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news.Shire, a specialty biopharmaceutical company, has filed a lawsuit in the US District Court of New York against Mylan Inc, Mylan Pharmaceuticals Inc and Matrix Laboratories for infringement of Shire's US patent.
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The lawsuit was filed in response to an abbreviated new drug application (ANDA) filed by Mylan seeking the FDA approval to market and sell generic versions of Shire’s 500mg, 750mg, and 1gm Fosrenol (lanthanum carbonate) products.
Under the Hatch-Waxman Act, because Shire filed its patent infringement lawsuit within 45 days of receiving Mylan’s paragraph IV notification letter, the FDA must refrain from approving Mylan’s ANDA for 30 months, or until a district court decision finding that the patent is invalid or not infringed, whichever occurs earlier. The stay on generic approval will expire on April 26, 2012 unless terminated earlier.
Shire said that it will continue to evaluate the situation throughout the litigation and will take all necessary actions to protect its rights to the fullest extent possible.