Glenmark Successfully Dismisses Patent Infringement Suit Brought by AstraZeneca
- Sterne, Kessler, Goldstein & Fox P.L.L.C.
AstraZeneca Pharmaceuticals filed a patent infringement case against Sterne Kessler client Glenmark Generics after it submitted an abbreviated new drug application (ANDA) with the FDA to market a generic version of its cholesterol lowering drug, Crestor®. However, on December 15, 2010, a federal judge ruled that AstraZeneca can not use two method patents to block generic versions Crestor®, because Glenmark Generics sought to market a version of the drug for uses not covered by those patents.
AstraZeneca claimed it could sue the generic maker for patent infringement under the Hatch-Waxman Act because Crestor® was approved by the FDA to treat the conditions listed in the asserted patents. However, Sterne Kessler successfully moved to dismiss the action, arguing that the Hatch-Waxman Act only creates a viable infringement claim if a generic drug manufacturer seeks approval for specific uses claimed by the brand-name company's patent -- the Judge agreed.
The case is AstraZeneca Pharmaceuticals LP, et al. v. Glenmark Generics Inc., USA, case number 10-341, in the US District Court for the District of Delaware.