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Warner Chilcott may settle patent dispute with Lupin on Loestrin 24 Fe and Femcon Fe contracepive pills

Friday, October 30, 2009, 15:08 This news item was posted in Patents category and has 0 Comments so far.

Warner Chilcott is likely to settle lawsuit against Lupin for alleged infringement of its patents covering oral contraceptive pills Loestrin 24 Fe and Femcon Fe.

Warner Chilcott in its patent lawsuit alleged that Lupin, through approval to sell generic versions of Loestrin 24 Fe and Femcon Fe, is violating patents which are valid till 2014 and 2019.

Warner Chilcott has voluntarily taken off one of the cases filed in the US District Court of Maryland.

Acting upon a voluntary dismissal petition filed by Warner, the US District Court of Maryland signed off on the notices of voluntary dismissal without prejudice filed by Warner Chilcott, reports said.

Warner Chilcott has another lawsuit pending against Lupin in the district court of Delaware.

Lupin might have reached a settlement with Warner Chilcott on Loestrin 24 Fe and Femcon Fe generic patents, reports said.

Warner Chilcott filed two separate lawsuits against Lupin in Maryland on September 11 which alleged infringement of the patent for Loestrin and the other one for infringement of a Femcon patent. Similar cases were also filed on September 9 in district court of Delaware.

Lupin has filed abbreviated new drug applications (ANDAs) under 21 USC seection 355 (j) seeking approval for manufacturing selling generic versions of Losetrin Fe and Femcon Fe in US.

Warner Chilcott’s contraceptive formulations Losetrin Fe and Femcon Fe contain synthetic versions of of female hormones northindrone and ethinyl estradiol.

The contraceptive pill Loestrin Fe has 1 mg northindrone and 0.02 mg ethinyl estradiol followed by 4 ferrous fumerate tablets.

While Femcon Fe, previously known as Ovcon 35 Fe comprises 0.4 mg northindrone and 0.035 mg ethinyl estrdiol along with 7 ferrous fumerate in the form of chewable palatable tablets.

Warner Chilcott’s Loestrin Fe contains 24 tablets while Femcon Fe is sold as a 28-day oral contraceptive regimen that contains 21 chewable tablets meant for the 28-day cycle.

Both Losetrin Fe and Femcon Fe were approved in US for the indication of preventing pregnancy for women who elect to use it as a method of contraception.

Femcon Fe were approved in US on November 14, 2003

Lupin  by filing generic applications for these Femcon Fe has committed an an act of infringement violated Warner Chilcott’s US patent No.5,552,394 (’394) and 6,667,050 (’050)

The ‘394 patent, issued by the US Patent Office on September 3, 1996, is entitled “Low Dose Oral Contraceptive with Less Breakthrough Bleeding and Sustsined Efficacy.

Warner Chilcott’s ‘050 patent was issued on December 23, 2003 under the title “Chewable Oral Contraceptive”.

Lupin’s submission before USFDA to obtain approval for manufacturing and selling of the therapeutic equivalents of Femcon Fe before the term of expiration of their respective patents are not valid and  enforceable, Warner Chilcott alleged in the two separate lawsuits filed on September 9 praying relief under 35 USC section 271 (e) (4).

Loestrin 24 Fe and Femcon Fe have a combined sale of up to $300 million a year, which forms a significant portion of Warner’s $940 million revenues in 2008.

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