Takeda Pharmaceuticals, U.S.A., Inc. v. Burwell
78 F. Supp. 3d 65
| D.D.C. | 2015Background
- Colcrys (Takeda/Mutual) is an FDA‑approved 0.6 mg single‑ingredient oral colchicine tablet; Mutual relied on prior ColBenemid/Col‑Probenecid findings, new AGREE trial (low‑dose regimen for acute flares), and drug‑drug interaction (DDI) studies. FDA issued safety communications based on those data.
- West‑Ward/Hikma sought to reintroduce a 0.6 mg single‑ingredient colchicine product. An initial West‑Ward 505(b)(2) tablet application (referencing Col‑Probenecid) was deemed improper as duplicative of Colcrys; FDA advised withdrawal.
- West‑Ward reformulated as Mitigare (capsule) and filed a 505(b)(2) relying on published literature, Col‑Probenecid findings, and West‑Ward’s own DDI studies; West‑Ward did not reference Colcrys or certify to Colcrys patents.
- FDA reviewed both Mutual’s (Colcrys) and West‑Ward’s data, concluded West‑Ward’s submissions were sufficient to approve Mitigare for prophylaxis, and approved with labeling that differs from Colcrys (no AGREE low‑dose acute‑treatment regimen; more general DDI warnings).
- Takeda and Elliott sued FDA (and intervenors) claiming FDA unlawfully approved Mitigare without requiring reference to Colcrys and patent certifications, and that FDA acted arbitrarily in approving Mitigare’s differing label. District Court denied plaintiffs’ summary judgment and granted defendants’ cross‑motions.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDA was required to force West‑Ward to reference Colcrys and certify to Colcrys patents when approving Mitigare | Takeda/Elliott: FDA relied on Colcrys data in approving Mitigare; agency reliance should trigger 505(b)(2) reference and patent‑certification obligations (or statute requires certifying to all method‑of‑use patents claiming the active ingredient). | FDA/West‑Ward: Certification duty is tied to the applicant’s choice of/ reliance on a reference listed drug; FDA may consult third‑party data in its scientific review and need not force reference; statutory text limits certifications to patents of the referenced drug. | Court: FDA did not violate FDCA or its rules. Applicant — not the agency — chooses appropriate RLD; certification obligations attach to the drug the applicant relies on. FDA reasonably approved Mitigare without Colcrys reference or Colcrys patent certifications. |
| Scope of § 505(b)(2)(A) patent‑certification requirement | Elliott: Text requires certification to any patent claiming a use for the active ingredient for which applicant seeks approval (broad method‑of‑use reach). | FDA/West‑Ward: Statute unambiguously ties certification to the drug whose investigations the applicant relies upon; "such drug" refers to the referenced drug product, not all patents on the active ingredient. | Court: Statute unambiguously requires certification only for patents relating to the referenced listed drug (product or method‑of‑use patents for that RLD); even if ambiguous, FDA’s interpretation is reasonable under Chevron. |
| Whether FDA’s approval of Mitigare represented an unreasoned change in policy re: colchicine labeling (Citizen Petition position) | Takeda: FDA previously signaled that Colcrys labeling (low‑dose AGREE regimen and detailed DDI dose tables) should appear on single‑ingredient colchicine products; omission is arbitrary and capricious. | FDA: Citizen Petition demanded case‑by‑case review; Mitigare differs (capsule, prophylaxis‑only) and West‑Ward’s DDI studies conflicted with Mutual’s, justifying different label content after a reasoned scientific review. | Court: No arbitrary change. FDA addressed differences, explained its scientific basis for the more general DDI warnings and excluding the AGREE acute‑treatment regimen for Mitigare (approved only for prophylaxis). |
| Whether Mitigare is unsafe as labeled because it lacks Colcrys‑specific safety instructions | Takeda: Omitting Colcrys dosing guidance and specific DDI tables makes Mitigare unsafe. | FDA/Intervenors: Agency scientists reasonably concluded West‑Ward data did not warrant Colcrys‑style dose tables; general precautions and monitoring are adequate for Mitigare’s approval for prophylaxis. | Court: FDA’s scientific determinations entitled to deference; agency did not make a clear error of judgment. Plaintiffs’ safety challenge fails. |
Key Cases Cited
- Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353 (Fed. Cir. 2008) (describing Hatch‑Waxman balance between innovation incentives and generic competition)
- Pfizer Inc. v. Shalala, 182 F.3d 975 (D.C. Cir. 1999) (discussing expense and timing of drug development and regulatory context)
- Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) (standard for arbitrary and capricious agency action)
- Baltimore Gas & Elec. Co. v. Natural Res. Def. Council, Inc., 462 U.S. 87 (1983) (deference to agency scientific determinations)
- Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984) (two‑step framework for reviewing agency statutory interpretation)
- Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (2012) (distinguishing product patents from method‑of‑use patents and Hatch‑Waxman context)
- Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402 (1971) (presumption of regularity and scope of review under APA)
- Serono Laboratories, Inc. v. Shalala, 158 F.3d 1313 (D.C. Cir. 1998) (deference to FDA on drug‑approval and labeling matters)