Background
Advanced Accelerator Applications USA, Inc. (AAA), a subsidiary of Swiss pharmaceutical giant Novartis, holds several patents covering Lutathera — the brand name for lutetium-177 dotatate (Lu-177 DOTA-TATE), a targeted radiopharmaceutical approved by the FDA in 2018 for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutathera works by pairing a radioactive isotope (lutetium-177) with a targeting molecule that homes in on tumors bearing somatostatin receptors, delivering lethal radiation to cancer cells while sparing surrounding tissue.
When competing manufacturers Curium US LLC and related Curium entities sought FDA approval to market generic versions of Lutathera under the Hatch-Waxman framework (which governs generic pharmaceutical approvals and related patent disputes), AAA sued for patent infringement in the District of Delaware in October 2024. The case proceeded to a bench trial before Judge Noreika from December 15 through December 19, 2025, focusing on the validity of AAA’s patents — specifically four patents covering formulations of stable, concentrated radionuclide complex solutions used in the drug.
The Court’s Holding
Judge Noreika ruled that all asserted patent claims are invalid under the on-sale bar of 35 U.S.C. § 102(b)(1)(A). The on-sale bar provides that a patent claim is invalid if the claimed invention was “on sale in this country” more than one year before the effective filing date of the patent application. Where the sale or commercial offer occurred more than a year before the patent was filed, the inventor cannot claim patent protection on those already-commercialized inventions.
The four patents at issue — U.S. Patents 10,596,276; 12,151,003; 12,168,063; and 12,161,732 (along with related patents 11,904,027 and 12,144,873) — were found to cover inventions that were on sale before the critical date, precluding patent protection. Judge Noreika found the commercial activity surrounding the radiopharmaceutical formulations predated the effective filing dates by more than the permitted one-year grace period.
Key Takeaways
- On-sale bar catches radiopharmaceuticals too. Pharmaceutical patent holders must track the timing of any commercial activity relative to their patent filing dates. Clinical supply, compassionate use sales, or regulatory submissions that constitute a “sale” or “offer for sale” can trigger the bar even before a drug is FDA-approved.
- Generic entry may now be cleared. With the key patent claims invalidated, Curium’s path to marketing a generic lutetium-177 dotatate product is substantially cleared of these patent obstacles, potentially enabling lower-cost alternatives to Lutathera.
- Hatch-Waxman strategy implications. This ruling underscores the importance of Hatch-Waxman patent litigation for radiopharmaceuticals and other specialty drug classes. As the specialty pharma sector has grown, so has Hatch-Waxman litigation beyond traditional small-molecule drugs.
- Post-trial appeal likely. AAA/Novartis can appeal the ruling to the Federal Circuit, where it may argue that the commercialization activity found by the district court did not legally constitute a “sale” under the proper on-sale bar standard.
Why It Matters
Lutathera is one of the first commercially successful targeted radionuclide therapies, representing a new paradigm of cancer treatment. In 2023, Novartis reported Lutathera generated over $400 million in annual sales. A ruling invalidating the key patents protecting it could accelerate the entry of generic competition and significantly reduce costs for patients with GEP-NET cancers — who currently pay tens of thousands of dollars per treatment cycle.
More broadly, this case signals that “evergreening” strategies common in small-molecule pharma — filing continuation patents that extend protection well after initial commercialization — face the same on-sale bar scrutiny in the radiopharmaceutical space. Companies developing novel radiopharmaceuticals will need to carefully sequence their commercial activities and patent filings to avoid losing protection at the invalidation stage.