Warner Chilcott sues Lupin for breaching patents on generic oral contraceptives in US

Lupin has infringed Warner Chilcott’s valid patents on Losetrin Fe and Femcon Fe by seeking approval for their generic versions

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

Indian generic firm Lupin Ltd has been sued for alleged infringement of patents relating to the oral contraceptives Losetrin Fe and Fencon Fe owned by Puerto Rican Company  Warner Chilcott’s in the US 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 estrdiol.

The contraceptive pill Losetrin Fe has 1 mg northindrone and 0.02 mg ethinyl estrdiol 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 Losetron 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).

In May, Genzyme  Corporation of UK sued Lupin for alleged infringement of its patent in the United States District Court of Maryland on kidney disease drug Renvela.

Renvela pills which contains sevelamer carbonate – the new general version of sevelamer hydrochloride – as active ingredient was approved by US FDA on October 9,2007 for the control of serum phospherous in patients with chronic kidney disease on dialysis.

Genzyme’s litigation against Lupin on the infringement of Renagal-sevelamer hydrochloride 400 and 800 mg tablets was a follow up of the lawsuit started in March this year.

Genzyme, on its petition filed on May 14, 2009, has alleged that if approved for sale in US, Lupin would be infringing Genzyme’s one or more claims of valid patents viz. 545,’775,’013,’203,’846 and ‘151 prior to their expiration.

However, Lupin in a Notice Letter informed Genzyme that none of the above-said patents will be infringed by the ANDA as they are invalid and unenforceable in the manufacture and sales of sevelamer pills in US.

In April, Elan Pharma International and Fournier Laboratories Ireland have filed a lawsuit against Lupin Pharmaceuticals for infringing two patents covering TriCor (fenofibrate), 48 and 145 mg, a drug used to reduce cholesterol levels.

Similarly in another case Lupin, along with other Indian peers Sun Pharma, Wockhardt, were sued Pfizer, the world’s largest pharmaceutical company, alleging infringement alleging patent violation for seeking marketing approvals for the generic equivalents of its high-selling neuropathic pain management drug Lyrica in the United States.