WASHINGTON, Oct. 20,
2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) today announced its intention to file a
petition for a writ of certiorari in its
HETLIOZ® Abbreviated New Drug Application
litigation against Teva Pharmaceuticals USA, Inc., Apotex Inc. and Apotex Corp.
Vanda seeks to demonstrate that the
United States Court of Appeals for the Federal Circuit
(Federal Circuit) applied a flawed standard in assessing
obviousness when it affirmed a lower court decision finding several
of Vanda's HETLIOZ® patents invalid. Vanda's petition
seeks to show that the Federal Circuit's approach to obviousness
has deviated materially from KSR Int'l Co. v. Teleflex Inc.,
550 U.S. 398, 416 (2007), which trains the obviousness inquiry on
whether the claimed innovations "do more than yield a predictable
result." Vanda believes that the Federal Circuit's approach
improperly invalidates critical patent rights, which are necessary
to ensure robust pharmaceutical research and development.
"Properly calibrated patent protection is essential to
pharmaceutical innovation, which is in turn critical for advances
in public health. Vanda intends to pursue its interest in this
matter and the interests of innovators, patients and the American
public in the proper interpretation of the U.S. patent laws," said
Mihael H. Polymeropoulos, M.D.,
Vanda's President, CEO and Chairman of the Board.
Chief Justice Roberts extended
the time for the filing of Vanda's forthcoming petition, which
Vanda expects to file by January 12,
2024.
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 Twitter @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 petition the
U.S. Supreme Court and continue to protect its
HETLIOZ® patents, the expected timing of the
petition filing and the substance and intended effect of the
petition, 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, Vanda's ability to file the
petition by January 12, 2024, have
certiorari granted and prevail in proceedings before the U.S.
Supreme Court. 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-intends-to-petition-the-us-supreme-court-in-its-hetlioz-anda-litigation-301962822.html
SOURCE Vanda Pharmaceuticals Inc.