[xii][i] See 42 U.S.C. § 262(m) (Section 351 of the Public Health Service Act). Notice that under § 262(m)(1), the rules for submitting pediatric studies are the same for both drugs and biologics under § 505A of the Federal Food, Drug, and Cosmetic Act (FDCA) (codified as 21 U.S.C. § 355a). More precisely, § 262(m)(1) carves out the exclusivity benefits in §§ 505A (b)-(c) for drugs, which are then re-inserted as §§ 262(m)(2)-(3) as applicable to biologics given the different exclusivity periods.

search Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act, U.S. Food & Drug Administration (May 17, 2023).Guidance – Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations, U.S. Food & Drug Administration (May 17, 2023).See Guidance – How to Comply with the Pediatric Research Equity Act, U.S. Food & Drug Administration (September 2005).88 Fed. Reg. 31766.See 21 CFR 201.23, 201.57(c)(7)(ii)(a). FDA defines “pediatric population” as the age group from birth to younger than seventeen years of age. See21 CFR 201.57(c)(9)(iv)(A); Regulatory Considerations Guidance at FN 1.See Unofficial Guidance – Understanding Unapproved Use of Approved Drugs “Off Label”, U.S. Food & Drug Administration (Feb. 5, 2018).See Status Report – The Pediatric Exclusivity Provision, U.S. Food & Drug Administration (Jan. 2001); FDAMA Public Law 105-115, 111 Stat. 2296 (Nov. 21, 1997).21 U.S.C. 355a(b),(c).See Status Report – The Pediatric Exclusivity Provision at FN 8.See Status Report – BPCA and PREA, U.S. Food & Drug Administration (July 2016).See 21 U.S.C. 355a(b),(c). Regulatory Considerations Guidance at p. 24.21 U.S.C. 355c(a)(1).21 U.S.C. 355c(a)(2)(A).21 U.S.C. 355c(a)(3)-(4), (k). 21 U.S.C. 355c(a)(3)(A).See Guidance – Rare Pediatric Priority Review Vouchers, U.S. Food & Drug Administration at p. 18 (July 2019).See id. At p. 19;Pediatric Drug Development: Challenges and Opportunities, National Library of Medicine (December 28, 2018).See Regulatory Considerations Guidance at p. 4.See id. at p. 21.See id. at p. 2.See id.See Scientific Considerations Guidance. Despite the fact that the PREA requirements typically do not apply to orphan drugs, a sponsor that submits an application to market a drug for an orphan indication may still be eligible to qualify for pediatric exclusivity. Additionally, if orphan designation is granted after approval of a drug, and post-marketing studi

Case Name:Otsuka Pharmaceutical Co., Ltd. v. Burwell, Civ. No. GJH-15-852, 2015 U.S. Dist. LEXIS 68230 (D. Md., May 27, 2015) (Hazel, J.)Drug Product and Patent(s)-in-Suit:Abilify® (aripiprazole); N/ANature of the Case and Issue(s) Presented:The issue here concerns whether the FDA was precluded from approving generic versions of Abilify® until its orphan drug exclusivity expires in December 2021 because 21 U.S.C. § 355a(o) does not permit such pediatric information to be omitted from a generic drug’s label. Otsuka first obtained approval from the FDA to manufacture and market Abilify on November 15, 2002.

On May 27, 2015, the U.S. District Court for the District of Maryland granted FDA and the Defendant-Intervenors summary judgment against Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”), holding that FDA appropriately interprets the Food, Drug, and Cosmetic Act (“FD&C Act”) when it grants abbreviated new drug applications (“ANDAs”) by carving out information that is protected by orphan drug exclusivity from the ANDA labeling, so long as the drug “remains safe and effective for the remaining non-protected conditions of use” without the carved-out language.As previous discussed (see the most recent blog here), Otsuka sought to stop the approval of generic versions of Abilify® (aripiprazole) by arguing that 21 U.S.C. §355a(o) permits FDA to allow generic drugs to omit pediatric labeling in only two scenarios: a) when the branded drug is protected by a patent and b) when the drug has non-orphan drug exclusivity. Abilify®’s blocking Patent No. 5,006,528 (“the ’528 patent”) expired on April 20, 2015, and Otsuka had already attempted to enjoin generic entry based on some of its other patents, but had so far been unsuccessful.

With this in mind, Judge Urbina addressed each of FDA's decisions: FDA's Decision that the Effective Date of the Federal Circuit's Ruling is the Date it Issues its MandateJudge Urbina agreed with FDA's decision that Pfizer is entitled to pediatric exclusivity, though he used different reasoning to get there. He reasoned that because 21 USC 355a(c)(2)(B) is silent "as to the particular court which may determine the patent dispute," the January 24, 2006 Northern District of Illinois Order in Pfizer v. Apotex triggered Pfizer's pediatric exclusivity. And, moreover, that decision "is effective and remains so during the pendency of the appeal unless the district court's judgment is stayed or until the Federal Circuit issues its mandate."

Mylan’s ANDA product infringes the ’229 patent. Pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any final approval of Mylan’s ANDA product shall be a date not earlier than Aug. 18, 2019, the date of expiration of the ’229 patent together with a period of pediatric exclusivity awarded to Novartis under 21 U.S.C. § 355a. Pursuant to 35 U.S.C. § 271(e)(4)(B), Mylan is enjoined from engaging in the commercial manufacture, use, offer for sale, sale, in the US and/or importation into the US of its ANDA product until Feb. 18, 2019.

If FDA once again denies Amgen pediatric exclusivity, then we’ll probably see the parties back in court. Regardless of whether FDA decides to grant pediatric exclusivity, or if the exclusivity is ordered granted by a court, the Order states that “any future decision requiring FDA to accept Amgen’s study reports for Sensipar (cinacalcet) under 21 U.S.C. § 355a(d)(3) . . . shall be deemed to relate back, nunc pro tunc, to May 22, 2017, the date of FDA’s initial determination.” As we previously explained, a “relate back” decision is important here, because pediatric exclusivity extends all other types of Orange Book-listed patent and non-patent marketing exclusivity an application holder may have under the FDC Act, provided that at the time pediatric exclusivity is granted there is not less than nine months of term remaining.

This five-year period of exclusivity was extended until December 24, 2005, due to Cephalon’s status as an orphan drug. 3 In March 2006, Cephalon obtainedpediatric exclusivity, which added an additional six months of exclusivity. 21 U.S.C. § 355a(c). Thus, in the absence of the ‘516 patent, Cephalon’s exclusivity period for modafinil would have ended on June 24, 2006.

These rulings have been seen as a success for the FDA as the court held that the federal agency was correct in its interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) in a manner to allow the sale of generic versions of Abilify with labeling that omits Otsuka’s exclusivity protected indication for Tourette’s syndrome. The suit revolves around FDCA provision 21 U.S.C. §355a(o), which states that proposed generics “shall not be considered ineligible for approval… 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 exclusivity…” While Otsuka argued that this provision only allows the FDA to omit pediatric information from generic drug labels in these two instances, the FDA contended that this provision prevents them from denying approvals based on these omissions, but does not prevent them from allowing omissions in other instances. The court responded to this argument by holding that “Otsuka cannot… turn a provision limiting FDA’s disapproval authority into a provision limiting its approval authority.”

In order to make any generic Abilify approval decisions, however, the agency may also need to consider other potentially important parts of the regulatory scheme, which Otsuka’s letter does not take into account. These may include the scope of the permissible difference to the same labeling requirement in the statute (see 21 U.S.C. § 355(j)(2)(A)(v)), regulations (see 21 C.F.R. § 314.94(a)(8)(iv)), and applicable case law, as well as the effect of 21 U.S.C. § 355A(o) on labeling that is protected by both Hatch-Waxman and orphan exclusivity. FDA may also deem it important to consider arguments potentially raised by generic drug sponsors.