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
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* 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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