In interference proceedings over CRISPR gene editing technology, the US Court of Appeals for the Federal Circuit today said the Patent Trial and Appeal Board must revisit their findings that The Broad Institute — a research consortium for the Massachusetts Institute of Technology and the President and Fellows of Harvard College — has priority over the Regents of the University of California, the University of Vienna and inventor Emmanuelle Charpentier. Writing for the court, US Circuit Judge Jimmie V. Reyna said the board legally erred in holding that because the breakthrough touted by Regents resulted from “extensive or undue” experimentation, replication by a person of skill in the art was unlikely. Along the way, the panel said, the board disregarded key evidence that only routine techniques were necessary for Regents' scientists to achieve a reduction to practice.
The Patent Trial and Appeal Board applied the wrong standard for conception when finding The Broad Institute enjoys priority to an invention covering a gene editing system containing a “single-guide” ribonucleic acid that edits or cleaves DNA in eukaryotic cells, a US appeals court said.In so ruling today (see here), a three-judge panel on the US Court of Appeals for the Federal Circuit weighed in on an inventorship dispute that has played out across the globe between The Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier (Regents, collectively), and Broad, a research consortium of scientists from the Massachusetts Institute of Technology and the President and Fellows of Harvard College.
US Circuit Judge Jimmie V. Reyna, joined by US Circuit Judges Todd Hughes and Tiffany Cunningham, said the board must revisit their finding in favor of Broad in an interference proceeding.
Regents, led by Nobel Prize-winning scientists Charpentier and Jennifer Doudna, along with co-inventor Martin Jinek, publicly disclosed in June 2012 experiments they planned to test their theory that the natural editing capabilities of CRISPR systems — the immune response of prokaryotic cells — can be used to edit DNA in eukaryotic cells.
The single RNA CRISPR-Cas9 system was presented at a conference at the University of California, Berkeley, and later published in an article appearing in the journal Science soon thereafter
“Over the remainder of 2012, scientists from laboratories outside of Regents . . . attempted to use the system to edit DNA in eukaryotic cells. Of these laboratories outside Regents, five reported success from July to December 2012, using expression vector or microinjection techniques,” the Federal Circuit explained.
Among them was Feng Zhang, a Broad scientist who “immediately planned tests using the system to edit eukaryotic DNA,” and later submitted the results of his own studies also to Science.
A race to patent ensued — with both sides filing a series of applications relating to CRISPR, prompting the board to declare an interference between claim 18 of Broad's U.S. Patent No. 8,697,359 and claim 156 of Charpentier, Doudna and Jinek's U.S. Patent Application No. 15/981,807.
After construing “guide RNA” as inclusive of only “a single-molecule RNA configuration” the board turned to a motion by Regents for a determination it is entitled to the benefit of the May 2012 filing date for its US patent application No. 61/652,086, or P1. Alternatively, Regents sought the October 2012 priority date corresponding to application No. 61/716,256, or P2, or January 2013 filing date of No. 61/757,640, or P3.
Only the latter request was honored, with the board finding that neither P1 nor P2 reduced to practice count 1 of the interference and that both failed to satisfy the written description requirement of Section 112 of The Patent Act.
That determination effectively rendered Broad the senior party, with the board awarding a priority date of October 2012 to correspond with Zhang’s submission to Science.
To that end, according to the board, at the time the manuscript was submitted, Regents did not yet know whether their system was capable of producing the effects on genes in a eukaryotic cell.
Those findings must be revisited.
Remanding, the Federal Circuit said “the Board relied almost exclusively on Regents’ scientists’ statements expressing uncertainty about whether the experiments had succeeded and suggesting modifications to their CRISPR-Cas9 system to conclude that they did not have a ‘definite and permanent idea.’”
However, the panel clarified, scientists need not know an invention will work in order to prove conception.
The board was required — but failed — to consider whether a POSA could have reduced the invention to practice, along with evidence of purported experimental success by others, the Federal Circuit found. A third mistake was made when the board refused to substantively engage with evidence by Regents that its scientists used routine methods or skills in their successful, subsequent editing of eukaryotic DNA.
On remand, the panel counseled, “the later party to reduce to practice will have the opportunity to show, under a conception date established by the correct standard, either (1) it was ‘the first to conceive of the invention and that it exercised reasonable diligence in later reducing that invention to practice,’ Cooper v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir. 1998), or (2) it had ‘prior conception of the claimed subject matter and communication of the conception to the adverse claimant.’ Price v. Symsek, 988 F.2d 1187, 1190 (Fed. Cir. 1993).”
They lastly considered and rejected Regents’ challenge to the board’s Section 112 holding, and agreed with Regents that Broad’s conditional cross-appeal on the construction of “guide RNA” is moot.
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