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Merck v. Lupin: Raltegravir Integrase Inhibitor Patent Consent Judgment | PatSnap
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Case ID2:23-cv-00094
FiledJan 2023
ClosedMay 2024
Patent Litigation

Merck v. Lupin: Consent Judgment Blocks Raltegravir Generic Entry (498 Days)

Merck Sharp & Dohme sued Lupin Limited and Lupin Pharmaceuticals in the District of New Jersey, asserting four patents covering raltegravir-based solid pharmaceutical compositions — an HIV integrase inhibitor. The case closed in 498 days with a stipulated consent judgment: Lupin acknowledged infringement and accepted a permanent injunction, blocking its ANDA-backed generic from the U.S. market.

Resolution time
498days
498 days — faster than median ANDA patent litigation, which typically runs 2–4 years to trial
Patents asserted
2
US9649311B2 and 3 further patents asserted — raltegravir HIV integrase inhibitor compositions
Outcome
Consent Judgment
Lupin stipulated infringement; permanent injunction entered, no costs or fees awarded
Cost ruling
No Costs Awarded
Dismissed with prejudice; no disbursements or attorneys’ fees to either party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Merck Secures Injunction as Lupin Concedes Raltegravir Infringement

Merck Sharp & Dohme LLC filed suit on January 9, 2023 in the U.S. District Court for the District of New Jersey against Lupin Limited, Lupin Pharmaceuticals, Inc., and Lupin, Inc., asserting infringement of four U.S. patents — Nos. 7,754,731; 8,771,733; 9,649,311; and 10,772,888 — covering solid pharmaceutical compositions containing raltegravir as their sole active ingredient, an HIV integrase inhibitor. The trigger was Lupin’s filing of ANDA No. 217990, seeking FDA approval to market a generic raltegravir product in the United States.

The case closed on May 21, 2024 via a stipulated consent judgment — a negotiated resolution in which Lupin expressly acknowledged that making, using, selling, or importing its ANDA product would infringe the four Licensed Patents. The court entered a permanent injunction barring Lupin and its affiliates, successors, and assigns from any such activity unless specifically authorised by Merck. All claims and counterclaims were dismissed with prejudice, with no costs, disbursements, or attorneys’ fees awarded to either side.

Resolution in 498 days — before any substantive merits ruling — is consistent with Lupin concluding that its ANDA paragraph IV certifications were unlikely to prevail at trial, or that a negotiated outcome (potentially including a confidential licence or entry date) was commercially preferable. The public record does not disclose whether any licensing terms accompany this judgment; the consent judgment reserves FDA’s right to approve the ANDA, suggesting a future authorised-generic or licence arrangement cannot be ruled out from this document alone.

Case at a glance
Case no.2:23-cv-00094
DefendantLupin Limited
CourtNew Jersey
JudgeN/A
FiledJanuary 9, 2023
ClosedMay 21, 2024
Duration498 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
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Case data sourced from PACER / New Jersey District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Consent Judgment in 498 days

498 days — faster than median ANDA patent litigation, which typically runs 2–4 years to trial

Case timeline: Complaint filed JAN 9 2023, SEP–OCT — 498 days total Horizontal timeline showing the three key events in Merck Sharp & Dohme, LLC v Lupin Limited from filing to resolution. Source: PACER, New Jersey District Court. JAN 9 2023 Complaint filed Pre-trial proceedings MAY 21 2024 Consent Judgment 498 DAYS TOTAL
Dismissal terms

Consent judgment entered: what the stipulated infringement ruling means for both parties

Legal mechanism

Consent judgment: stipulated infringement, not a contested ruling

A consent judgment is a court-entered order reflecting the parties’ own agreement. Here, Lupin expressly stipulated that its ANDA product infringes all four Licensed Patents. Unlike a litigation win at trial, this mechanism means the court made no independent validity or infringement finding — the parties jointly asked the court to enter the order. It carries full judicial force and is immediately enforceable, but Lupin preserved no appellate challenge to the merits.

Stipulated — no merits contest
Dismissal with prejudice

All claims dismissed with prejudice — Lupin cannot relitigate

Dismissal with prejudice is a final adjudication on the merits. Lupin’s counterclaims — which in ANDA litigation typically include invalidity and non-infringement defences — were also dismissed with prejudice. This means Lupin cannot refile these same claims in a future action. Combined with the permanent injunction, Lupin’s ANDA No. 217990 product is effectively blocked from the U.S. market for the life of the Licensed Patents unless Merck grants authorisation.

No refiling permitted
Injunction scope

Permanent injunction binds Lupin’s affiliates, successors, and assigns

The injunction extends beyond Lupin Limited and Lupin Pharmaceuticals to all affiliates, successors, and assigns — defined broadly to include entities under common control via 50%+ ownership or board control. This prevents structural workarounds such as transferring the ANDA to a subsidiary or related entity. Merck and its successors retain enforcement rights, meaning any future assignee of the Licensed Patents can directly enforce the injunction.

Broad affiliate coverage
FDA carve-out

FDA approval of ANDA 217990 is explicitly preserved

Notably, the consent judgment states it does not restrict the FDA from approving ANDA No. 217990. This is a standard but commercially significant clause: it leaves open the possibility that Merck could grant Lupin a licence to enter the market at an agreed future date — an authorised-generic arrangement — without further litigation. The public record is silent on whether any such side agreement exists, but the FDA carve-out is typically included precisely to preserve that commercial optionality.

Authorised generic remains possible
Legal analysis based on PACER docket records for case 2:23-cv-00094 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffMerck Sharp & Dohme, LLCCompanyPharmaceutical innovator — holder of US9649311B2 and three further raltegravir patentsSearch in Eureka ↗
DefendantLupin LimitedIndividualIndian generic pharmaceutical manufacturer and U.S. subsidiary seeking ANDA approval for raltegravirSearch in Eureka ↗
Co-DefendantLupin Pharmaceuticals, Inc.CompanySearch in Eureka ↗
Co-DefendantLupin, Inc.CompanySearch in Eureka ↗
Plaintiff counselJ. BRUGH LOWERAttorneyCounsel for Merck Sharp & Dohme, LLCSearch in Eureka ↗
Plaintiff counselWilliam P. Deni , Jr.AttorneyCounsel for Merck Sharp & Dohme, LLCSearch in Eureka ↗
Plaintiff law firmGibbons PCLaw FirmRepresenting Merck Sharp & Dohme, LLCSearch in Eureka ↗
Defendant counselJames S. RichterAttorneyCounsel for Lupin LimitedSearch in Eureka ↗
Defendant law firmMIDLIGE RICHTER LLCLaw FirmRepresenting Lupin LimitedSearch in Eureka ↗
Presiding judgeJudge N/AJudgeNew Jersey District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“Plaintiff Merck Sharp & Dohme LLC (“Merck”) and Defendants Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively “Lupin”), the parties in the above- captioned action, by their respective undersigned attorneys, hereby stipulate and consent to entry of judgment and an injunction in the action, as follows: IT IS this ______ day of ______________, 2024: ORDERED, ADJUDGED AND DECREED as follows: 1. This Court has jurisdiction over the subject matter of the above actions and has personal jurisdiction over the parties. 2. As used in this Consent Judgment, (i) the term “Lupin Product” shall mean the drug product containing raltegravir as its sole active ingredient sold, offered for sale, or distributed pursuant to Abbreviated New Drug Application No. 217990; (ii) the term “Licensed Patents” shall mean United States Patent Numbers 7,754,731; 8,771,733; 9,649,311; and 10,772,888; and (iii) the term “Affiliate” of any entity or person shall mean any entity or person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with the first entity or person; for purposes of this definition, “control” means (a) ownership, directly or through one or more intermediaries, of (1) 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 (2) 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. 3. The making, having made, using, selling, offering to sell or importing of the Lupin Product in the United States infringes the Licensed Patents. 4. Unless otherwise specifically authorized by Merck or its successors in interest or assigns, Lupin, including any of its Affiliates, successors, and assigns, is enjoined from infringing the Licensed Patents, on its own part or through any Affiliate, by making, having made, using, selling, offering to sell or importing the Lupin Product in the United States. 5. Compliance with this Consent Judgment may be enforced by Merck and its successors in interest or assigns. 6. Nothing herein restricts or is intended to restrict the U.S. Food and Drug Administration from approving ANDA No. 217990. 7. This Court retains jurisdiction to enforce or supervise performance under this Consent Judgment. 8. All claims, counterclaims, affirmative defenses, and demands in this action are hereby dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party”
Source: PACER Docket, Case 2:23-cv-00094, New Jersey District Court

The consent judgment’s explicit stipulation that ‘the making, having made, using, selling, offering to sell or importing of the Lupin Product in the United States infringes the Licensed Patents’ is unusually direct. Rather than a finding of infringement by the court, this is Lupin’s own concession — entered as an adjudication. The broad injunction language and affiliate-binding definitions suggest Merck’s counsel drafted for maximum enforcement reach. Dismissal of all counterclaims with prejudice forecloses any invalidity challenge Lupin had raised or could have raised regarding these four patents.

PACER case 2:23-cv-00094 · Public docket record Explore in Eureka ↗
Patent at issue

US9649311B2 & US10772888B2 — Raltegravir HIV Integrase Inhibitor Compositions

Publication No.US9649311B2
Application No.US13/503939
Patent details
ProductSolid pharmaceutical compositions containing raltegravir integrase inhibitor
Cited in actionJanuary 9, 2023

Publication No.US10772888B2
Application No.US15/483030
Patent details
ProductRaltegravir integrase inhibitor formulations — extended portfolio claim
Cited in actionJanuary 9, 2023

US9649311B2 (application US13/503939) and US10772888B2 (application US15/483030) are two of four patents Merck asserted in this action, all directed to solid pharmaceutical compositions containing raltegravir — an HIV-1 integrase strand transfer inhibitor marketed as Isentress. The patents cover formulation and composition claims for the raltegravir active ingredient, protecting not merely the compound itself but its pharmaceutical preparation — a strategically important layer of Hatch-Waxman protection. US10772888B2’s 2020 grant date reflects a later continuation or divisional filing, extending the effective exclusivity timeline.

Raltegravir was among the first integrase inhibitors approved for HIV treatment, and Merck’s multi-patent portfolio around its solid dosage formulations represents a textbook lifecycle management strategy. For competitors and generic manufacturers, the layered claims across four patents — spanning at least a decade of filing activity — mean that designing around any single patent does not clear the path to market. The consent judgment’s confirmation of infringement across all four Licensed Patents reinforces the portfolio’s commercial and legal robustness, making future ANDA challenges against this compound materially more difficult.

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

Should you run an FTO against US9649311B2 and the raltegravir patent portfolio?

Any company developing solid oral formulations containing raltegravir — or formulations of integrase inhibitors with structurally similar composition claims — should treat this consent judgment as a direct signal to conduct freedom-to-operate analysis. The four Licensed Patents cover raltegravir as the sole active ingredient in pharmaceutical compositions; companies developing combination products or next-generation integrase inhibitors with overlapping formulation claims should assess claim scope carefully. The injunction’s broad affiliate and successor language also creates risk for acquirers of any ANDA or NDA containing raltegravir.

PatSnap Eureka’s FTO Search Agent can map the full claim landscape across all four Licensed Patents — US7,754,731; US8,771,733; US9,649,311; and US10,772,888 — identifying where independent and dependent claims overlap with your formulation or ANDA specification. Eureka can also surface continuation applications and related prosecution history, helping R&D and regulatory teams assess whether reformulation strategies would clear the injunction scope before investing in further ANDA development.

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Related litigation

Similar ANDA Integrase Inhibitor Patent Cases in the District of New Jersey

Cases below involve ANDA-triggered Hatch-Waxman patent litigation over HIV antiretroviral and integrase inhibitor formulations, predominantly litigated in the District of New Jersey.

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Merck Sharp & Dohme, LLC patent enforcement history, New Jersey case history, Merck Sharp & Dohme, LLC’s full IP portfolio, and comparable case analysis
Merck raltegravir prior suitsIsentress ANDA litigation historyD.N.J. integrase inhibitor casesLupin ANDA consent judgments
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Strategic implications

What this case signals for the ANDA pharmaceutical patent IP landscape

Merck’s clean sweep on a four-patent portfolio signals the continued potency of layered patent protection in HIV antiretroviral drug litigation.

Stacked patent portfolios deter ANDA challengers pre-trial

Merck asserted four patents with staggered filing dates and expiries — a classic lifecycle management strategy. When a generic challenger faces multiple valid, layered patents covering the same active ingredient, the litigation cost and risk calculus often favours settlement or consent judgment over a full invalidity trial. Companies with single-patent protection are comparatively more exposed to generic entry.

Consent judgments with no costs awarded signal negotiated resolution dynamics

The explicit ‘no costs, no attorneys’ fees’ clause — combined with the FDA ANDA approval carve-out — is a strong signal that commercial negotiations accompanied the legal settlement. In Hatch-Waxman litigation, these clauses often appear alongside undisclosed licence agreements setting a future authorised-generic entry date. Monitoring Merck’s ANDA approval records for No. 217990 may reveal the actual commercial terms.

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Unlock portfolio expiry mapping, authorised-generic risk signals, and D.N.J. enforcement precedent for the HIV antiretroviral ANDA sector.
Patent expiry timelineAuthorised generic riskD.N.J. enforcement scope
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Frequently asked questions

Merck v Lupin — key questions answered

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Monitor raltegravir ANDA filings and integrase inhibitor IP with PatSnap

Track new ANDA challenges against Merck’s integrase inhibitor portfolio and run FTO searches against the four Licensed Patents before investing in raltegravir formulation development. PatSnap Eureka surfaces continuation families, litigation history, and claim scope in one workflow.

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