Case Explained: NORWICH PHARMACEUTICALS, INC v. ROBERT F. KENNEDY, JR

Court: United States Court of Appeals for the District of Columbia Circuit Filed: 2026-06-26 The D.C. Circuit affirmed the district court’s grant of summary judgment to the FDA and Salix Pharmaceuticals, holding that the FDA did not act arbitrarily or capriciously by delaying final approval of Norwich Pharmaceuticals’ amended ANDA No. 214369 until October 2029. The court ruled that the Delaware District Court’s final judgment, issued pursuant to 35 U.S.C. § 271(e)(4)(A), explicitly barred the FDA from granting final approval of “Norwich’s ANDA No. 214369” until the expiration of Salix’s hepatic-encephalopathy patents, regardless of whether Norwich amended the application to remove the infringing indication. The court applied a plain meaning standard to the judgment text, concluding that an amended version of the specific numbered application remains subject to the original injunction. Furthermore, the court found that context confirmed this reading, noting that the Delaware District Court had explicitly rejected Norwich’s request for language excluding amended applications and that Norwich had previously argued the judgment required modification because it blocked approval of the amended ANDA. Consequently, Norwich is barred from obtaining final FDA approval of its generic competitor until the patent expiration date, as the court declined to interpret the judgment as implicitly permitting immediate approval of a modified application. Do It For The Case Law is a news reporting service. Nothing in this episode constitutes legal advice.