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Otsuka Pharmaceutical Co., Ltd. v. Burwell

United States District Court, D. Maryland, Southren Division

April 29, 2015



GEORGE J. HAZEL, District Judge.

On April 28, 2015 at 1:30 pm, Defendant Food and Drug Administration ("FDA") granted approval of the sale of four generic versions of the prescription brand drug aripiprazole, which is marketed and sold under the brand name of Abilify® by Plaintiffs Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical Inc. (collectively, "Otsuka"). In this action, Otsuka challenges FDA's[1] approval of these generic drugs pursuant to the Administrative Procedure Act ("APA"), 5 U.S.C. § 701, et seq. Specifically, Otsuka seeks a temporary restraining order and/or preliminary injunction to stay the effectiveness of these approvals, to prohibit FDA from granting any further approvals of generic versions of Abilify®, and to prohibit the recent recipients of FDA-approvals from selling the generic versions of Abilify®. At 3:15 pm on April 28, 2015, just two hours after FDA approved generic versions of Abilify®, the Court conducted a hearing on Otsuka's motion for a temporary restraining order and/or preliminary injunction during which Otsuka, FDA, and Defendant-Intervenors[2] presented their respective arguments for or against the issuance of injunctive relief. Based on these arguments, as well as the arguments presented in the parties' respective briefs, the Court will DENY Otsuka's motion for a temporary restraining order and/or preliminary injunction.


This case involves the interplay between statutory exclusivities, particularly orphan drug exclusivity, statutory and regulatory mandates that require labels of generic drugs to contain the same information as their brand counterpart, and requirements that pediatric information be included on drug labels. Specifically, Otsuka, the new drug application holder for Abilify®, contends that, as a result of FDA's recent approval of a pediatric indication for Abilify® that is protected by orphan drug exclusivity, FDA is precluded from approving an ANDA for a generic version of Abilify® until its orphan drug exclusivity expires in December 2021 because section 505A(o) of the Federal Food, Drug, and Cosmetic Act ("FDCA") does not permit this type of pediatric information to be omitted from a generic's label.

A. Statutory and Regulatory Framework

1. New Drug Applications and Supplemental New Drug Applications

Under the FDCA, pharmaceutical companies seeking to market the initial version of a drug (also known as the "innovator" or "pioneer" drug) must first obtain FDA approval by filing a new drug application ("NDA") containing extensive scientific data demonstrating the safety and effectiveness of the drug. See 21 U.S.C. § 355(a), (d). A sponsor may thereafter submit a supplemental new drug application ("sNDA") seeking FDA's approval of a new indication of an already approved drug. See 21 C.F.R. § 314.70(b). Drug sponsors must justify the labeling change proposed in the supplement by submitting data supporting the safety and effectiveness of the drug for the new indication. See 21 U.S.C. § 355(a) and (d); see also 21 C.F.R. § 314.70(b)(3)(iv)-(v). FDA will refuse to approve the sNDA if, among other reasons, the sponsor's investigations do not show that the drug is safe or effective for "the conditions of use prescribed, recommended, or suggested in the proposed labeling." 21 U.S.C. § 355(d)(1), (2), (5).

2. Abbreviated New Drug Applications

The Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Amendments), codified at 21 U.S.C. § 355 and 35 U.S.C. §§ 156, 271, & 282, permits a drug manufacturer to submit an abbreviated new drug application ("ANDA") requesting approval of a generic version of an already approved drug product. See 21 U.S.C. § 355(j). ANDA applicants need not submit clinical data to demonstrate the safety and efficacy of the generic product, as with an NDA. See id. Rather, an ANDA relies on FDA's previous findings that the product approved under the NDA is safe and effective. Among other information, an ANDA must include data showing that the generic drug product is bioequivalent to the innovator product. See 21 U.S.C. § 355(j)(2)(A)(iv), (j)(4)(F); see also 21 C.F.R. § 314.127(a)(6)(i), 314.94(a)(7).

3. Orphan Drug Exclusivity

To justify the costly and risky investment of time and money in preparing and submitting NDAs and sNDAs, Congress has provided these applicants with certain periods of statutory exclusivity during which they can sell their product without generic competition. One of these periods of statutory exclusivity is found in the Orphan Drug Act ("ODA") provisions of the FDCA, Pub. L. 97-414, 96 Stat. 2049. There, Congress encouraged drug manufacturers to develop drugs for the treatment of rare diseases or disorders affecting small patient populations. One of the incentives that Congress provided in the ODA is a seven-year period of market exclusivity for approved orphan drugs. See 21 U.S.C. § 360cc(a). FDA's regulations provide that, when a drug receives orphan exclusivity, "no approval will be given to a subsequent sponsor of the same drug for the same use or indication for 7 years." 21 C.F.R. § 316.3(b)(12).

4. Labeling Requirements

FDA has promulgated regulations requiring certain pediatric information to be included on a prescription drug's label.[3] For example, in the "Indications and Usage" section of the Full Prescribing Information portion, "[i]f evidence is available to support the safety and effectiveness of the drug or biological product only in selected subgroups of the larger population ( e.g., ... patients in a special age group )... a succinct description of the limitations or usefulness of the drug and any uncertainty about anticipated clinical benefits, " must be included. 21 C.F.R. § 201.57(c)(2)(i)(B) (emphasis added). Elsewhere the regulations explain that, "[i]f there is a specific pediatric indication different from those approved for adults that is supported by adequate and well-controlled studies in the pediatric population, it must be described under the Indications and Usage' section." § 201.57(c)(9)(iv)(B).

Likewise, the "Dosage and Administration" section "must state the recommended dose and, as appropriate, " among other things, "[d]osages for each indication and subpopulation. " § 201.57(c)(3)(C) (emphasis added). This section must include appropriate pediatric dosage information "[i]f there is a specific pediatric indication different from those approved for adults that is supported by adequate and well-controlled studies in the pediatric population." § 201.57(c)(9)(iv)(B).

The regulations require that the labeling also includes other specific pediatric information. Where a specific pediatric indication has been demonstrated by adequate and wellcontrolled studies, the pediatric use section "must cite any limitations on the pediatric indication, " among other things. Id. "If there are specific statements on pediatric use of the drug for an indication also approved for adults that are based on adequate and well-controlled studies in the pediatric population, they must be summarized in the Pediatric use' subsection...." § 201.57(c)(9)(iv)(C).

5. The "Same Labeling" Requirement

Generally, generic drugs must contain the same information on their labels as the label of their respective brand-name predicate drug. See 21 U.S.C. § 355(j)(2)(A)(v), (j)(4)(G); 21 C.F.R. § 314.94(a)(8)(iv). Nonetheless, there are situations where ANDA applicants may carve out from proposed labeling patent or exclusivity-protected conditions of use and obtain approval for the remaining non-protected conditions of use. For example, the FDCA allows for exceptions if "the new [ANDA] drug and the listed drug are produced or distributed by different manufacturers." 21 U.S.C. § 355(j)(2)(A)(v); see also 21 C.F.R. §§ 314.94(a)(8)(iv), 314.92(a)(1), 314.127(a)(7). In such cases, ANDA applicants may, for example, carve out indications protected by patent or exclusivity in certain circumstances.

Additionally, Congress enacted section 505A(o) of the FDCA which identifies certain situations where the FDA cannot deny approval based on the omission of pediatric information on a brand's label, from the generic's label. Section 505A(o) provides:

A drug for which an application has been submitted or approved under section 355(j) of this title shall not be considered ineligible for approval under that section or misbranded under section 352 of this title on the basis that the labeling of the drug omits a pediatric indication or any other aspect of labeling pertaining to pediatric use when the omitted indication or other aspect is protected by patent or by three-year exclusivity under [Section 505(j)(5)(F)(iii) or (iv)].

21 U.S.C. § 355a(o)(1). According to Otsuka, "[t]he only labeling omissions the statute allows are those expressly delineated: pediatric indications or information pertaining to pediatric use protected by patent or by three-year exclusivity under § 355(j)(5)(F)." ECF No. 77 at 22.[4] Otsuka therefore maintains that FDA cannot omit pediatric labeling information that is protected by orphan drug exclusivity. See id. FDA, on the other hand, contends that section 505A(o) "does not limit [its] authority to carve out pediatric labeling where a carve-out would otherwise be appropriate; instead, it provides FDA with additional authority to retain Hatch-Waxmanprotected pediatric information in ANDA ...

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