United States: CAFC To Hear CRISPR-Cas9 Appeal This Spring

On April 30, 2018, the Federal Circuit will hear oral argument in Regents of the Univ. of Cal. v. The Broad Institute, Appeal No. 2017-1907 (Fed. Cir.), a case concerning the revolutionary genome-editing technology known as "CRISPR-Cas9." CRISPR-Cas9 stands for Clustered Regularly Interspaced Palindromic Repeats. The "Cas9" component is a protein (i.e., a nuclease) associated with the system. The CRISPR-Cas9 system occurs naturally in prokaryotic cells and helps these cells detect and destroy viral attacks. Prokaryotic cells are unicellular organisms that are typically very simple in function and structure (e.g., bacteria). By contrast, eukaryotic cells are generally multi-cellular and more complex (e.g., mammals). Scientists in this case invented a markedly better version of the naturally occurring CRISPR-Cas9 system that allows scientists to edit mammalian genomes (e.g., human DNA) with enhanced efficiency and precision.

The case pits Regents of the University of California, University of Vienna, and Emmanuelle Charpentier (collectively, "UC") against The Broad Institute, Inc., Massachusetts Institute of Technology, and President and Fellows of Harvard (collectively, "Broad") in an interference dispute that will decide who has priority to the claimed invention.

The relevant timeline is as follows. In May 2012, UC filed a provisional patent application describing CRISPR-Cas9 as a gene editing technology in any environment (e.g., prokaryotic or eukaryotic cells). (Appellants' Br. at 8) In June 2012, UC publicly disclosed its technology in the journal Science ("Jinek 2012 article"). (Appellants' Br. at 9) According to UC, the Jinek 2012 article also reveals experiments involving the system and discloses how the system has the potential to work in, and improve upon, editing DNA in eukaryotic cells. (Appellants' Br. at 9)

Broad challenged UC's timeline in certain respects. According to Broad, Dr. Feng Zhang, the inventor of Broad's CRISPR-Cas9 technology, began working on a CRISPR-Cas9 system in eukaryotic cells in 2011 and filed an invention disclosure memorandum explaining his invention shortly thereafter. (Appellees' Br. at 18) In January 2012, five months before the Jinek 2012 article, Dr. Zhang submitted an NIH grant proposal relating to "the design of a mammalian [i.e., eukaryotic] CRISPR expression system." (Appellees' Br. at 19) In December 2012, Broad filed its first patent application covering the use of CRISPR-Cas9 technology in eukaryotic cells. (Appellees' Br. at 19)

The underlying interference proceeding commenced when UC asked the PTAB to declare an interference between UC and Broad patent applications. (Appellants' Br. at 16) Broad countered by filing a motion to dissolve the interference on the ground that UC's and Broad's claims are not interfering subject matter. (Appellants' Br. at 16) The main issue before the PTAB was whether UC's claims directed to CRISPR-Cas9 technology in any environment-if considered prior art-rendered obvious Broad's claims directed to CRISPR-Cas9 technology in eukaryotic cells. (Appellants' Br. at 16) Broad conceded that UC's claims would have motivated a skilled person to use UC's claimed methods in eukaryotic cells, but argued that a skilled person would not have had a reasonable expectation of success in doing so. (Appellants' Br. at 17) The PTAB agreed with Broad and terminated the interference. UC appealed.

In its appeal brief, UC argued that the PTAB applied an inappropriately high standard for demonstrating a reasonable expectation of success. (Appellants' Br. at 2, 22) The PTAB agreed with UC on three key facts: (1) UC's 2012 disclosures provided skilled artisans with ample motivation to use CRISPR-Cas9 technology in a eukaryotic cell; (2) well-known techniques were available to do so; and (3) six separate research groups easily and quickly used UC's technology in eukaryotic cells. (Appellants' Br. at 5) UC argued that these factual determinations compel the conclusion that a skilled person would have had a reasonable expectation of success in using CRISPR-Cas9 technology in eukaryotic cells. (Appellants' Br. at 5)

UC characterized the "reasonable expectation of success" standard applied by the PTAB as improperly requiring "pre-experimentation certainty." (Appellants' Br. at 22) According to UC, the PTAB's standard required "instructions in the prior art that would be specifically relevant to CRISPR-Cas9 and would instruct those of ordinary skill how to achieve activity with that system in eukaryotic cells" or "success in similar methods or products." (Appellants' Br. at 17) Finally, the PTAB erred in dismissing UC's evidence of use in related systems (e.g., prokaryotic cells) because those disclosures did not "guarantee" success in eukaryotic cells. (Appellants' Br. at 20)

Broad counters by explaining that there was real doubt in the prior art concerning whether UC's technology would work in eukaryotic cells. Broad identified five categories of evidence that each supported the PTAB's finding of no reasonable expectation of success, including: (1) contemporaneous statements by the UC inventors expressing doubts about building a CRISPR-Cas9 system in eukaryotic cells (a UC inventor stated after Jinek 2012 that "getting CRISPR to work in human cells" would be "a profound discovery"); (2) contemporaneous statements by skilled artisans (including an article written by UC's expert in the interference) articulating doubts about whether using a CRISPR-Cas9 system in eukaryotic cells would work; (3) evidence of other research groups that tried to engineer CRISPR-Cas9 systems in eukaryotic cells and were unsuccessful; (4) evidence of the differences between prokaryotic and eukaryotic cells; and (5) evidence of hurdles that skilled artisans encountered when trying to transfer technology (other than CRISPR-Cas9) from prokaryotic to eukaryotic cells.

Why is this case important? First, because it concerns one of the most ground-breaking biotechnology inventions in recent memory–CRISPR-Cas9. Second, this may be one of the last significant patent interference proceedings because the Leahy-Smith America Invents Act ("AIA") changed the US from a first-to-invent system to a first-to-file system to determine priority, meaning that interference proceedings are not available for patent applications filed on or after March 16, 2013.

This appeal is certainly one to watch as the parties proceed through oral argument towards a final decision.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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