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ViiV Healthcare v. Lupin — HIV Integrase Inhibitor Patent | PatSnap
Patent Litigation

ViiV Healthcare v. Lupin: Consent Judgment on HIV Integrase Inhibitor Patent

ViiV Healthcare, Shionogi, and ViiV Healthcare UK sued Lupin Limited and Lupin Pharmaceuticals in Delaware over US9242986, covering carbamoylpyridone HIV integrase inhibitor synthesis. The parties resolved the 497-day dispute through a court-entered consent judgment that enjoins Lupin's ANDA No. 216470 product from the market.

Resolution time
497days
497 days from filing to consent judgment — typical for ANDA patent disputes resolved pre-trial
Patents asserted
1
US9242986 — carbamoylpyridone HIV integrase inhibitor synthesis and intermediates
Outcome
Consent Judgment
Agreed by parties, entered by the court on 14 March 2023; binding and final with retained jurisdiction to enforce
Cost ruling
No Costs Awarded
Dismissed with prejudice; no costs, disbursements, or attorneys' fees awarded to any party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

ANDA infringement action over HIV integrase inhibitor synthesis ends in consent judgment

On 2 November 2021, ViiV Healthcare Company, Shionogi & Co., Ltd., and ViiV Healthcare UK (No. 3) Limited (collectively 'ViiV') filed suit in the Delaware District Court against Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively 'Lupin'), asserting infringement of US Patent No. 9,242,986. The patent covers the synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates. The trigger was Lupin's Abbreviated New Drug Application No. 216470, which sought regulatory approval for a generic drug product in the same therapeutic class.

The recorded basis of termination is Consent Judgment. The docket order, entered 14 March 2023 and signed by Judge Mitchell S. Goldberg, is styled as a stipulated consent to entry of judgment, injunction, and dismissal. Under its terms, Lupin and its affiliates are permanently enjoined from infringing US9242986 by making, using, selling, offering to sell, importing, or distributing the Lupin ANDA product. The District Court expressly retained jurisdiction to enforce or supervise performance. All claims were dismissed with prejudice, with no costs or attorneys' fees awarded to either side.

The case closed in 497 days — before any substantive merits ruling — which is consistent with pre-trial resolution common in Hatch-Waxman ANDA litigation. Notably, the consent judgment expressly preserves Lupin's right to maintain its Paragraph IV certification and to challenge the validity, enforceability, or infringement of US9242986 in any future action involving a product other than ANDA No. 216470. The specific commercial terms, if any, beyond those recited in the public order are not disclosed in the available record.

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Case at a glance
DefendantLupin Limited
CourtDelaware District Court
JudgeMitchell S. Goldberg
FiledNovember 2, 2021
ClosedMarch 14, 2023
Duration497 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 497 days

497 days from filing to consent judgment — typical for ANDA patent disputes resolved pre-trial

Case timeline: Complaint filed NOV 2 2021 — 497 days total Horizontal timeline showing the three key events in ViiV Healthcare, Co. v Lupin Limited from filing to resolution. Source: PACER, Delaware District Court. NOV 2 2021 Complaint filed Pre-trial proceedings MAR 14 2023 Consent Judgment 497 DAYS TOTAL
Patent at issue

US9242986 — Carbamoylpyridone HIV Integrase Inhibitor Synthesis

Publication No.US9242986B2
Application No.US14/272823
Patent details
ProductSynthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Cited in actionNovember 2, 2021
Technical brief · sourced from PatSnap patent database
US9242986B2Primary patent
Patent figurePatent figure
Technology summary
By integrating an early bromination step in the synthesis of pyridone compounds, the process effectively attaches an amide side chain, addressing the limitations of existing methods and resulting in compounds with improved HIV integrase inhibition and pharmaceutical properties.
Representative claim (1 of 6 independent)
1. A crystal form of a sodium salt of a compound of formula AA having characteristic diffraction peaks at 6.4°±0.2°, 9.2°±0.2°, 13.8°±0.2°, 19.2°±0.2° and 21.8°±0.2° degrees two-theta in an X-ray powder diffraction pattern.
Technical background
FIELD OF THE INVENTION The present invention comprises modifications of known processes for synthesizing compounds having HIV integrase inhibitory activity. BACKGROUND OF THE INVENTION WO 2006/116764 published 2 Nov. 2006, incorporated by reference in its entirety, describes various compounds and detailed synthetic schemes for their preparation. In particular, a reaction sequence is depicted at page 79 thereof wherein 3-benzyloxy-2-methyl-1H-pyridine-4-one of formula 3 is there brominated to the bromopyridine 4 the…
Patent family
59 family members across 20 jurisdictions (RU, CN, US, ES, BR, SG, AU, CA, MX, WO, EP, JP)
PatSnap Eureka · FTO Search Agent
Should you run an FTO analysis against US9242986?

Any pharmaceutical company or CMO developing, manufacturing, or seeking ANDA approval for a carbamoylpyridone HIV integrase inhibitor or a product that uses the synthesis routes or intermediates covered by US9242986 should conduct a freedom-to-operate analysis before advancing development or filing regulatory submissions. The consent judgment enjoins Lupin's specific ANDA product but, by its own terms, does not bind third parties — meaning the patent remains fully enforceable against other market entrants.

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Official verdict

Official order — verbatim text

Plaintiffs ViiV Healthcare Company, Shionogi & Co., Ltd., and ViiV Healthcare UK (No. 3) Limited (hereinafter collectively, “ViiV”), and Defendants Lupin Limited and Lupin Pharmaceuticals, Inc. (hereinafter collectively, “Lupin”), the parties in the above-captioned action, have resolved this action. Now the parties, by their respective undersigned attorneys, hereby stipulate and consent to entry of judgment and an injunction and dismissal in this action as follows: IT IS this 10th day of March, 2023: ORDERED, ADJUDGED AND DECREED as follows: 1. No party contests subject matter or personal jurisdiction. 2. As used in this Consent Judgment, (i) the term “Lupin Product” shall mean a drug product sold, offered for sale or distributed pursuant to Abbreviated New Drug Application No. 216470 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, Case 1:21-cv-01561-MSG Document 45 Filed 03/14/23 Page 1 of 3 PageID #: 182 ME1 44317891v.1 “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. 3. Except as specifically authorized, Lupin, including any of its Affiliates, successors and assigns, is enjoined from infringing United States Patent Number 9,242,986 (“the ‘986 patent”), on its own part or through any Affiliate, by making, having made, using, selling, offering to sell, importing or distributing of the Lupin Product. 4. Compliance with this Consent Judgment may be enforced by ViiV and its successors in interest, or assigns, as permitted by the parties. 5. This District Court retains jurisdiction to enforce or supervise performance under this Consent Judgment. 6. All claims and demands in this action are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party. 7. Nothing herein prohibits or is intended to prohibit Lupin or any of its Affiliates from maintaining any “Paragraph IV Certification” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) or 21 U.S.C. § 314.94(a)(12) (as amended or replaced) with respect to the ‘986 patent or any other patent. 8. Nothing herein shall have preclusive or other res judicata effect on Lupin in any other pending or future action or proceeding involving a product other than the Lupin Case 1:21-cv-01561-MSG Document 45 Filed 03/14/23 Page 2 of 3 PageID #: 183 ME1 44317891v.1 Product, and nothing prohibits or is intended to prohibit Lupin from challenging the validity, enforceability or infringement of the ‘986 patent or any other patent in any other action or proceeding involving a product other than the Lupin Product. 9. As a result of the dismissal of this suit, the 30-month stay under 21 U.S.C. § 355(j)(5) (as amended or replaced) is terminated and no longer in effect.
Source: PACER Docket, Case 1:21-cv-01561, Delaware District Court

The consent judgment order recites an agreed injunction and dismissal with prejudice, entered by the Delaware District Court on 14 March 2023. The order's express preservation of Lupin's Paragraph IV certification rights and its disclaimer of res judicata effect for products beyond ANDA No. 216470 are notable: they indicate the parties resolved this specific ANDA dispute without a merits adjudication of US9242986's validity or infringement, leaving both issues open for future proceedings.

PACER case 1:21-cv-01561 · Public docket record Explore in Eureka ↗
Judgment terms

Consent judgment: what the agreed resolution means for both parties

Legal mechanism

A court-entered judgment binding both parties by agreement

A consent judgment is a binding, court-entered judgment reflecting terms agreed by the parties — it carries the full force of a judicial order. Here, the Delaware District Court entered judgment on 14 March 2023, simultaneously imposing an injunction and dismissing all claims with prejudice. The court expressly retained jurisdiction to enforce or supervise compliance, giving ViiV a direct enforcement path if Lupin breaches the order's terms.

Court retains enforcement jurisdiction
Patent holder outcome

ViiV secures an injunction blocking Lupin's ANDA product

ViiV and its co-plaintiffs obtained a permanent injunction preventing Lupin and its affiliates from making, using, selling, offering to sell, importing, or distributing any product sold under ANDA No. 216470 that would infringe US9242986. The 30-month Hatch-Waxman stay is terminated as a result of the dismissal — suggesting Lupin's ANDA product is, in practice, blocked under the injunction rather than the stay mechanism. The specific commercial terms beyond the public order are not disclosed in the available record.

Injunction entered; '986 patent enforced
Defendant outcome

Lupin enjoined on ANDA No. 216470 but retains future challenge rights

Lupin and its affiliates are enjoined from commercialising the specific ANDA product. However, the consent judgment expressly carves out Lupin's right to maintain its Paragraph IV certification against US9242986 and to challenge the patent's validity, enforceability, or infringement in any future action involving a different product. This is a significant reservation: Lupin's litigation options with respect to US9242986 are not foreclosed for other ANDA filings or products.

Paragraph IV rights preserved
Commercial implications

Injunction reinforces ViiV's integrase inhibitor market position near-term

The consent judgment blocks generic entry via ANDA No. 216470 without a merits ruling on US9242986's validity. For the HIV integrase inhibitor space, this means ViiV's carbamoylpyridone compound retains protection against this particular generic challenge. The explicit preservation of Lupin's Paragraph IV and challenge rights, however, signals the competitive pressure on US9242986 is not permanently resolved — future validity challenges from Lupin or other ANDA filers remain possible.

Generic entry blocked for ANDA 216470
Legal analysis based on PACER docket records for case 1:21-cv-01561 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffViiV Healthcare, Co.CompanyGlobal HIV pharmaceutical group — holder of US9242986 covering carbamoylpyridone HIV integrase inhibitor synthesisSearch in Eureka ↗
Co-PlaintiffShionogi & Co., Ltd.CompanySearch in Eureka ↗
Co-PlaintiffViiv Healthcare UK (No.3) LimitedCompanySearch in Eureka ↗
DefendantLupin LimitedIndividualLupin Limited and Lupin Pharmaceuticals, Inc. — Indian generic pharmaceutical group seeking ANDA approval for HIV therapySearch in Eureka ↗
Co-DefendantLupin Pharmaceuticals, Inc.CompanySearch in Eureka ↗
Plaintiff counselAlexandra M. JoyceAttorneyCounsel for ViiV Healthcare, Co.Search in Eureka ↗
Plaintiff counselCaitlin HoganAttorneyCounsel for ViiV Healthcare, Co.Search in Eureka ↗
Plaintiff counselDaniel OAttorneyCounsel for ViiV Healthcare, Co.Search in Eureka ↗
Plaintiff law firmMcCarter & English LLPLaw FirmRepresenting ViiV Healthcare, Co.Search in Eureka ↗
Defendant counselDavid A. BilsonAttorneyCounsel for Lupin LimitedSearch in Eureka ↗
Defendant counselJohn C. PhillipsAttorneyCounsel for Lupin LimitedSearch in Eureka ↗
Defendant counselMatthew V. AndersonAttorneyCounsel for Lupin LimitedSearch in Eureka ↗
Defendant counselWilliam A. RakoczyAttorneyCounsel for Lupin LimitedSearch in Eureka ↗
Defendant counselXiaomei CaiAttorneyCounsel for Lupin LimitedSearch in Eureka ↗
Defendant law firmPhillips, Goldman, McLaughlin & Hall PALaw FirmRepresenting Lupin LimitedSearch in Eureka ↗
Presiding judgeJudge Mitchell S. GoldbergJudgeDelaware District CourtSearch in Eureka ↗
R&D signals

R&D signals in the HIV integrase inhibitor patent space

Forward-looking patent intelligence derived from ViiV, Shionogi, and Lupin's activity in the carbamoylpyridone HIV integrase inhibitor domain — beyond the litigation outcome.

Patent portfolio

ViiV and Shionogi's integrase inhibitor filing activity

ViiV Healthcare and Shionogi co-own a broad portfolio around HIV integrase strand transfer inhibitors, including synthesis, formulation, and combination therapy patents. Monitoring their recent PCT and US prosecution activity in the carbamoylpyridone class can reveal where next-generation INSTI protection is being built — and where future ANDA litigation risk may concentrate.

ViiV/Shionogi INSTI portfolio
Technology landscape

Filing trends in carbamoylpyridone INSTI chemistry

Patent filing activity around second-generation integrase strand transfer inhibitors has accelerated as dolutegravir and bictegravir drive clinical adoption. Tracking claim scope trends — particularly synthesis routes, polymorphic forms, and combination formulations — can reveal whitespace for generic developers or identify crowded areas where design-arounds are needed.

INSTI filing trend analysis
Competitor IP posture

Lupin's HIV antiviral patent and ANDA pipeline

Lupin Limited has an active generics pipeline in the HIV antiviral space, as evidenced by ANDA No. 216470. Analysing Lupin's own patent filings and ANDA-linked Paragraph IV certifications in this class can signal which integrase inhibitor compounds they are targeting next — intelligence valuable to both brand and generic competitors.

Lupin HIV generics pipeline
Whitespace opportunity

Adjacent synthesis and formulation whitespace near US9242986

US9242986 covers specific synthesis routes and intermediates for carbamoylpyridone INSTIs. Patent mapping around this claim space may reveal adjacent synthesis methods, crystalline forms, or prodrug strategies not yet claimed — potential whitespace for generic developers seeking non-infringing routes or innovators building next-generation INSTI chemistry.

INSTI synthesis whitespace
Related litigation

Similar HIV integrase inhibitor ANDA patent cases in Delaware

Explore related Hatch-Waxman infringement actions involving HIV integrase inhibitor patents litigated in the Delaware District Court, including other ViiV and Shionogi enforcement actions.

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ViiV Healthcare, Co. patent enforcement history, Delaware District Court case history, ViiV Healthcare, Co.'s full IP portfolio, and comparable case analysis
ViiV v. other ANDA filersShionogi ANDA litigation historyDelaware ANDA consent judgmentsINSTI patent enforcement cases
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Strategic implications

What this case signals for the HIV integrase inhibitor IP landscape

This consent judgment illustrates how Hatch-Waxman ANDA disputes over carbamoylpyridone HIV integrase inhibitors are being resolved — and what it means for future challengers.

Paragraph IV carve-outs are becoming standard defensive language

The explicit preservation of Lupin's Paragraph IV certification rights in the consent judgment reflects a growing trend in ANDA litigation: defendants negotiate to keep future challenge optionality open even when conceding on a specific product. IP teams monitoring US9242986 should treat this as a signal that the patent remains contested territory.

ViiV's multi-entity plaintiff structure signals coordinated IP enforcement

Filing with three co-plaintiffs — ViiV Healthcare Co., Shionogi & Co., and ViiV Healthcare UK (No.3) — reflects a coordinated enforcement posture typical of co-owned pharmaceutical patents. In-house teams at generic companies should map co-ownership structures before filing ANDA Paragraph IV certifications against ViiV's HIV portfolio.

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Full strategic analysis in PatSnap Eureka
Unlock deeper analysis of US9242986 enforcement patterns and Hatch-Waxman ANDA strategy signals from this Delaware District Court case.
Validity challenge risk scoreViiV portfolio filing trendsANDA litigation benchmarks
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Frequently asked questions

ViiV v Lupin — key questions answered

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Track HIV integrase inhibitor patent enforcement with PatSnap

Monitor US9242986 and ViiV's broader INSTI portfolio for new ANDA filings, validity challenges, and enforcement actions. PatSnap Eureka's FTO Search Agent maps carbamoylpyridone claim scope against your pipeline before you file.

Disclaimer

This page is compiled from public court dockets and third-party patent and litigation data via PatSnap Eureka, and is provided for general informational purposes only. The information shown — including party names, patent and application numbers, dates, case status, outcomes, and any analysis — may be incomplete, may not reflect the most recent filings or legal status, and may contain errors or omissions. Verify all details against official court records (for example, PACER) and the relevant patent office before relying on them.

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