Appeals Court Reopens CRISPR Patent Dispute, Shaking Gene Editing Landscape

A federal appeals court has reignited the long-standing CRISPR patent controversy, potentially reshaping the intellectual property landscape for gene editing technologies. The decision, which challenges a previous ruling favoring the Broad Institute, has sent ripples through the biotech industry and raised questions about the future of CRISPR-based therapeutics.

Patent Board's Decision Overturned

The U.S. Court of Appeals has found fault with a 2022 ruling by the Patent Trial and Appeal Board (PTAB) that had awarded key CRISPR patents to scientists from the Broad Institute of Harvard and the Massachusetts Institute of Technology (MIT). The appeals court has ordered the PTAB to reconsider its decision, citing an incorrect application of legal standards in the original ruling.

At the heart of the dispute is the question of who first conceived the idea of using CRISPR-Cas9 for editing eukaryotic cells. The PTAB had previously determined that the Broad team, whose work underpins Editas Medicine's intellectual property, was first to conceive this application. However, the appeals court has now challenged this conclusion, focusing on the legal definition of conception in scientific discovery.

Implications for Biotech Companies

The court's decision has significant implications for several biotech companies:

• Editas Medicine, which holds an exclusive license from the Broad Institute, may face uncertainty regarding its intellectual property position.
• CRISPR Therapeutics and Caribou Biosciences, which have licensed CRISPR-Cas9 technology from the opposing side of the dispute, could potentially benefit from a reconsideration of the patents.

Editas CEO Gilmore O'Neill has stated that the ruling "does not affect our ability to license our IP, nor does it change existing licenses we have issued." However, the reopening of the case introduces a new element of uncertainty into the CRISPR patent landscape.

Scientific Conception vs. Legal Standards

The appeals court's decision hinges on the interpretation of scientific conception in patent law. While the PTAB had ruled that Jennifer Doudna and Emmanuelle Charpentier didn't conceive the use of CRISPR-Cas9 in eukaryotic cells due to uncertainty about its efficacy, the appeals court argued that what matters is whether the scientists "had a definite and permanent idea," not whether they were certain it would work.

This distinction could prove crucial as the PTAB reassesses the early work of Doudna and Charpentier, including discussions about eukaryotic applications dating back to March 2012, months before the publication of their seminal paper demonstrating CRISPR-Cas9 editing in test tubes.

As the biotech industry awaits the PTAB's reconsideration, the outcome of this latest chapter in the CRISPR patent saga could have far-reaching consequences for gene editing research and commercialization efforts worldwide.