American Sales Co. v. AstraZeneca LP, 845 F.3d 470

Background

Multiple plaintiff groups (End-Payor Class, Direct-Purchaser Class, Individual Retailers) filed petitions for panel rehearing and petitions for rehearing en banc after an adverse panel opinion; this order addresses primarily panel rehearing petitions and denies them as without merit.
End-Payor Class sought remand on permanent injunction grounds, arguing the panel adopted an argument the FTC raised; the court found the class waived the injunctive-relief issue by not briefing it on appeal.
The court explained plaintiffs failed to show good cause to excuse waiver or to demonstrate the real and immediate threatened injury required for injunctive relief under Section 16 of the Clayton Act.
Direct-Purchaser Class and Individual Retailers argued the panel required proof of patent invalidity to pursue an at-risk launch theory and asserted a conflict with FTC v. Actavis and other circuits; the court rejected those characterizations.
The panel clarified it did not announce a per se rule requiring conclusive proof of invalidity, only that under these case-specific circumstances some evidence of invalidity or noninfringement was appropriate before permitting an at-risk launch theory at trial.
The court reviewed exclusion of two pieces of evidence for abuse of discretion and found no abuse; Judges Lynch and Thompson also voted to deny rehearing en banc.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Waiver of injunctive-relief issue	End-Payor: Remand needed because panel adopted FTC’s view on antitrust injury, so issue not waived	Defendants: Plaintiffs failed to brief the injunctive-relief question on appeal, so it was waived	Court: Issue waived; plaintiffs gave no good cause to excuse waiver and failed to show real/immediate threatened injury needed for injunction
At-risk launch theory evidence standard	Direct-Purchasers: Panel required conclusive proof of patent invalidity before permitting at-risk-launch theory	Defendants: Some evidence of invalidity or noninfringement is required under facts here; no per se rule	Court: No per se rule; under these facts district court did not err in requiring some evidence of invalidity/noninfringement before allowing at-risk theory
Alleged conflict with Actavis and other circuits	Plaintiffs: Panel’s approach conflicts with Actavis and other circuit precedents, creating a circuit split	Defendants: Panel adhered to Actavis; differences reflect litigation stage and evidentiary burdens	Court: No conflict—Actavis allows using payment size as surrogate for patent weakness; other cases were decided at pleading stage and are not inconsistent given differing procedural contexts
Exclusion of two evidentiary items	Plaintiffs: Excluded evidence was improperly withheld and prejudicial	Defendants: District court’s evidentiary rulings were within discretion	Held: Reviewed for abuse of discretion; record shows no abuse, so exclusion stands

Key Cases Cited

United States v. Olano, 507 U.S. 725 (Sup. Ct. 1993) (rules on plain-error and waiver)
Rivkin v. Century 21 Teran Realty LLC, 494 F.3d 99 (2d Cir. 2007) (excusing failure to invoke an issue explicitly by name)
New England Surfaces v. E.I. du Pont de Nemours & Co., 546 F.3d 1 (1st Cir. 2008) (declining to address an undeveloped issue on appeal)
In re New Motor Vehicles Canadian Export Antitrust Litig., 522 F.3d 6 (1st Cir. 2008) (standing for injunctive relief under Section 16 requires threatened, real and immediate injury)
O’Shea v. Littleton, 414 U.S. 488 (Sup. Ct. 1974) (injunctive relief requires real and immediate threat, not conjectural harm)
FTC v. Actavis, Inc., 133 S. Ct. 2223 (Sup. Ct. 2013) (reverse-payment settlements can violate antitrust law; payment size may serve as surrogate for patent weakness)
Gen. Elec. Co. v. Joiner, 522 U.S. 136 (Sup. Ct. 1997) (abuse-of-discretion standard for evidentiary rulings)
Easley v. Reuss, 532 F.3d 592 (7th Cir. 2008) (panel rehearing cannot raise issues not presented on appeal)