PDL Biopharma Sued Sun Pharmaceutical Over Cardene® I.V. Patent

On April 16 and 17, 2007 US-based biopharmaceutical company PDL Biopharma has filed patent infringement complaints in the US District Court for the Eastern District of Michigan Southern Division and District Court for the District of New Jersey against India-based generic drug manufacture - Sun Pharmaceutical Industries alleging infringement of the US Patent No. 5,164,405 (the ‘405 patent) covering marketed Cardene® I.V. formulation. Cardene® I.V. is a parenteral composition of nicardipine hydrochloride in 2.5 mg/ml dosage strength. The complaint filed in response to Sun’s submission of the abbreviated new drug application (ANDA) No. 78-405 to the US FDA seeking approval to sell generic approval of injectable nicardipine hydrochloride product before the expiration of the Orange Book listed ‘405 patent. In its complaint, PDL Biopharma alleged that Sun’s ANDA product would infringe, either literally and/or under the doctrine of equivalents, at least one claim of the ‘405 patent pursuant to USC 35 § 271(e)(2).