In AstraZeneca Pharmaceuticals LP v. Apotex Corp., the key issue before the US Court of Appeals for the Federal Circuit was whether the district court erred in dismissing method-of-use patent infringement claims brought by AstraZeneca under Section 271(e)(2) of the Hatch-Waxman Act. AstraZeneca filed its suits based on Abbreviated New Drug Applications (ANDAs) filed by the defendants that carved out methods of use previously patented by AstraZeneca.

AstraZeneca markets the cholesterol drug rosuvastatin calcium under the brand name Crestor. It holds three related patents on this drug, including two method-of-use patents claiming methods for treating conditions related to genetic and heart diseases.

A group of generic pharmaceutical manufacturers filed ANDAs to market generic versions of rosuvastatin calcium. These generic drugs are FDA-approved to treat high cholesterol and the specific illnesses covered by AstraZeneca's two method-of-use patents. However, the ANDAs requested approval only to treat certain forms of high cholesterol and excluded the treatments claimed in AstraZeneca's two patents. The generic drug manufacturers submitted statements with their ANDAs asserting that they excluded all uses claimed in AstraZeneca's method-of-use patents.

Based on these ANDAs, AstraZeneca filed suit in April 2010 for method-of-use patent infringement under Section 271(e)(2) of the Hatch-Waxman Act. The generic drug manufacturers moved to dismiss the claims. The US District Court for the District of Delaware dismissed AstraZeneca's claims and ruled that, based on these ANDAs, AstraZeneca failed to state a valid claim under Section 271(e)(2) of the Hatch-Waxman Act.

In its decision, the Federal Circuit affirmed the district court's decision and held that AstraZeneca has not stated a valid claim under Section 271(e)(2) of the Hatch-Waxman Act.

AstraZeneca argued on appeal that the generic drug manufacturers would infringe its two method-of-use patents by the unlicensed sales of generic drugs for FDA-approved, patent-protected uses. Applying its reasoning and precedent from Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003), the Federal Circuit rejected this argument. The Federal Circuit reiterated its holding from Warner-Lambert, holding that:

To minimize the risk of liability for method-of-use patent infringement under Section 271(e)(2) of the Hatch-Waxman Act, generic drug manufacturers should ensure they properly limit the scope of regulatory approval they seek for new generic drugs to exclude patented uses.