AAA vs Curium: LUTATHERA® Lutetium-177 Dotatate Patent Suit Dismissed in 14 Days
Advanced Accelerator Applications filed suit against Curium US LLC and three affiliated entities in the Missouri Eastern District Court, asserting three patents covering lutetium Lu 177 dotatate — the active ingredient in LUTATHERA®. The case was voluntarily dismissed without prejudice just 14 days after filing, leaving the underlying infringement claims unresolved.
A 14-day radiopharmaceutical patent action with no merits ruling
In October 2024, Advanced Accelerator Applications USA, Inc. and its Swiss parent Advanced Accelerator Applications SA filed a patent infringement action in the Missouri Eastern District Court against Curium US LLC, Curium International Trading BV, Curium Netherlands BV, and Curium US Holdings LLC. The complaint asserted three US patents — US10596276B2, US10596278B2, and US11904027B2 — all directed to lutetium Lu 177 dotatate, the radiopharmaceutical compound marketed by AAA as LUTATHERA®, a treatment for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
On 1 November 2024, just 14 days after filing, plaintiffs filed a notice of voluntary dismissal without prejudice pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(i). Because this mechanism is available only before the defendant serves an answer or a motion for summary judgment, the dismissal required no court order and imposed no conditions. The case closed immediately, with no adjudication on the merits, no claim construction, and no costs order entered against either party.
A 14-day lifespan is notably brief even for cases that resolve early, suggesting the dismissal may reflect rapid strategic recalibration — possibly related to ongoing ANDA or regulatory proceedings, licensing discussions, or parallel litigation in another forum. The public record is silent on the specific driver. Because the dismissal is without prejudice, AAA retains the ability to refile the same claims against the Curium entities, meaning competitive risk for Curium in the lutetium-177 radiopharmaceutical space has not been eliminated.
Filing to Voluntary dismissal in 14 days
Closed in 14 days — among the shortest lifespans for multi-patent pharma infringement actions in this district
Voluntarily dismissed: what Rule 41 without prejudice means for both parties
Rule 41(a)(1)(A)(i): a unilateral exit before defendant responds
Federal Rule of Civil Procedure 41(a)(1)(A)(i) allows a plaintiff to dismiss a case as of right — without a court order — before the defendant serves an answer or summary judgment motion. That threshold had not been crossed here. The dismissal is self-executing the moment the notice is filed, meaning no judicial approval was required and no conditions could be imposed by the court.
No court order requiredThe public record does not resolve the full strategic picture
A dismissal without prejudice means the claims are not extinguished — AAA can refile the same three patents against the same Curium entities at any time within the applicable statute of limitations. A dismissal with prejudice would have barred refiling permanently. The notice here expressly states ‘without prejudice’, preserving AAA’s enforcement options fully. The public record is silent on what commercial or legal development prompted the early exit.
Refiling rights preservedCurium faces ongoing patent exposure — no safe harbour granted
Because the dismissal is without prejudice, Curium US LLC and its affiliates have not secured any ruling that their lutetium Lu 177 dotatate activities are non-infringing or that the asserted patents are invalid. No estoppel arises from this dismissal. Curium should treat the three asserted patents as live enforcement risks and monitor for refiling activity or parallel regulatory proceedings that could presage a renewed action.
No infringement findingLUTATHERA® patent portfolio remains an active market barrier
The lutetium-177 PSMA and dotatate radiopharmaceutical market is commercially significant and growing. AAA’s three-patent portfolio covering Lu 177 dotatate formulations continues to cloud the freedom to operate for any competitor seeking to commercialise a competing product. The rapid dismissal without prejudice, combined with no merits ruling, suggests this litigation chapter may be a precursor rather than a conclusion — any new entrant or generic filer in this space should treat these patents as live.
Competitive risk intactFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Advanced Accelerator Applications USA, Inc. | Company | Radiopharmaceutical company — holder of US10596276B2, US10596278B2, and US11904027B2Search in Eureka ↗ |
| Co-Plaintiff | Advanced Accelerator Applications, SA | Company | Search in Eureka ↗ |
| Defendant | Curium US LLC | Company | Curium US LLC and affiliates — radiopharmaceutical manufacturer and distributorSearch in Eureka ↗ |
| Co-Defendant | Curium International Trading BV | Individual | Search in Eureka ↗ |
| Co-Defendant | Curium Netherlands BV | Individual | Search in Eureka ↗ |
| Co-Defendant | Curium US Holdings LLC | Company | Search in Eureka ↗ |
| Plaintiff counsel | James F. Bennett | Attorney | Counsel for Advanced Accelerator Applications USA, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Michael J. Kuhn | Attorney | Counsel for Advanced Accelerator Applications USA, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Philip Allen Cantwell | Attorney | Counsel for Advanced Accelerator Applications USA, Inc.Search in Eureka ↗ |
| Plaintiff law firm | DOWD BENNETT LLP – St. Louis | Law Firm | Representing Advanced Accelerator Applications USA, Inc.Search in Eureka ↗ |
| Presiding judge | Judge John M. Bodenhausen | Judge | Missouri Eastern District CourtSearch in Eureka ↗ |
Official order — verbatim text
The notice of voluntary dismissal cites Rule 41(a)(1)(A)(i) and expressly states ‘without prejudice’, meaning no merits determination was made and no preclusive effect attaches. The phrasing is unambiguous: AAA’s three asserted patents remain fully enforceable and Curium receives no estoppel protection. The absence of any defendant law firm on the docket suggests the dismissal was filed before service was completed, which is consistent with the rule’s pre-answer timing requirement. No inference of patent weakness or licensing resolution can be drawn from the public record alone.
US10596276B2, US10596278B2 & US11904027B2 — lutetium Lu 177 dotatate radiopharmaceutical patents
All three asserted patents — US10596276B2, US10596278B2, and US11904027B2 — relate to lutetium Lu 177 dotatate, a targeted radionuclide therapy that binds to somatostatin receptors overexpressed on gastroenteropancreatic neuroendocrine tumors. LUTATHERA® is the FDA-approved commercial embodiment. The application numbers suggest US10596276B2 and US10596278B2 share a close filing date in October 2018, while US11904027B2 was filed in March 2020, suggesting continuation or divisional prosecution strategy to extend portfolio coverage.
The radiopharmaceutical sector is experiencing significant commercial growth, driven by approvals of targeted radionuclide therapies and pipeline expansion into prostate cancer and other indications. AAA, as a Novartis subsidiary and the originator of LUTATHERA®, holds a structurally strong position in this space. A three-patent assertion against a direct competitor like Curium — which operates across multiple jurisdictions — signals that AAA is actively maintaining portfolio enforcement as a commercial barrier, particularly as Curium expands its own radiopharmaceutical manufacturing and distribution capabilities internationally.
Should you run an FTO against US10596276B2, US10596278B2 & US11904027B2?
Any company developing, manufacturing, importing, or distributing lutetium Lu 177 dotatate products — including contract manufacturers, hospital radiopharmacies, or companies pursuing NDA or ANDA pathways for competing Lu 177 dotatate formulations — should treat these three patents as live enforcement risks. This case demonstrates that AAA is willing to file in US federal court against competitors, even where rapid dismissal follows. The without-prejudice closure means all three patents remain available for immediate re-assertion.
PatSnap Eureka’s FTO Search Agent can map your product’s technical features against the claim sets of US10596276B2, US10596278B2, and US11904027B2, identify prosecution history estoppel, locate prior art that may support invalidity arguments, and surface any continuation applications still pending in this family. For radiopharmaceutical R&D and regulatory teams preparing US market entry for Lu 177 dotatate products, a structured FTO analysis against this portfolio is a prerequisite to filing.
Run a freedom-to-operate analysis on US10596276B2 to assess your product’s exposure
Run FTO in Eureka →Similar radiopharmaceutical patent infringement cases in US district courts
Explore related lutetium-177 and targeted radionuclide patent disputes filed in US district courts, including comparable Hatch-Waxman and infringement actions in the radiopharmaceutical sector.
What this case signals for the radiopharmaceutical IP landscape
A 14-day patent suit against a named competitor signals strategic optionality, not abandonment. AAA’s enforcement posture in lutetium-177 remains active.
Without-prejudice dismissal preserves AAA’s full enforcement arsenal
Voluntary dismissal under Rule 41(a)(1)(A)(i) without prejudice leaves all three patents fully enforceable and all claims unresolved. AAA can refile against Curium or any other party. Competitors in the Lu 177 dotatate space should not interpret this closure as a retreat or as any signal of patent weakness.
14-day lifespan is consistent with a pre-litigation negotiation trigger
Filing and rapidly dismissing a complaint before any defendant response is a recognised tactic to initiate settlement or licensing discussions under litigation pressure. The short duration here — and the absence of any defendant law firm on record — suggests Curium may not have been served or engaged before dismissal, consistent with an out-of-court resolution attempt.
Advanced v Curium — key questions answered
AAA USA Inc. and AAA SA filed a patent infringement suit against Curium US LLC and three affiliates on 18 October 2024 in Missouri Eastern District Court, asserting three patents covering LUTATHERA® (lutetium Lu 177 dotatate). On 1 November 2024 — just 14 days later — plaintiffs filed a notice of voluntary dismissal without prejudice under Rule 41(a)(1)(A)(i). No merits ruling was issued and all three patents remain enforceable.
A dismissal without prejudice means AAA’s infringement claims are not extinguished. AAA retains the right to refile the same claims against Curium or any other party within the applicable statute of limitations. No estoppel, no preclusion, and no finding of invalidity or non-infringement attaches to the Curium entities as a result of this dismissal.
AAA asserted three US patents: US10596276B2 (application US16/175261), US10596278B2 (application US16/175239), and US11904027B2 (application US16/827606). All three relate to lutetium Lu 177 dotatate formulations and are associated with LUTATHERA®, AAA’s FDA-approved radiopharmaceutical therapy for gastroenteropancreatic neuroendocrine tumors.
The public record does not disclose the reason for the 14-day dismissal. The absence of any defendant law firm on the docket suggests Curium may not have been served before dismissal, which is consistent with Rule 41(a)(1)(A)(i)’s pre-answer requirement. Possible explanations include out-of-court licensing or settlement discussions, a strategic decision to refile in a different forum, or developments in a parallel regulatory or ANDA proceeding — but none can be confirmed from publicly available records.
No. The without-prejudice dismissal provides Curium with no safe harbour. The three asserted patents — US10596276B2, US10596278B2, and US11904027B2 — remain valid and enforceable. Curium received no non-infringement finding and no invalidity ruling. Any Curium entity seeking to commercialise a competing Lu 177 dotatate product in the US should conduct a formal freedom-to-operate analysis against these patents before proceeding.
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