Delaware Court Clears Path for Curium's Lutetium Lu 177 Dotatate in GEP-NETs, Invalidating Novartis Patents
Key Insights
The Delaware U.S. District Court ruled that all relevant patent claims asserted by Novartis/AAA against Curium (search)'s Lutetium Lu 177 dotatate (search) are invalid and not infringed, representing a complete victory for Curium.
The decision enables Curium (search) to launch its targeted radioligand therapy in the U.S. for somatostatin receptor (search)-positive gastroenteropancreatic neuroendocrine tumors (search) (GEP-NETs) in adults.
Curium (search) brings over 100 years of nuclear medicine experience and a 30-year commitment to the NET community, with existing diagnostic products and a late-stage pipeline in prostate cancer.
A decisive ruling from the Delaware U.S. District Court has cleared the regulatory path for Curium (search) to bring its Lutetium Lu 177 dotatate (search) product to the U.S. market, invalidating all patent claims brought by Novartis subsidiary Advanced Accelerator Applications (AAA). Justice Noreika adjudicated that all relevant patent claims asserted by Novartis/AAA are invalid and not infringed by Curium, representing what the company described as a complete victory.
The June 18, 2026 decision paves the way for Curium (search)'s plans to launch its Lutetium Lu 177 dotatate (search) product and commercialize a therapy for the treatment of somatostatin receptor (search)-positive gastroenteropancreatic neuroendocrine tumors (search) (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults across the United States.
Executive Perspectives on the Ruling
Renaud Dehareng, Curium (search)'s group chief executive officer, emphasized the strategic importance of the decision: "We are pleased with the court's decision. Curium is focused on building a durable theranostics platform that pairs our diagnostic leadership with targeted radioligand therapies — and doing so with the operational discipline required to serve patients reliably at scale."
Michael Patterson, Curium (search)'s North American chief executive officer, underscored the patient-access implications: "This outcome brings Curium a step closer in our mission to deliver what patients, clinicians and health systems need: timely access to critical targeted radiopharmaceuticals."
Curium (search)'s Established Nuclear Medicine Heritage
Curium (search) brings substantial infrastructure and expertise to the radioligand therapy space. The company has more than 100 years of experience in nuclear medicine and a long-standing commitment of over 30 years to the NET community. It currently supplies diagnostic products that help detect neuroendocrine tumors and maintains a pipeline of investigational drugs in development.
Headquartered in Boston, Curium (search) operates in more than 70 countries with a workforce of over 3,800 employees and four manufacturing sites. The company's portfolio includes over 45 products that advance patient care, positioning it to meet the significant supply and distribution demands of the radiopharmaceuticals market.
Theranostics Platform and Pipeline Expansion
Curium (search)'s strategy centers on a theranostics approach — integrating diagnostic capabilities with targeted therapeutic radiopharmaceuticals. Beyond GEP-NETs, the company is advancing a late-stage pipeline exploring opportunities in prostate cancer, signaling broader ambitions in the oncology radiopharmaceutical landscape.
The favorable court decision removes a significant barrier to market entry, potentially introducing competition into the U.S. radioligand therapy market for neuroendocrine tumors and expanding treatment access for patients with these rare malignancies.