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Patent Landscape

Patent Landscape:
CRISPR Gene Editing

Two Nobel laureates. One contested patent. The Broad Institute vs UC Berkeley dispute has cost tens of millions in legal fees and determined who controls the most consequential biological technology of our time.

CRISPR-Cas9 is a gene editing system adapted from a bacterial immune mechanism — and it is the subject of the most significant patent dispute in modern biotech. The story centers on two groups: Jennifer Doudna's lab at UC Berkeley, which demonstrated CRISPR-Cas9 editing in purified biochemical systems in 2012, and Feng Zhang's lab at the Broad Institute, which demonstrated the system working inside eukaryotic (human and animal) cells in 2013. The question of who holds the patent on CRISPR in eukaryotic cells — the commercially valuable application for human therapeutic gene editing — has been contested before the USPTO's Patent Trial and Appeal Board for nearly a decade.

The patent landscape matters because CRISPR therapy is now real medicine. In December 2023, the FDA approved Casgevy — a CRISPR-based treatment for sickle cell disease developed by CRISPR Therapeutics and Vertex Pharmaceuticals — making it the first approved gene editing therapy in history. The patents that govern Casgevy, and all future CRISPR therapies, determine who can develop treatments, who must pay royalties, and ultimately how accessible these transformative medicines can become.

Key Patents

US8,697,3592014

CRISPR-Cas9 Gene Editing in Eukaryotic Cells

Broad Institute / MIT / Harvard (Feng Zhang)

The most contested patent in modern biotechnology history. Covers CRISPR-Cas9 gene editing in eukaryotic cells — the cells of animals, plants, and fungi that are the target of therapeutic applications. Feng Zhang's lab at the Broad Institute was granted this patent after a controversial interference proceeding against UC Berkeley's earlier filing.

US10,000,7722018

CRISPR-Cas9 System and Methods for Genome Editing

University of California Berkeley (Jennifer Doudna)

Jennifer Doudna and Emmanuelle Charpentier's fundamental CRISPR-Cas9 work — demonstrating that the system could edit DNA in a test tube — predated Zhang's eukaryotic application. UC Berkeley has fought a years-long PTAB interference proceeding claiming their work covered the eukaryotic application too. The dispute has cost both institutions tens of millions in legal fees.

US10,465,1762019

Base Editing — Chemical Modification of DNA Without Double-Strand Breaks

Broad Institute / David Liu / Beam Therapeutics

David Liu's base editing patent covers a more precise variant of CRISPR that chemically converts one DNA base to another without cutting both strands of the double helix. This reduces the risk of unintended edits (off-target effects) that have been a concern with standard CRISPR-Cas9. Beam Therapeutics was founded to commercialize this technology.

US10,301,6512019

Prime Editing — Precision Gene Writing Without Double-Strand Breaks

Broad Institute / David Liu

Prime editing is the 'find and replace' of gene editing — capable of making any of the 12 possible base-to-base conversions, small insertions, or small deletions at specified genomic locations. This patent portfolio, also commercialized through Prime Medicine, represents the third generation of CRISPR tools.

US10,787,6842020

CRISPR-Based Therapeutics Delivery Using Lipid Nanoparticles

CRISPR Therapeutics / Intellia Therapeutics

Gene editing requires delivery of the CRISPR machinery into target cells — and lipid nanoparticle (LNP) delivery is the leading method. This patent landscape covers the specific LNP formulations used to deliver CRISPR components in vivo, which proved critical when Intellia demonstrated the first in vivo human CRISPR editing in 2021.

US10,975,3932021

Anti-CRISPR Proteins for Controlling Gene Editing Activity

University of California Berkeley

Anti-CRISPR proteins are naturally occurring inhibitors of CRISPR systems that can serve as an off-switch for gene editing. These proteins allow researchers to limit CRISPR activity after delivery — addressing safety concerns about off-target edits. The patent covers use of anti-CRISPRs as a control mechanism in therapeutic applications.

Key Players

Broad Institute (MIT/Harvard)

Holds the dominant eukaryotic CRISPR patent position in the United States after winning the 2017 PTAB interference proceeding against UC Berkeley. Broad licenses its CRISPR IP to Editas Medicine (exclusive for human therapeutics) and many other companies. The Broad's strategy is to maintain control of the most commercially valuable CRISPR applications while broadly licensing for research use.

UC Berkeley / Jennifer Doudna

UC Berkeley licenses its CRISPR IP to CRISPR Therapeutics, Intellia Therapeutics, and Caribou Biosciences — the companies founded by Doudna and her collaborators. While the US eukaryotic patent dispute went against Berkeley, they won in Europe. The international IP landscape remains split, creating a complex global licensing situation for any company operating across jurisdictions.

Editas Medicine

Holds an exclusive license to Broad Institute's CRISPR patents for human therapeutic applications, making Editas the most IP-advantaged therapeutic CRISPR company in the US. This exclusivity, however, also created tension when Doudna-affiliated companies challenged its scope — and when multiple companies moved forward with therapies regardless.

CRISPR Therapeutics / Intellia Therapeutics

Licensed from UC Berkeley and operating under a different patent framework than Editas. CRISPR Therapeutics and Vertex Pharmaceuticals received FDA approval for the first CRISPR therapy (Casgevy) in December 2023 — making it the first approved gene editing treatment in history, and validating the commercial value of Berkeley's patent position.

What to Watch

01

PTAB Interference Proceedings

The Broad vs Berkeley dispute initiated multiple PTAB interference proceedings — the administrative process for determining who invented first. The PTAB ruled for Broad in the US in 2017, but Berkeley appealed and the case reached the Federal Circuit. Meanwhile, additional interference proceedings around base editing and prime editing are unfolding through the same process.

02

Therapeutic Application Patents

The first wave of CRISPR patents covered the fundamental mechanism. The second wave — now being filed and litigated — covers specific therapeutic applications: sickle cell disease (Casgevy), cancer immunotherapy (CRISPR-engineered T cells), rare genetic disorders. Each application creates a new patent cluster, and the licensed companies are racing to file before their exclusivity windows close.

03

CRISPR in Agriculture

Plant gene editing using CRISPR is a separate patent domain from human therapeutics — with different assignees, different regulatory frameworks, and different IP dynamics. Pioneer (Corteva), Bayer Crop Science, and DuPont have built agricultural CRISPR portfolios that are largely independent of the Broad/Berkeley dispute. USDA deregulation of CRISPR-edited crops has opened a commercial agricultural market that is now generating its own patent wars.

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