Supreme Court Upholds Myriad's cDNA Patent Claims
Court Also Highlights Patent Eligibility of Method Claims
SALT LAKE CITY, Utah, June 13, 2013 - Myriad Genetics, Inc. (Nasdaq:MYGN) today said the Supreme Court of the United States upheld its patent claims on complementary DNA, or cDNA. However, the Court ruled that five of Myriad's claims covering isolated DNA were not patent eligible. Following today's decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis® test.
Importantly, the Court noted that many of Myriad's unchallenged claims are method claims applying knowledge about the BRCA 1 and BRCA 2 genes. While these method claims were not at issue in this case, the Court highlighted Federal Circuit Judge Bryson's opinion that, "[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications to that knowledge."
"We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward," said Peter D. Meldrum, president and CEO. "More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples' lives and lowering overall healthcare costs."
BRACAnalysis is the leading genetic test worldwide to determine if a patient has an increased risk of hereditary breast and ovarian cancer and has been used by more than a million women to assess their risk of hereditary breast and ovarian cancer. BRACAnalysis testing is widely reimbursed by private insurance companies, Medicare and Medicaid. As a result of the Affordable Care Act, the vast majority of at-risk patients can receive BRACAnalysis testing with no out-of-pocket costs — meaning no co-pays or deductibles. Additionally, more than 35,000 at-risk patients in need have participated in Myriad's patient assistance programs that provide free tests or other financial assistance.
"We are collaborating with the medical and scientific communities to improve patient access to genetic testing and facilitate research worldwide. Already, more than 10,000 scientific papers have been published on the BRCA genes, ranking them among the most researched genes in history. We are committed to advancing scientific knowledge even further, and Myriad will continue to encourage and support academic research studies conducted on the BRCA genes," said Meldrum. "While we are confident that Myriad offers the highest quality genetic tests in the world, we also support patients' rights to seek second opinion tests from any of the many laboratories conducting BRCA testing for the purpose of confirming the Myriad test result."
The case is the Association for Molecular Pathology v. Myriad Genetics. Myriad was represented by a team of lawyers from Jones Day, including Gregory A. Castanias, Brian M. Poissant, Laura A. Coruzzi, Sasha Mayergoyz, and Jennifer L. Swize.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 click here.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, Melaris, TheraGuide, Prezeon, Panexia and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-F, MYGN-GSafe 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 validity, enforceability and strength of the Company's remaining patents, patent claims and intellectual property protection for its BRACAnalysis testing following the Supreme Court's decision; and the Company's strategic directives under the caption "About Myriad Genetics". These "forward-looking statements" are management's present 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 described in the forward-looking statements. These risks 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; risks related to changes in the governmental or private insurers reimbursement levels for our tests; 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 tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our 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 the healthcare system or 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 claims or challenges to the validity 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.