PHILADELPHIA, Pennsylvania and DUBLIN, Ireland, March 16 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY) announces that it has filed a lawsuit in the U.S. District Court of the Southern District of New York against Barr Laboratories, Inc. ("Barr") for infringement of three of Shire's patents: U.S. Patent No. 5,968,976 ("'976 Patent"); U.S. Patent No. 7,381,428 ("'428"); and U.S. 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(R) (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 is confident in its intellectual property portfolio protecting FOSRENOL(R), and will enforce its patents against infringers to the fullest extent allowed by law.
Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the specialist
physician. Shire focuses its business on attention deficit hyperactivity
disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)
diseases as well as opportunities in other therapeutic areas to the extent
they arise through acquisitions. Shire's in-licensing, merger and acquisition
efforts are focused on products in specialist markets with strong
intellectual property protection and global right
|SOURCE Shire Plc|
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