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.
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Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No. Description
Press release of Vanda Pharmaceuticals Inc. dated January 13,
99.1 2020.
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document).
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