Federal Circuit Affirms-in-Part CRISPR Patent Ruling in Broad Institute v. UC Regents

Introduction

In one of the most consequential gene-editing patent disputes of the decade, the U.S. Court of Appeals for the Federal Circuit issued a split ruling in *The Broad Institute, Inc. v. The Regents of the University of California* (Case No. 22-1653), affirming in part, vacating in part, and remanding the central appeal — while simultaneously dismissing the cross-appeal. The case, which spans 1,123 days from its April 2022 filing to its May 2025 closure, centers on U.S. Patent No. US8697359B1, covering CRISPR-Cas systems and methods for altering expression of gene products — arguably the most commercially significant biotechnology innovation of the 21st century.

For patent attorneys, IP professionals, and R&D leaders operating in the biotech and genomics sectors, this ruling carries immediate strategic implications: it reshapes the contours of CRISPR patent validity litigation and signals how the Federal Circuit will scrutinize patentability challenges involving complex, rapidly evolving biological technologies.

Case Overview

The Parties

The Patent at Issue

This landmark case involved U.S. Patent No. US8697359B1 (Application No. US14/054414) covering foundational methods of genome editing using the CRISPR-Cas9 mechanism in eukaryotic cells. These claims hold enormous commercial relevance across therapeutics, agriculture, and industrial biotechnology.

Legal Representation

The Plaintiff, Broad Institute, was represented by Raymond N. Nimrod of Quinn Emanuel Urquhart & Sullivan, LLP. The Defendant, UC Regents, was represented by Eldora L. Ellison of Sterne, Kessler, Goldstein & Fox, PLLC.

Litigation Timeline & Procedural History

The appeal was filed in the District of Columbia circuit jurisdiction and adjudicated at the Federal Circuit — the exclusive appellate forum for U.S. patent matters — following lower-level proceedings on patentability.

• Appeal Filed: April 15, 2022
• Court: Court of Appeals for the Federal Circuit
• Case Closed: May 12, 2025
• Duration: 1,123 days (~3 years)

The verdict cause was classified under Patentability / Invalidity-Cancellation Action, confirming this appeal arose from a challenge to the validity of Broad’s core CRISPR patent rather than a traditional infringement assertion at the district court level. The mixed disposition — affirmed-in-part, vacated-in-part, and remanded — indicates the Federal Circuit found merit in aspects of both parties’ positions, a nuanced outcome with meaningful downstream consequences.

The Verdict & Legal Analysis

Outcome

The Federal Circuit issued the following disposition in Case No. 22-1653:

AFFIRMED-IN-PART, VACATED-IN-PART, AND REMANDED as to the main appeal; DISMISSED as to the cross-appeal.

No damages award is applicable in this context, as the underlying action is a patentability/invalidity challenge rather than a direct infringement claim seeking monetary relief. The cross-appeal dismissal narrows the live issues on remand to those preserved under the main appeal.

Legal Significance

This ruling contributes to an evolving body of Federal Circuit precedent governing patentability standards for breakthrough biotechnologies. Key doctrinal questions implicated include:

• Written description and enablement under 35 U.S.C. § 112 for pioneering biological methods
• Priority and inventorship standards in interference-adjacent proceedings
• Claim scope of method patents covering transformative platform technologies

The partial remand preserves uncertainty over the ultimate validity of US8697359B1 claims, meaning the CRISPR patent landscape remains in flux for all stakeholders relying on freedom-to-operate (FTO) analyses touching Broad’s portfolio.