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Federal Court Allows Vanda's HETLIOZ® Patent Lawsuit to Proceed against Teva and Apotex

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Vanda Pharmaceuticals announced that the U.S. District Court for the District of Delaware has allowed its patent lawsuit against Teva Pharmaceuticals and Apotex to proceed. The suit, filed in December 2022, alleges patent infringement related to HETLIOZ®. Teva and Apotex's motions for judgment on the pleadings were denied on June 27, 2024. The court determined that the issues of patentability require further claim construction and fact development. Vanda aims to seek an injunction to stop the defendants from marketing their generic versions of HETLIOZ® until the patent expires.

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  • None.

Negative

  • Vanda’s ongoing legal battle may incur significant legal expenses.
  • Potential delays in case resolution could impact Vanda's financial performance.

News Market Reaction 1 Alert

-1.24% News Effect

On the day this news was published, VNDA declined 1.24%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

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

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/federal-court-allows-vandas-hetlioz-patent-lawsuit-to-proceed-against-teva-and-apotex-302186901.html

SOURCE Vanda Pharmaceuticals Inc.

FAQ

What was the outcome of Vanda Pharmaceuticals' patent lawsuit against Teva and Apotex?

The U.S. District Court for the District of Delaware denied Teva and Apotex's motions for judgment on the pleadings, allowing Vanda's lawsuit to proceed.

When did Vanda Pharmaceuticals file the patent infringement lawsuit against Teva and Apotex?

Vanda filed the patent infringement lawsuit in December 2022.

What is Vanda Pharmaceuticals seeking from the court in its lawsuit against Teva and Apotex?

Vanda is seeking an order to stop Teva and Apotex from marketing their generic versions of HETLIOZ® until the patent expires.

What court is handling Vanda Pharmaceuticals' lawsuit against Teva and Apotex?

The U.S. District Court for the District of Delaware is handling the lawsuit.

What is Vanda Pharmaceuticals' stock symbol?

Vanda Pharmaceuticals' stock symbol is VNDA.
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