Federal Circuit CRISPR Patent Remand Ignites ‘Conception’ Debate

A favorable appeals court ruling repositioned a coalition of universities and Nobel laureates to win credit for inventing a breakthrough CRISPR gene-editing technology and lucrative rights to a US patent that’s been contested for more than a decade.

The US Court of Appeals for the Federal Circuit directed the Patent Trial and Appeal Board to reassess its findings on whether CVC—the coalition including the Universities of California and Vienna—or the Harvard- and- MIT-affiliated Broad Institute first conceived of the CRISPR-Cas9 gene editing technology for animal cells. The May 12 ruling unwound Broad’s 2022 victory in an “interference” proceeding, in which the PTAB determines who owns an invention when there are multiple patent applications for the same technology.

The answer to the “conception” question—which, despite changes in the law, is still sparking debates among practitioners—could be worth hundreds of millions of dollars to the parties, and multiple attorneys said it has significant implications for the biotech companies who license the technology from one or the other. A patent licensing entity associated with Broad in late 2023 said in a filing with the US Securities and Exchange Commission it had inked a deal potentially worth hundreds of millions based on a CRISPR therapy used to treat sickle cell disease.

Highlighting how the IP landscape underlying gene-editing technology has only grown more complicated as the case has progressed, a post on the University of California’s website after the opinion pointed to CVC’s 61 other US patents that “claim compositions and methods for the use of CRISPR-Cas9 gene editing in all cell types” and aren’t part of the interference dispute with Broad.

“While this 14-year battle has slowly played out at the PTAB and in the appellate court, there’s this completely insane licensing web” that’s cropped up as labs seek to develop novel therapies using gene editing, said Chelsea Loughran, a patent litigator at Wolf Greenfield with a background in life sciences technologies. “Far broader patent portfolios” have developed in the space as the fight progressed, she noted.

“Innovation doesn’t stop just because the court takes long to make a decision,” she said. “A lot of companies have decided to take a license with one side or the other.”

Conceiving CRISPR

CVC claims they hit on their CRISPR-Cas9 system invention in 2011 or 2012. The US Patent and Trademark Office, however, granted a patent covering the technology to Broad in 2016. Three years later the PTAB determined a pending CVC patent application overlapped with the Broad patent, leading the tribunal to declare an interference. The PTAB ruled for Broad, and CVC appealed in April 2022.

The PTAB was right to reject two even earlier priority dates tied to provisional patent applications CVC submitted, which were deemed to lack written description support, Judge Jimmie V. Reyna said in his opinion.

The panel separately ruled that scientists at CVC, including Jennifer Doudna and Emmanuelle, conceived of the invention before Broad achieved a successful lab result, and it proceeded to lay out how CVC could win the interference under that scenario by showing its researchers exercised reasonable diligence in their experiments and reduced the invention to practice.

The “decision creates an opportunity for the PTAB to reevaluate the evidence under the correct legal standard and confirm what the rest of the world has recognized: that the Doudna and Charpentier team were the first to develop this groundbreaking technology for the world to share,” CVC’s lawyer, Jeff Lamken of MoloLamken, said in a press release after the opinion issued.

Broad said in a statement that on remand it’s “confident the PTAB will reach the same conclusion and will again confirm Broad’s patents, because the underlying facts have not changed.”

‘Interference’ Precedent

The doctrine of conception comes up in interferences, but those proceedings have dwindled since the US switched in 2013 to a system that awards patents not to the first inventor to conceive of an innovation but rather the first inventor to file their patent application. Still, the legal principle could continue to be important in certain circumstances, such as determining when an idea created by an AI system built by humans was conceived, said Jacob Sherkow, who teaches law and medicine at the University of Illinois and has studied the case closely.

Sherkow said the Federal Circuit was wrong in several respects in its analysis on conception.

“The court erred repeatedly in calling things legal error that were actually just factual error,” Sherkow said.

Under a 1999 US Supreme Court opinion, the Federal Circuit must defer to the PTAB on factual determinations unless they aren’t supported by substantial evidence.

Kevin E. Noonan, a patent lawyer and chair of McDonnell Beohnen Hulbert & Berghoff’s biotech and pharmaceuticals practice group, defended the opinion and said the judges hewed closely to the court’s precedent. CVC raised questions of law in its appeal, he said, and the court was right to decide those issues.

“What the court did here is total black-letter interference conception law,” Noonan said.

Sherkow and Noonan also disagreed over the court’s focus on the successes of third-party labs getting the gene-editing process to work on animal cells in its conception analysis.

Noonan argued the court was correct to find the “successes of others” were relevant to determining whether a disclosure CVC made at a public talk was key to unlocking the patented technology and to nailing down when CVC’s conception was complete.

Sherkow countered that Reyna’s opinion strayed from Federal Circuit precedent, which endorses the position that courts can point to difficulties third parties have executing an idea in practice to show that an invention wasn’t conceived.

“It doesn’t follow as a matter of law or logic that if you didn’t think your invention was going to work but others got it to work, that you invented your invention,” Sherkow said. “To the contrary, maybe others invented your invention.”

The case is Regents of the Univ. of Cal. v. Broad Inst., Fed. Cir., 22-1594, 22-1653.