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.
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.
Filing to Consent Judgment in 318 days
318 days — resolved before trial, consistent with negotiated Hatch-Waxman consent timelines
Consent judgment entered: what the terms mean for both parties
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 settlementActelion 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 preservedMylan 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 undisclosedMacitentan 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 sectorFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Actelion Pharmaceuticals, Ltd. | Company | Pharmaceutical innovator — holder of US7094781B2 and US10946015B2 covering macitentanSearch in Eureka ↗ |
| Co-Plaintiff | Actelion Pharmaceuticals US, Inc. | Company | Search in Eureka ↗ |
| Defendant | Mylan, NV | Company | Generic pharmaceutical manufacturer — filer of ANDA No. 211161 for macitentan 10 mg tabletsSearch in Eureka ↗ |
| Plaintiff counsel | Bruce M. Wexler | Attorney | Counsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Chad L. Taylor | Attorney | Counsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Frank E. Simmerman , Jr. | Attorney | Counsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Frank Edward Simmerman , III | Attorney | Counsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Jessica Stauring | Attorney | Counsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Mark Russell Sperling | Attorney | Counsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Mi Zhou | Attorney | Counsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Preston K. Ratliff , II | Attorney | Counsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Sarah E. Spencer | Attorney | Counsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Plaintiff law firm | Paul Hastings LLP (NY) | Law Firm | Representing Actelion Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Plaintiff law firm | Simmerman Law Office PLLC | Law Firm | Representing Actelion Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Defendant counsel | Elizabeth M. Crompton | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Gordon H. Copland | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Robert L. Florence | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Tasneem Amin Dharamsi | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | William J. O’Brien | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant law firm | Parker Poe Adams & Bernstein LLP | Law Firm | Representing Mylan, NVSearch in Eureka ↗ |
| Defendant law firm | Parker Poe Adams & Bernstein LLP (Greenville) | Law Firm | Representing Mylan, NVSearch in Eureka ↗ |
| Defendant law firm | Steptoe & Johnson PLLC – Bridgeport | Law Firm | Representing Mylan, NVSearch in Eureka ↗ |
| Presiding judge | Judge Thomas S Kleeh | Judge | West Virginia Northern District CourtSearch in Eureka ↗ |
Official order — verbatim text
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.
US7094781B2 & US10946015B2 — Macitentan compound and formulation patents
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.
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.
Run a freedom-to-operate analysis on US7094781B2 to assess your product’s exposure
Run FTO in Eureka →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.
Related patent case — similar technology
Comparable case in the same technology domain. Patent holder and defendant reached resolution after proceedings.
SettledRelated infringement action — same court
Comparable Macitentan 10 mg oral tablets-adjacent infringement action. Patent enforcement dynamics analysed in depth.
Active · District CourtRelated invalidity challenge — appellate outcome
Combined invalidity and infringement action in the same technology space. Decided after substantive proceedings.
DecidedActelion Pharmaceuticals, Ltd.’s broader IP enforcement history
Actelion Pharmaceuticals, Ltd.’s full litigation history covering prior enforcement, licensing activity, and inter partes review proceedings.
Portfolio viewWhat 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.
Termination of 30-month stay flags a likely agreed launch window
The express termination of the 30-month stay under 21 U.S.C. § 355(j)(5)(B)(iii) in a consent judgment typically signals that the parties have agreed on a specific future entry date that renders the stay mechanism redundant. Monitoring Mylan’s ANDA status with FDA and watching for authorised generic agreements will indicate when the market opens.
West Virginia Northern District: a jurisdiction choice worth noting for pharma IP
Filing in W.D. West Virginia rather than Delaware or New Jersey — the most common Hatch-Waxman venues — may reflect strategic considerations around judge assignment or Mylan’s registered presence. IP teams tracking pharmaceutical ANDA disputes should account for emerging venue patterns outside traditional hubs, particularly where consent judgments may be the anticipated endpoint.
Actelion v Mylan — key questions answered
Solely for settlement purposes, Mylan admitted that the claims of the licensed patent (US7094781B2) are valid and enforceable, and that the claims would be infringed by any commercial manufacture, use, sale, offer for sale, or importation of the Mylan macitentan product in the United States prior to patent expiry. This admission is limited to the settlement context and does not constitute a general estoppel.
Actelion asserted two patents: US7094781B2 (application no. US10/433041) and US10946015B2 (application no. US15/900586). Both patents relate to macitentan, the active ingredient in Opsumit, an endothelin receptor antagonist approved for pulmonary arterial hypertension. The dual assertion is consistent with Actelion’s multi-layer patent strategy across the macitentan franchise.
Under 21 U.S.C. § 355(j)(5)(B)(iii), filing a Hatch-Waxman infringement action automatically triggers a 30-month stay of FDA approval for the challenged ANDA. The consent judgment expressly terminates this stay for ANDA No. 211161. This typically signals that the parties have negotiated a specific agreed entry date, making the statutory stay mechanism redundant. The actual agreed launch date is not disclosed in the public record.
The consent judgment preserves Mylan’s right to maintain or file paragraph IV certifications with respect to ANDA No. 211161 at any time, and explicitly states that nothing in the judgment restricts this. However, the validity admission made for settlement purposes and the court-entered injunction create a significant practical and legal barrier to any immediate re-challenge by Mylan or its affiliates in this specific action context.
The public record does not specify the precise venue rationale. However, Hatch-Waxman plaintiffs have some flexibility in venue selection based on where the defendant has a registered presence or conducts business. West Virginia Northern District is an atypical venue for pharmaceutical ANDA cases compared to Delaware or New Jersey. The choice may reflect Mylan’s corporate registration or operational ties to the region, or a strategic preference for this court’s docket.
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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