CRISPR/Cas9 gene editing appeal filed
CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences and ERS Genomics announced that The Regents of the University of California, the University of Vienna and Dr. Emmanuelle Charpentier (collectively UC), co-owners of foundational intellectual property relating to CRISPR/Cas9 genome engineering, submitted an appellate brief to the U.S. Court of Appeals for the Federal Circuit seeking reversal of a decision by the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) in an interference proceeding relating to CRISPR/Cas9 gene editing technology. In the appeal, UC requests reversal of the PTAB’s decision terminating the interference between certain CRISPR/Cas9 patent claims owned by UC and claims of the Broad Institute, Harvard University and the Massachusetts Institute of Technology (collectively, Broad).
In its brief to the Federal Circuit (Case No. 17-1907), UC asserts that the PTAB’s February 15, 2017 determination that the UC patent claims did not make the Broad’s patent claims obvious is based on a misapplication of controlling legal standards established by U.S. Supreme Court and Federal Circuit precedent. In its decision, the PTAB had concluded that UC’s claims covering CRISPR/Cas9 single guide gene editing technology and its application in any cellular or non-cellular setting did not make obvious Broad’s claims covering application of the same technology limited to use in eukaryotic cellular settings.
In its brief, UC sets forth multiple errors in the PTAB’s holding that the use of CRISPR/Cas9 in eukaryotes is separately patentable as alleged by Broad, including the following:
With respect to the obviousness of applying the technology to eukaryotic cells, U.S. Supreme Court and Federal Circuit precedents clearly mandate that obviousness determinations be based on an “expansive and flexible approach” including consideration of “the inferences and creative steps that a person of ordinary skill in the art would employ.” In contrast, the PTAB applied a narrow and restrictive approach that ignored certain key evidence, including the steps actually employed by those of skill in the art at the time, and also effectively required a “guarantee” that UC’s CRISPR/Cas9 invention would work in eukaryotic cells, when well-established case law requires only a “reasonable expectation of success.”
With respect to the reasonable expectation of success standard that establishes obviousness, the PTAB effectively ignored U.S. Supreme Court and Federal Circuit case law, which emphasize that an invention can be obvious if it is “obvious to try,” even if success is not guaranteed, “[w]hen there is a design need or market pressure to solve a problem,” “there are a finite number of identified, predictable solutions,” and experimentation leads to “the anticipated success.”
The PTAB ignored U.S. Supreme Court and Federal Circuit precedent highlighting that the occurrence of what appear to be simultaneous “inventions” arising close together in time is itself strong evidence of their obviousness, and accordingly requiring that such evidence be considered in any obviousness analysis. In contrast, in terminating the interference, the PTAB essentially dismissed as “irrelevant” the evidence that six different laboratories successfully applied UC’s claimed CRISPR/Cas9 invention in eukaryotic cells using conventional techniques within months after UC publicly disclosed the invention - some of them prior to Broad’s first filing.
The PTAB effectively ignored that Broad’s own eukaryotic application of UC’s CRISPR/Cas9 invention had simply utilized conventional prior art techniques. As a consequence, it failed to consider that Broad’s alleged invention did not reflect any significant innovation on Broad’s part, an important issue under applicable precedent.
The PTAB failed to hold Broad to its burden of proving, among other things, the effective priority date for its patent claims, as required by the PTAB’s own rules and Federal Circuit precedent. By not requiring the Broad to meet its burden of proof, and by merely assuming that all of the Broad’s claims were entitled to their earliest possible filing date despite Broad’s failure of proof, the PTAB improperly ignored relevant intervening art that made the Broad’s claims obvious.
As explained in UC’s brief, application of the correct legal standards to the case is believed to require reversal of the PTAB’s decision. For these reasons, UC requests that the Federal Circuit instruct the PTAB to reinstate the interference proceeding so that it can properly determine priority of inventorship, as previously requested by UC. The PTAB’s failures to consider pertinent evidence and apply appropriate legal standards should at the very least require the matter to be remanded so that the PTAB can properly consider the evidence related to obviousness and Broad’s no-interference-in-fact motion using appropriate legal standards.
In the PTAB’s February decision terminating the interference proceeding prematurely, it had not yet considered the teachings of UC’s own prior-filed patent application with respect to using CRISPR/Cas9 in eukaryotic cells. Instead, the PTAB only addressed the threshold question of whether use in eukaryotic cells can be separately patentable from use in all settings as covered by UC’s claims. However, determinations on the underlying substantive matters have recently been made in parallel prosecution before the U.S. Patent & Trademark Office (USPTO). The USPTO has rejected a series of patent applications filed by Broad that are directed to uses of CRISPR/Cas9 technology in eukaryotic cells as being non-novel in view of UC’s prior-filed patent application, which the USPTO examiners considered to have effectively taught use of the CRISPR/Cas9 technology in eukaryotic cells. In addition, patent applications filed by Sigma-Aldrich and Toolgen that similarly claim use of CRISPR/Cas9 in eukaryotic cells (both of which filed applications before Broad’s application) have likewise recently been rejected as being either non-novel or obvious in view of the prior-filed UC patent application with specific respect to its teachings regarding application of the invention to use in eukaryotic cells.
Consistent with the substantive determinations reached by the USPTO regarding the broad teachings of the UC patent application, UC’s corresponding cases covering use of CRISPR/Cas9 in all settings, including in eukaryotic cells, have been advanced to grant or decisions to grant in numerous jurisdictions worldwide, including in the United Kingdom, the nearly 40 other countries that are members of the European Patent Convention, and more recently in other jurisdictions such as Australia, New Zealand, Singapore and China.