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AstraZeneca v. Cipla: Acalabrutinib Patent Consent Judgment | PatSnap
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Case ID1:22-cv-00162
FiledFeb 2022
ClosedJun 2024
Patent Litigation

AstraZeneca & MSD v. Cipla: Acalabrutinib Patent Consent Judgment

AstraZeneca, Acerta Pharma, and Merck Sharp & Dohme filed suit against Cipla in Delaware over six patents protecting acalabrutinib 100 mg capsules (Calquence). After 860 days of litigation, the parties reached a negotiated settlement memorialised in a consent judgment that enjoins Cipla from launching its generic ANDA product except as specifically authorised.

Resolution time
860days
860 days — longer than the typical 30-month Hatch-Waxman stay, suggesting active contested proceedings before settlement
Patents asserted
6
US9796721, US10167291, US10272083 and 3 further patents asserted covering acalabrutinib BTK inhibitor chemistry
Outcome
Consent Judgment
Resolved by consent judgment; claims dismissed without prejudice per agreed settlement terms
Cost ruling
No Costs
Consent judgment expressly provides no costs, disbursements, or attorneys’ fees awarded to either party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Six-Patent Hatch-Waxman Battle Over Calquence Ends in Injunction

Filed on 4 February 2022 before Judge Gregory B. Williams in the District of Delaware, this Hatch-Waxman action saw Acerta Pharma B.V., AstraZeneca AB, AstraZeneca UK Limited, AstraZeneca Pharmaceuticals LP, and Merck Sharp & Dohme B.V. assert six U.S. patents — US9796721, US10167291, US10272083, US10239883, US9758524, and US7459554 — against Cipla Limited and Cipla USA, Inc. The asserted patents relate to the BTK inhibitor compound acalabrutinib, marketed as Calquence, in 100 mg oral capsule form. Cipla had filed ANDA No. 216507 with Paragraph IV certifications seeking to market a generic version before patent expiry.

The case closed on 13 June 2024 via a consent judgment entered on 12 June 2024. Under the settlement, Cipla and its affiliates are enjoined from infringing the three ‘Asserted Patents’ (US9796721, US10167291, US10272083) by making, using, selling, or importing its ANDA product, except as specifically authorised under the underlying settlement agreement. All claims and defences between the parties were dismissed without prejudice and without costs. Importantly, the consent judgment explicitly preserves Cipla’s existing Paragraph IV certification and does not prohibit FDA from granting final ANDA approval.

At 860 days, the litigation ran well beyond the standard 30-month automatic stay triggered by Hatch-Waxman notice, suggesting substantive contested proceedings prior to settlement. The preservation of Cipla’s Paragraph IV certification and FDA approval pathway is commercially significant — it is consistent with a royalty-bearing or date-certain launch licence embedded in the confidential settlement agreement, a structure commonly used in Hatch-Waxman resolutions. The precise authorised launch date and any royalty terms remain undisclosed in the public record.

Case at a glance
Case no.1:22-cv-00162
DefendantCipla Limited
CourtDelaware
JudgeGregory B. Williams
FiledFebruary 4, 2022
ClosedJune 13, 2024
Duration860 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
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 Consent Judgment in 860 days

860 days — longer than the typical 30-month Hatch-Waxman stay, suggesting active contested proceedings before settlement

Case timeline: Complaint filed FEB 4 2022, APR–MAY — 860 days total Horizontal timeline showing the three key events in Acerta Pharma B.V. v Cipla Limited from filing to resolution. Source: PACER, Delaware District Court. FEB 4 2022 Complaint filed Pre-trial proceedings JUN 13 2024 Consent Judgment 860 DAYS TOTAL
Settlement terms

Consent judgment and injunction: what the settlement means for both parties

Legal mechanism

Consent judgment combines settlement and enforceable court order

A consent judgment is a hybrid instrument: it is simultaneously a negotiated settlement and a binding court order. Unlike a simple voluntary dismissal, it is entered by the court and carries full injunctive force. Here, the District Court retains ongoing jurisdiction to enforce compliance, meaning any breach by Cipla can be treated as contempt of court — a significantly stronger enforcement posture for AstraZeneca than a contractual remedy alone.

Court-enforceable injunction
Dismissal qualifier

Dismissed without prejudice — but injunction caps practical exposure

The claims are formally dismissed without prejudice, meaning AstraZeneca and MSD are not barred from re-filing on the same patents against Cipla if circumstances change. However, the operative constraint on Cipla is the injunction itself, not the dismissal. Without prejudice here primarily preserves flexibility for plaintiffs; Cipla’s commercial conduct is governed by the terms of the confidential settlement agreement and the injunction, not by the dismissal label.

W/o prejudice + active injunction
Generic challenger outcome

Cipla enjoined but retains ANDA and Paragraph IV certification

Cipla cannot launch its generic acalabrutinib product except as specifically authorised under the settlement agreement. Critically, however, the consent judgment explicitly preserves Cipla’s Paragraph IV certification and does not block FDA from granting final ANDA approval. This structure is consistent with a negotiated future entry date — Cipla likely secured a licensed launch window, the terms of which are confidential. Its first-filer status and ANDA remain intact for that future date.

Enjoined with licensed entry option
Commercial implications

Calquence exclusivity preserved near-term; generic entry date controlled

For AstraZeneca, the consent judgment effectively extends commercial exclusivity for Calquence on Cipla’s ANDA timeline while avoiding litigation risk on six patents through trial. For the broader acalabrutinib market, the settlement signals that the patent estate is sufficiently robust to compel a negotiated entry — rather than a contested invalidity or non-infringement win for the generic. Other ANDA filers should assess their own Paragraph IV exposure against the same patent portfolio.

Exclusivity defended via settlement
Legal analysis based on PACER docket records for case 1:22-cv-00162 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffAcerta Pharma B.V.IndividualAstraZeneca/Acerta Pharma — oncology patent holder for acalabrutinib BTK inhibitor (Calquence)Search in Eureka ↗
Co-PlaintiffAstraZeneca ABIndividualSearch in Eureka ↗
Co-PlaintiffAstrazeneca Pharmaceuticals, LPCompanySearch in Eureka ↗
Co-PlaintiffMerck Sharp & Dohme, B.V.IndividualSearch in Eureka ↗
Co-PlaintiffAstraZeneca UK LimitedIndividualSearch in Eureka ↗
DefendantCipla LimitedIndividualCipla Limited and Cipla USA — generic pharmaceutical manufacturer seeking ANDA approval for acalabrutinib capsulesSearch in Eureka ↗
Co-DefendantCIPLA USA, Inc.CompanySearch in Eureka ↗
Plaintiff counselAlexander S. ZolanAttorneyCounsel for Acerta Pharma B.V.Search in Eureka ↗
Plaintiff counselAlexandra M. JoyceAttorneyCounsel for Acerta Pharma B.V.Search in Eureka ↗
Plaintiff counselDaniel M. SilverAttorneyCounsel for Acerta Pharma B.V.Search in Eureka ↗
Plaintiff counselDavid I. BerlAttorneyCounsel for Acerta Pharma B.V.Search in Eureka ↗
Plaintiff counselKevin Hoagland-HansonAttorneyCounsel for Acerta Pharma B.V.Search in Eureka ↗
Plaintiff counselMin Kyung JeonAttorneyCounsel for Acerta Pharma B.V.Search in Eureka ↗
Plaintiff counselSarahi UribeAttorneyCounsel for Acerta Pharma B.V.Search in Eureka ↗
Plaintiff counselStanley E. FisherAttorneyCounsel for Acerta Pharma B.V.Search in Eureka ↗
Plaintiff law firmMcCarter & English LLPLaw FirmRepresenting Acerta Pharma B.V.Search in Eureka ↗
Defendant counselAnil H. PatelAttorneyCounsel for Cipla LimitedSearch in Eureka ↗
Defendant counselHarold M. StoreyAttorneyCounsel for Cipla LimitedSearch in Eureka ↗
Defendant counselJenna BruceAttorneyCounsel for Cipla LimitedSearch in Eureka ↗
Defendant counselMatthew B. GoellerAttorneyCounsel for Cipla LimitedSearch in Eureka ↗
Defendant counselPeter L. GiuntaAttorneyCounsel for Cipla LimitedSearch in Eureka ↗
Defendant counselSteven L. CaponiAttorneyCounsel for Cipla LimitedSearch in Eureka ↗
Defendant law firmK&L Gates, LLPLaw FirmRepresenting Cipla LimitedSearch in Eureka ↗
Presiding judgeJudge Gregory B. WilliamsJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“Plaintiffs Acerta Pharma B.V., AstraZeneca UK Limited, AstraZeneca Pharmaceuticals LP, AstraZeneca AB (collectively, "AstraZeneca"), and Merck Sharp & Dohme B.V. ("MSD") (collectively, with AstraZeneca, "Plaintiffs"), and Defendants Cipla Limited and Cipla USA, Inc. (collectively, "Cipla") which are parties in the above-captioned action, have agreed to terms and conditions representing a negotiated settlement of this action and have set forth those terms and conditions in a Settlement Agreement (the "Settlement Agreement"). Now the parties, by their respective undersigned attorneys, hereby stipulate and consent to entry of judgment and an injunction in this action as follows: IT IS this 12th day of June,2024 ;ORDERED, ADJUDGED AND DECREED as follows: This District Court has jurisdiction over the subject matter of the above action and has personal jurisdiction over AstraZeneca, MSD, and Cipla. As used in this Consent Judgment, (i) the term "Cipla Products" shall mean the Generic Acalabrutinib Products that are sold, offered for sale or distributed pursuant to ANDA No. 216507, including any supplements or amendments thereto, (and defined in greater detail in the Settlement Agreement); and (ii) the term "Affiliate" shall mean, with respect to a Party, any entity or person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with such Party. For purposes of this definition, "control" means (a) ownership, directly or through one or more intermediaries, of (i) more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or (ii) more than fifty percent (50%) of the equity interests in the case of any other type of legal entity or status as a general partner in any partnership, or (b) any other arrangement whereby an entity or person has the right to elect a majority of the board of directors or equivalent governing body of a corporation or other entity or the right to direct the management and policies of a corporation or other entity. Except as specifically authorized pursuant to the Settlement Agreement, Cipla, including any of its Affiliates, successors and assigns, is enjoined from infringing U.S. Patent Nos. 9,796,721, 10,167,291, and 10,272,083, (the "Asserted Patents") on its own part or through any Affiliate, by making, having made, using, selling, offering to sell, importing or distributing of the Cipla Products. Compliance with this Consent Judgment may be enforced by AstraZeneca, MSD, and their successors in interest, or assigns, as permitted by the terms of the Settlement Agreement. 3. 4 Nothing in this Consent Judgment prohibits Cipla or its Affiliates from maintaining its existing Paragraph IV Certification to the Asserted Patents or prohibits FDA from granting final approval to Cipla’s ANDA. This District Court retains jurisdiction to enforce or supervise performance under this Consent Judgment and the Settlement Agreement. All claims, affirmative defenses, and demands in this action between AstraZeneca, Merck, and Cipla, and only between AstraZeneca, Merck, and Cipla, are hereby dismissed without prejudice and without costs, disbursements or attorneys’ fees.”
Source: PACER Docket, Case 1:22-cv-00162, Delaware District Court

The consent judgment is notable for its dual function: it operates as both a contractual settlement record and a court-entered injunction with ongoing judicial supervision. The explicit retention of jurisdiction by the Delaware District Court means enforcement disputes bypass ordinary breach-of-contract proceedings and can be escalated directly as contempt. The dismissal ‘without prejudice and without costs’ is standard Hatch-Waxman consent judgment boilerplate but does not diminish the injunction’s force. The three patents named in the injunction clause (US9796721, US10167291, US10272083) appear to be the commercially critical composition and synthesis patents; the remaining three asserted patents are not referenced in the injunctive relief paragraph, suggesting they may have been resolved separately or were of lower commercial priority in the settlement negotiations.

PACER case 1:22-cv-00162 · Public docket record Explore in Eureka ↗
Patent at issue

US9796721, US10167291, US10272083 — acalabrutinib BTK inhibitor patents

Publication No.US10239883B2
Application No.US15/668385
Patent details
Productacalabrutinib BTK inhibitor compound synthesis and intermediates
Cited in actionFebruary 4, 2022

Publication No.US10272083B2
Application No.US15/112968
Patent details
Productacalabrutinib compound formulations and oral dosage forms
Cited in actionFebruary 4, 2022

Publication No.US9758524B2
Application No.US15/019543
Patent details
Productacalabrutinib synthesis processes and crystalline forms
Cited in actionFebruary 4, 2022

Publication No.US10167291B2
Application No.US15/707508
Patent details
Productacalabrutinib pharmaceutical compositions and methods of use
Cited in actionFebruary 4, 2022

Publication No.US9796721B2
Application No.US15/200875
Patent details
Productacalabrutinib compound and BTK inhibition methods
Cited in actionFebruary 4, 2022

Publication No.US7459554B2
Application No.US10/965182
Patent details
ProductBTK inhibitor compound chemistry and therapeutic use
Cited in actionFebruary 4, 2022

The six asserted patents span different layers of the acalabrutinib intellectual property estate. US9796721 and US10167291 relate to acalabrutinib compound chemistry and formulations, while US10272083 covers synthesis or crystalline aspects critical to manufacturing. US10239883 and US9758524 extend coverage to additional compound variants or intermediates. US7459554, the earliest-priority patent in the group, covers foundational BTK inhibitor chemistry. Together, they create overlapping protection across composition-of-matter, formulation, and process dimensions — a typical multi-layer strategy for a blockbuster oncology small molecule.

Acalabrutinib (Calquence) is a second-generation BTK inhibitor approved for mantle cell lymphoma and CLL/SLL, generating multi-billion dollar annual revenues for AstraZeneca. The breadth of the asserted patent portfolio — spanning composition, formulation, synthesis, and method-of-use claims across six patents — is strategically designed to maximise the barrier to generic entry. The involvement of MSD as co-plaintiff suggests collaborative commercialisation rights that further complicate the competitive landscape. For generic manufacturers, each patent layer represents an independent invalidity challenge burden, substantially increasing the cost and risk of a contested ANDA path.

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 acalabrutinib patent estate?

Any pharmaceutical company developing a BTK inhibitor, acalabrutinib formulation, or seeking ANDA approval for a generic acalabrutinib product should treat this six-patent portfolio as a primary FTO priority. The portfolio’s multi-layer structure — spanning compound, synthesis, and formulation claims across patents with different priority dates and expiry cliffs — means a clearance analysis must be conducted patent-by-patent. The Cipla settlement demonstrates that even a well-resourced generic filer concluded settlement was preferable to contested litigation across this estate.

PatSnap Eureka’s FTO Search Agent can map each of the six asserted patents against your target product’s composition, manufacturing process, and formulation — identifying potential design-around opportunities, IPR petition targets, and expiry timelines. Eureka’s claim charting and prior art discovery tools help IP teams prioritise which patents in the acalabrutinib portfolio represent the greatest validity risk before committing to an ANDA filing strategy or BTK inhibitor development programme.

PatSnap Eureka FTO Search

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Related litigation

Similar Hatch-Waxman BTK inhibitor patent cases in Delaware District Court

Explore comparable Hatch-Waxman ANDA patent infringement cases involving BTK inhibitors and oncology small molecules litigated in the District of Delaware.

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Strategic implications

What this case signals for the BTK inhibitor and oncology generics IP landscape

The Cipla consent judgment reinforces AstraZeneca’s multi-layered acalabrutinib patent estate and sets a precedent for how Hatch-Waxman challengers are absorbed.

Six-patent assertion depth deters generic challengers from going to trial

Asserting six patents across composition, formulation, and method-of-use dimensions creates prohibitive litigation cost and invalidity risk for ANDA filers. Cipla’s settlement before trial — despite 860 days of proceedings — is consistent with a challenger calculation that clearing all six patents through adjudication was commercially unviable compared to negotiating a licensed entry date.

Preserved Paragraph IV certification signals a date-certain generic entry deal

The explicit preservation of Cipla’s Paragraph IV status and FDA approval pathway in the consent judgment is a strong structural signal that the confidential settlement includes a negotiated launch date. IP teams monitoring competitive timelines for acalabrutinib should treat Cipla’s ANDA as commercially live for a future authorised entry window, not as permanently blocked.

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Frequently asked questions

B.V. v Cipla — key questions answered

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Monitor acalabrutinib patent risk before your next ANDA or BTK programme

PatSnap Eureka tracks live ANDA filings, IPR petitions, and litigation events across the acalabrutinib patent estate. Run an FTO search on AstraZeneca’s six-patent portfolio to identify expiry cliffs, claim vulnerabilities, and design-around pathways before committing to development or filing.

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