Pfizer, Inc., v. Dr. Reddy’s Laboratories, Ltd., et al. (Federal Circuit)
February 27, 2004 on 9:53 am | In Caselaw |Pfizer, Inc., v. Dr. Reddy’s Laboratories, Ltd., et al.
Federal Circuit
February 27, 2004
Before MAYER, Chief Judge, NEWMAN and LOURIE, Circuit Judges. Opinion by NEWMAN, dissenting opinion by MAYER.
Pfizer’s patent (USPN 4,572,909) covers Norvasc®, an anti-hypertensive, anti-ischemic drug product whose active ingredient is amlodipine. The specification describes clinical data of amlodipine besylate and amlodipine maleate. Pfizer selected the besylate salt for regulatory review. Upon regulatory review, the term was extended 1252 days (Hatch-Waxman Act) (patent was to expire Feb. 25, 2003). Dr. Reddy’s sought use of amlodipine maleate, arguing that the term extension only applied to amlodipine besylate. District court agree with Dr. Reddy’s, dismissing Pfizer’s complaint. Pfizer appealed. Federal Circuit reversed, finding that “the district court misconstued the statute…the Act by its terms extended the term of the patent for the registered uses of the drug product including its salt esters.”
UPDATE: Court released an updated coversheet. March 10, 2004
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