Jazz Pharmaceuticals Ireland Limited v. Invagen Pharmaceuticals, Inc.
Infringement action filed 4 Sep 2025 in the United States District Court for the District of New Jersey and closed 19 Mar 2026, with US12324806B2 asserted. Recorded basis of termination: case consolidated.
Case record
- Patent involved
- US12324806B2
- Application no.
- US18/448122
- Case no.
- 3:25-cv-15276
- Verdict cause
- Infringement action
- Court
- D.N.J.
- Court level
- District Court
- Case region
- New Jersey
- Chief judge
- None recorded
- Trial level
- First instance
- Filed – Closed
- 4 Sep 2025 – 19 Mar 2026
- Duration
- 196 days
- Basis of termination
- Case Consolidated
- Products & marks
- Lurbinectedin for injection, 4 mg/vial · Zepzelca® (lurbinectedin) for injection, for intravenous use, 4 mg/vial
- Validity challenges
- None recorded
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Method of treating SCLC and managing hepatotoxicity
Provided are methods for the treatment of SCLC patients by administering therapeutic amounts of lurbinectedin by intravenous infusion. Also provided are methods of treating cancer by administering lurbinectedin in combination with other anticancer drugs, in particular topoisomerase inhibitors. The invention further relates to the administration of lurbinectedin in combination with anti-emetic agents for effective control of symptoms related to nausea and vomiting, reduced lurbinectedin dosages to achieve a safer administration and an increase in the number of treatment cycles. Stable lyophilized formulations of lurbinectedin are also provided.
- Legal status
- Active
- Granted
- 10 Jun 2025
- Earliest priority
- 21 Nov 2019
- Est. expiry
- 29 May 2040
- Validity challenges
- None recorded
- Licences recorded
- None recorded
- Inventors
- KAHATT, CARMEN · FERNANDEZ, JOSÉ MARÍA · FUDIO, SALVADOR · SOTO, ARTURO · LARDELLI, PILAR · FERNANDEZ, CRISTIAN
- Classification
- A61K31/4995A61K9/00A61K9/19A61K31/4738A61K31/4745A61K31/573A61K38/19A61K45/06A61K47/12A61K47/26A61P11/00A61P35/00C07D515/22C07D519/00
- Prosecution counsel
- BALLARD SPAHR LLP
- Examiner
- KOSAR, ANDREW D
Parties of record
Jazz Pharmaceuticals Ireland Limited
- Core tech
- Not recorded
- Counsel
- Alexander Lee Callo · Charles Michael Lizza · Damien N. Dombrowski · Dominick A. Conde · Erin Austin · Erin K. Belfield · Sarah Ann Sullvian · Whitney Meier Howard
- Firm
- Saul Ewing, LLP, Venable, LLP
Invagen Pharmaceuticals, Inc.
- Core tech
- Not recorded
- Counsel
- Andrew J. Miller · Stuart D. Sender
- Firm
- Windels Marx Lane & Mittendorf LLP
Counsel of record
Basis of termination
From the record · verbatim“WHEREAS, Plaintiffs Jazz Pharmaceuticals Ireland Limited and Pharma Mar, S.A. (collectively, “Plaintiffs”) initiated Civil Action No. 3:24-cv-09110 (RK)(RLS) (“24-09110”) against Apicore US LLC, Archis Pharma LLC, and VGYAAN Pharmaceuticals LLC; Cipla (EU) Limited, Cipla Limited, Cipla USA, Inc., and InvaGen Pharmaceuticals, Inc. (collectively, “InvaGen”); MSN Laboratories Pvt. Ltd. and MSN Pharmaceuticals Inc. (collectively, “MSN”); RK Pharma, Inc.; Sandoz, Inc.; and Zydus Lifesciences Global FZE, Zydus Lifesciences Limited, and Zydus Pharmaceuticals (USA) Inc. (collectively, “Zydus”), and WHEREAS, VGYAAN Pharmaceuticals LLC, Apicore US LLC, and Archis Pharma LLC were dismissed from Civil Action No. 24-09110 on November 12, 2024, and WHEREAS, Sandoz Inc. was dismissed from Civil Action No. 24-09110 on March 27, 2025, and WHEREAS, Dr. Reddy’s Laboratories, Inc. (together with RK Pharma, Inc., “RK”) (RK, InvaGen, MSN, and Zydus, collectively, “Defendants,” and each, “defendant group”) was added as a named defendant to Civil Action No. 24-09110 on September 22, 2025, and WHEREAS, Plaintiffs Jazz Pharmaceuticals Ireland Limited and Pharma Mar, S.A. initiated Civil Action No. 3:25-cv-15276 (RK)(RLS) (“25-15276”) against Apicore US LLC, Archis Pharma LLC, InvaGen, MSN, RK, Sandoz, Inc., VGYAAN Pharmaceuticals LLC, and Zydus, and WHEREAS, Sandoz, Inc. was dismissed from Civil Action No. 25-15276 on December 22, 2025, and WHEREAS, VGYAAN Pharmaceuticals LLC, Apicore US LLC, and Archis Pharma LLC were dismissed from Civil Action No. 25-15276 on January 15, 2026, and Case 3:25-cv-15276-RK-RLS Document 86 Filed 03/19/26 Page 2 of 3 PageID: 2080 -2- WHEREAS, Civil Action Nos. 24-09110 and 25-15276 each relate to Plaintiffs’ allegations of infringement of patents listed in the FDA’s publication entitled “Approved Drug Products with Therapeutics Equivalence Evaluations” (the “Orange Book”) for Plaintiffs’ Zepzelca® drug product; WHEREAS, the parties submitted a letter to the Court on January 30, 2026, raising a case management dispute that was ripe for the Court’s review, which set forth the parties’ positions concerning consolidation of Civil Action Nos. 24-09110 and 25-15276, and WHEREAS, this Court held a case management conference with the parties on March 3, 2026, concerning consolidation of Civil Action Nos. 24-09110 and 25-15276, and WHEREAS, this Court determined good cause exists to consolidate these actions for all purposes; IT IS HEREBY ORDERED that Civil Action Nos. 24-09110 and 25-15276 are consolidated for all purposes. A consolidated case scheduling order shall be separately entered concurrently herewith. All papers shall be maintained in Civil Action No. 24-09110 and Civil Action No. 25-15276 shall be administratively terminated by the Clerk’s Office. IT IS FURTHER ORDERED that the Pretrial Scheduling Order (ECF No. 71) shall otherwise remain in full force and effect.”
Case 3:25-cv-15276 · D.N.J. · closed 19 March 2026
Related cases
Three questions this record usually leads to. Each one runs against the full litigation and patent corpus, and cites what it finds.
Frequently asked questions
What is case 3:25-cv-15276?
3:25-cv-15276 is a patent infringement action brought by Jazz Pharmaceuticals Ireland Limited against Invagen Pharmaceuticals, Inc., filed on 4 Sep 2025 in the United States District Court for the District of New Jersey. The case closed on 19 March 2026.
Which patent was asserted in 3:25-cv-15276?
US12324806B2 (“Method of treating SCLC and managing hepatotoxicity”), assigned to PHARMA MAR, S.A., currently active. The record also lists Lurbinectedin for injection, 4 mg/vial and Zepzelca® (lurbinectedin) for injection, for intravenous use, 4 mg/vial.
How was case 3:25-cv-15276 terminated?
The recorded basis of termination is case consolidated. The termination text reads: “WHEREAS, Plaintiffs Jazz Pharmaceuticals Ireland Limited and Pharma Mar, S.A. (collectively, “Plaintiffs”) initiated Civil Action No. 3:24-cv-09110 (RK)(RLS) (“24-09110”) against Apicore US LLC, Archis Pharma LLC, and VGYAAN Pharmaceuticals LLC; Cipla (EU) Limited, Cipla Limited, Cipla USA, Inc., and InvaGen Pharmaceuticals, Inc. (collectively, “InvaGen”); MSN Laboratories Pvt. Ltd. and MSN Pharmaceuticals Inc. (collectively, “MSN”); RK Pharma, Inc.; Sandoz, Inc.; and Zydus Lifesciences Global FZE, Zydus Lifesciences Limited, and Zydus Pharmaceuticals (USA) Inc. (collectively, “Zydus”), and W
How long did case 3:25-cv-15276 take?
196 calendar days, from filing on 4 Sep 2025 to closure on 19 March 2026.
Who were the attorneys and the judge in 3:25-cv-15276?
Alexander Lee Callo, Charles Michael Lizza, Damien N. Dombrowski, Dominick A. Conde, Erin Austin, Erin K. Belfield, Sarah Ann Sullvian and Whitney Meier Howard are recorded as counsel for plaintiff Jazz Pharmaceuticals Ireland. Andrew J. Miller and Stuart D. Sender appear for defendant Invagen Pharmaceuticals.
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