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Glenmark Successfully Dismisses Patent Infringement Suit Brought by AstraZeneca

  • 12.21.10
  • 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.

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