By: Sarah Alberstein

UC Berkeley and MIT’s Broad Institute have been battling over the patent to coveted CRISPR/Cas-9 technology since 2012.[1] CRISPR/Cas-9 technology can be used to “silence mutated organismal DNA, replace it with correct sequences, or both in conjunction…[and] to sustain and lengthen the lifespan of…bacterial cultures by protecting them from viral attack…minimiz[ing] hassle and time spent re-growing cultures following a viral attack while maximizing efficiency for the researcher.”[2] What’s more, unlike previous gene-editing technologies, CRISPR-Cas-9 “makes it possible to observe specific effects of a particular gene and thus allows for more precise data collection and observation” while minimizing down-stream mutation.[3] The implications of CRISPR/Cas-9 are immense. For example, CRISPR/Cas-9 has the potential to cure previously incurable diseases, like Alzheimer’s and HIV, remove malaria from mosquitos, develop new drugs, alter livestock and agricultural crops, and develop new cancer treatments.[4] It is no surprise that there would be controversy over who owns and controls the patent for this powerful technology.

As of April 2018, the U.S. Patent and Trademark Office “had issues 60 CRISPR-related patents to nearly 20 different organizations.”[5] However, there is one patent in particular which has been hotly contested – the patent that covers the use of CRISPR-Case9 to edit DNA in mammals.[6] In May 2012, Berkeley filed a patent application for the use of CRISPR/Cas-9 to “edit genes in various types of cells.”[7] In December 2012, the Broad Institute and MIT filed a patent for the use of CRISPR/Cas-9 to “modify DNA in eukaryotic cells.”[8] In April 2014, the USPTO granted the Broad Institute their December 2012 patent, which UC Berkeley subsequently contested as being too similar to UC Berkeley’s May 2012 patent.[9] In February 2017, the USPTO ruled in favor of the Broad Institute stating that the Broad Institute’s December 2012 patent was not an obvious extension of UC Berkeley’s May 2012 patent.[10] In June 2018, the USPTO granted a patent to UC Berkley for the use of CRISPR/Cas-9 to edit single-stranded RNA, and a patent for the use of CRISPR/Cas-9 to edit genome regions of 10 to 15 nucleotides long.[11]

Finally, in September 2018, the US Court of Appeals for the Federal Circuit upheld the USPTO’s ruling in favor of the Broad Institute’s December 2012 patent for the use of CRISPR/Cas-9 in editing eukaryotic cells.[12] As a result, the Broad Institute has the rights to “commercialize products developed by using the CRISPR/Cas-9 system to make targeted changes to the genomes of eukaryotes – a group of organisms that includes plants and animals…cover[ing] a wide swath of potential CRISPR/Cas-9 products.”[13] While the results of this case seem to indicate that the patent war over CRISPR/Cas-9 technologies is coming to a close, there is still some movement within the industry. UC Berkeley could appeal the US Court of Appeals decision to the US Supreme Court which, given the zeal each institution has exhibited during this patent dispute, is not outside the realm of possibility.[14] Moreover, the CRISPR/Cas-9 technology landscape is ever-evolving. Already, researchers “have discovered new enzymes to replace Cas-9, and modified the CRISPR/Cas-9 system to manipulate the genome in many ways…”[15] It seems then that there are many technological advancements and patent disputes to come.

 

[1]Jessica Kim Cohen, UC Berkeley and Broad Institute’s Legal Dispute Over CRISPR Ownership: A Timeline of Events,Becker’s Health IT & CIO Report (June 21, 2018), https://www.beckershospitalreview.com/data-analytics-precision-medicine/uc-berkeley-and-broad-institute-s-legal-dispute-over-crispr-ownership-a-timeline-of-events.html.

[2]Sarah Alberstein, CRISPR/Cas-9: The Ethics of Implementation, Grounds: Virginia Journal of Bioethics (Aug. 3, 2016), https://issuu.com/vabioethics/docs/vol._1__iss._1_final.

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[4]Mark Crawford, 8 Ways CRISPR-Cas9 can Change the World, ASME (May 2017),https://www.asme.org/engineering-topics/articles/bioengineering/8-ways-crisprcas9-can-change-world.

[5]Jessica Kim Cohen, UC Berkeley and Broad Institute’s Legal Dispute Over CRISPR Ownership: A Timeline of Events,Becker’s Health IT & CIO Report (June 21, 2018), https://www.beckershospitalreview.com/data-analytics-precision-medicine/uc-berkeley-and-broad-institute-s-legal-dispute-over-crispr-ownership-a-timeline-of-events.html.

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[12]Heidi Ledford, Pivotal CRISPR Patent Battle won by Broad Institute, Nature(Sept. 10, 2018), https://www.nature.com/articles/d41586-018-06656-y.

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