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CRISPR Technologies: Overcoming Patentability Challenges in an Increasingly Difficult Patent Landscape

July 05, 2018
Post by Sarah M. Dickhut

The term “CRISPR,” which is an acronym for Clustered Regularly Interspaced Short Palindromic Repeats, generally refers to RNA-guided genome editing technology used to engineer the genetic material of organisms with high accuracy and precision. It has wide applications in a variety of fields including genetics, biology, agriculture, medicine, and digital data storage, to name a few. More specifically, CRISPR technology allows researchers to inexpensively, efficiently and accurately insert, delete, knock down, or up-regulate targeted genes. This kind of targeted gene editing has entirely modified the pace and course of gene research.

Since CRISPR technology was harnessed for genome editing in late 2012 to early 2013, advances in CRISPR uses and methods have radically advanced. What was once a new frontier of research in 2013, quickly progressed into preliminary human trials in China in 2016 and human trials in the U.S. scheduled for later this year.

However, the rapid progression of CRISPR-based innovations may pose a challenge to patentability. The best publicized battle over CRISPR patentability is between the Broad Institute of MIT and the University of California (UC) Berkeley. In January of 2018, the EPO revoked one of the Broad Institute’s patents relating to CRISPR (although the revocation was based on an invalid priority claim, rather than patentability) and in April the Federal Circuit announced that it will hear oral arguments for the U.S. case between UC-Berkeley and the Broad Institute.

Independent of the battle between UC-Berkeley and the Broad Institute, other companies and innovators seeking to patent inventions involving CRISPR technologies will likely have to contend to more difficult obviousness rejections. The obviousness rejections for CRISPR-based innovations may become more difficult for two reasons. First, because of the rapid advancement in the field, CRISPR methods, procedures, and applications which might have otherwise been viewed as not obvious because the innovation may not have had the same expectation of success or because the innovation might not have been foreseeable, will be more likely viewed as another obvious variant of available CRISPR technologies. Second, it will likely be harder for Examiners to avoid hindsight bias. In other words, it will be difficult for Examiners to view the inventiveness of a given application at the time the application was filed (as is required for an obviousness analysis), as it may be difficult to determine what the state of the art was when the field was changing so rapidly. Both factors will make the CRISPR landscape more challenging for innovators.

To avoid or at least mitigate these issues, innovators and attorneys drafting patent applications should take care to explicitly note how their CRISPR methods and protocols differ from what was available in the field at the time. These differences should also then be clearly connected to improved or otherwise unexpected results. A strong showing of significantly improved (i.e. synergistic) results or unexpected efficacy will go a long way in circumventing obviousness challenges in CRISPR innovations.

Sarah Dickhut is an Associate Attorney in the Chemical/Biotech Patent Practice Group at McKee, Voorhees & Sease, PLC. For additional information please visit www.ipmvs.com or contact Sarah directly via email at sarah.dickhut@ipmvs.com.



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The attorneys of McKee, Voorhees & Sease, P.L.C. designed this blog as an informational and educational resource about intellectual property law for our clients, other attorneys, and the public as a whole. Our goal is to provide cutting-edge information about recent developments in intellectual property law, including relevant case law updates, proposed legislation, and intellectual property law in the news.

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