Otsuka Pharmaceutical Co., Lt v. Thomas Price
2017 U.S. App. LEXIS 16487
| D.C. Cir. | 2017Background
- Otsuka’s Abilify Maintena (monthly injectable aripiprazole formulation) received two successive 3‑year exclusivity periods under 21 U.S.C. § 355(c)(3)(E)(iii) and (iv); the second expires Dec. 5, 2017.
- Alkermes submitted a (b)(2) application to approve Aristada, an injectable whose active moiety is N‑hydroxymethyl aripiprazole (a prodrug that metabolizes to aripiprazole).
- FDA approved Aristada, finding Aristada and Abilify Maintena have different "active moieties" and that exclusivity bars apply only to drugs with the same active moiety.
- Otsuka challenged the FDA decision, arguing FDA’s same‑moiety scope conflicts with the FDCA, conflicts with agency regulations/past statements, and was adopted without required notice‑and‑comment rulemaking.
- The district court granted summary judgment to FDA and Alkermes; the D.C. Circuit affirmed, sustaining FDA’s interpretation and rejecting Otsuka’s statutory and regulatory challenges.
Issues
| Issue | Plaintiff's Argument (Otsuka) | Defendant's Argument (FDA) | Held |
|---|---|---|---|
| Scope of 3‑year exclusivity (romanettes iii & iv): what relationship must second drug bear to first | "Legal equivalence" should block approval where a second drug relies on or is otherwise tied to the first (broader than same active moiety) | Exclusivity applies only to drugs that share the same active moiety; scope aligns with innovation protected | Court: FDA interpretation reasonable under Chevron; same‑moiety limitation upheld |
| Meaning of "such drug" in §355(b)(1) and transfer to exclusivity provisions | "Such drug" should encompass both the applied‑for and any relied‑upon drug, supporting legal equivalence | "Such drug" reasonably read to refer to the applied‑for drug in §355(b)(1) and to the approved first‑in‑time drug in the romanettes | Court: FDA reading reasonable; Otsuka fails to show statute unambiguously compels its reading |
| Consistency with FDA regulations | Absence of explicit same‑moiety text in romanette iii/iv regs implies broader scope; romanette ii rule cannot be read to limit iii/iv | Regulations mirror the statute and permit same‑moiety reading; express romanette‑ii language doesn’t imply rejection elsewhere | Court: Regulations accommodate FDA’s interpretation; not plainly erroneous or inconsistent |
| Need for notice‑and‑comment rulemaking | FDA changed position and therefore must have used notice‑and‑comment | FDA’s current position is consistent with existing regulations and is not a substantive rule change requiring notice | Court: No notice‑and‑comment required; FDA acknowledged prior statements and justified change |
Key Cases Cited
- Chevron U.S.A., Inc. v. Natural Res. Def. Council, 467 U.S. 837 (deference to reasonable agency statutory interpretation)
- Actavis Elizabeth LLC v. FDA, 625 F.3d 760 (D.C. Cir.) (FDA active‑moiety analysis and treatment of prodrugs)
- Cablevision Sys. Corp. v. FCC, 649 F.3d 695 (agency interpretation sustained where reasonable)
- FCC v. Fox Television Stations, Inc., 556 U.S. 502 (agency may change positions if reasons are explained)
- Comm’r v. Lundy, 516 U.S. 235 (identical words in same Act ordinarily have same meaning, subject to context)
- U.S. Telecom Ass’n v. FCC, 400 F.3d 29 (notice‑and‑comment rulemaking requirements)