Sequenom Comments On U.S. Court Of Appeals For The Federal Circuit Decision On '540 Patent

02 Dec, 2015, 17:15 ET from Sequenom, Inc.

SAN DIEGO, Dec. 2, 2015 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company committed to enabling healthier lives through the development of innovative products and services, today issued a statement on the decision by the U.S. Court of Appeals for the Federal Circuit on the Company's U.S. Patent No. 6,258,540 ("'540 Patent").

The U.S. Court of Appeals for the Federal Circuit today announced that it denied Sequenom's petition for en banc re-hearing of the Court's earlier decision upholding the ruling of the United States District Court for the Northern District of California that the claims of Sequenom's '540 patent are not patent eligible under the patent eligibility criteria established by the Supreme Court's Mayo Collaborative Services v. Prometheus Laboratories decision. This result was not unexpected given the earlier ruling by a three-judge panel of the Court of Appeals that said it was "bound by the sweeping language of the test set out in Mayo."  However, denial of the petition was considered as a necessary first step to having the case potentially heard on appeal by the Supreme Court of the United States.

In concurring opinions, three Circuit Judges expressed concern that the current interpretation of the Mayo decision may discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences, which are often driven by discovery of new natural laws and phenomena.  However, the Judges stated that despite the claims reciting "innovative and practical uses" for circulating, cell-free fetal DNA, they are bound by the language of Mayo, and any further guidance must come from the Supreme Court, not the U.S. Court of Appeals for the Federal Circuit.  In a dissenting opinion, Circuit Judge Newman expressed her view that "the new diagnostic method here is novel and unforeseen, and is of profound public benefit" and stated: "I agree with my colleagues that this case is wrongly decided.  However, I do not share their view that this incorrect decision is required by Supreme Court precedent."

As previously stated, as a practical matter, Sequenom believes that the ruling has little business impact as it has been operating under the District Court's invalidity ruling since October, 2013 and due to the pooling arrangement of NIPT intellectual property entered into with Illumina, Inc. in December, 2014.  In addition, valid and enforceable patents with claims equivalent to those of the '540 Patent are issued in Europe, Japan, Hong Kong, Canada and Australia. 

Sequenom understands that patent eligibility under 35 U.S.C. section 101 is an emerging and complex set of issues and is considering a further appeal to the Supreme Court of the United States.

About Sequenom  Sequenom, Inc. (NASDAQ: SQNM) is committed to enabling healthier lives through the development of innovative products and services.  The Company serves patients and physicians by providing early patient management information.  To learn how Sequenom is interpreting the genome to improve your life, 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® GENOME, MaterniT21® PLUS, NextView®, SensiGene®, VisibiliT™ and Sequenom Laboratories are trademarks of Sequenom, Inc.  All other trademarks and service marks are the property of their respective owners.

Forward-Looking Statements 

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 Quarterly Report on Form 10-Q 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.



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