Argument Preview

Two cases being argued in May at the Federal Circuit attracted amicus briefs. One of these cases is Regents of the University of California v. Broad Institute, Inc. In this case, the Federal Circuit will review a judgment of the Patent Trial and Appeal Board in an interference proceeding concerning competing patent applications related to the CRISPR-Cas9 gene-editing system. This is our argument preview.

In their opening brief, the appellants (the Regents of the University of California, University of Vienna, and Emmanuelle Carpenter) set the stage for this case. They argue:

Jennifer Doudna, Emmanuelle Charpentier, and their colleagues invented a revolutionary technology for editing DNA—the CRISPR-Cas9 gene-editing system. This case concerns who is entitled to patents for using that system to edit genes in eukaryotic (e.g., plant or animal) cells: Doudna and Charpentier, who invented the technology, announced it to the world, and received the Nobel Prize for it; or a scientist at the Broad Institute who took their design and then (along with many others) promptly reduced it to practice using routine methods.

They argue “Doudna and Charpentier, along with co-inventors Martin Jinek and Krzysztof Chylinski (collectively, ‘CVC’) conceived of and described every element of the invention before Broad’s first alleged conception.” But, they continue, the Patent Trial and Appeal Board “awarded priority to Broad because it purportedly reduced the invention to practice first.” According to the appellants, however, the PTAB “reached that backward result through multiple legal errors.”

As for the PTAB’s alleged errors, the appellants first argue that the PTAB applied the wrong law regarding conception. According to the appellants, “[c]onception occurs—and an invention merits protection—once the inventor’s idea is complete enough for a skilled artisan to put the invention into working form.” They argue the PTAB erred when it “departed from that objective standard.” They contend the PTAB defied precedent by requiring CVC to “know its invention would work.” 

Next, the appellants maintain the PTAB erred because patent law should reward inventors, not artisans who “test another’s invention to find it works.” They contend that “Zhang cannot be the inventor” because he “added nothing but instead (improperly) obtained every limitation of the count from CVC.” 

The appellants also argue the PTAB “fell short of the standards imposed by the Administrative Procedure Act” by failing to support its conclusions to its findings and ignoring relevant evidence. They contend that the PTAB’s approach “fell well short of reasoned decisionmaking.”

The appellants, lastly, contend that the PTAB applied the wrong legal standard for written description, inappropriately asking the inventors to “convince artisans the invention would work.”

In their opening brief, the cross-appellants (The Broad Institute, Inc., Massachusetts Institute of Technology, and President and Fellows of Harvard College) provide their own overview of this case:

In this Interference, CVC asserted that it was the first to conceive of and reduce to practice the subject matter of Count 1, directed to using engineered CRISPR-Cas9 systems to modify DNA in eukaryotic cells. Substantial evidence supports the PTAB’s decision rejecting CVC’s assertion. . . . The PTAB’s decisions comprise 180-plus pages, hundreds of record citations, and numerous credibility findings; its determinations are the epitome of reasoned decision-making under the APA.

Regarding Broad’s conditional cross appeal (which the Court need not address if it affirms the priority decision), the PTAB interpreted Broad’s claim term “guide RNA” too narrowly by limiting it to “only a single-molecule RNA configuration,” excluding dual-molecule RNA configurations.

The cross-appellants respond to each of the issues raised by the appellants.

Regarding the PTAB’s analysis of conception, the cross-appellants maintain the “PTAB correctly recited and applied the legal standard from” the Federal Circuit’s precedent. They argue that, “[a]t both parties’ urging, the PTAB applied this objective standard and used it to make many findings adverse to CVC, including three key fact-findings.” And, they say, “CVC never raised” one of its argument about the appropriate “legal standard for conception before the PTAB and so it is inappropriate for CVC to assert the PTAB erred on a point never brought before it.” Moreover, they say, “[n]owhere in the 23-plus pages of discussion and application of” the Federal Circuit’s “objective standard does the PTAB state any requirement that the inventor ‘know’ the invention would work.”

They say the appellant’s argument that Zhang cannot be an inventor “relies on an incorrect characterization of the invention as simply the use of an sgRNA.”

Regarding the appellant’s APA argument, the cross appellants say it “is based on mischaracterizations of the PTAB’s detailed findings, which are supported by extensive record citations and easily meet the APA standard.”

The cross-appellants also reject the appellant’s argument concerning the written description requirement. According to the cross-appellants, “CVC wrongly accuses the PTAB of improperly requiring a working example or a reasonable expectation of success when it found P1 and P2 lacked adequate written description.”

The cross-appellants also presented arguments supporting their conditional cross-appeal. “If the Court agrees with Broad’s construction of ‘guide RNA,'” they say, “it should vacate and remand the PTAB’s decisions denying Broad’s Motions 2 and 3, which both relied on its incorrect and narrow interpretation.”

In their response and reply brief, the appellants reiterate that the PTAB’s decision regarding conception should not stand because the PTAB did not apply the correct legal standard. They argue that, while “Broad concedes conception does not require inventors to know the invention will work,” the PTAB demanded that the appellants prove that they “‘knew’ it would work.” Additionally, they argue, “the supposed ‘findings’ Broad invokes to defend the PTAB’s decisions are the products of the very legal error Broad seeks to sidestep.” Moreover, the appellants contend, awarding the invention to cross-appellants is improper because they are “copyist[s] who flout the originality requirement.”  They again argue that the PTAB’s decision fails APA review and that their patent application “amply” satisfied the written description requirement. 

In response to the cross-appeal, they first contend that, given that the cross-appellants only challenge the PTAB on “the same single ground for each motion” and “the PTAB denied Broad’s motions 2 and 3 on multiple, independent grounds,” no relief is available because any error wouldn’t alter the result. Second, the appellants argue, “[o]n the merits, the PTAB properly construed ‘guide RNA’ to mean signal-guide RNA.” 

In their reply brief, the cross-appellants maintain their position that the PTAB failed to give the term “guide RNA” its “broader reasonable interpretation.” 

A group of scientists filed an amicus brief in support of the appellants and reversal. They argue that, while the “scientific method requires researchers to approach experiments with objectivity . . . and professional skepticism,” the PTAB treated that objectivity “as evidence that the CVC inventors lacked a definite and permanent idea” of how to use their invention. They contend that affirming this outcome will “harm science.” 

Oral argument will be heard on Tuesday, May 7. We will monitor this case and report on any developments.