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Crestor Patent Battle Could Have Ripple Effect: Is A Salt Equivalent To Base Compound?

 
• By Brenda Sandburg

Watson filed a 505(b)(2) NDA for a zinc salt of AstraZeneca’s Crestor, which AstraZeneca claims infringes its patent; if Watson prevails more generic manufacturers may pursue this pathway around a patent.

Last year AstraZeneca PLC won a court ruling upholding the patent on its cholesterol lowering blockbuster Crestor (rosuvastatin calcium). But Allergan PLC has another approach that may circumvent the patent and could provide a template for generic manufacturers in future cases.

Watson Laboratories Inc. (which became Actavis in January) filed a new drug application for a zinc salt of rosuvastatin in July 2010, eliciting a patent infringement suit by AstraZeneca....

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