3:33 PM
Oct 04, 2018
 |  BC Innovations  |  Tools & Techniques

No crisp upper hand in CRISPR

What the most recent CRISPR ruling means for companies looking to access the IP

While the most recent ruling in the ongoing CRISPR IP battle maintained the Broad Institute’s dominant patent position in the U.S., University of California Berkeley’s dominant position in Europe, coupled with the looming possibility of additional interference cases, means that companies may still have to seek licenses from both parties to create global therapeutics.

On Sept. 10, the U.S. Court of Appeals for the Federal Circuit (CAFC) upheld a no interference-in-fact decision made by the Patent Trial and Appeal Board (PTAB) last year in a case pitting the Regents of the University of California against the Broad Institute of MIT and Harvard.

The ruling confirmed no legal mistakes were made during PTAB’s examination but did not re-examine the evidence (see “Seeking CRISPR Answers”). Its outcome has firmed up the Broad Institute’s IP advantage in the U.S. -- at least in the short term.

But the interference is just one fight in the battle over ownership of foundational CRISPR-Cas9 claims.

Three patent attorneys who spoke with BioCentury agreed that while UC Berkeley is likely out of plays for this interference, it still has plenty of other options for arguing it was first to invent CRISPR-Cas9 gene editing for eukaryotic cells. Those options include additional interference cases and challenges that re-examine the validity of the claims either before or after issue, respectively.

Michael Stramiello, an IP attorney at Paul Hastings LLP, told BioCentury that other interference claims had already been made but were put on hold while the first case worked its way through the courts. Stramiello does not represent any of the parties involved.

While UC Berkeley is likely out of plays for this interference, it still has plenty of other options for arguing it was first to invent CRISPR-Cas9 gene editing.

Of the 12 Broad patents involved in the recent interference, ToolGen Inc. has filed suggestions of interference against five of them and “it’s not yet clear how the Patent Office will respond,” said Stramiello. According to Stramiello, a sixth awaits anonymously requested ex parte reexamination and UC’s other pending applications may give rise to additional interference disputes.

“We might see the spotlight turn a little bit toward these other challenges that were waiting in the wings as the high-profile interference played out,” he added. “I expect there to be additional discussion about who first invented it.”

Even before it considers any new cases, UC has one issued patent in the U.S. that it claims has broad coverage, meaning that certain companies may need to license it to create CRISPR-based therapeutics. The patent covers certain RNA guide strand formats.

UC is also the dominant player in Europe and has issued patents with broad claims in China, Japan, Australia, New Zealand and Mexico, suggesting companies will need licenses from different parties in different places to commercialize products internationally.

Yet while the two academic organizations and inventors are the ones fighting the patent battle, for drug developers, the gatekeepers of the IP are the three companies with exclusive licenses to use the patents for therapeutic applications. Those are Editas Medicine Inc., which has rights to Broad’s patents, and CRISPR Therapeutics AG and Intellia Therapeutics Inc., which have access to UC Berkeley’s IP from separate assignees listed on the patent.

Any other companies hoping to gain access to the IP will need...

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