U.S. Patent & Trademark Office. (Photo: Diego M. Radzinschi/NLJ.)
There may be no clear winners once the dust settles on a patent interference case involving two marquee research universities and billions of dollars in licensing fees tied to a revolutionary gene-editing tool.
The University of California, Berkeley, and the Broad Institute at the Massachusetts Institute of Technology both laid out their arguments Tuesday in a case that seeks to determine which was the first to invent a technique known as CRISPR-Cas9 in multicellular organisms.
CRISPR, which stands for clustered regularly interspaced short palindromic repeats, can be used to add or delete DNA from cells in order to fight diseases, reverse genetic mutations or to improve crop resistance to pests and drought. The technique, similar to a movie editor splicing specific scenes in and out of a film, is sparking a gold rush in medical research despite uncertainty over who holds the patent.
Tuesday’s hearing before three judges with the U.S. Patent and Trademark Office focused on whether MIT’s 14 patents applying CRISPR to multicellular organisms were obvious given UC-Berkeley’s earlier research and patent application, which focused on single-celled organisms.
Arguing for Berkeley, Todd Walters of Buchanan Ingersoll & Rooney said the DNA-splicing technique is virtually the same regardless of whether it’s used on a single-cell or multicell organism.
MIT’s lawyer, Steven Trybus of Jenner & Block, countered that Berkeley described only how to use the technique in simple organisms, but MIT took it a step further and applied it to plants and animals. This broader application is where licensing kicks in for medicine and agriculture. It was not until MIT’s research was published that the field broke open and became accessible to the average scientist, Trybus said.
If either side walked in with a winner-takes-all attitude Tuesday, Arizona State University professor Robert Cook-Deegan, who specializes in patents and inventions, said the judges’ questions indicated they may be considering a ruling that leaves both sides dissatisfied.
That could mean Berkeley’s broad provisional patent, which was filed first, is recognized while most of MIT’s specific patents, which were approved first, are thrown out for interfering with Berkeley’s. The judges indicated they could carve out exceptions for some of MIT’s patents for using a specific bacterium not included in Berkeley’s patent.
“If so, it’s possible there doesn’t have to be winner-take-all,” Cook-Deegan said at a panel discussion at American University following the hearing. “It could be two partial winners and two partial losers here.”
Jacob Sherkow, an associate professor for the Innovation Center for Law and Technology at New York Law School, said Berkeley came into Tuesday’s hearing with a stronger hand since the burden of proof lies on MIT.
But Sherkow said it appears the judges may let MIT “walk away with some patents,” primarily those that specifically use the bacteria Staphylococcus aureus.
The judges questioned both sides on whether respective university researchers’ optimism for success in their own experiments met the legal threshold for likely to succeed, whether Berkeley’s broad patent excludes all of MIT’s research, and whether expanding CRISPR for use in multicellular organisms was as obvious as Berkeley claimed. The outcome will have few ramifications on patent policy, but it is garnering attention because it features a fight between two key universities, and because it’s likely the last significant case to invoke “interference.” Interference focuses on who was the first to invent something while the America Invents Act, passed in 2011, shifts the test to who was first to file.