Shire plc has filed a lawsuit in the US District Court of the Southern District of New York against Barr Laboratories, Inc for infringement of three of Shire's patents: US Patent No 5,968,976 ("'976 Patent");US Patent No 7,381,428 ("'428"); and US Patent No 7,465,465 ("'465").
The lawsuit was filed in response to an ANDA (Abbreviated New Drug Applications) filed by Barr seeking FDA approval to market and sell generic versions of Shire's 500 mg, 750 mg, and 1 g Fosrenol (Lanthanum Carbonate) products.
Under the Hatch-Waxman Act, because Shire filed its patent infringement lawsuit within 45 days of receiving Barr's Paragraph IV notification letter, the FDA must refrain from approving Barr's ANDA for 30 months, or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier. The stay on generic approval will expire on April 26, 2012 unless terminated earlier.
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.