Astrazeneca Pharmacuticals LP v. Apotex Corp.

Charging a §271(e)(2) patent infringement claim confers subject matter jurisdiction upon federal courts. In order to state a claim under §271(e)(2) for pharmaceutical use, the Abbreviated New Drug Application of the defendant must claim a use that was already patented.

Astrazeneca Pharmaceuticals LP (“Astrazenca”) appealed from the United States District Court for the District of Delaware dismissing their §271(e)(2) patent infringement claims for lack of subject matter jurisdiction. The Court of Appeals for the Federal Circuit affirmed the decision of the District Court, but stated different reasons for the dismissal. The Court of Appeals held that alleging a §271(e)(2) claim was adequate for conferring jurisdiction upon the District Court under the Court’s power of original jurisdictions arising under patent law. The Court of Appeals, however, affirmed the dismissal of the §271(e)(2) claims due to a lack to state a claim. The Court stated that a §271(e)(2) claim exists when another’s filing of Abbreviated New Drug Applications (“ANDAs”) with the FDA claims material that has already been patented, but in this case the defendants’ ANDAs claimed a different use from Astrazenca’s process patents. The Court of Appeals also dismissed Astrazenca’s claim of future infringement of uses that would, in the future, be stated on the labels of the defendants drugs when placed into the market place for lack of ripeness of the claim. AFFIRMED.