Case Filed: Jul 02, 2014
Origin Case: 3:11-cv-07228
Case Summary:
Puerto Rico-based pharmaceutical
company, Warner Chilcott, now a subsidiary of Actavis, filed a complaint
against India-based generic drug maker, Lupin as a result of the latter filing
ANDA seeking approval to market a generic version of GeneressTM Fe,
before expiration of US patent covering use
of the drug. The suit was originally filed in New Jersey District Court in Dec 2011.
The case is currently open in Appeal court concerning the district court’s
judgment against Warner Chilcott.
Patent-in-Suit:
The patent in suit is: US6667050
entitled ‘Chewable oral contraceptive,’ issued on Dec 23, 2003 and expires[i]
by Jun 12, 2021. Warner Chilcott is the current assignee[ii]
of the patent (source: MaxVal’s Assignment
Database). The ‘050 patent relates to an oral contraceptive delivery system
involving alternate dosages to improve compliance.
As in Complaint:
Warner Chilcott alleged that
Lupin submitted to the FDA an abbreviated new drug application (ANDA) no. 20-3448
to obtain approval to engage in the commercial manufacture, use, or sale of a
generic version of GeneressTM Fe. Lupin have notified FDA and Warner
Chilcott that the ‘050 patent is purportedly invalid, unenforceable and/or will
not be infringed by the manufacture of the ANDA product.
NDA Holder:
Watson, another subsidiary of
Actavis, is the holder of New Drug Application (NDA) no. 22-573 for GeneressTM
Fe, which contains the active ingredients, norethindrone and ethinyl estradiol.
The drug was approved by the FDA in Dec 2010 and is indicated for the
prevention of pregnancy in women.
Generess™ Fe:
GeneressTM Fe is sold
as a 28-day oral contraceptive regimen that includes 24 chewable tablets
comprising 0.8 mg norethindrone and 0.025 mg ethinyl estradiol and 4 chewable
ferrous fumarate tablets (placebo).
District Court Judgment:
A bench trial was held in Jan as
well as in Feb 2014 and as a result, judgment was entered in Apr favoring
defendant’s counterclaims of non-infringement. Additionally, the ‘050 patent
was declared invalid as obvious.
See 2014-1582
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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.
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