Wednesday, July 9, 2014

Warner Chilcott Appeals District Court’s Judgment Favoring Lupin

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.

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 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.

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