Item 8.01 Other Events
On September 2, 2022, Exelixis, Inc. (Exelixis) filed a complaint in the United
States District Court for the District of Delaware (the Delaware District Court)
for patent infringement against Teva Pharmaceutical Industries Limited, Teva
Pharmaceuticals Development, Inc. and Teva Pharmaceuticals USA, Inc.
(individually and collectively referred to as Teva), asserting infringement of
U.S. Patent No. 11,298,349 (the September 2022 Teva ANDA Complaint) arising from
Teva's amendment of its Abbreviated New Drug Application (ANDA). In May 2021,
Exelixis received notice that Teva had filed an ANDA with the U.S. Food and Drug
Administration (FDA) for a generic version of CABOMETYX® (cabozantinib) tablets
(20 mg / 40 mg / 60 mg). Exelixis received notice on July 29, 2022, that Teva
had filed a Paragraph IV certification against U.S. Patent No. 11,298,349, and
as amended, Teva's ANDA now requests approval to market a generic version of
CABOMETYX tablets prior to expiration of U.S. Patent No. 11,298,349. In the
September 2022 Teva ANDA Complaint, Exelixis is seeking, among other remedies,
equitable relief enjoining Teva from infringing U.S. Patent No. 11,298,349, as
well as an order that the effective date of any FDA approval of Teva's ANDA
would be a date no earlier than the expiration of U.S. Patent No. 11,298,349 on
February 10, 2032. The September 2022 Teva ANDA Complaint is Exelixis' second
case against Teva and involves an Exelixis patent that is different from those
asserted in Civil Action No. 21-00871 (the 2021 Teva ANDA Action), which is
described below. A trial has not yet been scheduled in connection with the
September 2022 Teva ANDA Complaint.
The 2021 Teva ANDA Action arises from a complaint filed by Exelixis against Teva
in June 2021, asserting infringement of U.S. Patents No. 9,724,342
(formulations), 10,034,873 (methods of treatment) and 10,039,757 (methods of
treatment), which are listed in the Approved Drug Products with Therapeutic
Equivalence Evaluations, also referred to as the Orange Book. The 2021 Teva ANDA
Action was scheduled for a bench trial in June 2023; however, in February 2022,
the parties filed a stipulation to stay all proceedings, which was entered by
the Delaware District Court, and this case was administratively closed. Exelixis
is seeking, among other remedies, equitable relief enjoining Teva from
infringing U.S. Patents No. 9,724,342, 10,034,873 and 10,039,757, as well as an
order that the effective date of any FDA approval of Teva's ANDA would be a date
no earlier than the expiration of the patents at issue in the 2021 Teva ANDA
Action, the latest of which expires on July 9, 2033.
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