District of Delaware Allows Generic Drug Manufacturers to Carve Out Two AstraZeneca Patents Claiming FDA-Approved Uses of Crestor
By Joseph M. OMalley & Ryan H. Coletti
On December 15, 2010, the United States District Court for the District of Delaware granted a motion to dismiss nine related patent infringement actions intended to block Defendant generic drug manufacturers from marketing the cholesterol-lowering drug rosuvastatin calcium, marketed as Crestor®. AstraZeneca Pharmaceuticals LP, et al. v. Apotex Corp., et al., Nos. 10-338, 10-339, 10-340, 10-341, 10-342, 10-343, 10-344, 10-345, 10-346, 10-584, slip. op. (D. Del. Dec. 15, 2010). In a consolidated opinion and order, Judge Robert B. Kugler held that AstraZeneca Pharmaceuticals LP and related Plaintiffs did not have standing to bring infringement claims under 35 U.S.C. § 271(e)(2) based on two patents claiming FDA-approved methods of using rosuvastatin calcium. Based on Defendants abbreviated new drug applications (ANDAs) that overlapped with some but not all of Plaintiffs Orange Book-listed patents, the Court held that there was no case or controversy because Defendants sought to manufacture and market the drug for FDA-approved indications that are not covered by any claim of Plaintiffs asserted patents.