Crestor Federal Circuit Decision Holds ANDA Applicants Seeking to Market Drug for Non-Patented Use Do Not Infringe

by Kyle Deighan

Thumbnail image for federalcircuit.jpgOn February 9, the Federal Circuit held that AstraZeneca failed to state a claim for patent infringement under 35 U.S.C. §271(e)(2) against generic pharmaceutical manufacturers that filed abbreviated new drug applications (“ANDAs”) seeking approval for uses of Crestor® (rosuvastatin calcium) not covered by AstraZeneca’s patents. The case is AstraZeneca Pharms. LP v. Apotex Corp..

AstraZeneca alleged that ANDA filings by various generics infringed or would infringe several of its patents covering methods of using rosuvastatin calcium. These patents covered methods of using rosuvastatin compounds to treat heterozygous familial hypercholesterolemia (“HeFH”) and elevated C-reactive protein (“CRP”). As per the Hatch-Waxman Act, AstraZeneca filed a New Drug Application (“NDA”) and obtained approval from FDA to market the drug. FDA approved several indications for using rosuvastatin calcium, including those uses claimed in AstraZeneca’s patents. Additionally, FDA approved the drug for treating homozygous familial hypercholesterolemia (“HoFH”) and hypertriglyceridemia, uses not covered by AstraZeneca’s patents-in-suit.

Defendants filed ANDAs seeking to market generic versions of the drug, but submitted so-called Section viii Statements under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) indicating they sought approval for uses not covered by the patents. In other words, the ANDA filers requested approval to treat only HoFH and hypertriglyceridemia while “carving out” the indications covered by AstraZeneca’s listed patents. The ANDA filers moved to dismiss AstraZeneca’s complaint for several reasons, including that the complaints failed to state a claim for patent infringement under Section 271(e)(2) because the ANDA filers were not seeking approval for uses of rosuvastatin calcium claimed in AstraZeneca’s patents.

The district court agreed with the ANDA filers, dismissing AstraZeneca’s infringement claims. First, it found that it lacked subject matter jurisdiction, because AstraZeneca could not assert a valid claim under Section 271(e)(2) and thus there was no justiciable case or controversy. The court then found that AstraZeneca failed to state a claim for relief under Section 271(e)(2), because AstraZeneca could not allege that the ANDA filers sought approval to market rosuvastatin calcium for the uses claimed by AstraZeneca in their patents.

The Federal Circuit, although finding the court did have subject matter jurisdiction, agreed with the District Court that dismissal was ultimately proper because AstraZeneca had failed to state a claim for patent infringement under Section271(e)(2). The court held that

[A] patented method of using a drug can only be infringed under §271(e)(2) by filing an ANDA that seeks approval to market the drug for that use . . . Thus, an ANDA seeking to market a drug not covered by a composition patent for unpatented methods of treatment cannot infringe under §271(e)(2). AstraZeneca has not alleged, nor could it allege, that Appellees’ ANDAs seek FDA approval for uses of rosuvastatin calcium covered by the [patents-in-suit] as would be required to state a viable §271(e)(2) claim.
The Court also found AstraZeneca’s policy arguments unavailing. AstraZeneca argued that such a holding “ignore[s] market realities because even if a generic drug is formally approved only for unpatented uses, pharmacists and doctors will nonetheless substitute the generic for all indications once it becomes available.” The Court found AstraZeneca’s position unpersuasive, because it would allow pioneer drug manufacturers like AstraZeneca to “maintain de facto indefinite exclusivity over a pharmaceutical compound by obtaining serial patents for approved methods of using the compound and then wielding Section 271(e)(2) ‘as a sword against any competitor’s ANDA seeking approval to market an off-patent drug for an approved use not covered by the patent.'”