SAN DIEGO, March 21, 2016 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company committed to enabling healthier lives through the development of innovative products and services, announced that it filed a petition today with the Supreme Court of the United States to review decisions by lower Federal courts that the claims of Sequenom's U.S. Patent No. 6,258,540 ("'540 Patent") are not patent eligible under the patent eligibility criteria established by the Supreme Court's Mayo Collaborative Services v. Prometheus Laboratories decision. In the petition, Sequenom urges the Court to hear the case because the Court is uniquely suited to reconcile and interpret the patent eligibility criteria established in its Mayo decision. Those overly-expansive patent eligibility criteria have not only negatively impacted Sequenom's patent, but have put into jeopardy the patentability of existing and future diagnostic method patent claims.
The judges at the U.S. Court of Appeals for the Federal Circuit felt "bound by the sweeping language of the test set out in Mayo" to hold the '540 patent invalid. The judges, and the twelve organizations that supported Sequenom at the Court of Appeals, recognized that an expansive application of the Mayo test for patent eligibility, such as in this case, will lead to untenable results—invalidating previously irreproachable inventions and precipitating what Court of Appeals Judge Lourie called "a crisis of patent law and medical innovation." The Court of Appeals emphasized that the only clarifications that can avoid such results "must come from the Supreme Court."
"We continue to believe that the groundbreaking techniques embodied in the '540 patent are eligible for patent protection," said Dirk van den Boom, Ph.D., President and CEO of Sequenom. "More broadly, we believe our case provides a compelling opportunity for the Supreme Court to clarify patent eligibility criteria to protect the significant investments made by Sequenom and other life science organizations that have undoubtedly advanced the standard of patient care and treatment, as well as encouraging future such investments."
Sequenom believes that the existing lower court ruling will have little on-going business impact as the Company has been operating under the District Court's invalidity ruling since October, 2013, as well as the pooling arrangement of NIPT intellectual property entered into with Illumina, Inc. in December, 2014.
Separate and apart from any U.S. Supreme Court review of Sequenom's '540 patent, the Company maintains valid and enforceable patents with claims equivalent to those of the '540 patent in Europe, Japan, Hong Kong, Canada and Australia. Sequenom and Illumina are currently pursuing infringement actions in some of those jurisdictions.
Sequenom, Inc. (NASDAQ: SQNM) is a pioneering genetic testing company dedicated to women's health through the development of innovative products and services. The Company serves patients and physicians by providing early patient management information. For more information, visit www.sequenom.com.
About Sequenom Laboratories
Sequenom Laboratories™, a CAP-accredited and CLIA-certified molecular diagnostics laboratory, has developed a broad range of laboratory tests, with a focus principally on prenatal care. Branded under the names HerediT®, HerediT® UNIVERSAL, MaterniT® GENOME, MaterniT21® PLUS, NextView®, SensiGene® and VisibiliT™, these molecular genetic laboratory-developed tests provide early patient management information for obstetricians, geneticists, and maternal fetal medicine specialists. Sequenom Laboratories is changing the landscape in genetic diagnostics using proprietary cutting edge technologies. Visit www.laboratories.sequenom.com and follow @SequenomLabs.
SEQUENOM®, HerediT®, MaterniT®, NextView®, SensiGene®, VisibiliT™ and Sequenom Laboratories™ are trademarks of Sequenom, Inc. All other trademarks and service marks are the property of their respective owners.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the development of innovative products and services and the expected impact of the Court's decision. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company's filings with the Securities and Exchange Commission, including without limitation the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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SOURCE Sequenom, Inc.