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Boehringer Ingelheim v. Mylan: Linagliptin Patent Consent Judgment | PatSnap
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Case ID1:20-cv-00019
FiledFeb 2020
ClosedNov 2025
Patent Litigation

Boehringer Ingelheim v. Mylan: Linagliptin Patent Dispute Ends in Consent Judgment After 2,119 Days

Boehringer Ingelheim’s four-entity plaintiff group sued Mylan across three consolidated actions over five patents protecting Tradjenta® and Jentadueto® linagliptin diabetes therapies. The case closed on 24 November 2025 via a consent judgment that permanently enjoins Mylan from launching its generic ANDA products until the last of the five patents expires — a commercially significant outcome spanning nearly six years of litigation.

Resolution time
2119days
5.8 years from filing to consent judgment — well above the typical 2–3 year ANDA trial timeline
Patents asserted
1
US9486526B2 and 4 further patents asserted covering linagliptin and linagliptin/metformin formulations
Outcome
Consent Judgment
Negotiated resolution; Mylan enjoined from market entry until last patent expiry
Cost ruling
No Costs
Dismissed without prejudice and without costs, disbursements, or attorney fees to any party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Six-year Hatch-Waxman battle locks Mylan out of linagliptin generics market

Boehringer Ingelheim Pharmaceuticals Inc. and three affiliated entities filed suit on 5 February 2020 in the West Virginia Northern District Court before Judge Thomas S. Kleeh, asserting infringement of patents covering their blockbuster type 2 diabetes drugs Tradjenta® (5 mg linagliptin) and Jentadueto® (2.5 mg linagliptin/metformin). The litigation encompassed three consolidated civil actions — Nos. 1:20-cv-00019, 1:20-cv-00090, and 1:24-cv-00082 — and ultimately involved five patents: US9,415,016; US9,486,526; US10,022,379; US11,033,552; and US11,911,388.

The case closed on 24 November 2025 through a court-entered consent judgment negotiated between the parties. Under its terms, Mylan’s ANDA products — generic equivalents of both Tradjenta® and Jentadueto® — are judicially confirmed to infringe the asserted patent clusters, and Mylan is permanently enjoined from manufacturing, selling, or distributing those generics in the United States until the latest expiration of all five patents, including any patent term extensions. All underlying claims and counterclaims were dismissed without prejudice and without any award of costs or attorneys’ fees.

A 2,119-day litigation cycle is notable even by Hatch-Waxman standards, likely reflecting the complexity of consolidating three separate ANDA actions and the breadth of the patent portfolio asserted. The addition of a third civil action in 2024 — four years into the original dispute — suggests that Boehringer continued to expand its enforcement perimeter as new patents issued. The precise commercial terms of any underlying licensing or settlement agreement remain confidential; the public record confirms only the injunction, the infringement findings, and the maintenance of Mylan’s Paragraph IV certifications.

Case at a glance
Case no.1:20-cv-00019
DefendantMylan, NV
CourtWest Virginia Northern
JudgeThomas S Kleeh
FiledFebruary 5, 2020
ClosedNovember 24, 2025
Duration2119 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
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Case data sourced from PACER / West Virginia Northern District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Consent Judgment in 2119 days

5.8 years from filing to consent judgment — well above the typical 2–3 year ANDA trial timeline

Case timeline: Complaint filed FEB 5 2020, DEC–JAN — 2119 days total Horizontal timeline showing the three key events in Boehringer-Ingelheim v Mylan, NV from filing to resolution. Source: PACER, West Virginia Northern District Court. FEB 5 2020 Complaint filed Pre-trial proceedings NOV 24 2025 Consent Judgment 2119 DAYS TOTAL
Dismissal terms

Consent judgment entered: what the agreed injunction means for both parties

Legal mechanism

Consent judgment is a binding court order, not merely a settlement

A consent judgment has the force of a judicial decree. Unlike a private settlement agreement, it is enforceable directly through the court — including by preliminary injunction — if violated. Paragraph 8 of the order preserves jurisdiction in this district for enforcement. The court found jurisdiction and formally adjudged infringement at Mylan’s request, giving Boehringer a strong enforcement instrument without a contested trial.

Court-ordered injunction
Patent holder outcome

Boehringer secures full market exclusivity through all five patent expiries

The consent judgment delivers Boehringer its primary commercial objective: Mylan is enjoined from entering the US market with generic linagliptin or linagliptin/metformin until the latest of the five patent expiries, including any PTE or PTA. Infringement findings on six patent/product combinations are judicially recorded, strengthening Boehringer’s position against any future ANDA challengers who may attempt to distinguish Mylan’s litigation posture.

Exclusivity preserved
Generic challenger outcome

Mylan enjoined from launch but retains ANDA approvals and Paragraph IV certs

Mylan is blocked from commercialising its ANDA products during the patent term but retains meaningful optionality: the FDA may grant or maintain final ANDA approvals at any time, and Mylan keeps its Paragraph IV certifications. This preserves Mylan’s ability to launch immediately upon patent expiry — or earlier if any patent is later invalidated in a separate proceeding — without re-filing its ANDAs.

ANDA intact, launch deferred
Commercial implications

Linagliptin generics market entry delayed; portfolio breadth deters rivals

Five-patent coverage across two formulations signals a layered exclusivity strategy typical of mature branded small-molecule franchises. Competitors holding their own linagliptin ANDAs should note that patents US11,033,552 and US11,911,388 — the most recently issued — likely carry expiry dates well into the 2030s, suggesting extended brand protection. The infringement findings, though consent-based, may influence how other generic filers approach design-around strategies.

Extended brand window
Legal analysis based on PACER docket records for case 1:20-cv-00019 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffBoehringer-IngelheimIndividualGlobal pharmaceutical group — holder of US9486526B2 and four further linagliptin patentsSearch in Eureka ↗
Co-PlaintiffBoehringer Ingelheim Pharma GmbH & Co., KGCompanySearch in Eureka ↗
Co-PlaintiffBoehringer Ingelheim CorporationCompanySearch in Eureka ↗
Co-PlaintiffBoehringer Ingelheim International, GMBHCompanySearch in Eureka ↗
DefendantMylan, NVCompanyMylan NV and affiliates, ANDA filers seeking generic approval for linagliptin tabletsSearch in Eureka ↗
Co-DefendantMylan Laboratories LimitedIndividualSearch in Eureka ↗
Co-DefendantMylan, Inc.CompanySearch in Eureka ↗
Plaintiff counselAndrew WalterAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselAshley RossAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselBryan S. HalesAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselChristopher IlardiAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselChristopher J. CitroAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselDavid R. PogueAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselEliana ApplebaumAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselJames F. CompanionAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselJames F. HurstAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselJeanna M. WackerAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselJordan Lee DamronAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselLeora Ben-AmiAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselMira Atanassova MulvaneyAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselSam KwonAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselSandra K. LawAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselShaoyao YuAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselSteven Robert RubyAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselTasha Francis GerasimowAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselThomas F. FlemingAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff law firmCarey, Douglas, Kessler & Ruby, PLLCLaw FirmRepresenting Boehringer-IngelheimSearch in Eureka ↗
Plaintiff law firmCarey, Douglas, Kessler and Ruby PLLCLaw FirmRepresenting Boehringer-IngelheimSearch in Eureka ↗
Plaintiff law firmKirkland & Ellis LLP (Chicago)Law FirmRepresenting Boehringer-IngelheimSearch in Eureka ↗
Plaintiff law firmKirkland & Ellis LLP (NY)Law FirmRepresenting Boehringer-IngelheimSearch in Eureka ↗
Plaintiff law firmSchrader Companion Duff & Law, PLLCLaw FirmRepresenting Boehringer-IngelheimSearch in Eureka ↗
Defendant counselDeepro R. MukerjeeAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselGarrett Matthew SpikerAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselGordon H. CoplandAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselGuylaine HacheAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselJillian Schurr-HendrixAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselJitendra MalikAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselJoseph M. JanuszAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselLance A. SoderstromAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselMatthew M. HolubAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselSara M. PistilliAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselWilliam J. O’BrienAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant law firmKatten Muchin Rosenman LLPLaw FirmRepresenting Mylan, NVSearch in Eureka ↗
Defendant law firmKatten Muchin Rosenman LLP (Chicago)Law FirmRepresenting Mylan, NVSearch in Eureka ↗
Defendant law firmKatten Muchin Rosenman LLP (NC)Law FirmRepresenting Mylan, NVSearch in Eureka ↗
Defendant law firmSteptoe & Johnson PLLCLaw FirmRepresenting Mylan, NVSearch in Eureka ↗
Defendant law firmSteptoe & Johnson PLLC – BridgeportLaw FirmRepresenting Mylan, NVSearch in Eureka ↗
Presiding judgeJudge Thomas S KleehJudgeWest Virginia Northern District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“Plaintiffs Boehringer Ingelheim Pharmaceuticals Inc., Boehringer Ingelheim International GMBH, Boehringer Ingelheim Corporation, and Boehringer Ingelheim Pharma GmbH & Co. KG (collectively “Boehringer” or “Plaintiffs”), and Defendants Mylan Pharmaceuticals Inc., Mylan Inc., and Mylan Laboratories Limited (“Mylan” or “Defendants”) have agreed to terms and conditions representing a negotiated resolution of claims and defenses in Civil Action No. 1:20-cv-00019, 1:20-cv-00090, and 1:24-cv-00082. Now the parties, by their respective undersigned attorneys, hereby stipulate and consent to entry of judgment in this action as follows: IT IS, this 24th day of November, 2025 HEREBY ORDERED, ADJUDGED AND DECREED that: 1. For purposes of this action only, this Court has jurisdiction over the subject matter of the above action and has personal jurisdiction over the parties. Case 1:20-cv-00019-TSK Document 427 Filed 11/24/25 Page 1 of 4 PageID #: 11027 2 2. As used in this Consent Judgment, (i) the term “the ’016 patent” means U.S. Patent No. 9,415,016, (ii) the term “the ’526 patent” means U.S. Patent No. 9,486,526, (iii) the term “the ’379 patent” means U.S. Patent No. 10,022,379, (iv) the term “the ’552 patent” means U.S. Patent No. 11,033,552, (v) the term “the ’388 patent” means U.S. Patent No. 11,911,388, (vi) the term “MYLAN Generic Equivalent Lina Product” shall mean the products described in Abbreviated New Drug Application (“ANDA”) No. 208431, including tablets containing 5 mg linagliptin as generic versions of the Boehringer Tradjenta® Product, (vii) the term “MYLAN Generic Equivalent Lina/Met Product” shall mean the product described in ANDA No. 208430, including tablets containing 2.5 mg linagliptin and metformin as generic versions of the Boehringer Jentadueto® Product, (viii) the term “MYLAN ANDA Products” shall mean the MYLAN Generic Equivalent Lina Product and the Mylan Generic Equivalent Lina/Met Product, and (ix) the term “Affiliate” shall mean any entity controlling, controlled by, or under common control with a Party, but only as long as such control continues, where “control” means: (1) the ownership of at least fifty percent (50%) of the equity or beneficial interest of such entity, or the right to vote for or appoint a majority of the board of directors or other governing body of such entity; or (2) the power to directly or indirectly direct or cause the direction of the management and policies of such entity by any means whatsoever. 3. In the absence of a license, the ’526, ’552, and ’388 Patents are infringed by the MYLAN Generic Equivalent Lina Product. 4. In the absence of a license, the ’016, ’379, and ’388 Patents are infringed by the MYLAN Generic Equivalent Lina/Met Product. 5. Except as specifically authorized or otherwise agreed between the parties, Mylan, including any of its successors and assigns, is enjoined from making, having made, using, selling, Case 1:20-cv-00019-TSK Document 427 Filed 11/24/25 Page 2 of 4 PageID #: 11028 3 offering to sell, importing or distributing the MYLAN ANDA Products in the United States, on its own part or through any Affiliate, officer, agent, servant, employee or attorney, or through any person in concert or coordination with Mylan or its Affiliates, through and until the latest expiration of the ’016, ’526, ’379, ’552, and ’388 Patents, including any patent term extension and/or patent term adjustment. 6. Plaintiffs acknowledge that Defendant is entitled to maintain its Paragraph IV certification to the ’016 patent, the ’526 patent, the ’379 patent, the ’552 patent and the ’388 patent pursuant to 21 C.F.R. § 314.94(a)(12)(v). 7. Nothing herein shall prevent FDA from granting or maintaining final approval to Mylan’s ANDA No. 208430 and/or Mylan’s ANDA No. 208431 at any time. 8. The Parties agree that, in the event of violation of the terms of this Consent Judgment or any related agreement(s), jurisdiction and venue for an action to enforce performance under this Consent Judgment, including for a preliminary injunction against the breaching conduct, exists in this District Court, and the Parties hereby waive any and all defenses based on personal jurisdiction and venue. 9. This Court retains jurisdiction to enforce or supervise performance under this Consent Judgement and any related agreement(s). 10. The Complaint and all other claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.”
Source: PACER Docket, Case 1:20-cv-00019, West Virginia Northern District Court

The consent judgment’s infringement findings in paragraphs 3 and 4 are judicially operative declarations, not mere admissions: the court formally adjudged that, absent a licence, specific Mylan ANDA products infringe specific patent clusters. For Boehringer, this creates a robust enforcement record. For Mylan, the findings are expressly limited to ‘this action only,’ preserving theoretical invalidity arguments in any future proceeding. The dismissal without prejudice of all other claims leaves counterclaims — including any invalidity or inequitable conduct defences — unresolved on the merits, meaning neither party obtained a final adjudication beyond the infringement declarations expressly consented to.

PACER case 1:20-cv-00019 · Public docket record Explore in Eureka ↗
Patent at issue

US9486526B2 — linagliptin formulation patent at the core of Tradjenta® ANDA dispute

Publication No.US9486526B2
Application No.US14/294630
Patent details
ProductLinagliptin tablet formulations for type 2 diabetes (DPP-4 inhibitor)
Cited in actionFebruary 5, 2020

US9,486,526 (application no. US14/294,630) is one of five Boehringer Ingelheim patents asserted in this litigation, all covering aspects of linagliptin — a DPP-4 inhibitor approved for type 2 diabetes management. The ‘526 patent was specifically found to be infringed by Mylan’s generic equivalent of the Tradjenta® 5 mg linagliptin tablet (ANDA No. 208431). As part of a continuation family, the patent sits within a portfolio that also covers the linagliptin/metformin combination marketed as Jentadueto®, demonstrating layered formulation and method-of-use coverage across both commercial products.

The five-patent portfolio — spanning US9,415,016 through the recently issued US11,911,388 — reflects a deliberate evergreening strategy in the DPP-4 inhibitor class, where new continuation filings were timed to maintain litigation leverage as the original patents aged. For competitors in the oral antidiabetic space, the ‘388 patent’s 2024 issuance and its inclusion in a 2024 civil action demonstrates that the portfolio is actively expanding. Any entity considering ANDA filings for linagliptin-containing products must evaluate the full continuation family to assess realistic first-generic launch timing.

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

Should you run an FTO against US9486526B2 and the Boehringer linagliptin portfolio?

Any pharmaceutical or generic drug company developing DPP-4 inhibitor formulations, linagliptin combination products, or dosage forms similar to Tradjenta® or Jentadueto® should treat this patent family as a high-priority FTO target. The consent judgment confirms that tablet formulations covered by five separate patents were found to infringe — meaning design-arounds must clear all five claims simultaneously, not just US9,486,526 in isolation. R&D teams evaluating metformin/linagliptin fixed-dose combinations face the most acute risk given the ‘016 and ‘379 patent coverage of the Jentadueto® equivalent.

PatSnap Eureka’s FTO Search Agent can map the full Boehringer linagliptin continuation family, identify which claims cover specific formulation parameters (dosage, excipient composition, administration method), and flag any post-grant review petitions filed against the ‘552 or ‘388 patents. For ANDA filers, Eureka can overlay patent expiry projections — including PTE and PTA adjustments — to model the realistic earliest generic entry date across all five patents, enabling more accurate go/no-go decisions before an ANDA filing.

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Related litigation

Similar Hatch-Waxman DPP-4 inhibitor patent cases in US district courts

Explore comparable Hatch-Waxman ANDA infringement actions involving DPP-4 inhibitor and oral antidiabetic drug patents litigated in US district courts.

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Strategic implications

What this case signals for the Hatch-Waxman and diabetes drug IP landscape

A six-year, five-patent consent judgment in linagliptin offers concrete lessons for ANDA filers, brand defenders, and FTO analysts in the GLP-1/DPP-4 space.

Portfolio depth, not single-patent breadth, is the ANDA defence playbook

Boehringer’s ability to assert five patents across two formulations — and to add a third action in 2024 as new patents issued — illustrates how a rolling continuation strategy can sustain Hatch-Waxman pressure throughout a litigation cycle. Generic entrants should map the full continuation family, not just the originally asserted patents, before filing Paragraph IV certifications.

Consent judgments with infringement findings create precedent risk for subsequent ANDA filers

Although the findings are explicitly limited to this action, a judicially entered infringement determination against a specific ANDA product strengthens the brand holder’s credibility in future Hatch-Waxman suits. Other generic filers targeting the same Tradjenta® or Jentadueto® formulations should expect Boehringer to cite these findings and may face a higher settlement threshold.

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Frequently asked questions

Boehringer-Ingelheim v Mylan — key questions answered

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Monitor the linagliptin patent landscape before your next ANDA or FTO decision

The Boehringer v. Mylan consent judgment covers five patents across two commercial products — but new continuations may still issue. Use PatSnap Eureka to track real-time patent filings, PTAB petitions, and ANDA activity across the full DPP-4 inhibitor class before committing to a Paragraph IV strategy.

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