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ACADIA Pharmaceuticals v. Teva | Pimavanserin Patent Litigation | PatSnap
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Case ID1:20-cv-00986
FiledJul 2020
ClosedMay 2024
Patent Litigation

ACADIA v. Teva: Nuplazid Pimavanserin Patent Dispute Stayed in Delaware

ACADIA Pharmaceuticals filed suit against Teva in Delaware’s federal district court in July 2020, asserting four patents covering pimavanserin tartrate 34 mg oral capsules — the active ingredient in Nuplazid. After nearly 1,383 days, the case was stayed by consent order, binding both parties to the outcome of parallel Hatch-Waxman proceedings against other ANDA defendants rather than proceeding to independent trial.

Resolution time
1383days
1,383 days active before stay — well above the median Hatch-Waxman first-instance duration
Patents asserted
4
US7601740B2, US10449185B2, US7732615B2, and US10646480B2 — four pimavanserin patents asserted
Outcome
Case Stayed
Proceedings suspended by consent; outcome bound to parallel multi-defendant ANDA litigation
Cost ruling
Fees Excluded
Stay order expressly carves out willful infringement, 35 U.S.C. § 285 fees, and costs from Teva’s exposure
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Four-Patent Hatch-Waxman Stay Ties Teva’s Fate to Other ANDA Defendants

ACADIA Pharmaceuticals, Inc. initiated this Hatch-Waxman infringement action on 24 July 2020 in the District of Delaware before Judge Gregory B. Williams, asserting four Orange Book-listed patents — US7601740B2, US10449185B2, US7732615B2, and US10646480B2 — against Teva Pharmaceutical Industries in connection with Teva’s ANDA seeking approval for pimavanserin tartrate 34 mg oral capsules, the generic equivalent of Nuplazid (NDA 210793). Nuplazid is ACADIA’s flagship CNS drug approved for hallucinations and delusions associated with Parkinson’s disease psychosis.

Rather than proceeding to trial, the action was terminated on 7 May 2024 via a detailed consent stay order. Under its terms, all proceedings involving Teva are suspended pending a contested merits judgment against at least one other ANDA defendant. Crucially, any such judgment automatically binds Teva: a ruling in ACADIA’s favour triggers a judgment of infringement and validity against Teva; a ruling against ACADIA triggers a judgment of non-infringement or invalidity for Teva. Teva also agreed not to launch its ANDA product before patent expiry or entry of a favourable final judgment, and waived the right to challenge any Orange Book-listed patent at the USPTO or PTAB during the stay.

The 1,383-day duration before reaching this stay reflects the complexity typical of multi-defendant Hatch-Waxman portfolios. The structure of the order — with Teva’s fate entirely tied to parallel proceedings and fees expressly excluded from Teva’s exposure — suggests a negotiated risk-allocation rather than a capitulation. What remains unknown from the public record is which other defendants remain active in the parallel litigation, the anticipated trial date against those defendants, and whether any co-defendants have already settled and triggered the most-favoured-nation clause embedded in paragraph 4 of the consent order.

Case at a glance
Case no.1:20-cv-00986
CourtDelaware
JudgeGregory B. Williams
FiledJuly 24, 2020
ClosedMay 7, 2024
Duration1383 days
OutcomeCase Stayed
Verdict causeInfringement Action
BasisCase Stayed
Prior Art Intelligence
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Case data sourced from PACER / Delaware District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Case Stayed in 1383 days

1,383 days active before stay — well above the median Hatch-Waxman first-instance duration

Case timeline: Complaint filed JUL 24 2020, JUN–JUL — 1383 days total Horizontal timeline showing the three key events in ACADIA Pharmaceuticals, Inc. v Teva Pharmaceutical Industries, Ltd. from filing to resolution. Source: PACER, Delaware District Court. JUL 24 2020 Complaint filed Pre-trial proceedings MAY 7 2024 Case Stayed 1383 DAYS TOTAL
Dismissal terms

Case stayed by consent: what the order means for both parties

Legal mechanism

A consent stay is not a dismissal — the case remains live

A consent stay suspends all proceedings without resolving the merits. Unlike a dismissal with or without prejudice, the case retains its docket number and jurisdiction. Here, the stay is explicitly conditional: it lifts automatically once a contested merits judgment is entered against any other ANDA defendant, triggering a parallel judgment against Teva. The court retains authority to lift the stay for good cause at either party’s request.

Proceedings suspended, not ended
Patent holder outcome

ACADIA secures market exclusivity without further litigation cost

ACADIA effectively obtained a launch restraint from Teva — paragraph 5 prevents Teva from importing, selling, or manufacturing its ANDA product until patent expiry or a favourable final judgment. ACADIA also preserved all injunctive and damages rights if Teva launches at-risk. The stay lets ACADIA concentrate resources on the live defendants rather than managing duplicative proceedings, while the MFN clause in paragraph 4 ensures Teva cannot free-ride on any future settlement.

Launch restraint secured
Defendant outcome

Teva avoids trial but accepts outcome-binding risk

Teva’s agreement to be bound by the merits outcome in parallel proceedings is a significant concession: if any other defendant loses at trial or on appeal, that judgment automatically propagates to Teva. In exchange, Teva avoids immediate litigation expense and is expressly shielded from willful-infringement findings, 35 U.S.C. § 285 fee awards, and cost rulings — a meaningful carve-out that limits downside exposure beyond the core infringement question.

Bound by parallel outcome
Commercial implications

Nuplazid patent wall reinforced across the ANDA field

The four-patent portfolio, combined with launch restraints across multiple ANDA defendants, extends Nuplazid’s effective market protection well beyond any single expiry date. The PTAB challenge waiver in paragraph 6 — covering all Orange Book patents for NDA 210793 including US11452721 — removes Teva as a potential IPR petitioner, narrowing the avenues through which the patent wall could be dismantled. Competitors and product teams in the CNS generic space should monitor the active parallel proceedings closely.

Multi-patent launch restraint
Legal analysis based on PACER docket records for case 1:20-cv-00986 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffACADIA Pharmaceuticals, Inc.CompanyCNS pharmaceutical company — holder of US7601740B2 and three further pimavanserin patentsSearch in Eureka ↗
DefendantTeva Pharmaceutical Industries, Ltd.CompanyGlobal generic pharmaceutical manufacturer seeking ANDA approval for pimavanserin tartrate 34 mgSearch in Eureka ↗
Co-DefendantTeva Pharmaceutical Industries, Ltd.CompanySearch in Eureka ↗
Plaintiff counselBruce M. WexlerAttorneyCounsel for ACADIA Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff counselChad J. PetermanAttorneyCounsel for ACADIA Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff counselCharles E. DavisAttorneyCounsel for ACADIA Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff counselJames Darlington TaylorAttorneyCounsel for ACADIA Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff counselJessica Marie JonesAttorneyCounsel for ACADIA Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff counselScott F. PeachmanAttorneyCounsel for ACADIA Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff law firmSaul Ewing Arnstein & Lehr LLPLaw FirmRepresenting ACADIA Pharmaceuticals, Inc.Search in Eureka ↗
Defendant counselIvan M. PoullaosAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant counselJohn W. ShawAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant counselKaren Elizabeth KellerAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant counselKatherine D. HundtAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant counselLinda A. GreeneAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant counselMichael K. NutterAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant counselNathan Roger HoeschenAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant law firmShaw Keller LLPLaw FirmRepresenting Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Presiding judgeJudge Gregory B. WilliamsJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“1. All claims between Plaintiff and Teva and all proceedings and acts involving Teva in the Action shall be stayed in their entirety pending the conclusion of the Action. 2. If judgment of the District Court regarding the validity and/or infringement of the asserted claims of the Patents-In-Suit (which does not include a judgment that is entered as a result of settlement, consent judgment, stipulated judgment, sanctions, procedural default, or other judgment or disposition that is not an actual contested decision on the merits of the case) as to at least one defendant is entered, then Plaintiff and Teva agree as follows: Subject to subparagraph 2 d., Plaintiff and Teva will be bound by the judgment of the District Court in the Action. b. Following the judgment of the District Court, a judgment will be entered in favor of either Plaintiff and/or Teva. That is, if judgment of the District Court is entered in Plaintiff’s favor with respect any of the asserted claims, then a judgment shall be entered for Plaintiff and against Teva with respect to infringement and validity of those asserted claims of the Patents-In-Suit. On the other hand, if judgment of the District Court is entered· against Plaintiff with respect any of the asserted claims, then a judgment shall be entered for Teva and against Plaintiff with respect to non-infringement and/or invalidity of those asserted claims of the Patents-In-Suit. c. Notwithstanding the above, any judgment of the District Court entered in the Action concerning the issues of willful infringement and/or exceptional case under 35 U.S.C. § 285, or costs under 28 U.S.C. § 1920, or any other decision or ruling on fees or costs, shall not be entered in favor of or against Teva as it pertains to the Action. d. Notwithstanding the above, nothing in this agreement will prevent Plaintiff or Teva from appealing or participating in the appeal of any judgment of the District Court that is referenced in subparagraph 2 a. with the exception that Teva may not appeal or participate in the appeal of any portion of such judgment that relates to issues of willful infringement and/or exceptional case under 35 U.S.C. § 285, or costs under 28 U.S.C. § 1920, or any other decision or ruling on fees or costs. Moreover, Plaintiff and Teva will be bound by any Final Judgment 1 that results from such an appeal, unless the United States Supreme Court grants certiorari and issues a decision on the merits, in which case Plaintiff and Teva will be bound by that judgment and any subsequent Final Judgment in the event of a remand. To the extent Teva imports, sells, offers for sale, or manufactures in the United States the Teva ANDA Product prior to both the expiration of the Patents-In-Suit and entry of any such Final Judgment, Plaintiff retains its right to seek relief, including injunctive relief and damages. 3. In the event of any settlement with any other defendant of the Action results in such other defendant receiving a license, covenant, or other authorization to market a generic equivalent of Nuplazid® in the United States under the Patents-In-Suit, Plaintiff shall inform Teva of the effective date of such license, covenant, or other authorization, and Teva will have the option to settle the Action on terms that are materially the same. At Teva’s request, Plaintiff will promptly prepare a settlement agreement embodying such materially similar terms and Teva will have twenty (20) business days to accept or reject that settlement agreement unless otherwise extended by Plaintiff. 4. If the Action is resolved as to all of the other defendants ( except any other defendants who have agreed to stay their case pending resolution of the Action) by settlement or any other type of stipulated, consent or otherwise agreed final judgment or dismissal (such as a dismissal that results from the withdrawal of a defendant’s ANDA or conversion to a Paragraph III certification) prior to the entry of a Final Judgment, then Plaintiff and Teva will agree to execute an agreement and be bound by settlement terms materially the same as the terms of the then last executed settlement agreement entered between Plaintiff and any other defendant in the Action. 5. Teva agrees that it will not import, sell, offer for sale, or manufacture in the United • States the Teva ANDA Product prior to the earliest ef (1) the expiration of all the Patents-In-Suit and U.S. Patent No. 11 ,452,721; (2) the entry of a Final Judgement in the Action holding all the asserted claims of the Patents-In-Suit and U.S. Patent No. 11 ,452,721 (if asserted) not infringed and/or invalid; (3) the authorized entry date of the Teva ANDA Product pursuant to a license to the Patents-In-Suit and U.S. Patent No. 11 ,452,721. 6. Teva further agrees that, during the pendency of the stay, it will not file or assist in the filing of any petition for post-grant review, inter partes review, or any other validity challenge before the United States Patent and Trademark Office or Patent Trial and Appeal Board, concerning U.S. Patent No. 11 ,452,721or any patent listed in the Orange Book for New Drug Application 210793. 7. Plaintiff and Teva further agree that either Plaintiff or Teva may move to lift the stay for good cause shown under any other circumstance which, in the District Court’s judgment, taking into account Plaintiffs and Teva’s agreements as stated herein and without relieving Plaintiff or Teva of the spirit of the obligations entered into herein, renders enforcement of Plaintiffs and Teva’s agreed stay unjust or inequitable. In the event the stay is lifted pursuant to this paragraph, Plaintiff and Teva further agree to meet and confer regarding an appropriate schedule for the remainder of the litigation.”
Source: PACER Docket, Case 1:20-cv-00986, Delaware District Court

The consent stay order is a negotiated procedural disposition rather than a merits ruling. Its core mechanism — binding Teva to the outcome of contested proceedings against other defendants — is a sophisticated risk-transfer device. The explicit carve-outs for willful infringement, § 285 fees, and costs suggest Teva’s counsel successfully limited downside exposure to the core validity and infringement questions. The order’s reference to ‘actual contested decision on the merits’ as the trigger for binding effect means that settlements, consent judgments, or default judgments against other defendants will not automatically bind Teva, preserving a degree of procedural protection.

PACER case 1:20-cv-00986 · Public docket record Explore in Eureka ↗
Patent at issue

US7601740B2 and three further patents — pimavanserin compound and formulation portfolio

Publication No.US7601740B2
Application No.US10/759561
Patent details
Productpimavanserin compound and pharmaceutical compositions
Cited in actionJuly 24, 2020

Publication No.US10449185B2
Application No.US16/363378
Patent details
Productpimavanserin tartrate oral formulations and dosage forms
Cited in actionJuly 24, 2020

Publication No.US7732615B2
Application No.US11/235558
Patent details
Productpimavanserin synthesis and salt forms
Cited in actionJuly 24, 2020

Publication No.US10646480B2
Application No.US16/571554
Patent details
Productpimavanserin tartrate capsule formulations and methods of use
Cited in actionJuly 24, 2020

The four asserted patents — US7601740B2, US10449185B2, US7732615B2, and US10646480B2 — collectively protect the compound pimavanserin, its tartrate salt form, oral capsule formulations, and associated methods of use. Pimavanserin is a selective serotonin inverse agonist and antagonist at 5-HT2A receptors, approved as Nuplazid for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. The staggered application dates across the portfolio — spanning US applications from the mid-2000s through 2019 — create a layered exclusivity structure extending beyond any single patent’s expiry.

For the CNS pharmaceutical sector, this four-patent Orange Book portfolio represents a classic lifecycle management architecture: compound patents provide foundational protection, while later formulation and method-of-use patents extend market exclusivity as earlier patents age. All four patents are listed in the Orange Book for NDA 210793, meaning any ANDA filer must certify against each. The PTAB challenge waiver secured from Teva removes one of the most effective generic tools for dismantling such portfolios, and competitors active in CNS small-molecule generics should treat this portfolio as a high-litigation-risk target requiring comprehensive FTO analysis before ANDA commitment.

Patent data sourced from USPTO via PatSnap Eureka patent database Search patent records in Eureka ↗
Freedom to operate

Should you run an FTO against the Nuplazid pimavanserin patent portfolio?

Any pharmaceutical company developing a generic pimavanserin tartrate product — whether as a 34 mg oral capsule or in any reformulated dosage form — must conduct a full freedom-to-operate analysis against all four Orange Book-listed patents. With ACADIA actively enforcing this portfolio in Delaware and securing PTAB challenge waivers from ANDA defendants, the risk of infringement exposure at launch is significant. R&D teams should also monitor US11452721, referenced in the consent order as an additional patent requiring launch clearance.

PatSnap Eureka’s FTO Search Agent enables pharmaceutical IP teams to map claim scope across all four asserted patents simultaneously, identify prosecution history estoppel, and surface relevant prior art that could support design-around or invalidity arguments. Eureka’s Orange Book monitoring tools track new listings and certificate-of-correction filings in real time — critical for a portfolio where new formulation patents can be added during active ANDA litigation. Run your pimavanserin FTO analysis in Eureka before committing ANDA formulation resources.

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Related litigation

Similar Hatch-Waxman pimavanserin and CNS drug patent cases in Delaware

Cases below involve Hatch-Waxman ANDA challenges to CNS pharmaceutical patents in the District of Delaware, with comparable multi-patent Orange Book enforcement strategies.

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ACADIA Pharmaceuticals, Inc. patent enforcement history, Delaware case history, ACADIA Pharmaceuticals, Inc.’s full IP portfolio, and comparable case analysis
ACADIA v. AurobindoACADIA v. Hikma NuplazidCNS ANDA stays DelawarePimavanserin PTAB petitions
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Strategic implications

What this case signals for the CNS pharmaceutical IP landscape

The ACADIA–Teva consent stay is a template for managing multi-defendant Hatch-Waxman portfolios efficiently while preserving maximum enforcement leverage.

Consent stay orders concentrate risk in the most-contested proceeding

By binding Teva to the outcome against other defendants, ACADIA avoids duplicative trial costs while keeping its legal position intact. This approach is increasingly common in large Hatch-Waxman portfolios where many ANDAs are filed simultaneously. Practitioners should note that the MFN clause in paragraph 4 creates a settlement floor: any licence granted to one defendant effectively sets the price for all stayed defendants.

PTAB challenge waivers in consent orders are a growing brand-company tactic

Paragraph 6 of the consent order expressly bars Teva from filing IPRs or PGRs against any patent in the Nuplazid Orange Book listing during the stay. This neutralises a key generic strategy — using PTAB as a parallel invalidity forum. In-house IP teams at CNS pharmaceutical companies should evaluate whether similar waivers can be negotiated as part of early Hatch-Waxman stay agreements to protect Orange Book listings from administrative erosion.

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Full strategic analysis in PatSnap Eureka
Two gated insights cover CNS pharma patent strategy and District of Delaware Hatch-Waxman consent order risk allocation.
MFN clause risk analysisPTAB waiver strategyOrange Book expiry ladder
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Frequently asked questions

ACADIA v Teva — key questions answered

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Run your pimavanserin FTO before your ANDA investment commits

With four active patents and a PTAB waiver blocking one key challenger, the Nuplazid patent wall carries real launch risk. PatSnap Eureka maps claim scope, expiry ladders, and litigation history across the full NDA 210793 Orange Book portfolio so your team can assess clearance before committing formulation resources.

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