Curium Wins Patent Dispute Against Novartis AAA, Clearing U.S. Path for Lu-177 Dotatate Launch

A Delaware federal court ruling invalidating all patent claims asserted by Novartis subsidiary Advanced Accelerator Applications (AAA) against Curium positions a second Lu-177 dotatate supplier to enter the U.S. market, with direct consequences for radioligand therapy procurement, manufacturing capacity planning, and competitive supply assurance for GEP-NET treatment programs.

Judge Noreika of the U.S. District Court for the District of Delaware issued the decision on June 17, 2026, finding all relevant claims both invalid and not infringed by Curium's Lutetium Lu 177 dotatate product. The ruling constitutes a complete adjudication in Curium's favor, removing the primary legal barrier to a U.S. commercial launch targeting somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut presentations in adults.

For QA directors and supply chain leads at health systems and specialty pharmacies currently dependent on a single-source Lu-177 dotatate supplier, the ruling introduces a credible second-source scenario that warrants qualification planning. Curium operates four manufacturing sites globally and holds a radiopharmaceutical portfolio spanning more than 45 products across over 70 countries, giving it an established GMP infrastructure from which a U.S. launch would be executed. The company also cites more than 30 years of supply history to the neuroendocrine tumor community through diagnostic radiopharmaceuticals, a track record relevant to assessing supplier reliability under 21 CFR Part 211 vendor qualification requirements.

Regulatory affairs leads should note that the court decision addresses patent exclusivity, not regulatory approval status. Curium has not publicly confirmed an approved NDA or BLA for its Lu-177 dotatate product in the U.S., and the timeline to commercial availability will depend on any outstanding FDA review milestones. Plant heads at contract manufacturing organizations active in the radioligand therapy space should read the ruling as a signal that competitive manufacturing capacity for Lu-177 conjugates is entering a new phase, with implications for capacity allocation, isotope sourcing agreements, and batch release scheduling.

Curium's group CEO Renaud Dehareng framed the company's intent around operational scale and theranostic platform integration, pairing diagnostic capabilities with targeted radioligand therapies. North American CEO Michael Patterson cited patient access to targeted radiopharmaceuticals as the operational priority driving the launch strategy.

The pace at which Curium converts this legal clearance into a commercially available, FDA-compliant Lu-177 dotatate product will be the measurable outcome that procurement and regulatory teams across U.S. oncology networks will be tracking closely.

Source: Curium via GlobeNewswire, June 18, 2026.