By Sharon Begley
It’s baaaaack, that reputation-shredding, stock-moving fight to the death over key CRISPR patents. On Monday morning in Washington, D.C., the U.S. Court of Appeals for the Federal Circuit will hear oral arguments in University of California v. Broad Institute. Questions?
How did we get here? The patent office ruled in February 2017 that the Broad’s 2014 CRISPR patent on using CRISPR-Cas9 to edit genomes, based on discoveries by Feng Zhang, did not “interfere” with a patent application by UC based on the work of UC Berkeley’s Jennifer Doudna. In plain English, that meant the Broad’s patent, on using CRISPR-Cas9 to edit genomes in eukaryotic cells (all animals and plants, but not bacteria), was different from UC’s, which described Doudna’s experiments using CRISPR-Cas9 to edit DNA in a test tube—and it was therefore valid. The Patent Trial and Appeal Board concluded that when Zhang got CRISPR-Cas9 to work in human and mouse cells in 2012, it was not an obvious extension of Doudna’s earlier research, and that he had no “reasonable expectation of success.” UC appealed, and here we are.
What’s the morning line? UC has its back to the wall. As in an appeal of a criminal case, this appeal is all about the law and whether the patent office interpreted and applied it correctly; there won’t be any dramatic new evidence. UC’s lawyers “won’t whip out a document and say aha!” said biotech patent attorney Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff. Instead, UC will have to persuade the judges that the patent board ignored evidence, that its decision was not based on what a reasonable person would consider “substantial evidence,” or that it misapplied the law on obviousness or expectation of success.
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