Takeaway: Pay attention to the biggest gene patent pre-suit at the Patent and Trademark Appeals Board over ownership rights complicated by two patent filing histories around the time the American Invents Act shifted the U.S. to a “first-to-file” system.
CRISPR (“Clustered Regularly-Interspaced Short Palindromic Repeats”) is a biotechnology breakthrough technology that allows scientists to “hack” into the DNA with more precision than ever before and manipulate the genomes of life, from single cell organisms to plants and maybe eventually humans. With potentially billions of dollars in licensing rights at stake, the rights to the CRISPR technology has recently gone under the microscope in an interference proceeding at the Patent and Trademark Appeals Board (“PTAB”) at the United States Patent and Trademark Office (“USPTO”).
The two scientists involved are Dr. Feng Zhang, a bioengineer at The Broad Institute, and Dr. Jennifer Doudna, a molecular biologist at the University of California, Berkeley.
In March 2013, Dr. Doudna, along with French researcher Emmanuelle Charpentier and five other scientists as co-inventors, filed a patent application with 155 claims that related to CRISPR.
In October 2013, Dr. Zhang filed his own CRISPR patent application, later than Dr. Doudna, but obtained a speedier review and was issued the CRISPR patent in 2014. The two parties were not able to resolve their issues through negotiation and thus the issue of patent ownership was eventually brought to the USPTO.
Interestingly, because the United States switched from a “first-to-invent” system to a “first-to-file” system in March 2013, the key question is whether Dr. Zhang, who filed after Dr. Doudna, is eligible to be grandfathered under the old rules.
The “interlocutory stage” of the case just began, which is similar to that of an early stage of a civil law suit where one party seeks to dismiss the complaint based on the basic facts. The review process will be lengthy; the preliminary process itself could take a year. The case can then be appealed to the U.S. Court of Appeals for the Federal Circuit, although the two sides could potentially reach a settlement agreement depending on the outcome.