Information about licensing CRISPR-Cas9 systems

Q. What CRISPR-Cas9 patents have been issued to Broad Institute and MIT?

A. As of September 2015 the United States Patent and Trademark Office (USPTO) has issued 20 CRISPR and Cas9 patents, including a robust portfolio of 13 CRISPR patents to the Broad Institute, MIT and affiliated groups for inventions from Dr. Feng Zhang and the Zhang lab.

To date the United States Patent and Trademark Office has issued 20 CRISPR patents, including a robust portfolio of 13 CRISPR patents to the Broad Institute, MIT and affiliated groups for inventions from Dr. Zhang and the Zhang lab.

Zhang is a core member of the Broad Institute and a faculty member at MIT’s McGovern Institute for Brain Research and Department of Brain and Cognitive Sciences. As such, his CRISPR patents are assigned jointly to Broad Institute and MIT. For convenience they are often referred to as the ‘Broad patents’, but Broad Institute is acting on behalf of both institutions in managing this IP portfolio.

These patents cover mammalian genome editing methods and other distinct inventions optimizing the CRISPR-Cas9 components and system. The USPTO has further issued three additional genome editing-related patents to Harvard University relating to CRISPR inventions of Broad Senior Associate member George Church and the Church lab and also of Broad Institute member David Liu and the Liu lab.

In addition the European Patent Office (EPO) has granted four of Broad’s patent applications as of September, 2015.

Q. Can CRISPR be patented?

A. No. CRISPR itself cannot be patented. CRISPR is a naturally-occurring bacterial process, but this process, on its own, does not work in mammalian cells. What Broad has patented are engineered components and compositions specifically altered from their naturally-occurring form to be useful in methods for editing the genomes of living mammalian cells.

Q. If it holds the patent, why does Broad Institute share CRISPR-Cas9 with tens of thousands of researchers around the world?

A. Broad Institute is an academic non-profit research organization. Our faculty develop innovative techniques, create analytical tools, and make groundbreaking discoveries that we share with the global scientific community to benefit human health.

Broad Institute, MIT, and Harvard University partners have made CRISPR-Cas9 technology broadly available to the research community. Broad Institute is working with Addgene, a non-profit plasmid repository, to offer Zhang lab CRISPR plasmids and reagents to accelerate academic research. As of September, 2015 Addgene had shared nearly 24,000 reagents with users worldwide. In addition we have non-exclusively licensed many industry partners for development of research tools and reagents and will continue to do so.

Q. Other parties have challenged the Broad patents. How do you respond to these claims?

A. Feng Zhang and the Broad Institute of MIT and Harvard was the first to invent a method for eukaryotic genome editing -- based on unique research that had been underway at the Zhang lab since February 2011. This was further reflected in a January 2012 federal grant application to the National Institutes of Health and culminated in the manuscript submitted on October 5, 2012 that was published in Science on January 3, 2013 as Cong et al.

Zhang was also clearly first to file a patent application that described and enabled such a method. The Broad patent application of December 12, 2012 described a successful method for using CRISPR-Cas9 to accomplish genome editing in living mammalian cells, using approaches that were not envisioned in any earlier publications or techniques.

Other groups had filed patent applications related to CRISPR before the Broad application, but these applications did not describe genome editing techniques in eukaryotic cells -- which were demonstrated in Cong et al.

Zhang’s patent application and published paper included an actual method, one that was the result of nearly two years of independent, focused and successful effort at the Broad Institute and MIT – a method that has since become the standard for genome editing.

Q. How did Broad’s request for accelerated review by the US Patent Office affect the patent-review process? Did it cause other parties to be bypassed?

A. No. Expediting a patent application via the "fast track" process (called “accelerated examination”) simply means that the application will be considered more quickly and that the Broad had to agree to respond more quickly to questions raised by the USPTO. It does not change the level of scrutiny applied to the application -- the same process of comparing the application to all other potentially-related patents takes place and the decision rendered by the USPTO is the same as it would have been had the process not been fast-tracked. In this case, Broad's applications were considered against those from UC Berkeley and other institutions, as they would have been regardless of whether the patent had been examined via the accelerated review process or otherwise.

Broad was not the first to file a patent request related to CRISPR. However, Broad was the first to file a patent that described an actual invention -- experimental data regarding a successful method for mammalian genome editing.