Case Filed: Jun
03, 2014
Court: New
Jersey District Court
Judge: Freda L.
Wolfson
Case Summary:
Astrazeneca filed
a patent infringement lawsuit concerning Sandoz’s filing of abbreviated new
drug application (ANDA) with the U.S. Food and Drug Administration (FDA)
seeking approval to engage in the commercial manufacture, use and sale of its
fulvestrant injection, 250 mg/5 mL product, which is a generic version of
AstraZeneca’s Faslodex® (fulvestrant injection) product, prior to the
expiration of their four U.S. patents.
Patents-in-Suit:
The patents
involved in the suit are: US6774122, US7456160, US8329680 and US8466139
entitled ‘Formulation,’ issued on Aug 10, 2004, Nov 25, 2008, Dec 11, 2012 and
Jun 18, 2013, respectively. All the patents are scheduled to expire[i]
by Jan 10, 2020. Astrazeneca is the current assignee[ii]
of the patents-in-suit (source: MaxVal’s Assignment
Database.) The use of Faslodex® (fulvestrant injection) is covered by the
claims of the ’122, ’160, ’680 and ’139 patents.
NDA Holder:
AstraZeneca is
the current holder[iii]
of approved new drug application (NDA) No. 21-344 for Faslodex® in 50 mg/mL
dosage forms (source: Patent
Marker). Faslodex® (fulvestrant injection) is an estrogen receptor
antagonist approved by the FDA for the treatment of hormone receptor positive
metastatic breast cancer in postmenopausal women with disease progression
following antiestrogen therapy.
As in Complaint:
Sandoz notified
AstraZeneca that it submitted ANDA No. 205935 seeking approval from FDA and
included that the ’122, ’160, ’680, and ’139 patents are invalid,
unenforceable, and/or will not be infringed by the manufacture, use,
importation, sale or offer for sale of Sandoz’s ANDA product. Astrazeneca claimed
that Sandoz is knowingly and willfully infringing the patents-in-suit.
According to
AstraZeneca, no allegations were made that the claims of the ’122, ’160, ’680, and
’139 patents are not infringed by Sandoz’s ANDA Product.
The complaint
further stated that the notice letter lacked any legal or factual basis for
non-infringement of any claims of the patents-in-suit.
AstraZeneca seeks
unspecified damages, costs and expenses.
See 3:14-cv-03547
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[i] Expected expiration date. Patent
Term Estimator is a free web-based tool that automatically calculates patent
terms and expiration dates for U.S. utility patents.
[ii] MaxVal offers Patent Assignment
Alert service where subscribers receive email alerts when assignments relating
to target applications, patents or entities of interest are recorded.
[iii] Patent Marker provides
an online environment where patentees can virtually mark products and search
products for patent-related information.
