Earlier this month, the Federal Circuit heard oral argument in Regents of the University of California v. Broad Institute, Inc., a patent case that attracted an amicus brief. In this case, the Federal Circuit is reviewing a judgment of the Patent Trial and Appeal Board in an interference proceeding concerning competing patent applications related to using the CRISPR-Cas9 gene-editing system in eukaryotic (e.g., plant or animal) cells. Judges Reyna, Hughes, and Cunningham heard the argument. This is our argument recap.
Jeffrey A. Lamken argued for the Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively, “CVC”). Lamken began his argument by contending the PTAB applied the wrong legal standard related to conception. According to Lamken, “whether conception is complete depends on whether skilled artisans can reduce the invention to practice . . . with ordinary skill and without further invention.” Instead of discussing what level of skill it took to reduce the concept to practice, he argued, the PTAB analyzed whether or not CVC subjectively knew its idea would work. According to Lamken, an inventor does not need to know that his invention will work to have a complete conception. “You don’t give the invention to the guy who tested it and proves it works,” he argued. “You give the invention to the person who had the thought.”
The judges asked for clarification about how conception can be complete if significant experimentation was required. They also asked if there is a line between “routine experimentation performed by skilled artisans which doesn’t interfere with conception and the type of experimentation that takes an idea, changes it, and adds something new to it.” In response, Lamken stated that, if inventive skill were required to reduce the idea to practice, then the conception would not have been complete. A judge then asked if the PTAB found that the experimentation by any party in the current case was inventive or “added something.” Lamken responded, “no.” He explained that, while the PTAB claimed there were “technical reasons” the Broad Institute reduced the invention to practice first, the PTAB did not identify those reasons or explain what techniques were inventive or required above ordinary skill. A judge questioned whether the PTAB’s acknowledgement that “only routine materials and techniques were required” to reduce CRISPR-Cas9 to practice in eukaryotic cells would suggest CVC is correct. Lamken agreed.
One judge then asked, if the court agreed the PTAB applied the wrong legal standard, whether the court needed to reach Lamken’s arguments that errors were made based on the Administrative Procedure Act. In response, Lamken indicated it would be up to the court’s discretion. He clarified, however, that, if the court agrees that the wrong legal standard was used, the court must remand and cannot reverse outright unless the court can say “with confidence” that there is only one possible outcome on remand. Lamken also argued the court should remand if the court agrees with CVC on its conception claims but not its written description claims. Lamken then briefly explained these latter claims, arguing the PTAB again applied the wrong legal standard. A provisional application, he argued, does not need to convince a skilled artisan that the invention will work or explain every barrier to making it work. The application, he continued, need only disclose the invention so people can understand what the invention is.
Raymond N. Nimrod argued for The Broad Institute, Inc., Massachusetts Institute of Technology, and President and Fellows of Harvard College. He began by arguing there was no finding that routine materials and techniques were needed to make CRISPR-Cas9 work in eukaryotic cells. A judge then asked if there was a finding or evidence to suggest that something other than routine prior art techniques were used to reduce the invention to practice. Nimrod acknowledged that the PTAB did not make this finding, but he pointed to twelve different adaptations The Broad Institute’s inventor made to the system in order to reduce it to practice on eukaryotic cells. The judge then clarified with Nimrod that, while these techniques were being used for the first time in this specific context, the underlying techniques were modified versions of previous techniques.
One judge pointed out that, if the legal standard the PTAB used was incorrect, then it does not matter that CVC could not initially make the idea work. The judge also indicated that, even if CVC could not initially make the idea work, that does not mean others were not using prior art techniques. Additionally, the judge continued, the PTAB made no finding that the techniques used by The Broad Institute went beyond the techniques of a skilled artisan. In response, Nimrod argued CVC put in no evidence that any of the other labs were using ordinary skill. He went on to argue that, in the present case, knowledge that the idea will work is required because functionality itself was a claim element.
Nimrod argued the PTAB found CVC did not have an operative invention based on emails suggesting CVC did not “have a plan.” Nimrod explained that what is required is a demonstration that the inventor had a “definite and permanent understanding as to whether and how” the invention would work. This, he argued, justified the PTAB’s focus on whether CVC knew the invention would work.
On rebuttal, Lamken distinguished precedent by arguing that in a previous case no prior art techniques existed to reduce the invention to practice. A judge then asked if CVC had argued that the other experimenters used anything other than prior art techniques given that the PTAB did not make a finding on this point. Lamken maintained CVC repeatedly argued that the other experimenters did not innovate and used only ordinary skills. Lamken finished by reiterating that, while the PTAB claimed there were “technical reasons” for The Broad Institute reducing the invention to practice first, the PTAB should have but did not provide those reasons or make a finding as to whether The Broad Institute’s actions involved ordinary skill or inventiveness.
Nimrod concluded the argument by addressing the cross-appeal. A judge interrupted him, however, to clarify that the court would not need to reach the cross-appeal if the court remands based on an error with respect to the relevant legal standard. Nimrod agreed.
We will continue monitoring this case and report on developments.