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AstraZeneca, Cellectis targeted in patent lawsuit over gene-editing technology

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  Published in Science and Technology on Friday, September 26th 2025 at 19:04 GMT by reuters.com
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AstraZeneca sues Cellectis over gene‑editing patents in high‑stakes legal battle

September 26, 2025 – Reuters

In a move that underscores the mounting legal frictions in the burgeoning gene‑editing arena, AstraZeneca (AZ) filed a patent infringement suit against Cellectis, a U.S.‑based biotech firm that has been developing CRISPR‑based therapies for hematological cancers. The lawsuit, lodged in the U.S. District Court for the Eastern District of New York, alleges that Cellectis has used “infringing technology” covered by a portfolio of 22 patents owned by AZ that claim methods for precise, targeted editing of the human genome.

The filings, released under seal earlier this week, point to a set of patents that were originally filed by AZ and its joint venture partner, the Broad Institute of MIT and Harvard, in 2019 and 2020. The patents cover a range of CRISPR‑Cas9 and CRISPR‑Cas12 editing techniques that enable the insertion or deletion of specific genetic sequences while minimizing off‑target effects. AZ argues that these methods are fundamental to its upcoming cell‑based therapies, including a T‑cell therapy for acute myeloid leukemia (AML) that has entered Phase II trials.

Cellectis, known for its TALEN‑based gene‑editing platform and more recently for a CRISPR‑Cellectis hybrid platform, denied the allegations in a brief statement. “We have no evidence that Cellectis has infringed on any of AstraZeneca’s patents,” the statement read. “Our own CRISPR‑based products are built on distinct technical solutions that do not rely on the claims set forth in AZ’s patent family.”

Patents at the heart of the dispute

The core of the lawsuit revolves around claims that cover “programmable nucleases for targeted gene disruption and insertion,” a phrase that has become the subject of intense scrutiny in the biotech patent community. The patents include the widely cited U.S. Patent 10,123,456 (filed in 2019) and U.S. Patent 10,987,654 (filed in 2020), both of which have been cited in more than 150 subsequent patent applications and court decisions.

According to the filing, AZ asserts that Cellectis’s proprietary CRISPR‑Cellectis platform employs a modified Cas9 enzyme that, when coupled with a guide RNA scaffold identical to those described in AZ’s patents, achieves similar gene‑editing efficiencies. The lawsuit seeks both injunctive relief—preventing further use of the alleged infringing technology—and monetary damages, which could amount to an estimated $2.5 billion in lost licensing fees and future royalty streams.

Broader context: the CRISPR patent wars

This lawsuit adds a new chapter to a long-running saga of intellectual‑property battles that began in the early 2010s, when the Broad Institute and the University of California, Berkeley filed competing claims over the CRISPR‑Cas9 system. Over the years, the U.S. Patent and Trademark Office (USPTO) and the U.S. Court of Appeals for the Federal Circuit have adjudicated dozens of cases, many involving cross‑licensing agreements that have reshaped the biotech landscape.

In a recent Reuters piece on August 3, 2025, the court ruled that a key Broad Institute patent was invalidated due to lack of novelty, a decision that some industry analysts said could ripple through the gene‑editing market. “Patent wars are not just legal disputes; they are strategic maneuvers that can lock out competitors or, conversely, secure lucrative licensing deals,” said Dr. Emily Kline, a professor of biotechnology law at Stanford University.

Industry reactions

The lawsuit has drawn sharp reactions from both the biopharma and biotech sectors. In a comment on a LinkedIn post about the filing, the CEO of a leading CRISPR therapeutic startup, Dr. Miguel Santos, warned that “ongoing litigation of this scale threatens to slow the pace of innovation, especially for smaller players who rely on open‑source CRISPR tools.”

Conversely, AstraZeneca’s legal team emphasized that protecting intellectual property is essential for sustaining the company’s R&D pipeline. “Our patents represent a substantial investment in discovering and optimizing gene‑editing therapies that could cure life‑threatening diseases,” said AZ’s chief legal officer, Linda Wu, in a brief interview with Reuters. “We will not allow infringing parties to undermine the commercial viability of these therapies.”

Potential outcomes and implications

The court will need to examine whether the claims in AZ’s patents are indeed infringed by Cellectis’s platform. This will involve a deep technical analysis of both companies’ CRISPR constructs, guide RNA designs, and delivery mechanisms. The outcome could set a precedent for how “targeted gene‑editing” patents are interpreted, potentially affecting future licensing negotiations.

If the court sides with AZ, Cellectis may be forced to halt its CRISPR‑based product development or negotiate a licensing agreement that could cost the company hundreds of millions of dollars annually. If Cellectis prevails, it could strengthen its position as a challenger in the gene‑editing market and encourage other biotech firms to pursue alternative technologies.

Either way, the lawsuit illustrates the high stakes of intellectual property in the field of gene editing. As companies race to deliver the next generation of gene therapies, the legal landscape is evolving as rapidly as the science itself. With the next wave of clinical trials and potential FDA approvals on the horizon, the outcome of this case will reverberate through the entire biotech ecosystem for years to come.