Friday, June 6, 2014

Astrazeneca Sues Sandoz to Delay Generic Faslodex

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. 

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 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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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.

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