Science, People & Politics issn:1751598x. Issue one 2017.

US Patent and Trial Appeal Board
transcends biology

By Helen Gavaghan

Earlier this month the United States Patent and Trademark Office settled an Intellectual
Property dispute which may prove to be the most significant in biology for the twenty-first
century. At issue was whether, given the state of the art at the time, what one party claimed as
invention for the gene-editing system known as CRISPR-cas9* could have been thought to be
obvious in another setting. Settings under discussion in this case are prokaryotic and
eukaryotic biology - namely all of life. The IP dispute is known as an alleged interference.

The conclusion reached by the administrative patent judges was that the parties to the dispute
had patentably distinct subject matter.

Rarely are litigants more prestigious, and rarely do they have deeper pockets. In this case the
disputants were the Broad Institute Inc., Massachusetts Institute of Technology and
President and Fellows of Harvard College v. Regents of the University of California, the
University of Vienna, and Emmanuelle Charpentier.

Throughout the decision handed down the judges write of the University of California and their
co-litigants as UC (these are the senior party in the litigation), and of their opponents as "The
Broad" (the junior partner in the litigation). UC are the Movants in the dispute, and had argued
that their claim to the invention of CRISPR-cas9, not restricted to any environment, would obvi-
ously also work in eukaryotes. The Broad, with different claims for CRISPR-cas9 in eukaryotes,
disagreed, and argued it was not obvious that CRISPR-cas9 would work for gene editing in
eukaryotes. The Patent Trial and Appeal Board judges agreed with Broad.

As "The Movants" the burden of proof remained with UC, and the case was decided on the pre-
ponderance of the evidence. The administrative patent judges reached their conclusion
per curiam. In other words, UC lost, and "The Broad" has a distinct patent application and
claims for the CRISPR-cas9 system in eukaryotes. And vice versa.

Each side fielded experts in molecular biology and genetics to support their case. The legal
argument came down to whether, in light of the art at the time, there was a reasonable
likelihood that a person with an ordinary knowledge of the art could have expected the CRISPR
-cas9 system as invented by UC in vitro and in prokaryotes to work in eukaryotes.

On nearly every biological argument UC failed to convince the judges that CRISPR-cas9
in eukaryotes was obvious. Where doubt was raised, UC's point was argued out of significance
by the judges drawing on biology, case law and expert opinions presented to them.

The judges point out they gave greater weight to expert opinions of the time about obviousness

NOMINAL PUBLICATION DATE 24TH FEBRUARY 2017..........................GO TO PAGE 7 | 5

Issue 1 (Jan-Mar), 2017............................................Science, People & Politics ISSN 1751-598X print and online