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Actelion v. Mylan: Macitentan Patent Consent Judgment | PatSnap
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Case ID1:23-cv-00088
FiledNov 2023
ClosedSep 2024
Patent Litigation

Actelion v. Mylan: Macitentan ANDA Dispute Ends in Consent Judgment

Actelion Pharmaceuticals filed a Hatch-Waxman infringement action against Mylan NV over ANDA No. 211161 for generic macitentan 10 mg tablets, asserting two patents including US7094781B2. The case resolved in 318 days via consent judgment, with Mylan admitting validity and enforceability of the licensed patent solely for settlement purposes and accepting an injunction against commercial launch.

Resolution time
318days
318 days — resolved before trial, consistent with negotiated Hatch-Waxman consent timelines
Patents asserted
2
US7094781B2 and 1 further patent asserted — macitentan compound and formulation IP
Outcome
Consent Judgment
Mylan admitted validity; enjoined from launching generic macitentan pending patent expiry
Cost ruling
Not Reported
No fee award or cost ruling reflected in the public consent judgment record
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Hatch-Waxman consent judgment locks Mylan out of macitentan market

Actelion Pharmaceuticals Ltd. and its US affiliate filed suit on November 7, 2023 in the West Virginia Northern District Court before Judge Thomas S. Kleeh, asserting infringement of US7094781B2 and US10946015B2 against Mylan NV. The patents cover macitentan — an endothelin receptor antagonist marketed as Opsumit — and the infringement trigger was Mylan’s filing of ANDA No. 211161 seeking approval for generic macitentan 10 mg oral tablets. Under the Hatch-Waxman framework, that ANDA filing itself constitutes an act of infringement, giving Actelion standing to sue before any commercial launch.

The action closed on September 20, 2024 via a consent judgment entered by the court. Critically, Mylan admitted — solely for settlement purposes — that the claims of the licensed patent are valid, enforceable, and would be infringed by any commercial manufacture, use, sale, offer for sale, or importation of the Mylan product in the United States prior to patent expiry. The court entered a permanent injunction against Mylan and its affiliates, successors, and assigns accordingly. All claims, counterclaims, and affirmative defenses were dismissed. The 30-month stay associated with ANDA No. 211161 under 21 U.S.C. § 355(j)(5)(B)(iii) was expressly terminated.

Resolution in 318 days — before any substantive motion practice appears to have reached decision — is consistent with a negotiated outcome, likely reflecting an agreed-upon authorised generic or market entry date not disclosed in the public record. The retention-of-jurisdiction clause and the preserved right for Mylan to maintain paragraph IV certifications suggest the commercial arrangement between the parties remains confidential. The specific launch date authorised for Mylan, and whether royalty terms or revenue-sharing apply, are not derivable from the public consent judgment.

Case at a glance
Case no.1:23-cv-00088
DefendantMylan, NV
CourtWest Virginia Northern
JudgeThomas S Kleeh
FiledNovember 7, 2023
ClosedSeptember 20, 2024
Duration318 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 318 days

318 days — resolved before trial, consistent with negotiated Hatch-Waxman consent timelines

Case timeline: Complaint filed NOV 7 2023, APR–MAY — 318 days total Horizontal timeline showing the three key events in Actelion Pharmaceuticals, Ltd. v Mylan, NV from filing to resolution. Source: PACER, West Virginia Northern District Court. NOV 7 2023 Complaint filed Pre-trial proceedings SEP 20 2024 Consent Judgment 318 DAYS TOTAL
Dismissal terms

Consent judgment entered: what the terms mean for both parties

Legal mechanism

Consent judgment under Hatch-Waxman: what it means

A consent judgment is a court-entered, legally binding resolution agreed by both parties. Under the Hatch-Waxman framework, it typically memorialises a settlement in which the generic filer accepts an injunction, admits patent validity for settlement purposes, and receives a confidential authorised entry date in return. The court retains jurisdiction to enforce compliance, and all claims are dismissed with finality.

Court-supervised settlement
Patent holder outcome

Actelion secures injunction and validity admission

Actelion obtained a permanent injunction barring Mylan and all its affiliates from commercialising generic macitentan before patent expiry. Mylan’s admission of validity and enforceability — even qualified as being solely for settlement — eliminates any immediate litigation risk to the patent estate from this ANDA. Actelion retains full control over Opsumit’s exclusivity period under the terms entered by the court.

Injunction granted, exclusivity preserved
Generic challenger outcome

Mylan enjoined, but likely secures a future entry date

Mylan accepted an injunction and admitted patent validity for settlement purposes, foregoing any immediate generic launch. However, the preserved right to maintain paragraph IV certifications and the express termination of the 30-month stay are consistent with a negotiated, confidential entry date. The public record does not disclose when Mylan may launch, or whether it negotiated authorised generic rights or royalty terms.

Launch delayed; entry date undisclosed
Commercial implications

Macitentan exclusivity reinforced; market entry date opaque

For competing generic filers targeting macitentan, this consent judgment signals that Actelion’s patent estate is actively enforced and that at least one challenger has accepted validity rather than litigating invalidity to judgment. Any subsequent ANDA filer will face both the injunction against Mylan and a strengthened perceived validity posture for the asserted patents. The undisclosed commercial terms between Actelion and Mylan may shape the competitive timeline for other generic entrants.

Strong exclusivity signal for sector
Legal analysis based on PACER docket records for case 1:23-cv-00088 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffActelion Pharmaceuticals, Ltd.CompanyPharmaceutical innovator — holder of US7094781B2 and US10946015B2 covering macitentanSearch in Eureka ↗
Co-PlaintiffActelion Pharmaceuticals US, Inc.CompanySearch in Eureka ↗
DefendantMylan, NVCompanyGeneric pharmaceutical manufacturer — filer of ANDA No. 211161 for macitentan 10 mg tabletsSearch in Eureka ↗
Plaintiff counselBruce M. WexlerAttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff counselChad L. TaylorAttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff counselFrank E. Simmerman , Jr.AttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff counselFrank Edward Simmerman , IIIAttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff counselJessica StauringAttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff counselMark Russell SperlingAttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff counselMi ZhouAttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff counselPreston K. Ratliff , IIAttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff counselSarah E. SpencerAttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff law firmPaul Hastings LLP (NY)Law FirmRepresenting Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff law firmSimmerman Law Office PLLCLaw FirmRepresenting Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Defendant counselElizabeth M. CromptonAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselGordon H. CoplandAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselRobert L. FlorenceAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselTasneem Amin DharamsiAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselWilliam J. O’BrienAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant law firmParker Poe Adams & Bernstein LLPLaw FirmRepresenting Mylan, NVSearch in Eureka ↗
Defendant law firmParker Poe Adams & Bernstein LLP (Greenville)Law 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

“ORDERED, ADJUDGED AND DECREED as follows: 1. This District Court has jurisdiction over the subject matter of the above action and has personal jurisdiction over the parties. 2. As used in this Consent Judgment, Mylan mean the drug product sold, offered for sale or distributed pursuant to Abbreviated New Drug Application No. 211161 (including any supplements or amendments thereto or replacements Mylan ANDA No. 211161 ii) States Patent Number 7,094,781 that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with Mylan; f (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. Solely for the purposes of settling the Action, Mylan admits that the claims of the Licensed Patent are valid and enforceable, and that the claims of the Licensed Case 1:23-cv-00088-TSK Document 35 Filed 09/20/24 Page 2 of 4 PageID #: 283 – 3 – Patent would be infringed by the commercial manufacture, use, sale, offer for sale, or importation of the Mylan Product in the United States prior to expiration of the Licensed Patent. 4. Unless otherwise specifically authorized by Actelion, Mylan, including any of its Affiliates, successors and assigns, is enjoined from infringing the Licensed Patent, on its own part or through any Affiliate, by making, having made, using, selling, offering to sell, importing or distributing the Mylan Product in the United States. 5. This District Court retains jurisdiction to enforce or supervise performance under this Consent Judgment. 6. All claims, counterclaims, affirmative defenses and demands in this action party. 7. Nothing herein shall prohibit or restrict Mylan from maintaining or filing paragraph IV certifications in M 211161 under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or supplemented) and nothing herein shall prohibit or restrict at any time. Each party acknowledges and agrees that the 30- ANDA No. 211161 under 21 U.S.C. § 355(j)(5)(B)(iii) is hereby terminated.”
Source: PACER Docket, Case 1:23-cv-00088, West Virginia Northern District Court

The consent judgment is notable for its explicit validity and enforceability admission by Mylan, framed as being solely for settlement purposes — a standard carve-out that prevents the admission from being used as collateral estoppel in unrelated proceedings. The permanent injunction covering Mylan and all its affiliates, successors, and assigns is broadly drafted. The termination of the 30-month stay and the preserved paragraph IV certification rights together suggest the parties have a separate, undisclosed commercial agreement governing when Mylan may ultimately enter the market.

PACER case 1:23-cv-00088 · Public docket record Explore in Eureka ↗
Patent at issue

US7094781B2 & US10946015B2 — Macitentan compound and formulation patents

Publication No.US7094781B2
Application No.US10/433041
Patent details
Productmacitentan compound — endothelin receptor antagonist for pulmonary arterial hypertension
Cited in actionNovember 7, 2023

Publication No.US10946015B2
Application No.US15/900586
Patent details
Productmacitentan formulation and methods of use for pulmonary arterial hypertension
Cited in actionNovember 7, 2023

US7094781B2 (application no. US10/433041) covers macitentan, a dual endothelin receptor antagonist approved as Opsumit for the treatment of pulmonary arterial hypertension (PAH). The patent addresses the compound itself, placing it in the class of sulfamide-based ERA chemistry developed by Actelion. US10946015B2 (application no. US15/900586) represents a later-filed patent in the same family, likely covering formulation, dosing, or method-of-use aspects that extend the effective exclusivity profile of the macitentan franchise.

Macitentan carries significant commercial value as the active ingredient in Opsumit, a cornerstone PAH therapy with global revenues in the billions. The dual-patent assertion strategy used in this case — compound plus formulation/method — is characteristic of originator pharmaceutical companies seeking to create overlapping layers of protection that survive individual validity challenges. Any company developing generic endothelin receptor antagonists or biosimilar PAH therapies should treat this patent estate as a high-priority landscape to monitor, particularly given Actelion’s demonstrated willingness to litigate rapidly and secure binding injunctions.

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

Should you run an FTO analysis against US7094781B2 and US10946015B2?

Any pharmaceutical company developing or commercialising oral endothelin receptor antagonists, PAH combination therapies, or macitentan-containing formulations should treat these patents as priority FTO targets. The consent judgment confirms that at least one ANDA filer — Mylan — concluded that designing around or invalidating these claims was not commercially viable before the agreed resolution. R&D teams working on next-generation ERA chemistry or fixed-dose combination products in the PAH space face direct exposure.

PatSnap Eureka’s FTO Search Agent can map the full claim scope of US7094781B2 and US10946015B2 against your compound structure, formulation parameters, and intended indications. The agent identifies blocking claims, flags prior art relevant to any invalidity argument, and surfaces related Actelion family members in other jurisdictions — giving your IP and regulatory teams the landscape intelligence needed before an ANDA filing or IND submission.

PatSnap Eureka FTO Search

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Related litigation

Similar Hatch-Waxman ANDA cases involving pulmonary arterial hypertension patents

Cases filed in U.S. district courts asserting endothelin receptor antagonist and PAH compound patents against ANDA filers — comparable to Actelion v. Mylan in W.D. West Virginia.

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Access 40+ similar cases in PatSnap Eureka
Actelion Pharmaceuticals, Ltd. patent enforcement history, West Virginia Northern case history, Actelion Pharmaceuticals, Ltd.’s full IP portfolio, and comparable case analysis
Other Opsumit ANDA casesERA compound patent disputesActelion litigation historyPAH Hatch-Waxman trends
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Strategic implications

What this case signals for the pharmaceutical patent IP landscape

Actelion’s swift consent judgment reinforces how originator pharma companies manage ANDA threats to high-value compounds like macitentan.

Consent judgments in Hatch-Waxman frequently mask confidential entry deals

The public terms here — injunction, validity admission, preserved paragraph IV rights — are the standard architecture of a negotiated ANDA resolution. R&D and business development teams tracking Opsumit’s exclusivity window should assume a confidential authorised entry date exists, even though the public record is silent on specifics.

Two-patent assertion strengthens Actelion’s defensive posture

By asserting both US7094781B2 and US10946015B2, Actelion created a layered patent barrier covering the macitentan compound and likely its formulation or use. Generic challengers who might invalidate one patent still face exposure under the second. This multi-patent strategy is a best-practice model for Hatch-Waxman litigation in the cardiovascular and pulmonary disease space.

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30-month stay implicationsAuthorised generic risk signalsVenue strategy analysis
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Frequently asked questions

Actelion v Mylan — key questions answered

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Monitor the macitentan patent estate before your next ANDA decision

Actelion has demonstrated rapid enforcement of its macitentan IP. Use PatSnap Eureka to run FTO analysis on US7094781B2 and US10946015B2, track related family members globally, and receive alerts on new ANDA filings in the PAH space.

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