WASHINGTON, July 1, 2024
/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA)
today announced that the U.S. District Court for the District of
Delaware (the "Court") denied the
motions for judgment on the pleadings that were filed by Teva
Pharmaceuticals USA, Inc. ("Teva")
and Apotex Inc. and Apotex Corp. ("Apotex") and ordered that
Vanda's HETLIOZ® patent lawsuit may proceed.
Vanda brought this suit in December
2022, alleging patent infringement against Teva and Apotex
(the "Defendants"). The Defendants moved for judgment on the
pleadings in April 2023. On
June 27, 2024, the Court denied the
motions. The Court concluded that the issues of patentability were
not the same as those resolved in prior patent-infringement
litigation between the parties. It further concluded that the
Defendants raised issues that require claim construction and fact
development before the Court can resolve the case.
Vanda intends to proceed with discovery in the case to continue
pursuing its claims. Vanda will request relief from the Court that
includes an order requiring the Defendants to discontinue marketing
their generic versions of HETLIOZ® until the expiration
of the patent-in-suit and enjoining them from the commercial
manufacture, use, import, offer for sale and/or sale of these
products.
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 and follow us on X @vandapharma.
About HETLIOZ®
For full U.S. Prescribing Information for HETLIOZ®, including
indication and Important Safety Information, visit
www.hetlioz.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this press release, including, but not
limited to statements regarding Vanda's intentions to proceed with
discovery in pursuit of its claims and to request relief from the
Court, are "forward-looking statements" under the securities laws.
All statements other than statements of historical fact are
statements that could be deemed forward-looking statements.
Forward-looking statements are based upon current expectations and
assumptions that involve risks, changes in circumstances and
uncertainties. Important factors that could cause actual results to
differ materially from those reflected in Vanda's forward-looking
statements include, among others, the results of Vanda's discovery
and the Court's willingness to grant Vanda the relief that it
seeks. Therefore, no assurance can be given that the 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. Forward-looking statements
in this press release should be evaluated together with the various
risks and uncertainties that affect Vanda's business and market,
particularly those identified in the "Cautionary Note Regarding
Forward-Looking Statements", "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" sections of Vanda's most recent Annual Report on Form
10-K, as updated by Vanda's subsequent Quarterly Reports on Form
10-Q, Current Reports on Form 8-K and other filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov.
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 press release is
provided only as of the date of this press 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,
except as required by law.
Corporate Contact:
Kevin
Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Jim Golden / Jack Kelleher / Dan
Moore
Collected Strategies
VANDA-CS@collectedstrategies.com
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SOURCE Vanda Pharmaceuticals Inc.