La Jolla Pharma & GWU v. Gland Pharma & Fosun: Giapreza Patent Dispute Dismissed
La Jolla Pharmaceutical Company, La Jolla Pharma LLC, and The George Washington University brought a 10-patent infringement action in the District of New Jersey against Gland Pharma Ltd. and Fosun Pharma USA over generic angiotensin II (Giapreza®). After 1,060 days of litigation, all claims and counterclaims were dismissed without prejudice, leaving no merits ruling on record.
Ten-Patent Giapreza® Battle Ends Without Merits Ruling in New Jersey
Filed on 29 March 2022 in the U.S. District Court for the District of New Jersey, this action pitted La Jolla Pharmaceutical Company, La Jolla Pharma LLC, and academic co-plaintiff The George Washington University against generic challengers Gland Pharma Ltd., Fosun Pharma USA Inc., and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. The dispute centred on Giapreza® (angiotensin II acetate, 2.5 mg/mL), a vasopressor approved for septic or other distributive shock, and Gland’s proposed generic version of the same formulation.
The plaintiffs asserted ten U.S. patents spanning formulation, dosing method, and therapeutic-use claims. On 21 February 2025 — 1,060 days after filing — the parties filed a stipulation under Federal Rules of Civil Procedure 41(a)(1) and 41(c) dismissing all claims, counterclaims, and affirmative defenses without prejudice and without costs to any party. The without-prejudice designation means no party is barred from reasserting the same claims in future proceedings, and no judicial determination was made on the validity or infringement of any patent.
A resolution after nearly three years, with ten patents in play and multiple affiliated defendants, is consistent with a negotiated commercial arrangement — though the public record does not confirm or disclose any settlement terms, licensing agreement, or market-entry date. The absence of any cost award to either side, and the mutual without-prejudice framing, suggests the parties reached terms satisfactory enough to close the case without requiring an adjudicated outcome. What drove the resolution — whether product launch timing, licensing, or litigation economics — remains undisclosed.
Filing to Dismissed without Prejudice in 1060 days
1,060 days — nearly 3 years from filing to close, longer than median pharma ANDA disputes
Dismissed without prejudice: what the stipulated exit means for each side
Rules 41(a)(1) and 41(c): a consensual procedural exit
A stipulated dismissal under FRCP 41(a)(1) requires no court approval once signed by all parties and operates as a withdrawal of the action itself. Rule 41(c) extends the same mechanism to counterclaims. The without-prejudice designation is the critical qualifier: the dismissal does not operate as an adjudication on the merits, meaning any party could theoretically refile the same claims in a new action subject to any applicable statute of limitations or regulatory bar.
No merits adjudicationPatents survive unchallenged — but validity is untested
La Jolla and GWU exit with all ten patents intact and no adverse invalidity or non-infringement ruling on the record. Because the dismissal is without prejudice, they retain the right to assert these patents against Gland or Fosun — or other generic entrants — in future proceedings. The absence of a merits ruling also means no claim-scope narrowing through judicial construction occurred in this case, preserving maximum enforcement flexibility. However, the patents were never judicially validated either.
Patents enforceable, validity untestedGeneric challengers exit without an invalidity win — future risk remains
Gland Pharma and the Fosun entities avoided a merits ruling that could have found infringement or enjoined a product launch, but they also did not secure a declaration of invalidity or non-infringement. The without-prejudice framing means plaintiffs can refile if commercial circumstances change. Generic entrants in this space should treat the ten asserted patents as live enforcement risks until they expire, are adjudicated invalid, or are formally licensed — none of which occurred here.
No FTO certainty establishedAngiotensin II generic market: landscape remains legally unresolved
With no consent judgment, no ANDA carve-out, and no published settlement terms, the commercial pathway for Gland’s angiotensin II 2.5 mg/mL vial remains opaque to third parties. Other generic developers eyeing this market should note that ten patents covering formulation and method-of-use aspects survived this litigation uncontested. The resolution is consistent with a negotiated resolution — potentially involving a licensed launch date — but nothing in the public record confirms this, and competitors cannot rely on this case as precedent.
Market entry terms undisclosedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | La Jolla Pharmaceutical Company | Company | Pharmaceutical company and university — co-holders of Giapreza® angiotensin II patent portfolioSearch in Eureka ↗ |
| Co-Plaintiff | The George Washington University | Individual | Search in Eureka ↗ |
| Co-Plaintiff | La Jolla Pharma, LLC | Company | Search in Eureka ↗ |
| Defendant | Gland Pharma, Ltd. | Company | Gland Pharma Ltd. and Fosun Pharma entities — generic pharmaceutical manufacturers seeking market entrySearch in Eureka ↗ |
| Co-Defendant | Fosun Pharma USA, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | Shanghai Fosun Pharmaceutical (Group) Co., Ltd. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Charles H. Chevalier | Attorney | Counsel for La Jolla Pharmaceutical CompanySearch in Eureka ↗ |
| Plaintiff counsel | Christine A. Gaddis | Attorney | Counsel for La Jolla Pharmaceutical CompanySearch in Eureka ↗ |
| Plaintiff counsel | Stephen R. Donat | Attorney | Counsel for La Jolla Pharmaceutical CompanySearch in Eureka ↗ |
| Plaintiff law firm | Gibbons PC | Law Firm | Representing La Jolla Pharmaceutical CompanySearch in Eureka ↗ |
| Defendant counsel | Ahmed Muhammad Tan Riaz | Attorney | Counsel for Gland Pharma, Ltd.Search in Eureka ↗ |
| Defendant counsel | James S. Richter | Attorney | Counsel for Gland Pharma, Ltd.Search in Eureka ↗ |
| Defendant counsel | Justin Taylor Quinn | Attorney | Counsel for Gland Pharma, Ltd.Search in Eureka ↗ |
| Defendant law firm | ArentFox Schiff LLP | Law Firm | Representing Gland Pharma, Ltd.Search in Eureka ↗ |
| Defendant law firm | MIDLIGE RICHTER LLC | Law Firm | Representing Gland Pharma, Ltd.Search in Eureka ↗ |
| Defendant law firm | Robinson Miller LLC | Law Firm | Representing Gland Pharma, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulation invokes Rules 41(a)(1) and 41(c) to achieve a clean, court-approval-free exit. Crucially, the without-prejudice qualifier means the dismissal carries no res judicata effect — neither side is bound by any finding on infringement, validity, or claim scope. The express waiver of costs, disbursements, and attorneys’ fees to all parties is notable given the scale of the portfolio asserted; it is consistent with a negotiated resolution but the public record does not disclose any underlying terms.
US10548943B2 and nine further patents — Giapreza® angiotensin II formulations and methods
The ten asserted patents span U.S. patent numbers US9220745B2 through US11219662B2, with application dates ranging from a 2009 priority application (US12/639987, issuing as US9572856B2) through a 2021 application (US17/192453, issuing as US11219662B2). This multi-generational portfolio is characteristic of an evergreening strategy around Giapreza® (angiotensin II acetate), the first synthetic human angiotensin II approved by the FDA for vasodilatory shock. The claims collectively cover formulation, dosing methods, and therapeutic-use aspects of the product.
From a competitive intelligence standpoint, the breadth of this portfolio — ten patents across twelve-plus years of prosecution — creates substantial freedom-to-operate complexity for any generic or biosimilar developer targeting the angiotensin II vasopressor space. The inclusion of both formulation-type and method-of-use patents means that design-around approaches targeting only the composition claims may be insufficient. With Giapreza® addressing a critical-care indication, the commercial stakes for branded exclusivity are high, and the portfolio is likely to be aggressively monitored against future ANDA or 505(b)(2) filings.
Should your team run an FTO against the Giapreza® patent portfolio?
Any pharmaceutical manufacturer, generic drug developer, or contract manufacturer working on angiotensin II acetate injectable formulations — whether for ANDA, 505(b)(2), or out-of-scope hospital compounding purposes — should treat all ten patents named in this action as live enforcement risks. The without-prejudice dismissal created no FTO clearance. Expiry dates range across the 2030s depending on patent term adjustments, meaning several patents may remain in force for a decade or more.
PatSnap Eureka’s FTO Search Agent can map each of the ten asserted patents against your candidate formulation or manufacturing process, flag unexpired claims, surface prior art cited during prosecution, and identify any post-grant proceedings that may have narrowed or cancelled claims. Eureka also monitors new continuations or divisionals filed by La Jolla or GWU, alerting your IP team before new blocking IP crystallises — a critical capability given this portfolio’s demonstrated multi-year prosecution activity.
Run a freedom-to-operate analysis on US10548943B2 to assess your product’s exposure
Run FTO in Eureka →Similar angiotensin II and specialty injectable patent cases in U.S. district courts
Cases involving multi-patent specialty injectable drug portfolios asserted in New Jersey district courts against ANDA or generic entrants follow patterns relevant to this dispute.
What this case signals for the vasopressor and specialty pharma IP landscape
Ten patents, multiple generic defendants, and a without-prejudice exit: this case illustrates the layered complexity of branded specialty pharma enforcement.
Without-prejudice dismissals do not create clearance for third-party generics
A Rule 41 without-prejudice dismissal creates no precedent and no FTO for parties not named in the action. The ten patents asserted against Gland remain enforceable. Any generic developer — whether filing an ANDA or pursuing a 505(b)(2) path — for angiotensin II formulations must conduct independent FTO analysis and cannot rely on this case’s non-outcome as evidence of weak patents.
Multi-patent portfolio strategy increases settlement leverage in pharma disputes
Asserting ten patents across formulation, dosing, and method-of-use claims materially raises the cost and complexity of invalidity challenges. In this case, the breadth of the asserted portfolio — spanning applications filed from 2009 through 2021 — likely contributed to a prolonged 1,060-day dispute. Patent holders in specialty injectables should consider multi-layer portfolio structuring as a durable barrier to generic entry.
La v Gland — key questions answered
Ten U.S. patents were asserted: US10548943B2, US11096983B2, US10335451B2, US11219662B2, US10493124B2, US9220745B2, US9867863B2, US10500247B2, US9572856B2, and US10028995B2. All relate to angiotensin II acetate formulations and methods of use covering the branded product Giapreza®. The patents span application dates from 2009 to 2021.
The parties filed a stipulated dismissal under FRCP 41(a)(1) and 41(c) on 21 February 2025. The public record does not disclose the reason. A without-prejudice dismissal is consistent with a negotiated resolution — potentially a licensing agreement or agreed launch date — but no terms were made public. No costs or attorneys’ fees were awarded to any party.
No. A without-prejudice dismissal carries no preclusive effect and creates no FTO for parties not named in the action. The ten asserted patents remain enforceable. Generic developers targeting angiotensin II acetate formulations must conduct independent FTO analysis and cannot rely on this case’s non-merits outcome as any indicator of patent weakness or unenforceability.
The George Washington University was named as a co-plaintiff alongside La Jolla Pharmaceutical Company and La Jolla Pharma LLC, consistent with co-ownership of one or more of the ten asserted patents — a common structure when academic institutions contribute foundational research underlying a commercial drug product. University co-ownership can affect licensing terms, standing requirements, and litigation strategy.
The branded product at issue was Giapreza® (angiotensin II acetate), equivalent to 2.5 mg base/mL in solution — an FDA-approved vasopressor for distributive shock including septic shock. The defendants’ product was Gland Pharma’s angiotensin II 2.5 mg/mL vial, a proposed generic version of Giapreza® that the plaintiffs alleged infringed their patent portfolio.
PatSnap Eureka searches patents and litigation data to answer instantly.