952 F.3d 323
D.C. Cir.2020Background
- The Orphan Drug Act (ODA) grants a seven‑year marketing‑exclusivity bar under 21 U.S.C. § 360cc(a) after an orphan designation and FDA approval.
- FDA regulations treated drugs with the same active moiety as the "same drug" and required a post‑approval showing of clinical superiority to award exclusivity when a previously approved drug existed.
- Eagle’s drug Bendeka (same active moiety as Teva’s Treanda) received orphan designation (2014) and FDA approval (2015); FDA denied exclusivity because Eagle failed to prove clinical superiority.
- Eagle sued under the APA; the district court granted summary judgment holding § 360cc(a) unambiguous and that designation plus approval automatically yields exclusivity.
- The D.C. Circuit affirmed: § 360cc(a)’s plain text unambiguously bars FDA from imposing an additional post‑approval clinical‑superiority requirement for drugs designated and approved before the 2017 amendment; the 2017 amendment does not apply retroactively to this determination.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does § 360cc(a) unambiguously require automatic exclusivity upon orphan designation and FDA approval? | Eagle: text is an "if designation and approval, then exclusivity" rule requiring automatic exclusivity. | FDA: statute silent/ambiguous about serial exclusivity; context shows Congress did not intend repeatable exclusivity. | Yes — court held the text unambiguous: designation + approval triggers exclusivity. |
| Is FDA’s post‑approval clinical‑superiority requirement a permissible interpretation under Chevron? | Eagle: no need for Chevron; statute is clear so FDA cannot add requirements. | FDA: if statute ambiguous, its regulation is a reasonable exercise of authority. | Chevron step one: statute clear; FDA may not impose the post‑approval clinical‑superiority requirement for pre‑2017 approvals. |
| Do statutory structure, purpose, or legislative history create ambiguity to justify FDA’s interpretation? | Eagle: context and purpose do not override clear text; plausible‑hypothesis and regulatory options can prevent abuse. | FDA: structure/purpose (avoid evergreening/serial exclusivity, exceptions in § 360cc(b)) show Congress didn’t intend repeatable exclusivity. | No — court found structure, purpose, and history insufficient to overcome plain text. |
| Do the 2017 amendments (codifying clinical‑superiority requirement) affect this case or require a new determination under the amended statute? | Intervenors/Eagle (implicitly): district court’s remedy awards a right that existed pre‑2017; 2017 amendment not applicable. | Intervenors/FDA (argued on appeal): a court‑ordered grant would be a new determination subject to the 2017 change. | The argument was forfeited on appeal; court also held the 2017 amendments do not alter Eagle’s pre‑amendment entitlement. |
Key Cases Cited
- Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (framework for agency statutory deference)
- Engine Mfrs. Ass’n v. EPA, 88 F.3d 1075 (D.C. Cir. 1996) (presumption to follow clear statutory text)
- Barnhart v. Sigmon Coal Co., 534 U.S. 438 (2002) (courts must follow statutory language)
- Depomed, Inc. v. U.S. Dep’t of Health & Human Servs., 66 F. Supp. 3d 217 (D.D.C. 2014) (district court holding ODA requires automatic exclusivity)
- SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348 (2018) (agencies must follow unambiguous statutory commands)
- FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) (interpret statutes as coherent regulatory schemes)
- Zuni Pub. Sch. Dist. No. 89 v. Dep’t of Educ., 550 U.S. 81 (2007) (clear congressional intent ends interpretive inquiry)
- Otsuka Pharm. Co. v. Price, 869 F.3d 987 (D.C. Cir. 2017) (FDA approval required before marketing)