Catalyst Pharmaceuticals, Inc. v. Xavier Becerra, et al

  1. January 23, 2023

    After Catalyst Case, FDA Won't Stop Approving Orphan Drugs

    The U.S. Food and Drug Administration has said a loss in litigation involving a treatment for a rare autoimmune disease won't stop it from approving new orphan drugs if they have usage instructions different from a previous orphan drug that treats the same condition.

  2. January 02, 2023

    Health Care & Life Sciences Litigation To Watch In 2023

    Before the New Year's Eve confetti has even been swept up, lawyers specializing in health care and life sciences already have enough litigation to keep them busy for much of 2023, which is kicking off with federal courts eyeing suits that carry sweeping significance for administrative law, the False Claims Act, drug approvals, the opioid crisis and abortion rights.

  3. July 12, 2022

    Catalyst Inks Deal To End Its 'Orphan Drug' Case

    Florida-based Catalyst Pharmaceuticals Inc. has inked a deal to settle its patent case against a rival involving a drug that treats a rare autoimmune disease, ending litigation that made its way to the U.S. Supreme Court.

  4. April 12, 2022

    11th Circ. Undermined Rare-Disease Drugs, High Court Told

    Jacobus Pharmaceutical Co. Inc. said that the Eleventh Circuit created a circuit split and upended years of U.S. Food and Drug Administration policy when it ruled lucrative exclusivity for so-called orphan drugs extends not just to the specific approved uses but rather the entire drug.

  5. January 07, 2022

    11th Circ. Won't Rehear Catalyst's Win In 'Orphan Drug' Case

    The Eleventh Circuit declined on Friday a bid to rehear its finding that the U.S. Food and Drug Administration unlawfully infringed on an exclusivity period it awarded Catalyst Pharmaceuticals Inc. for a drug that treats a rare autoimmune disease when it approved a lower-cost version.

  6. November 17, 2021

    Drugmaker Says 11th Circ. Ruling Based On 'Straw Man'

    The maker of a drug for pediatric patients with a rare autoimmune disease told the Eleventh Circuit it must reconsider a panel ruling in favor of its rival Catalyst Pharmaceuticals Inc. en banc, arguing the panel "constructed a straw man" that misconstrues what was really in dispute.

  7. September 30, 2021

    11th Circ. Hands Catalyst Win In 'Orphan Drug' Case

    Florida-based Catalyst Pharmaceuticals Inc. won a decision on Thursday in the Eleventh Circuit, which found that the U.S. Food and Drug Administration unlawfully infringed on an exclusivity period it awarded the company for a drug that treats a rare autoimmune disease when it approved a lower-cost version.

  8. March 23, 2021

    11th Circ. Rips FDA's 'Invisible Ink' Interpretation Of Drug Act

    An Eleventh Circuit judge criticized the U.S. Food and Drug Administration's interpretation of the Orphan Drug Act during oral arguments Tuesday over its approval for two companies to make the same rare-disease drug, suggesting statutory text supporting its argument must have been written in "invisible ink."