Advanced Accelerator Applications USA, Inc. and its affiliate Advanced Accelerator Applications SA (together, ADACAP) filed Case No. 1:24-cv-01161 in the District of Delaware on 17 October 2024, asserting seven U.S. patents — including US10596276B2, US10596278B2, US11904027B2, US12151003B2, US12168063B2, US12161732B2, and US12144873B2 — against Curium US LLC and related Curium entities. The asserted patents all relate to lutetium Lu-177 dotatate radiopharmaceutical preparations, the active ingredient in ADACAP's LUTATHERA® injection, a targeted peptide receptor radionuclide therapy (PRRT) for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours. The action was triggered by Curium's New Drug Application No. 218525 filed under Section 505(b)(2) of the Hatch-Waxman Act.

On 24 June 2026, Judge Maryellen Noreika entered final judgment in favour of the Curium Defendants on all claims that proceeded to decision. The court ruled that Curium's NDA 218525 product will not infringe claim 13 of the '276 Patent, claims 3 and 8 of the '003 Patent, claim 6 of the '063 Patent, and claims 3, 6, and 15 of the '732 Patent. Additionally, those same claims were found invalid under 35 U.S.C. § 102(a) for being on sale more than one year before the effective filing dates of the claimed inventions — the so-called on-sale bar. All remaining ADACAP claims on the other asserted patents were dismissed with prejudice, and Curium's remaining defences and counterclaims were dismissed without prejudice as moot, subject to any appeal.

The case resolved entirely on the merits after a full memorandum opinion issued 17 June 2026, suggesting substantive trial or bench proceedings preceded the final order — though the specific procedural path to decision (bench trial, summary judgment, or otherwise) is not expressly identified in the available record. The on-sale bar finding, if upheld on appeal, significantly undermines ADACAP's ability to enforce any of these patents against Curium or future generic entrants. Curium retains its dismissed-without-prejudice counterclaims conditionally, dependent on the outcome of any appeal or Rule 60 relief, meaning the litigation posture is not entirely closed pending appellate activity.