The Association for Molecular Pathology, et al., v. Myriad Genetics, Inc., et al (Docket No. 11-725) to the Federal Circuit Court of Appeals. As a result of this decision by the Supreme Court, the United States Court of Appeals for the Federal Circuit will reconsider their decision dated July 29, 2011, which upheld Myriad's gene patents. In that decision, the Federal Circuit declared that the 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.
"While, this case should not have any direct impact to Myriad and its operations because of our extensive patent estate, it has great importance to the medical, pharmaceutical, biotechnology and other commercial 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," said Peter Meldrum, President and CEO of Myriad Genetics. "Thus, we are prepared to vigorously defend the patent claims granted to Myriad by the U.S. Patent and Trademark Office and believe that we will be successful."
Importantly, Myriad's intellectual property for the BRACAnalysis® test is strong with 23 issued patents and approximately 500 claims, including approximately 245 composition of matter claims and 240 method claims. Only 15 claims are at issue in this case; the rest of the claims remain in full force and effect providing Myriad with extensive patent protection.
Myriad is committed to researching and commercializing innovative molecular diagnostics tests, such as the BRACAnalysis test, to assess a person's risk of developing disease, guide treatment decisions and help improve patients' 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.
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 confirmatory 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. In a recent study published by the Duke Institute for Genome Sciences & Policy (IGSP) their findings stated that "Prices for BRCA 1 and 2 testing do not reflect an obvious price premium attributable to exclusive patent rights." There are more than 2,600 insurance payors, comprised of more than 80,000 insurance plans, which reimburse for the BRACAnalysis test. As a result, the weighted-average out-of-pocket cost for tested patients is less than $100.
Patent access to the BRACAnalysis test is extensive. The Duke Institute for Genome Sciences & Policy (IGSP) study also concluded that "It is, therefore, difficult to attribute reduced access to BRCA testing to patents. We cannot exclude the possibility that [Myriad's] investments in education about hereditary breast and ovarian cancer and testing have actually had the opposite effect of increasing access to testing." 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. As a result, Myriad has provided over 850,000 patients with BRACAnalysis test results.
Lastly, confirmatory testing is available for patients with positive test results as there are a number of laboratories in the U.S. available for confirmatory testing, including a large reference laboratory licensed by Myriad in 2001.
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 Myriad Genetics
Myriad Genetics, Inc. (Nasdaq:MYGN) is a leading molecular diagnostic company dedicated to developing and marketing transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess a patient's risk of disease progression and disease recurrence. Myriad's portfolio of nine molecular diagnostic tests 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 2011 annual revenue of over $400 million and more than 1,100 employees, Myriad is working on strategic directives, 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, the impact of this case on Myriad and its operations because of our extensive patent estate; the rigor of the defense of our patent claims granted to Myriad; our belief as to a successful outcome of the litigation; and the strong patent protection provided by Myriad's patents covering the Company's BRACAnalysis test; 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 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 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 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 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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