Depomed, Inc. v. United States Department of Health & Human Services
66 F. Supp. 3d 217
D.D.C.2014Background
- Depomed seeks seven-year orphan-drug exclusivity for Gralise after FDA designated it an orphan drug and approved it for marketing for PHN.
- Defendants argue exclusivity is not required because Neurontin (gabapentin) already exists for PHN and Gralise must be clinically superior to qualify.
- Neurontin was approved in 1993 (seizures) and 2002 (PHN) but never received orphan-drug designation or exclusivity.
- Abbott renewed designation for Gralise in 2010; FDA granted designation after evaluating a plausible clinical-superiority hypothesis.
- Gralise received FDA marketing approval in Jan 2011, but FDA maintained no seven-year exclusivity due to lack of proven clinical superiority.
- Statutory and regulatory framework: 21 U.S.C. § 360cc (a) and 360cc(b); 21 C.F.R. § 316.31(a) and 316.3(b)(13) define scope and the ‘same drug’ concept.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDA must recognize seven-year exclusivity upon designation and marketing approval | Depomed argues exclusivity attaches when designated and approved. | FDA contends ambiguity allows consideration of clinical superiority before granting exclusivity. | Unambiguous: exclusivity required once designated and approved. |
| Whether clinical-superiority requirement can override plain statutory text | Depomed argues section 360cc(a) is plain and not subject to superiority reasoning. | FDA argues regulatory framework permits superiority considerations to limit exclusivity. | Court does not reach superiority argument; text already mandates exclusivity. |
| Whether the FDA may impose extra criteria on exclusivity after designation/approval | Depomed asserts FDA cannot add criteria beyond statute/regulations. | FDA argues regulatory discretion could constrain exclusivity to avoid absurd results. | Court rejects attempted extra criteria; plain language governs. |
| Whether Baker Norton v. FDA supports FDA discretion here | Depomed relies on statutory interpretation; ambiguity not found. | FDA cites Baker Norton on ‘same drug’ ambiguity to justify flexibility. | Baker Norton does not control Chevron step-one here; statute clear. |
Key Cases Cited
- Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837 (1984) (establishes two-step framework for agency deference)
- Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 1060 (D.C. Cir. 1998) (absurd results may justify policy arguments in Chevron step-one analysis)
- Andrus v. Glover Const. Co., 446 U.S. 608 (1980) (enumerated exceptions doctrine; plain-language interpretation)
- NRDC v. Reilly, 983 F.2d 259 (D.C. Cir. 1993) (delegation and Chevron step-two principles)
- PGA Tour, Inc. v. Martin, 532 U.S. 661 (2001) (statutory interpretation and absurd-result considerations)
- Baker Norton Pharms., Inc. v. FDA, 132 F. Supp. 2d 30 (D.D.C. 2001) (word 'drug' ambiguity in exclusivity context)