Ravgen v. LabCorp: $384M Jury Verdict in Prenatal DNA Patent Case

Case Overview

In one of the most consequential prenatal diagnostics patent verdicts in recent memory, a Texas federal jury found Laboratory Corporation of America Holdings (LabCorp) liable for willful infringement of Ravgen, Inc.’s cell-free DNA (cfDNA) patent — awarding $384,223,100.20 in damages. Closed on February 19, 2025, after more than four years of litigation, Case No. 6:20-cv-00969 in the Western District of Texas stands as a landmark ruling in prenatal genetic testing patent infringement litigation.

The case targeted LabCorp’s commercially dominant non-invasive prenatal testing (NIPT) products — MaterniT21 PLUS, MaterniT Genome, and informaSeq — and ultimately confirmed both the validity and infringement of Claim 132 of U.S. Patent No. 7,332,277. For patent attorneys, IP professionals, and R&D teams operating in the genomics and molecular diagnostics space, this verdict demands careful analysis.

The Parties

Patents at Issue

This litigation involved two patents covering foundational method elements in non-invasive prenatal testing:

• • U.S. Patent No. 7,332,277 — The primary patent at issue. Claim 132 covers methods for obtaining fetal genetic information from maternal blood samples by analyzing cell-free fetal DNA while inhibiting cell lysis.
• • U.S. Patent No. 7,727,720 — Also cited in the litigation, covering related cfDNA-based diagnostic methods.

The **Accused Products** were LabCorp’s MaterniT21 PLUS, MaterniT Genome, and informaSeq tests, commercially significant NIPT offerings used to screen for chromosomal abnormalities.

Litigation Timeline & Procedural History

Filed on **October 16, 2020**, in the **Western District of Texas**, the case ran for **1,587 days** before final judgment on **February 19, 2025** — a duration reflecting the complexity of both the underlying science and the multi-front legal battles typical of high-value patent disputes.

Venue selection in the Western District of Texas was strategically deliberate. Chief Judge **Alan D. Albright** — known nationally for his patent-friendly docket management, accelerated scheduling, and reluctance to stay cases pending inter partes review — made the Waco Division a preferred forum for patent plaintiffs during this period.

The case proceeded through standard district court milestones: claim construction proceedings interpreting the key limitations of Claim 132, validity challenges targeting the ‘277 Patent, and ultimately a jury trial on both infringement and willfulness. Post-trial motions (ECF Nos. 293, 294, 303, 309, 311, 312, and 314) were resolved before final judgment was entered, confirming the jury’s findings and the court’s own trial rulings without overturning the core verdict.

The Verdict & Legal Analysis

Outcome

The final judgment is unambiguous and tripartite: LabCorp infringes Claim 132 of U.S. Patent No. 7,332,277; Claim 132 is not invalid; and LabCorp’s infringement was willful. Judgment was entered **in favor of Ravgen** in the amount of **$384,223,100.20** — a sum that reflects the substantial commercial revenue generated by LabCorp’s accused NIPT products over the damages period.

Verdict Cause Analysis

The jury’s **willfulness finding** is particularly significant. Under *Halo Electronics, Inc. v. Pulse Electronics, Inc.* (2016), willful infringement requires that the defendant’s conduct was deliberately or consciously wrongful. A willfulness determination opens the door to enhanced damages under 35 U.S.C. § 284 — up to treble the compensatory award — though the record does not indicate whether the court exercised that discretion here.

The **validity challenge failed**, meaning LabCorp’s invalidity arguments — likely including obviousness under 35 U.S.C. § 103 and possibly anticipation — did not persuade the jury. The survival of Claim 132 through both trial and post-trial motions strengthens the ‘277 Patent’s enforceability posture against other potential infringers in the NIPT market.

Claim construction of Claim 132 — specifically how the court interpreted the “inhibiting cell lysis” limitation central to Ravgen’s cfDNA methodology — almost certainly served as a pivotal battleground. The jury’s infringement finding implies that LabCorp’s accused testing processes fell within the construed scope of that claim.

Legal Significance

This verdict reinforces that **foundational method patents in genomic diagnostics retain robust enforceability** even as the underlying technology becomes widely adopted. The inability to invalidate Claim 132 — despite the resources LabCorp deployed — signals that Ravgen’s core IP withstands rigorous invalidity scrutiny.

The case also demonstrates that willfulness exposure in the NIPT space is real and consequential. Companies commercializing cfDNA-based tests without resolving freedom-to-operate (FTO) questions face not merely compensatory damages exposure but potential enhancement.