By Lawrence Hoffman
The University of California, Berkley (“UC”) and the Eli and Edythe L. Broad Institute of MIT and Harvard (“Broad”) are locked in an all-out battle (called an interference) before the U.S. Patent and Trademark Office Patent Trial and Appeal Board (the ‘PTAB’ or ‘Board’) over the past several years to determine who was the first inventor of the CRISPER-Cas9 gene editing technology.
The biotech world is wildly excited about the potential uses of this technology and the likely licensing fees could be in the billions of dollars.
The Board has just reached a decision in the matter. Broad definitely won the battle, but just what it won, and what UC lost, is far from clear.
For those of you (like me) not in the biotech field, CRISPER is the acronym for ‘Clustered Regularly Interspaced Short Palindromic Repeats’, a genetic phenomenon found in prokaryotic cells, i.e., those without nuclei such as those in bacteria. CRISPRs are not found in eukaryotic (plant and animal) cells. CRISPERs function as an immune system for such cells.
The Board did not actually determine priority of invention, but rather decided that the UC and Broad inventions were not the same, and not obvious variations of each other. It therefore ruled that there never should have been an interference. As a result, Broad, which already has 12 patents and one more on the way, will keep them all for now, and UC might also get a patent.
At the risk of oversimplification, the UC application discloses use for editing genes only in a prokaryotic environment. Also, the experiments disclosed were only in vitro. There is no mention or a suggestion in the UC application that the CRISPER-Cas9 technology will work, or should be used for editing genes in eukaryotic cells.
However, the claims of the UC application do not specify the environment. The disclosures and claims of Broad’s patents and the pending application, however, are directed specifically to use with eukaryotic cells. In brief, the PTAB said the eukaryotic species is patentable over UC’s generic claims because there was no concurrent reasonable expectation that UC’s technology would work with eukaryotic cells.
This saga is definitely not yet over. UC can appeal the Board’s decision to the Court of Appeals for the Federal Circuit (CAFC), or it can accept the reality of concurrent patents. If it doesn’t appeal, or if it loses the appeal, the result may be that users of the technology have to obtain licenses from both UC and Broad. However, the ultimate value of the UC patent is far from clear. The validity of the patent can be challenged in court, e.g., on the ground that the disclosure does not support generic claims. Alternatively, a court could reasonably find that, even apart from the question of validity, the claims cover only use in a prokaryotic environment. If either of these defenses succeeds, UC’s patent may end up essentially worthless.
There is even the horrible possibility (from UC’s standpoint) that the US PTO will reopen the prosecution of its application and reject its claims for lack of a written description to support its broad claims. UC may then have to narrow its claims to a prokaryotic environment. That, too, could make its patent worthless.
To read more, a comprehensive article dealing with many aspects of this case has been posted here: http://www.ipatent.co.il/crisper-cas9-broad-institute-1-berkeley-0-maybe/
About the author: Larry Hoffman has a B.S. in Electrical Engineering and Comp. Sci. from the Massachusetts Institute of Technology and a J.D. from the George Washington University School of Law. He has been practice since 1965 specializing in IP law and product liability defense. He is registered to practice before the USPTO, the U.S. Court of Appeals for the Federal Circuit and the state and federal courts in New York, Maryland, and the District of Columbia. His work includes preparation and prosecution of patents in countries throughout the world, and counseling on IP and product safety matters. He has been involved in the trial of close to 100 lawsuits of various kinds. You can reach him at Lawrence@ipatent.co.il.