Takeda Pharm., U.S.A., Inc. v. Burwell
| Decision Date | 13 January 2015 |
| Docket Number | Civil Action No. 14–cv–1668 KBJ, Civil Action No. 14–cv–1850 KBJ |
| Citation | 78 F.Supp.3d 65 |
| Parties | Takeda Pharmaceuticals, U.S.A., Inc., Plaintiff, v. Sylvia Mathews Burwell, in her official capacity as Secretary, United States Department of Health and Human Services, et al., Defendants, and Hikma Pharmaceuticals PLC, et al., Intervenor–Defendants. and Elliott Associates, L.P., et al., Plaintiffs, v. Sylvia Mathews Burwell, in her official capacity as Secretary, United States Department of Health and Human Services, et al., Defendants, and Hikma Pharmaceuticals PLC, et al., Intervenor–Defendants. |
| Court | U.S. District Court — District of Columbia |
Jessica L. Ellsworth, Susan Margaret Cook, Catherine E. Stetson, Hogan Lovells US LLP, Matthew D. McGill, Lucas C. Townsend, Mithun Mansinghani, Gibson Dunn & Crutcher LLP, Washington, DC, Michael Sitzman, Gibson, Dunn & Crutcher LLP, San Francisco, CA, for Plaintiff.
Jessica R. Gunder, U.S. Department of Justice, Washington, DC, for Defendant.
UNDER SEAL
a. No FDA Policy Establishes That FDA's Reliance—As Opposed To That Of The Section 505(b)(2) Applicant—Gives Rise To Patent Certification Obligations ... ––––
b. Even If Agency Reliance On Third–Party Data Is Relevant, FDA Did Not Approve Mitigare In Reliance On Mutual's Information ... ––––
The Hatch–Waxman Amendments to the Food, Drug, and Cosmetic Act (“FDCA”), Pub. L. No. 98–417, 98 Stat. 1585 (1984), “balance two competing interests in the pharmaceutical industry: (1) inducing pioneering research and development of new drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to market.” Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353, 1355 (Fed.Cir.2008) (internal quotation marks and citation omitted). Hatch–Waxman achieves this balance, in part, by allowing new applicants for drug approval to rely on research and data that an innovator company generates so long as the new applicant “references” the innovator's drug and “certifies” to the innovator's patents. See infra Part I.B.2; see also 21 U.S.C. § 355(b)(2)(A). Plaintiffs Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and Elliott Associates, L.P., Elliott International, L.P., and Knollwood Investments, L.P. (collectively, “Elliott”) allege that the Food and Drug Administration (“FDA”) upset Hatch–Waxman's careful balance when the agency approved an application that Hikma Pharmaceuticals PLC (“Hikma”) submitted through its U.S. agent West–Ward Pharmaceuticals Corp. (“West–Ward”) for a gout medication named Mitigare. Mitigare is a single-ingredient 0.6 milligram (“mg”) oral colchicine drug product that is substantially similar to Plaintiffs' colchicine drug, Colcrys, which FDA approved five years prior to Mitigare based in part on research studies that Takeda's predecessor Mutual Pharmaceutical Company, Inc. (“Mutual”) conducted. In seeking approval for Mitigare, West–Ward neither referenced Colcrys nor certified to the Colcrys patents, and Hikma has now authorized West–Ward to market a generic version of Mitigare that will compete with—and cost less than—Plaintiffs' Colcrys.
In the separate but consolidated complaints that Takeda and Elliott have filed in this Court against Defendants Sylvia Mathews Burwell (in her official capacity as Secretary of the Department of Health and Human Services) and Margaret Hamburg (in her official capacity as head of the FDA), Plaintiffs maintain that FDA's approval of Mitigare without a Colcrys reference or the related patent certifications violates the Administrative Procedure Act (“APA”) because that approval was inconsistent with the agency's procedural rules and the certification provisions of the FDCA. Plaintiffs also claim that FDA's approval of Mitigare was arbitrary and capricious because Mitigare's label lacks certain safety information that is on the Colcrys label—information that is related to Mutual's research and that FDA previously suggested should be on the label of future colchicine drug products. The lawsuits that Takeda and Elliott have filed (and in which Hikma and West–Ward have now intervened) request a stay or rescission of FDA's approval of Mitigare as a remedy for these alleged violations.
Before this Court at present are four cross-motions for summary judgment that the Plaintiffs, the Defendants, and the Defendant–Intervenors have submitted in the context of the two pending actions.1 This Court has considered these dispositive motions, the oppositions thereto, the supplemental briefing, and the arguments made orally at the two hearings that this Court has held in relation to this matter. Because this Court agrees with Defendants and Defendant–Intervenors that (1) no statute, regulation, or policy required FDA to reject West–Ward's application for Mitigare because the application did not reference Colcrys or certify to the Colcrys patents; (2) FDA's scientific judgment that Mitigare is safe as labeled is well-reasoned and entitled to deference; and (3) FDA did not make an unreasoned change in policy when it approved Mitigare, Takeda's Motion for Summary Judgment in Takeda Pharmaceuticals U.S.A., Inc. v. Burwell, No. 14–1668–KBJ (D.D.C.), is DENIED; Elliott's Motion for Summary Judgment in Elliott Associates, L.P. v. Burwell, No. 14–1850–KBJ (D.D.C.), is DENIED; and Defendants' and Defendant–Intervenors' cross-motions for summary judgment in Elliott Associates, L.P. v. Burwell, No. 14–1850–KBJ (D.D.C.), are GRANTED . This Court issued a separate order consistent with this opinion on January 9, 2015.
The instant dispute involves two drug products, both of which have the active ingredient colchicine, which is a pharmacological substance that has been used historically for the treatment of gout.2 Plaintiffs have a financial interest in Colcrys—an FDA-approved 0.6 mg single-ingredient oral colchicine tablet—and they have brought this challenge to Defendant FDA's recent approval of Intervenors' Mitigare, which is a 0.6 mg single-ingredient oral colchicine capsule. In order to understand the Plaintiffs' challenge fully, some background information about both colchicine itself and FDA's prior approval of Plaintiff's Colcrys, is necessary. The underlying facts are not in dispute.
Doctors have used colchicine—an agent derived from the Colchicum Autumnale plant—to treat gout for centuries. (See Admin. R. (hereinafter, “AR”) at 3 ().) Colchicine can be used both for the targeted treatment of gout flares (“acute treatment”) and for longer-term maintenance treatment that is aimed at preventing flares (“prophylaxis”). (See id. at 4, 116–17, 157, 204.) However, there is a relatively small window of doses in which colchicine provides therapeutic benefits without causing severe complications. (See AR at 202.) This “narrow therapeutic index” means that minor dosing changes can have a grave effect on patient outcomes because toxic levels of colchicine can be reached relatively quickly and “can result in serious life-threatening adverse events and death.” (Id.; see also id. at 117 ().) Even doses of colchicine that are within the normal therapeutic range can be toxic if colchicine is used concomitantly with certain other drugs called “CYP3A4 and P-gp inhibitors.” (Id. at 202.)
Consistent with colchicine's long history, drug manufacturers in the...
To continue reading
Request your trial
-
Otsuka Pharm. Co. v. Burwell
...new drugs[,] and (2) enabling competitors to bring low-cost, generic copies of those drugs to market[,]’ " Takeda Pharm., U.S.A., Inc. v. Burwell , 78 F.Supp.3d 65, 68 (D.D.C. 2015) (quoting Janssen Pharmaceutica, N.V. v. Apotex, Inc. , 540 F.3d 1353, 1355 (Fed. Cir. 2008) ). As mentioned, ......
-
Ranbaxy Labs., Ltd. v. Burwell
...Ass'n. of Flight Attendants v. USAir, Inc., 24 F.3d 1432, 1436 (D.C.Cir.1994) (same); Takeda Pharms., USA v. Burwell, No. 14–1850, 78 F.Supp.3d 65, 69, 2015 WL 252806, at *2 n. 1 (D.D.C. Jan. 13, 2015) (consolidating consideration of preliminary injunction motion with summary judgment motio......
-
Veloxis Pharm., Inc. v. U.S. Food & Drug Admin., Civil Action No. 14–2126 (RBW)
...drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to market." Takeda Pharms., U.S.A., Inc. v. Burwell, 78 F.Supp.3d 65, 68, 2015 WL 252806, at *1 (D.D.C.2015) (internal quotation marks omitted). "[The] Hatch–Waxman Amendments created an abbreviated approval......
-
Genus Lifesciences, Inc. v. Azar
...used as an adjective, ... nearly always operates as a reference back to something previously discussed." Takeda Pharms., U.S.A., Inc. v. Burwell , 78 F. Supp. 3d 65, 99 (D.D.C. 2015). That, of course, is of limited help since Sentence 1 refers to three applications: the first-in-time applic......