Endocyte, Novartis & Purdue v. POINT Biopharma & Eli Lilly: PSMA Patent Case Dismissed Without Prejudice After Phase 3 Failure
Endocyte, Novartis Pharmaceuticals, and Purdue Research Foundation brought a patent infringement action against POINT Biopharma and Eli Lilly over US10624970B2, asserting that PNT2002 — a PSMA-targeted radioligand therapy — infringed their foundational PSMA-targeting patent. The case closed after 400 days when Lantheus, holding a licence to PNT2002, announced it would abandon the product following a Phase 3 overall survival readout.
How a Phase 3 trial failure ended a high-stakes PSMA patent dispute
Filed on 13 June 2024 in the Indiana Southern District Court, this action saw Endocyte, Inc., Novartis Pharmaceuticals Corporation, and Purdue Research Foundation jointly assert US10624970B2 — a patent covering PSMA-targeted radioligand compositions and methods — against POINT Biopharma Global Inc., POINT Biopharma Inc., and Eli Lilly and Co. The plaintiffs alleged that PNT2002, a PSMA-targeted radioligand product developed by POINT Biopharma under a licence and collaboration agreement with Lantheus Holdings, infringed their patent rights. Pluvicto® (lutetium PSMA-617), the FDA-approved PSMA radioligand therapy marketed by Novartis, forms the commercial backdrop to the dispute.
The case closed on 18 July 2025 through a stipulation of dismissal without prejudice under Federal Rule of Civil Procedure 41(a)(1)(A)(ii). The trigger was a commercial development external to the litigation: on 7 May 2025, Lantheus announced that the Phase 3 SPLASH study of PNT2002 had reached 100% of its prespecified overall survival events and that Lantheus would not pursue an NDA or further invest in the asset. With PNT2002’s commercial path effectively closed, both sides stipulated that continuing the litigation would not be a productive use of resources. All parties agreed to bear their own costs, attorneys’ fees, and disbursements.
The 400-day duration reflects a case that progressed through contested motion practice — defendants moved to dismiss, and the court granted the motion in part and denied it in part on 10 March 2025 — before being mooted by the Phase 3 outcome. The public record does not disclose whether any licensing discussion or commercial settlement accompanied the stipulation, and the without-prejudice dismissal leaves the door open for future enforcement should a new PSMA-targeted product raise equivalent infringement questions. What drove the ultimate resolution was not legal weakness on either side, but the disappearance of the commercial object of the dispute.
Filing to Dismissed without Prejudice in 400 days
400 days — resolved without merits ruling; above the median for PSMA pharmaceutical patent disputes
Dismissed without prejudice: what the stipulation means for both sides
Rule 41 stipulated dismissal without prejudice explained
A dismissal without prejudice under Fed. R. Civ. P. 41(a)(1)(A)(ii) terminates the current action but does not extinguish the underlying patent claims. Both parties sign the stipulation, and no court merits ruling is issued. Crucially, the patent holder retains the right to bring a new action for the same infringement if circumstances change — for example, if a successor product or new commercial arrangement raises equivalent infringement questions.
No merits ruling — claims survivePlaintiffs preserve enforcement rights despite no court victory
Endocyte, Novartis, and Purdue Research Foundation exit the litigation without a judgment against them and, critically, without any adverse ruling on the validity or scope of US10624970B2. The patent remains fully enforceable. With PNT2002’s commercial development halted, there was no injunctive or damages relief to pursue for now — but the without-prejudice dismissal means the plaintiffs can re-assert the patent against the same or similar defendants if a new PSMA-targeted product emerges from this lineage.
Patent validity uncontestedPOINT Biopharma and Eli Lilly exit without prejudice or liability finding
POINT Biopharma and Eli Lilly avoid a merits adjudication that could have resulted in an infringement finding, injunction, or damages award. Their partial win on the motion to dismiss had already narrowed plaintiffs’ claims, but the final dismissal is neutral — no court has found either non-infringement or invalidity of US10624970B2. If either entity pursues a reformulated or successor PSMA product, they will face the same patent landscape without the benefit of any defensive judgment from this case.
No defensive judgment obtainedPhase 3 failure reshapes PSMA radioligand competitive dynamics
PNT2002’s abandonment strengthens Novartis/Endocyte’s near-term market position in PSMA radioligand therapy, with Pluvicto® facing reduced near-term challenge. However, the unresolved US10624970B2 patent remains a live risk for any future entrant developing PSMA-targeted radioligand therapies. Companies — including those developing next-generation PSMA agents — should treat this patent as an active enforcement asset rather than a spent litigation instrument.
US10624970B2 remains enforceableFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | ENDOCYTE, INC. | Company | Pharma/biotech patent holders — PSMA-targeted radioligand therapy IP including US10624970B2Search in Eureka ↗ |
| Co-Plaintiff | Novartis Pharmaceutical Corporation | Company | Search in Eureka ↗ |
| Co-Plaintiff | Purdue Research Foundation | Individual | Search in Eureka ↗ |
| Defendant | POINT BIOPHARMA GLOBAL INC. | Company | POINT Biopharma (PSMA radioligand developer) and Eli Lilly (acquirer), with Lantheus as PNT2002 licenseeSearch in Eureka ↗ |
| Co-Defendant | POINT BIOPHARMA INC. | Company | Search in Eureka ↗ |
| Co-Defendant | Eli Lilly and Co. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Christie Corn | Attorney | Counsel for ENDOCYTE, INC.Search in Eureka ↗ |
| Plaintiff counsel | Jessamyn S. Berniker | Attorney | Counsel for ENDOCYTE, INC.Search in Eureka ↗ |
| Plaintiff counsel | Kandi Kilkelly Hidde | Attorney | Counsel for ENDOCYTE, INC.Search in Eureka ↗ |
| Plaintiff counsel | Maurita Elaine Horn | Attorney | Counsel for ENDOCYTE, INC.Search in Eureka ↗ |
| Plaintiff counsel | Max Accardi | Attorney | Counsel for ENDOCYTE, INC.Search in Eureka ↗ |
| Plaintiff counsel | Melissa B. Collins | Attorney | Counsel for ENDOCYTE, INC.Search in Eureka ↗ |
| Plaintiff counsel | Patricia Roman Hass | Attorney | Counsel for ENDOCYTE, INC.Search in Eureka ↗ |
| Plaintiff counsel | Stephen J. Fuzesi | Attorney | Counsel for ENDOCYTE, INC.Search in Eureka ↗ |
| Plaintiff counsel | Thomas Steven Fletcher | Attorney | Counsel for ENDOCYTE, INC.Search in Eureka ↗ |
| Plaintiff law firm | Frost Brown Todd LLP | Law Firm | Representing ENDOCYTE, INC.Search in Eureka ↗ |
| Plaintiff law firm | Williams & Connolly LLP | Law Firm | Representing ENDOCYTE, INC.Search in Eureka ↗ |
| Defendant counsel | Blaine M. Hackman | Attorney | Counsel for POINT BIOPHARMA GLOBAL INC.Search in Eureka ↗ |
| Defendant counsel | Bruce M. Wexler | Attorney | Counsel for POINT BIOPHARMA GLOBAL INC.Search in Eureka ↗ |
| Defendant counsel | Candace Polster | Attorney | Counsel for POINT BIOPHARMA GLOBAL INC.Search in Eureka ↗ |
| Defendant counsel | Eric W. Dittmann | Attorney | Counsel for POINT BIOPHARMA GLOBAL INC.Search in Eureka ↗ |
| Defendant counsel | Katherine A Helm | Attorney | Counsel for POINT BIOPHARMA GLOBAL INC.Search in Eureka ↗ |
| Defendant counsel | Martin J. Black | Attorney | Counsel for POINT BIOPHARMA GLOBAL INC.Search in Eureka ↗ |
| Defendant counsel | Pejmon Pashai | Attorney | Counsel for POINT BIOPHARMA GLOBAL INC.Search in Eureka ↗ |
| Defendant counsel | William A. McKenna | Attorney | Counsel for POINT BIOPHARMA GLOBAL INC.Search in Eureka ↗ |
| Defendant law firm | Dechert LLP | Law Firm | Representing POINT BIOPHARMA GLOBAL INC.Search in Eureka ↗ |
| Defendant law firm | Paul Hastings LLP | Law Firm | Representing POINT BIOPHARMA GLOBAL INC.Search in Eureka ↗ |
| Defendant law firm | Woodard, Emhardt, Henry, Reeves & Wagner LLP | Law Firm | Representing POINT BIOPHARMA GLOBAL INC.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Indiana Southern District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulation is careful to frame dismissal as resource preservation in response to a third-party commercial event — Lantheus’s NDA abandonment — rather than any concession on the merits. The without-prejudice designation is legally significant: it prevents either side from invoking res judicata or claim preclusion in any future action involving US10624970B2. The cost-bearing provision (each side pays its own) is consistent with a mutually agreed resolution rather than a litigation defeat. No royalty, damages figure, or licensing term appears in the public record.
US10624970B2 — PSMA-targeted radioligand therapeutic compositions
US10624970B2, filed under application number US15/990095, protects compositions and methods relating to prostate-specific membrane antigen (PSMA)-targeted radioligand therapies. PSMA is a cell-surface protein overexpressed in prostate cancer cells, making it a high-value target for diagnostic and therapeutic radioligand agents. The patent’s assignment to Endocyte and Purdue Research Foundation reflects the academic-commercial development pathway common to radiopharmaceutical innovation, with Novartis acquiring rights through its 2018 acquisition of Endocyte for approximately $2.1 billion — a deal centred specifically on PSMA-targeted pipeline assets including what became Pluvicto®.
US10624970B2 sits at the centre of the commercial PSMA radioligand space. Pluvicto® (lutetium PSMA-617), the first FDA-approved PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer, is the primary product in the Novartis/Endocyte commercial estate. Any competitor developing PSMA-targeting radioligand compounds — whether small molecule or antibody-based — must treat this patent as a primary FTO hurdle. With PNT2002 now abandoned, the patent’s enforcement significance shifts to other pipeline candidates, including next-generation PSMA agents in development across the radiopharmaceutical sector.
Should you run an FTO against US10624970B2 for your PSMA pipeline?
Any R&D team or product manager working on PSMA-targeted radioligand therapies — whether for prostate cancer diagnostics, therapeutics, or theranostic combinations — should conduct a freedom-to-operate analysis against US10624970B2 before advancing into IND-enabling studies or partnering discussions. This patent has been actively asserted in litigation and, following dismissal without prejudice, remains fully enforceable. The fact that Eli Lilly and POINT Biopharma could not obtain a non-infringement or invalidity ruling makes the claims even harder to design around without formal FTO guidance.
PatSnap Eureka’s FTO Search Agent allows you to map your PSMA compound or formulation against the claim landscape of US10624970B2, identify file-history estoppel positions, and surface related family members or continuation risk in a single workflow. Eureka cross-references litigation history alongside claim scope analysis — so you see not just what the patent says, but how it has been enforced and where courts have drawn boundaries. Upload your compound structure or target description and run a claim-by-claim FTO in minutes.
Run a freedom-to-operate analysis on US10624970B2 to assess your product’s exposure
Run FTO in Eureka →Similar PSMA radioligand and radiopharmaceutical patent cases
Explore related patent infringement actions involving PSMA-targeted therapies, radioligand compositions, and prostate cancer therapeutics litigated in US district courts.
What this case signals for the PSMA radioligand therapy IP landscape
The collapse of PNT2002’s Phase 3 programme, not litigation strategy, drove resolution — but the patent questions remain live for the sector.
Without-prejudice dismissal preserves future enforcement against PSMA entrants
US10624970B2 has never been adjudicated on the merits. Any future PSMA-targeted radioligand product — from any developer — that falls within the patent’s claim scope faces a fully preserved enforcement action. The exit of PNT2002 resolves this dispute, not the underlying IP exposure.
Phase 3 commercial risk can overtake litigation strategy in biotech patent disputes
This case illustrates how clinical and regulatory outcomes can moot patent litigation faster than any legal motion. IP teams monitoring competitive biotech litigation should track product development milestones alongside court dockets — trial failure can render years of litigation cost irrelevant overnight.
ENDOCYTE v POINT — key questions answered
The plaintiffs asserted US10624970B2, a patent covering PSMA-targeted radioligand therapy compositions and methods, filed under application US15/990095. The patent is assigned to Endocyte and Purdue Research Foundation, with Novartis holding commercial rights through its 2018 acquisition of Endocyte.
The parties stipulated to dismissal without prejudice under Rule 41(a)(1)(A)(ii) after Lantheus Holdings announced on 7 May 2025 that the Phase 3 SPLASH study of PNT2002 had reached its overall survival endpoint and that Lantheus would not pursue an NDA for the product. With PNT2002 commercially abandoned, both sides agreed that continuing the litigation would not be a productive use of resources.
No. A dismissal without prejudice does not constitute a merits ruling and does not extinguish the patent claims. US10624970B2 remains fully enforceable. Endocyte, Novartis, and Purdue Research Foundation retain the right to assert the patent against future PSMA-targeted products, including any successor assets developed by POINT Biopharma, Eli Lilly, or any other party.
On 10 March 2025, the Indiana Southern District Court granted defendants’ motion to dismiss in part and denied it in part. The public record does not specify which claims survived, but the partial denial indicates that at least some of the plaintiffs’ patent infringement theories were found sufficient to proceed to further litigation stages.
Eli Lilly acquired POINT Biopharma in a transaction completed in late 2023, making it the parent entity of the POINT Biopharma defendants. As the acquirer, Lilly assumed exposure for litigation relating to POINT Biopharma’s pipeline assets, including PNT2002. The case suggests that Lilly’s PSMA-related pipeline — including any assets retained from POINT Biopharma — remains subject to US10624970B2 enforcement risk.
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