Novo Nordisk vs. Mylan: GLP-1 Patent Dispute Dismissed Without Prejudice

Case Overview

The Parties

The Patent(s) at Issue

This closely watched case involved U.S. Patent No. 11,752,198 covering GLP-1 compositions and their uses, a technically and commercially critical area for diabetes and obesity treatments. The case was also consolidated in practice with related proceedings involving U.S. Patent No. 10,888,605.

• • US 11,752,198 — GLP-1 compositions and uses thereof
• • US 10,888,605 — GLP-1 related compositions and methods

Legal Representation

Novo Nordisk was represented by Morris, Nichols, Arsht & Tunnell LLP, with attorneys Jack B. Blumenfeld, Brian P. Egan, and Travis J. Murray. Mylan retained Stamoulis & Weinblatt LLC, represented by Stamatios Stamoulis.

Litigation Timeline & Procedural History

The complaint was filed on January 12, 2024, in the United States District Court for the District of Delaware — the jurisdiction of choice for pharmaceutical patent litigation. The case was assigned to Chief Judge Colm F. Connolly.

Over its 434-day lifespan, the case progressed through initial pleadings and counterclaims but did not advance to claim construction or trial. Mylan filed counterclaims challenging the ‘198 Patent (Seventh and Eighth Counterclaims in the related docket), suggesting an intent to pursue invalidity defenses before the parties ultimately agreed to stand down.

The relatively compressed resolution — compared to the average 2–3 year trajectory of contested Delaware pharmaceutical patent cases — suggests that parallel settlement or licensing negotiations progressed alongside the litigation, ultimately leading to the stipulated joint dismissal filed on March 21, 2025.

The Verdict & Legal Analysis

Outcome

The case closed via stipulated dismissal without prejudice pursuant to Federal Rules of Civil Procedure 41(a)(1)(A)(ii) and 41(c). Critically:

• • All infringement claims regarding U.S. Patent No. 11,752,198 were dismissed without prejudice.
• • All related counterclaims by Mylan concerning the ‘198 Patent were likewise dismissed without prejudice.
• • Each party bears its own costs, expenses, and attorneys’ fees — a cost-neutral resolution with no damages award disclosed.
• • No injunctive relief was granted or denied on the merits.

The companion case (1:23-cv-00101-CFC) involving the ‘605 Patent was simultaneously resolved under the same stipulation, consolidating the exit from both proceedings.

Verdict Cause Analysis

Because the dismissal was stipulated and without prejudice, no merits ruling was issued on infringement, claim validity, or claim construction. The legal record does not reflect a judicial finding regarding whether Mylan’s GLP-1 product infringed the ‘198 Patent or whether the patent’s claims were valid. This procedural posture is characteristic of one of several scenarios: a negotiated licensing arrangement, a decision by Novo Nordisk to abandon assertion of these specific claims strategically, Mylan altering its product formulation to avoid infringement exposure, or ongoing commercial negotiations that rendered continued litigation counterproductive.

The absence of a cost-shifting arrangement is notable. Under 35 U.S.C. § 285, exceptional case fee awards are available in patent litigation; the mutual bear-your-own-costs provision suggests neither party sought — or could sustain — an exceptionality argument, pointing toward an amicable, negotiated conclusion rather than a capitulation by either side.

Legal Significance

A dismissal without prejudice under Rule 41 preserves Novo Nordisk’s right to reassert the ‘198 Patent against Mylan in future proceedings, subject to applicable statutes of limitations and any agreement terms not reflected in the public record. This distinguishes the outcome sharply from a dismissal with prejudice or an adverse invalidity judgment — both of which would carry significant precedential weight.

For the GLP-1 patent litigation landscape, the case contributes no claim construction record and no validity findings, meaning the ‘198 Patent’s enforceability remains untested in this forum.

Strategic Takeaways

• • For Patent Holders: Dismissing without prejudice preserves optionality — particularly valuable when a patent’s commercial relevance may increase as the GLP-1 market expands. Novo Nordisk retains enforcement leverage for future contingencies.
• • For Accused Infringers: Mylan’s counterclaims position, while ultimately dismissed, signals the importance of preparing robust invalidity arguments as negotiating leverage, even if they never reach adjudication.
• • For R&D Teams: The involvement of an application-stage patent (App. No. 17/115,773 issuing as the ‘198 Patent) highlights the need for FTO (freedom-to-operate) analyses that account for continuation and continuation-in-part applications in active pharmaceutical portfolios — not just issued patents already in litigation.

Industry & Competitive Implications

The GLP-1 pharmaceutical space is among the most heavily litigated patent landscapes in modern drug development. With semaglutide and tirzepatide generating tens of billions in annual revenue, generic manufacturers face enormous commercial incentives to challenge branded GLP-1 patents aggressively under the Hatch-Waxman Act framework.

This dismissal, while procedurally inconclusive, reflects a broader trend: early-stage resolution of GLP-1 patent disputes through negotiation rather than full merits adjudication. This may reflect the commercial complexity of the space, where licensing arrangements, co-development agreements, or authorized generic pathways offer more value than protracted litigation for both originators and generics.

For companies developing GLP-1 products or adjacent peptide therapeutics, this case reinforces the need to monitor continuation patent filings by market leaders like Novo Nordisk. The ‘198 Patent, issuing from application 17/115,773, represents exactly the type of portfolio expansion strategy originators use to extend protection timelines beyond initial compound patents.

Competitors and in-house IP teams should also note Chief Judge Connolly’s active Delaware docket in pharmaceutical IP — his management philosophy can affect litigation strategy and timing in ways that influence settlement calculus early in proceedings.