- The University of California filed an appeal Wednesday aimed at overturning a February ruling by a federal panel, which had handed the rival Broad Institute of MIT and Harvard an important win in the closely watched legal fight over who should be granted patents on the genome-editing technology CRISPR-Cas9.
- Announced Thursday, UC's appeal sends the complex patent case to the U.S. Court of Appeals for the Federal Circuit for review.
- In mid-February, the Patent Trial and Appeal Board (PTAB) ruled that key patents held by the Broad on CRISPR-Cas9 do not overlap with competing claims from UC, effectively supporting the Broad's existing patents for use of the technology in eukaryotic cells specifically.
By appealing, UC hopes to win a reversal of the PTAB's February ruling and thereby bolster its efforts to secure patents on broad use of CRISPR in all cells, as well as in non-cellular settings.
"Ultimately, we expect to establish definitively that the team led by Jennifer Doudna and Emmanuelle Charpentier was the first to engineer CRISPR-Cas9 for use in all types of environments, including in non-cellular settings and within plant, animal and even human cells," said Edward Penhoet, associate dean of biology at UC and special adviser on CRISPR to the UC president and UC Berkeley chancellor.
Research into potential uses for CRISPR-Cas9 has exploded over the past several years, making foundational patents to the technology highly valuable.
Both the UC and the Broad have licensed use of CRISPR-Cas9 to an array of biotechs, which are racing to develop potentially revolutionary therapeutics for certain diseases, particularly those linked to identifiable genetic mutations.
The University of Vienna and Emmanuelle Charpentier, partners with UC, also joined in Wednesday's appeal.
But the Broad doesn't see any reason why the federal appeals court would come to different decision than the PTAB. "Given that the facts have not changed, we expect the outcome will once again be the same," the Broad Institute said in a statement.
"To overturn the PTAB decision, the Court would need to decide that the PTAB committed an error of law or lacked substantial evidence to reach its decision. Given the careful and extensive factual findings in the PTAB’s decision, this seems unlikely," the statement continued.
Editas Medicine, which licenses from the Broad, echoed that sentiment in a statement Thursday.
"We are not surprised an appeal was filed; however, we believe that, because the PTAB decision was well-reasoned, it will ultimately be upheld," the Cambridge-based biotech said in an emailed statement.
Meanwhile, in Europe ...
UC and its allies, however, are confident in the validity of UC's underlying patent claims, pointing to decisions in other jurisdictions that went the University's way.
Since the PTAB's decision, for example, the European Patent Office (EPO) said it plans to issue UC a broad patent covering use of a CRISPR-Cas9 single-guide system in cellular and non-cellular settings.
CRISPR Therapeutics, a biotech which licenses the technology from UC, sees this patent grant as underscoring the validity of UC's case.
"The EU decision to grant us those wide-ranging patents validates our story for the US as well, which is Emmanuelle Charpentier did the work first," said Samarth Kulkarni, chief business officer at CRISPR Therapeutics. "It gives us a lot more confidence about this appeal."
The PTAB only considered the narrow issue of whether UC's and the Broad's claims were distinct enough to be separately patentable and did not address the underlying issue of which party deserved a patent.
"We look at it as the EPO is in a sense a step ahead because they have already gotten to the substantive aspect of our case and our teachings and our patent application," explained CRISPR's Chief Legal Officer Tyler Dylan-Hyde in an interview. "Whereas the PTAB got short circuited prematurely before they got to the substantive questions and we are still dealing with the procedural aspects of that."
Even as the case moves to the federal appeals court, UC and its affiliated companies like CRISPR plan on moving ahead in parallel with other broader patent claims.
This is an important point because, as CRISPR's Dylan-Hyde points out, the appeals court could take as long as 12 to 18 months to reach a decision.
In the meantime, expect both sides to move forward with efforts to expand and strengthen their positions both legally and through further development of the technology.