Axsome Therapeutics & Antecip Bioventures v. Teva Pharmaceuticals — Dismissed Without Prejudice
Axsome Therapeutics and Antecip Bioventures II filed suit against Teva in the District of New Jersey, asserting four patents covering bupropion as a modulator of drug activity. After 690 days of litigation, all claims were dismissed without prejudice by stipulation under Rule 41(a)(1)(A)(ii), with no costs awarded to either side.
Four bupropion patents, one stipulated exit — with the door left open
Filed on March 24, 2023, this Hatch-Waxman-style infringement action was brought by Axsome Therapeutics, Inc. and its patent co-owner Antecip Bioventures II LLC against generic pharmaceutical manufacturer Teva Pharmaceutical Industries, Ltd. in the U.S. District Court for the District of New Jersey. The complaint asserted four issued U.S. patents — US10925842B2, US10940124B2, US10966942B2, and US10780064B2 — all directed to bupropion as a modulator of drug activity, a mechanism relevant to Axsome’s commercial CNS pipeline.
The case closed on February 11, 2025, when the parties entered into a joint stipulation of dismissal under Federal Rule of Civil Procedure 41(a)(1)(A)(ii). All claims, counterclaims, and affirmative defenses were dismissed without prejudice, and no costs or attorneys’ fees were awarded to any party. The District of New Jersey expressly retained jurisdiction to enforce or resolve disputes relating to the subject matter, a provision that typically accompanies an underlying settlement or licensing arrangement.
The 690-day duration before dismissal suggests substantive negotiations occurred well into the litigation lifecycle, though the public record does not disclose any licensing terms or commercial agreement. The without-prejudice designation and retained jurisdiction clause are consistent with a structured resolution — potentially involving a consent judgment, patent licence, or agreed-upon market entry date — but the terms remain confidential. The absence of a merits ruling leaves the validity and enforceability of all four patents undecided as a matter of public record.
Filing to Dismissed without Prejudice in 690 days
690 days in D.N.J. — longer than median Hatch-Waxman first-instance resolution
Dismissed without prejudice: what the stipulated exit means for both parties
Rule 41(a)(1)(A)(ii) stipulated dismissal — no merits adjudication
A dismissal under Fed. R. Civ. P. 41(a)(1)(A)(ii) requires agreement from all parties who have appeared and filed claims. It is a procedural exit — the court makes no finding on patent validity, infringement, or claim scope. The without-prejudice designation means the plaintiffs are not barred from refiling the same claims, provided the relevant statute of limitations and any agreed standstill periods permit it.
No merits rulingPatents survive intact — validity untested, enforcement rights preserved
Because no court ruled on the merits, all four bupropion modulation patents — US10925842B2, US10940124B2, US10966942B2, and US10780064B2 — remain valid and enforceable on their face. Axsome and Antecip retain the right to assert them against Teva or other generic filers in future proceedings. The retained-jurisdiction clause suggests the court may be called upon to enforce undisclosed settlement terms, adding a layer of ongoing protection for the patent holders.
Patents remain enforceableTeva exits without prejudice — market entry timeline remains undisclosed
Teva avoids an adverse infringement or validity ruling, but the without-prejudice dismissal means the litigation risk is not permanently extinguished. The express waiver of costs suggests a negotiated outcome rather than a tactical withdrawal. Any agreed-upon market entry date, licence, or consent-to-launch provision would be contained in a confidential side agreement not visible in the public docket, leaving Teva’s commercial position opaque to third-party observers.
No estoppel createdRetained jurisdiction and sealed terms signal a structured resolution
In Hatch-Waxman practice, a without-prejudice dismissal with retained court jurisdiction is a strong indicator of an underlying licensing or market-entry agreement. Competitors and follow-on generic filers should monitor Teva’s ANDA status and any subsequent 30-month stay activity. The four patents covering bupropion as a drug-activity modulator remain a live enforcement risk for any party seeking to commercialise a competing bupropion-based product in this mechanism class.
Watch for future ANDA filingsFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | AXSOME THERAPEUTICS, INC. | Company | CNS biopharmaceutical company — holder of US10925842B2 and three related bupropion modulation patentsSearch in Eureka ↗ |
| Co-Plaintiff | Antecip Bioventures II, LLC | Company | Search in Eureka ↗ |
| Defendant | Teva Pharmaceutical Industries, Ltd. | Company | Teva Pharmaceutical Industries, Ltd. — global generic and specialty drug manufacturerSearch in Eureka ↗ |
| Plaintiff counsel | Catherine Thisbe Mattes | Attorney | Counsel for AXSOME THERAPEUTICS, INC.Search in Eureka ↗ |
| Plaintiff counsel | Charles Michael Lizza | Attorney | Counsel for AXSOME THERAPEUTICS, INC.Search in Eureka ↗ |
| Plaintiff counsel | Sarah Ann Sullvian | Attorney | Counsel for AXSOME THERAPEUTICS, INC.Search in Eureka ↗ |
| Plaintiff counsel | William C. Baton | Attorney | Counsel for AXSOME THERAPEUTICS, INC.Search in Eureka ↗ |
| Plaintiff law firm | CATHERINE MATTES | Law Firm | Representing AXSOME THERAPEUTICS, INC.Search in Eureka ↗ |
| Plaintiff law firm | Saul Ewing, LLP | Law Firm | Representing AXSOME THERAPEUTICS, INC.Search in Eureka ↗ |
| Defendant counsel | Christine Intromasso Gannon | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | Gerard J. Cedrone | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | Liza M. Walsh | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | Patrick Steven Salamea | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant law firm | Goodwin Procter LLP | Law Firm | Representing Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant law firm | Walsh Pizzi O’Reilly Falanga LLP | Law Firm | Representing Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulation explicitly invokes Rule 41(a)(1)(A)(ii), confirming that all parties with live pleadings consented to the exit. The without-prejudice language means no res judicata effect attaches — Axsome and Antecip are not barred from asserting the same four patents in a subsequent action. The court’s express retention of jurisdiction over subject-matter disputes is a standard Hatch-Waxman settlement mechanism, strongly suggesting a confidential licence or market-entry agreement governs the commercial relationship between the parties going forward.
US10925842B2 — Bupropion as a modulator of drug activity
The four asserted patents — US10925842B2, US10940124B2, US10966942B2, and US10780064B2 — all originate from application numbers filed in the US16–US17 series, indicating a tightly clustered continuation family prosecuted around 2020–2021. They cover bupropion’s role as a modulator of drug activity, a mechanism that encompasses its use in combination therapies to potentiate or modify the pharmacological effect of co-administered agents — a technically distinct claim space from bupropion’s legacy antidepressant and smoking-cessation uses.
For Axsome’s commercial CNS portfolio — which includes products targeting major depressive disorder and agitation — this patent family provides a strategic enforcement perimeter against generic entrants seeking to launch bupropion-containing combination products. The four-patent cluster, all co-owned with Antecip Bioventures II, is consistent with a licensing-oriented portfolio strategy. Any company developing a bupropion combination product, ANDA filer, or CNS platform developer should map the full continuation family, as related applications may still be pending prosecution.
Should you run an FTO against US10925842B2 and the Axsome bupropion patent family?
If your R&D pipeline includes bupropion-containing combination therapies, CNS drug-modulation platforms, or any ANDA targeting a bupropion-based product, this four-patent family represents a non-trivial clearance risk. The without-prejudice dismissal against Teva provides no safe harbour for other parties — Axsome and Antecip retain full enforcement rights. The patents’ continuation-based structure means additional related claims may exist in pending applications not yet published.
PatSnap Eureka’s FTO Search Agent can map the full bupropion modulation patent family — identifying continuation, divisional, and continuation-in-part relationships across all four asserted patents. The tool surfaces claim-level overlap with your specific formulation or method, flags pending applications in the same family, and benchmarks claim scope against the prior art landscape, giving your team a defensible clearance position before committing to development or an ANDA filing.
Run a freedom-to-operate analysis on US10925842B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman bupropion and CNS drug patent cases in D.N.J.
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What this case signals for the CNS and bupropion IP landscape
A four-patent portfolio, a global generic challenger, and a confidential exit — this case carries signals for anyone operating in the bupropion or CNS drug-modulation space.
Without-prejudice dismissal preserves Axsome’s ability to re-litigate
The without-prejudice designation is not a clean win for Teva. Axsome and Antecip retain the right to refile on the same four patents. Companies planning a bupropion-related ANDA or NDA should not treat this dismissal as a clearance event — the patents remain live and the litigation risk is unresolved.
Retained jurisdiction is a structural enforcement lever for plaintiffs
The D.N.J. court’s retained jurisdiction over disputes ‘relating to the subject matter’ gives Axsome a fast path back to court if Teva deviates from any undisclosed agreement. This mechanism is routinely used in Hatch-Waxman settlements to enforce market-entry dates without requiring a new complaint.
AXSOME v Teva — key questions answered
The without-prejudice dismissal means no court ruled on the validity or infringement of the four asserted patents. All patents — US10925842B2, US10940124B2, US10966942B2, and US10780064B2 — remain legally enforceable, and Axsome and Antecip Bioventures II retain the right to refile identical claims against Teva or any other party.
Retained jurisdiction following a stipulated dismissal is a standard mechanism in Hatch-Waxman settlements. It allows either party to return to court to enforce undisclosed agreement terms — such as an agreed market-entry date or licence conditions — without filing a new lawsuit. It strongly suggests a confidential settlement governs the commercial relationship.
Axsome Therapeutics and Antecip Bioventures II asserted four U.S. patents: US10925842B2, US10940124B2, US10966942B2, and US10780064B2. All four cover bupropion as a modulator of drug activity and originate from a closely related continuation patent family filed in 2020–2021.
No. A without-prejudice dismissal under Rule 41(a)(1)(A)(ii) does not produce a merits ruling and creates no collateral estoppel or issue preclusion. The patents’ validity and infringement were never adjudicated. Teva’s affirmative defenses, including any invalidity positions, were also dismissed without prejudice.
Generic developers should monitor Teva’s ANDA status for bupropion-related products and watch for any future 30-month stay filings against other ANDA applicants. The four-patent family remains enforceable, and related continuation applications may still be pending. Any company with a bupropion combination product in development should conduct a full FTO analysis against the Axsome/Antecip patent portfolio.
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