Bausch Health v. Mylan: Plecanatide Patent Dispute Settled After 986 Days

After nearly three years of pharmaceutical patent litigation in West Virginia’s Northern District Court, Bausch Health Ireland Limited and Salix Pharmaceuticals, Inc. reached a confidential settlement with Mylan Pharmaceuticals Inc. in a high-stakes patent infringement dispute centered on Plecanatide oral tablets (3 mg) — the active-ingredient formulation marketed under the brand name Trulance®. Filed on September 1, 2022, and closed on May 14, 2025, Case No. 1:22-cv-00085 ran 986 days before concluding with a stipulated dismissal with prejudice.

The case is a textbook Hatch-Waxman ANDA litigation scenario: a branded pharmaceutical company protecting a portfolio of ten patents against a generic manufacturer’s Paragraph IV certification. The outcome — a negotiated settlement allowing Mylan to maintain its Paragraph IV certifications while permitting potential future FDA approval of ANDA No. 215686 — carries meaningful strategic implications for pharmaceutical patent litigation, generic drug market entry timing, and multi-patent portfolio defense strategies.

For patent attorneys, IP professionals, and R&D leaders operating in the pharmaceutical space, this case offers instructive lessons about settlement leverage, Hatch-Waxman procedural mechanics, and the value of broad patent portfolios in ANDA disputes.

Case Overview

The Parties

The Patents at Issue

This landmark case involved ten U.S. patents, including US11319346B2 and US11142549B2, alongside US7,041,786; US9,610,321; US9,616,097; US9,919,024; US9,925,231; US10,011,637; US11,834,521; and US12,146,003. These patents collectively cover formulation chemistry, peptide compositions, and methods of use relating to Plecanatide oral tablets, 3 mg.

The Accused Product

Mylan’s ANDA No. 215686 sought FDA approval for a generic version of Plecanatide oral tablets, 3 mg — a commercially significant gastrointestinal drug generating hundreds of millions in annual revenue for Salix.

Legal Representation

Plaintiffs were represented by Bryan C. Diner, Daniel R. Higginbotham, and Justin James Hasford of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP — one of the most prominent IP-focused law firms globally — alongside local counsel Thomas Combs & Spann, PLLC.

Defendant was represented by Gordon H. Copland and William J. O’Brien of Steptoe & Johnson PLLC (Bridgeport office).

Litigation Timeline & Procedural History

The complaint was filed on September 1, 2022, in the U.S. District Court for the Northern District of West Virginia, before Chief Judge Thomas S. Kleeh. The Northern District of West Virginia is an established venue for Hatch-Waxman litigation, given Mylan Pharmaceuticals Inc.’s historical corporate presence in Morgantown, West Virginia — making it a natural and strategically logical forum for defendants in ANDA disputes.

The case ran for 986 days — approximately 32 months — which falls within the typical range for Hatch-Waxman cases that settle before trial. The 30-month automatic stay under 21 U.S.C. § 355(j)(5)(B)(iii), triggered by the Plaintiffs’ timely filing within 45 days of receiving Mylan’s Paragraph IV notice letter, expired during the pendency of the litigation. The stipulated dismissal, filed May 14, 2025, confirmed expiration of the stay and resolved all claims and counterclaims with prejudice.

No trial record, Markman hearing ruling, or summary judgment decisions are publicly disclosed in the provided case data, suggesting the parties pursued settlement-track negotiations throughout the litigation lifecycle.

The Verdict & Legal Analysis

Outcome

The case was dismissed with prejudice pursuant to a Confidential Settlement and License Agreement executed between all parties. No damages, costs, disbursements, or attorney fees were awarded to either side. The specific financial terms of the license agreement were not disclosed publicly.

Critically, the settlement’s publicly filed stipulation reveals several significant concessions and acknowledgments:

• Plaintiffs acknowledged Mylan’s right to maintain its Paragraph IV certifications against all ten patents.
• The parties confirmed the 30-month stay had expired.
• Plaintiffs acknowledged that nothing prevents the FDA from granting final approval to ANDA No. 215686 at any time.
• Mylan is explicitly recognized as entitled to pursue and obtain FDA approval for its generic Plecanatide product prior to expiration of the ten listed patents.

Verdict Cause Analysis

This outcome strongly suggests the parties reached a negotiated early entry agreement — a common Hatch-Waxman settlement structure where the branded company grants the generic manufacturer a license to enter the market at a specified future date, prior to patent expiration, in exchange for the generic dropping its invalidity and non-infringement challenges.

The fact that Plaintiffs acknowledged Mylan’s right to maintain Paragraph IV certifications — rather than securing a retraction — indicates Mylan retained meaningful leverage throughout litigation, likely through validity challenges or non-infringement arguments that posed credible risk to the Plaintiffs’ patent portfolio.

Legal Significance

Several legally significant elements emerge from the stipulation:

1. Multi-patent portfolio strategy: Plaintiffs asserted ten patents across multiple patent families, a deliberate portfolio layering strategy designed to maximize litigation risk for the generic challenger and extend market exclusivity through overlapping claim coverage.
2. Paragraph IV certification survival: Mylan’s retention of its Paragraph IV certifications post-settlement is notable. In many Hatch-Waxman settlements, generic companies agree to withdraw Paragraph IV certifications in exchange for licensing rights. Here, Mylan preserved its certification posture, which may bear strategic relevance if the Settlement Agreement’s market entry date or licensing conditions are later disputed.
3. Court retains jurisdiction: The stipulation preserves district court jurisdiction to enforce the settlement — a standard but practically important provision ensuring efficient enforcement without refiling.

Strategic Takeaways

For Patent Holders: Building deep patent portfolios around pharmaceutical products — covering composition, formulation, method of use, and process claims across multiple patent families — creates settlement leverage even when individual patents face validity risks. The Bausch/Salix portfolio of ten patents exemplifies this layered approach.

For Accused Infringers: Early investment in comprehensive Paragraph IV certification strategies and ANDA litigation defense can yield favorable settlement terms, including pre-expiration market entry rights, even without a full trial on the merits.

For R&D and Regulatory Teams: Monitor 30-month stay expiration dates carefully. Once the stay expires, FDA approval becomes procedurally available regardless of pending litigation — a dynamic that reshapes settlement leverage and timelines significantly.

Industry & Competitive Implications

The resolution of this dispute has direct commercial implications for the Plecanatide market. With Mylan (now Viatris) positioned to obtain FDA final approval for ANDA No. 215686, generic competition to Trulance® is no longer a matter of “if” but “when,” contingent on the confidential license agreement’s entry date terms.

For Bausch Health and Salix, this outcome reflects the broader reality facing branded pharmaceutical companies as their drug patent estates age: aggressive ANDA challenges from well-resourced generic manufacturers are increasingly difficult to litigate through to favorable verdicts, making negotiated licensing the pragmatic endpoint in many disputes.

This case also reflects a continuing trend in Hatch-Waxman litigation where settlements — rather than judicial determinations on validity or infringement — resolve the vast majority of ANDA disputes. According to industry data, fewer than 5% of Hatch-Waxman cases proceed to a final merits decision, underscoring the settlement-centric nature of pharmaceutical patent litigation strategy.

Companies managing branded pharmaceutical portfolios should consider post-settlement regulatory monitoring, as FDA final approval timelines for ANDAs following stay expiration can move quickly.

FAQ

What patents were involved in Bausch Health v. Mylan (1:22-cv-00085)?

Ten U.S. patents were at issue, including US11319346B2 and US11142549B2, covering Plecanatide oral tablet formulations and related compositions.

What was the basis for dismissal in this case?

The parties entered a Confidential Settlement and License Agreement, resulting in a stipulated dismissal with prejudice filed May 14, 2025.

How might this settlement affect Plecanatide patent litigation?

Mylan’s acknowledged right to pursue FDA approval for its generic Plecanatide product prior to patent expiration signals forthcoming generic market entry, with timing governed by confidential license terms.