Narrower Patent Means CRISPR Victory for Broad Institute

By: Smitha Gundavajhala

On February 28, 2022, the US Patent and Trademark Office (USPTO) handed down a ruling in one of the most bitterly fought patent turf wars in biotechnology: the battle over the use of CRISPR-Cas9 in humans. The two major groups that were vying for recognition were the Broad Institute, consisting of researchers from Harvard, and MIT and CVC, consisting of researchers from UC Berkeley, the University of Vienna, and Emmanuelle Charpentier. 

CRISPR-Cas9 is a revolutionary gene editing tool that has implications for healthcare, agriculture, and more. CRISPRs are DNA sequences with proteins that act like scissors. Originally derived from bacterial genomes, CRISPR technology has since been extended to apply to eukaryotes, which are multicellular organisms. Examples of eukaryotes include plants, animals, and humans. As one might imagine, the latest evolution in CRISPR technology is immensely lucrative. The technology could be used to prevent viral infections and chronic conditions in humans, as well as to genetically modify produce to carry more nutrients.  Both Broad Institute and CVC stood to lose a great deal in their hard-fought dispute about the CRISPR-Cas 9 patent.

The dispute between these parties was complicated by timelines, the change in US patent law, and the contradictory decisions of different jurisdictions across the world. Jennifer Doudna of UC Berkeley was the first to file a patent application in 2012, a few months before Feng Zhang and the Broad Institute filed their patent application. However, prior to 2013, the USPTO’s rules were different: the agency awarded patents to the entity that was the “first to invent,” rather than the entity that was “first to file.” 

Thus, when Doudna asked USPTO to declare an “interference” between the two patents in 2015, the office had to consider which group was the first to invent by “reducing the concept to practice.” CVC argued that Broad Institute’s patent for gene editing in eukaryotes was a mere extension of CVC’s seminal work on CRISPR-Cas9. In 2017, the Patent Trial and Appeal Board (PTAB) ruled that Broad Institute’s patents were not derived from CVC’s patents. In 2019, PTAB again declined to declare an interference regarding claims to CRISPR-Cas9 technology used in eukaryotes, and confirmed that the Broad Institute’s patents were properly issued.

Ultimately, Doudna’s patent application did not explicitly address CRISPR-Cas9 applications for eukaryotes, and Zhang’s patent application did. Thus, Zhang and the Broad Institute were determined to be the “first to invent” CRISPR-Cas9 gene editing for humans. This year’s USPTO decision represents potential losses of billions in licensing revenue for UC Berkeley and priority of invention for Broad Institute.

However, this turf war is far from over and recognition of the Broad Institute’s and CVC’s patents varies across jurisdictions. Currently, CVC maintains fundamental CRISPR-Cas9 patents in over 80 jurisdictions, including China, Japan, and the European Union. CVC and the Broad Institute also face challenges in other countries: South Korea’s ToolGen and Germany’s Sigma Aldrich still have open interference motions with the Broad Institute. From the looks of it, the international fight for CRISPR-Cas9 patent recognition won’t be over any time soon, even while the dust has seemingly settled in the United States.

Reasonably Expecting to Change the World: The CRISPR-Cas9 Patent Battle

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By Michael Rebagliati

In addition to the cited sources, the author would like to thank a family member with far more scientific knowledge, Michael R. Rebagliati, Ph.D., for his essential scientific edits, commentary and analysis.

Right now, a new gene-editing technology called CRISPR-Cas9 is spreading throughout the scientific and business communities and into the public consciousness. The scientific implications are vast because CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is not just one scientific invention with one purpose. Rather, it is a natural process that has been harnessed and redirected into a gene-editing technique that is (relatively) easy to use. Moreover, its high efficiency means that scientists can use it to edit the genetic code of any gene in many kinds of organisms. Think Industrial Revolution for genetic engineering. Continue reading

The Arrival of CRISPR: Why The Genetically Modified Human Is No Longer Science Fiction

gattacaBy Miles Bludorn

The 1997 film Gattaca, set in “the not too distant future,” envisioned a world where parents possess complete control over the DNA they pass on to their children. The “future” forecasted in the film is now closer than ever with the latest advancement in genetic engineering known as CRISPR-Cas9 (“CRISPR”).

With the use of CRISPR, scientists, for the first time ever, can precisely edit, delete, and rearrange the DNA of nearly any living organism, including humans. Genetic editing using CRISPR takes place inside an embryo on what is known as the germ line. This allows scientists to edit the genetic material that can be inherited by the next generation. After altering, a genetic trait can be passed on to future generations. The potential of editing the germ line does not just mean that we will be able to control a child’s eye or hair color, it could also mean the ability to eliminate hereditary diseases altogether.

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