Thursday, March 21, 2013

Watson Sued Over Generic Version of Nexium

Plaintiffs: AstraZeneca AB, Aktiebolaget Hassle, AstraZeneca LP, KBI-E and KBI

Defendants: Watson Laboratories, Watson Pharma, and Actavis

A patent infringement case (3:13-cv-01669) was filed on Mar 19 in the District Court of New Jersey. The case involves 5 patents that relate to medicinal preparations and their use in the manufacture of pharmaceuticals.

The patent information as follows:
Patent Number
Current Assignee[1]
Issue Date
Expiry Date[2]

Feb 03, 1998
Feb 03, 2015

Mar 02, 1999
May 28, 2013
Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of omeprazole

Apr 09, 2002
May 30, 2017
Form of S-omeprazole

Apr 05, 2005
May 28, 2013

Aug 12, 2008
May 30, 2017
Form of S-omeprazole
Source: MaxVal’s Assignment Database

KBI-E and KBI have the exclusive rights in the above patents. 

As per the complaint, defendants seek FDA to approve their proposed product Esomeprazole Magnesium Delayed Release Capsules, 40 mg, containing the active ingredient esomeprazole magnesium, prior to the expiration of the patents-in-suit, as a generic version of the Nexium® product. The ANDA no. filed for the approval is 204358. AstraZeneca currently holds[3] the NDA no. 021153 for Nexium which was approved by FDA on February 20, 2001 (source: Patent Marker).

Nexium is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. It is also used to promote healing of erosive esophagitis (damage to the esophagus caused by stomach acid).
It may also be given to prevent gastric ulcer caused by infection with helicobacter pylori (H. pylori), or by the excessive use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Another case is recently filed by AstraZeneca is 3:13-cv-00091 against Dr. Reddy`s Laboratories, which is pending. If you are interested in knowing more about the case(s) filed, please contact us.
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[1] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
[2] 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.
[3] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

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