UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01. | Other Events. |
As previously disclosed, Vanda Pharmaceuticals Inc. (“Vanda”) has been involved in litigation with Roxane Laboratories, Inc. (“Roxane”) and its affiliates, West-Ward Pharmaceuticals International Limited and West-Ward Pharmaceuticals Corp (together, “West-Ward”), since Vanda filed a lawsuit against Roxane in the U.S. District Court for the District of Delaware (the “Delaware District Court”) for patent infringement in June 2014. The lawsuit was filed in response to Roxane’s submission to the U.S. Food and Drug Administration (the “FDA”) of an Abbreviated New Drug Application (“ANDA”) for a generic version of Fanapt® prior to the expiration of certain of Vanda’s patents covering Fanapt®, including U.S. Patent No. 8,586,610 (the “‘610 Patent”). In August 2016, the Delaware District Court ruled in Vanda’s favor, permanently enjoining Roxane from manufacturing, using, selling, offering to sell, distributing or importing any generic iloperidone product described in Roxane’s ANDA until the expiration of the ‘610 Patent in November 2027, or May 2028 if Vanda obtains pediatric exclusivity. In April 2018, following an appeal by Roxane of the Delaware District Court’s decision to the Federal Circuit Court of Appeals (the “Federal Circuit”), the Federal Circuit affirmed the Delaware District Court’s ruling. In June 2018, West-Ward, having replaced Roxane as defendants following the acquisition of Roxane by West-Ward’s parent company, Hikma Pharmaceuticals PLC, petitioned the Federal Circuit for a rehearing en banc. In August 2018, the Federal Circuit denied West-Ward’s petition. In January 2019, West-Ward filed a petition in the U.S. Supreme Court for a writ of certiorari seeking reversal of the Federal Circuit’s decision. In March 2019, the U.S. Supreme Court invited the Solicitor General of the U.S. to file a brief in the matter expressing the views of the U.S., and on January 13, 2020, the U.S. Supreme Court denied West-Ward’s petition.
A press release announcing the U.S. Supreme Court’s decision is attached hereto as Exhibit 99.1 and incorporated by reference herein.
Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit No. |
Description | |||
99.1 |
Press release of Vanda Pharmaceuticals Inc. dated January 13, 2020. | |||
104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: January 13, 2020 |
VANDA PHARMACEUTICALS INC. | |||||
By: |
/s/ Timothy Williams | |||||
Name: |
Timothy Williams | |||||
Title: |
Senior Vice President, General Counsel and Secretary |