Shire files infringement suit for two of its patents

PHILADELPHIA British drug maker Shire has filed a lawsuit in the U.S. District Court for the Southern District of New York against generic drug maker Natco Pharma over an alleged infringement of two of Shire’s patents, Shire announced Thursday.

Shire alleges that Natco infringed its ‘976 and ‘428 patents in filing a regulatory approval application with the Food and Drug Administration containing a Paragraph IV certification for a generic version of the kidney disease drug Fosrenol (lanthanum carbonate) in the 400 mg, 750 mg and 1 g strengths.

Under the Hatch-Waxman Act of 1984, Paragraph IV certification asserts that a branded drug maker’s patent for a drug is invalid, unenforceable or won’t be infringed by a generic version of the drug.