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Jacobus Pharmaceutical Company, Inc. v. Catalyst Pharmaceuticals, Inc., et al.
Paid petition · United States Court of Appeals for the Eleventh Circuit, No. 20-13922 · judgment September 30, 2021
Before the decision, well below the 4.1% base rate, with no standout signals pointing toward a grant.
Question presented
Congress intended the Orphan Drug Act (ODA) to incentivize the development of drugs for the treatment of rare diseases. To be eligible for the incentives, a sponsor must obtain an orphan-drug designation from the Food and Drug Administration (FDA) for a drug that “is being or will be investigated for a rare disease or condition.” 21 USC § 360bb(a)(1). The primary incentive to do so is a period of exclusivity, which prevents FDA from approving another sponsor’s application for the “same drug for the same rare disease or condition” for seven years. 21 USC § 360cc(a). For the past 30 years, FDA regulations have interpreted ODA exclusivity to prohibit the agency only from approving a second “same drug” for the same “use” as the prior-approved drug. Here, the Eleventh Circuit created a split with the Fourth and D.C. Circuits, concluding that the ODA unambiguously foreclosed FDA’s regulation. FDA designated Respondent’s drug, Firdapse® (amifampridine), as an orphan drug to treat LambertEaton Myasthenic Syndrome (LEMS) and subsequently approved it for adults with LEMS (the only population Respondent sought approval to treat). FDA approved Petitioner’s drug, Ruzurgi® (amifampridine), for a pediatric population, which Firdapse® was not approved to treat. The Eleventh Circuit held that the ODA foreclosed this result. The question presented is: Does the ODA unambiguously foreclose FDA’s decades-long, consistent interpretation that the scope of orphan-drug exclusivity is tied to a drug’s approved use?
Counsel of record
For petitioner
Marisa Christina Maleck
King & Spalding LLP
For respondent
Philip J. Perry
Latham & Watkins, LLP
Case
Conference history
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Proceedings
- Jul 22 2022Petition Dismissed - Rule 46.
- Jul 13 2022Joint stipulation for dismissal of the petition for a writ of certiorari pursuant to Rule 46 filed.
- Jul 11 2022Brief of Federal Respondents in opposition filed.
- May 31 2022Motion to extend the time to file a response is granted and the time for Catalyst Pharmaceuticals, Inc. to file a response is further extended to and including July 25, 2022.
- May 27 2022Motion of Catalyst Pharmaceuticals, Inc. to extend the time to file a response from June 24, 2022 to July 25, 2022, submitted to The Clerk.
- May 26 2022Motion to extend the time to file a response is granted and the time is further extended to and including July 11, 2022, for all respondents.
- May 25 2022Motion of the Solicitor General to extend the time to file a response from June 10, 2022 to July 11, 2022, submitted to The Clerk.
- May 23 2022Motion to extend the time to file a response is granted and the time for Catalyst Pharmaceuticals, Inc. to file a response is extended to and including June 24, 2022.
- May 20 2022Motion of Catalyst Pharmaceuticals, Inc. to extend the time to file a response from June 10, 2022 to June 24, 2022, submitted to The Clerk.
- May 05 2022Motion to extend the time to file a response is granted and the time is extended to and including June 10, 2022, for all respondents.
- May 04 2022Motion to extend the time to file a response from May 11, 2022 to June 10, 2022, submitted to The Clerk.
- Apr 07 2022Petition for a writ of certiorari filed. (Response due May 11, 2022)