486 F.Supp.3d 450
D.D.C.2020Background
- Genus’s cocaine HCl topical NDA (Goprelto) was approved Dec. 14, 2017 and conferred new chemical entity (NCE) exclusivity under 21 U.S.C. § 355(c)(3)(E)(ii) (Romanette ii).
- Lannett filed a 505(b)(2) NDA for a competing cocaine HCl product (Numbrino) on Nov. 29, 2017 (filed before Genus’s approval); FDA accepted and later issued a CRL, then approved Numbrino in Jan. 2020.
- Genus filed citizen petitions asking FDA to rescind acceptance or stop accepting submissions for Lannett’s application; FDA denied the petitions and approved Numbrino, prompting Genus’s suit.
- Central legal question: Does Romanette ii’s NCE exclusivity bar FDA from approving (as opposed to submitting) subsequent 505(b)(2) applications during the five-year exclusivity period, and what timeline governs approval?
- The court concluded Romanette ii bars submission for five years but does not bar approval; however, the approval of a subsequent 505(b)(2) must be made effective according to the Paragraph 3 timelines tied to the later application’s patent certification, and FDA failed to follow/apply those timelines here.
- Procedural posture: cross-motions for summary judgment; court denied FDA’s and Lannett’s summary judgment, granted Genus partial summary judgment on Count III, and remanded for agency compliance (separate order to follow).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Scope of Romanette ii exclusivity: does it bar approval or only submission of subsequent 505(b)(2)s? | Genus: Five-year NCE exclusivity bars both submission and approval of competing 505(b)(2) applications. | FDA/Lannett: Romanette ii bars only submission; FDA may approve applications filed before the NCE approval. | Court: Romanette ii bars submission but does not bar approval. |
| What does "such an application" in Sentence 2 refer to? | Genus: Refers to any subsequent 505(b)(2) application (the subject of Sentence 1). | FDA/Lannett: Refers only to subsequent 505(b)(2) applications that include Paragraph IV certifications. | Court: Refers back to the subject of Sentence 1—any subsequent competing 505(b)(2) application. |
| What does "in accordance with this paragraph" require for approval timing? | Genus: "This paragraph" includes subparagraph (E) and thus could extend approval timing five years. | FDA/Lannett: "This paragraph" does not require applying Paragraph 3 timelines here; and Lannett claims the clause targets Paragraph (C) only. | Court: "This paragraph" means 21 U.S.C. § 355(c)(3); approval timing must follow Subparagraphs (A)–(C) (the Paragraph 3 timelines tied to the later applicant’s patent certification). |
| Validity of FDA action approving Numbrino without applying Paragraph 3 timelines | Genus: FDA violated FDCA by approving Numbrino without applying Paragraph 3 timelines; FDA misapplied statute. | FDA: Approval was permissible because Romanette ii does not restrict approvals of already-filed applications. | Court: FDA’s legal conclusion (approvals allowed) correct, but FDA misinterpreted Romanette ii by failing to apply Paragraph 3 timelines; agency action set aside as unlawful and remanded. |
Key Cases Cited
- Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (2012) (explaining the Hatch‑Waxman abbreviated application pathways and statutory framework)
- Otsuka Pharm. Co. v. Price, 869 F.3d 987 (D.C. Cir. 2017) (discussing exclusivity provisions; circuit statement about Romanette ii was treated as dictum)
- Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) (arbitrary-and-capricious review requires reasoned explanation and rational connection between facts and agency action)
- Chevron U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837 (1984) (framework for judicial deference to reasonable agency statutory interpretations)
- Kisor v. Wilkie, 139 S. Ct. 2400 (2019) (courts should not find ambiguity simply because a text is difficult to read)
- Russello v. United States, 464 U.S. 16 (1983) (expressio unius canon: different language in related provisions suggests deliberate choice)
- Brown v. Gardner, 513 U.S. 115 (1994) (presumption of consistent usage: repeated terms in proximity bear same meaning)
- NLRB v. SW Gen., Inc., 137 S. Ct. 929 (2017) (statutory structure and hierarchical drafting conventions control precise cross‑references)
- PPG Indus. v. United States, 52 F.3d 363 (D.C. Cir. 1995) (when an agency commits an error of law, judicial inquiry ends)
- In re Grand Jury Investigation, 916 F.3d 1047 (D.C. Cir. 2019) (distinguishing dictum from holdings in appellate opinions)