WASHINGTON, Jan. 13, 2020 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced today that
the U.S. Supreme Court has denied the petition for a writ of
certiorari filed by West-Ward Pharmaceuticals (West-Ward), a
subsidiary of Hikma Pharmaceuticals, relating to Vanda's U.S.
Patent number 8,586,610 (the '610 Patent) for Fanapt®. This
order by the U.S. Supreme Court ensures that the '610 patent will
remain exclusive at least through November
2, 2027, absent further challenges from other parties.
By denying the petition for a writ of certiorari, the Supreme
Court leaves undisturbed the U.S. Court of Appeals for the Federal
Circuit decision that West-Ward's Abbreviated New Drug Application
for iloperidone infringed the '610 Patent, and that West-Ward had
not proven the '610 Patent invalid.
"We are pleased the U.S. Supreme Court denied certiorari and
that the Federal Circuit's decision stands," said Mihael H. Polymeropoulos, M.D., Vanda's
President and CEO. "Upholding our Fanapt® invention validates our
approach to innovation, and enables us to continue investing in
important, life-changing discoveries."
About Vanda Pharmaceuticals Inc.
Vanda is a leading
global biopharmaceutical company focused on the development and
commercialization of innovative therapies to address high unmet
medical needs and improve the lives of patients. For more on Vanda
Pharmaceuticals Inc., please visit www.vandapharma.com
About Fanapt®
For full U.S. Prescribing Information
for Fanapt®, including indication, Boxed Warnings and Important
Safety Information, visit our Web site at www.fanapt.com.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release, including, but not limited
to, the statement concerning the duration of patent exclusivity for
the '610 Patent, are "forward-looking statements" under the
securities laws. Forward-looking statements are based upon current
expectations that involve risks, changes in circumstances,
assumptions and uncertainties. Important factors that could cause
actual results to differ materially from those reflected in Vanda's
forward-looking statements include, among others, Vanda's
assumptions regarding the duration of exclusivity for the '610
Patent and the likelihood of additional challenges and other
factors that are described in the "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" sections of Vanda's annual report on Form 10-K for the
fiscal year ended December 31, 2018
and quarterly report on Form 10-Q for the quarter ended
September 30, 2019, which are on file
with the SEC and available on the SEC's website at www.sec.gov.
Additional factors may be described in those sections of Vanda's
annual report on Form 10-K for the fiscal year ended December 31, 2019, to be filed with the SEC in
the first quarter of 2020. In addition to the risks described above
and in Vanda's annual report on Form 10-K and quarterly reports on
Form 10-Q, other unknown or unpredictable factors also could affect
Vanda's results. There can be no assurance that the actual results
or developments anticipated by Vanda will be realized or, even if
substantially realized, that they will have the expected
consequences to, or effects on, Vanda. Therefore, no assurance can
be given that the outcomes stated in such forward-looking
statements and estimates will be achieved.
All written and verbal forward-looking statements attributable
to Vanda or any person acting on its behalf are expressly qualified
in their entirety by the cautionary statements contained or
referred to herein. Vanda cautions investors not to rely too
heavily on the forward-looking statements Vanda makes or that are
made on its behalf. The information in this release is provided
only as of the date of this release, and Vanda undertakes no
obligation, and specifically declines any obligation, to update or
revise publicly any forward-looking statements, whether as a result
of new information, future events or otherwise.
Corporate Contact:
AJ Jones II
Chief Corporate Affairs and Communications Officer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.