Gene editing patent ruling sways fortune of biotech hopefuls

After almost four years of wrangling over the gene-editing technology known as CRISPR-Cas9, the patent office denied University of California-Berkeley's challenge of a provisional patent granted in 2013 to the Broad Institute, associated with Harvard University and the Massachusetts Institute of Technology.

The patent dispute involved work led by Feng Zhang of the Broad Institute and Jennifer Doudna and Emmanuelle Charpentier at Berkeley. UC Berkeley's lawyer argued that Zhang's accomplishments in eukaryotes were an obvious extrapolation of Doudna and Charpentier's work, and the Broad's patent thus interfered with the earlier application; the Broad's lawyer argued that it wasn't obvious, and Zhang's work deserved the patent that it was granted.

Doudna is credited with being the first to figure out how to use CRISPR to program cells using the Cas9 enzyme. Companies such as Monsanto, GE Healthcare and others working with the Broad Institue or Doudna's CRISPR startup Caribou Bioscience may have to get licenses from both parties if they want to work on CRISPRing plants and animal cells for research.

In the U.S., whenever a patent application is submitted, a patent office examiner reviews it and decides whether or not to grant it a provisional patent. The battle was brought by the University of California, Berkeley when it challenged a dozen patents held by the Broad Institute, which is affiliated with Harvard and MIT.

The judges ruled Wednesday that the Broad technique was sufficiently different from Berkeley's technology, and therefore could be patented separately.

The US Patent and Trademark Office has called a victor in the intellectual property battle between east coast and west coast academics at three of the nation's most prestigious institutions of higher learning.

The ruling only applies to CRIPSR as it applies to living cells.

Jacob Sherkow, who specializes in patent law for matters of biological sciences at the New York Law School, said he thinks it would be worthwhile for Berkeley to take the matter to a federal appeals court.

The decision may come at just the right time as the use of CRISPR in modifying human embryos with certain heritable diseases was just approved by a science advisory panel formed by the National Academy of Sciences and the National Academy of Medicine this week. Berkeley could find ways to appeal or challenge Broad's patents in other ways, and several other challenges, including from the Rockefeller Institute and inventors in Korea are winding their way through the patent system.

After the Broad Institute was given a provisional patent for CRISPR-Cas9 for gene editing in plant, animal, and human cells in 2013, Berkeley put forth a challenge.

  • Joanne Flowers