Whether Congress implicitly ratified an FDA regulatory interpretation of the Orphan Drug Act's market exclusivity provision when it amended the statutory language without explicitly addressing the agency's longstanding regulatory construction

No question identified. : APPLICATION FOR EXTENSION OF TIME To the Honorable John G. Roberts, Jr., Chief Justice of the United States and Circuit Justice for the United States Court of Appeals for the D.C. Circuit: 1. Jazz Pharmaceuticals, Inc. respectfully requests a 46-day extension, up to and including November 10, 2025, to petition for a writ of certiorari. See 28 U.S.C. § 2101(c); Sup. Ct. R. 13.5. The D.C. Circuit issued its opinion and entered judgment on June 27, 2025. The opinion is available at 141 F.4th 254, and a copy is attached. Jazz’s cert petition is currently due September 25, 2025. See Sup. Ct. R. 13.3. This application has been filed on September 12, 2025, thirteen days before the time for filing the petition is set to expire. This Court has jurisdiction to review the D.C. Circuit’s decision under 28 U.S.C. § 1254(1). 2. Review is warranted because the D.C. Circuit split with other circuits over an important methodological question: what evidence is needed before courts may infer that Congress implicitly incorporated an agency regulation? a. This case involves the Orphan Drug Act of 1983, which Congress passed to spur investment in “orphan” drugs—treatments for rare disease and conditions. The statute authorizes FDA to “designate” a given drug “as a drug for a rare disease or condition.” 96 Stat. 2050, codified as amended at 21 U.S.C. § 360bb(a)(1). Then, if FDA later approves “a drug designated ... for a rare disease or condition,” the statute (as originally enacted) provided that the agency “may not approve another application ... for such drug for such disease or condition” for “seven years.” 96 Stat. at 2051, codified, as amended, at 21 U.S.C. § 360cc(a). The practical effect of this approval moratorium is that follow-on treatments are temporarily excluded from the market. This allows drugmakers to recoup their investment and serves as “the Act’s chief financial incentive.” Depomed, Inc. v. HHS, 66 F. Supp. 3d 217, 221 (D.D.C. 2014). In 1992—during Chevron’s heyday—FDA promulgated regulations to implement the Act. Relevant here, FDA claimed that the statutory phrase “such drug” was ambiguous, leaving a gap for the agency to fill. To that end, FDA announced that the moratorium would not prevent it from approving any follow-on drugs that it deemed “clinically superior.” 57 Fed. Reg. 62,076 (Dec. 29, 1992). FDA’s regulation thus provided that a “subsequent drug” that “can be shown to be clinically superior to the first drug ... will not be considered to be the same drug” as the first drug—and so will not be blocked by the moratorium. 21 C.F.R. § 316.3(b)(13)(i). Twenty-five years later, Congress passed the FDA Reauthorization Act of 2017, which made several changes to the Orphan Drug Act. Among other amendments, Congress provided that “21 U.S.C. § 360cc[] is amended ... in subsection (a) ... by striking ‘such drug for such disease or condition’ and inserting ‘the same drug for the same disease or condition’ .” § 607(a)(1), 181 Stat. at 1049 (emphases added). Congress made a similar change in subsection (b), striking “such holder provides” and replacing it with “the holder provides.” § 607(a)(2)(C), 131 Stat. at 1049. No legislative history explains why Congress replaced the word “such” in these provisions. b. Jazz has spent years developing treatments for narcolepsy: a rare, chronic, and debilitating sleep condition. While narcolepsy has no known cure, a drug called oxybate has been shown to treat its symptoms. At the request of Jazz’s predecessor, FDA designated oxybate as a treatment for narcolepsy. Then, in 2020, it approved Jazz’s oxybate product Xywav to treat narcolepsy. As FDA later acknowledged, the Orphan Drug Act thus barred the agency from “approv[ing] ... the same drug for the same disease or condition” until 2027. 21 U.S.C. § 360cc(a). Three years later—partway through the moratorium—FDA approved a rival oxybate treatment created by respondent Avadel CNS Pharmaceuticals, LLC. To get around th