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.