Wednesday, January 22, 2014

Court Issues Judgment Favoring Warner Chilcott against Watson in Patent Dispute

Case Filed: May 16, 2012

Case Closed: Jan 17, 2014

Court: New Jersey District Court

Judge: Joel A. Pisano

Case Summary:

Warner Chilcott sued Watson and Amneal for patent infringement to prevent them from selling a generic version of its oral contraceptive Lo Loestrin Fe. The cause of the suit was Watson’s filing of an Abbreviated New Drug Application (ANDA) no. 202982 with FDA for a pharmaceutical equivalent of Lo Loestrin® Fe before the expiration of plaintiffs' 2 patents covering the medication and its use. The patents involved in suit were:
  •      US5552394 entitled “Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy,” issued on Sep 03, 1996 and expiring* by Jul 22, 2014
  •         US7704984 entitled “Extended estrogen dosing contraceptive regimen,” issued on Apr 27, 2010 and expiring* by Apr 22, 2025

The ‘394 and ‘984 patent are currently assigned+ to Warner Chilcott (source: MaxVal’s Assignment Database).

Warner Chilcott is the current holder± of New Drug Application (NDA) No. 22-501, for Lo Loestrin® Fe (source: MaxVal Patent Marker), which contains the active ingredients norethindrone acetate and ethinyl estradiol and was approved by the FDA on October 21, 2010. It is indicated for the prevention of pregnancy in women who elect to use it as a method of contraception. Warner Chilcott said the Watson version would infringe the 2 patents and sought a Court order to prevent sales until the patents expire.

In February 2013, the '394 patent was dismissed from the case. The case is now concluded as the Court rendered its final verdict on Jan 17, 2014 ordering a judgment in favor of plaintiff against defendant as follows:
  • the 984 patent is not invalid
  • defendants infringe the ‘984 patent
  • the  effective date of any approval by the FDA of defendants’ ANDA should not be earlier than the expiration of the ’984 patent
See 3:12-cv-02928 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

* Expected expiration date using Patent Term Estimator, use our free tool or download our free Android app on Google Play Store. 

* 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.
+ MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
± Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

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