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Gene Editing and Patent Disputes

Innovations in the field of biotechnology have, through time, been approached with a mixture of skepticism, apprehension, opposition, and sometimes, acceptance. This is because these innovations raise social and ethical issues. One example that illustrates such issues is the CRISPR/Cas9 gene editing technique because the technique allows alteration of plant, animal and human genome. The CRISPR/Cas9 gene editing technique is unique in some aspect because the patent pertaining to this technique raises issues related to patent prosecution.

For instance, the CRISPR/Cas9 gene editing technique patent dispute is between the scientists at University of California, Berkeley (“University of California”) and the scientists at the Broad Institute of MIT and Harvard in Cambridge, Massachusetts (collectively referred to as “Broad”). The scientists at the University of California initiated their patent application on May 25, 2012, while the scientists at Broad initiated their patent application on December 12, 2012. The Broad team filed their application under the expedited review program and were granted patent in April 2014. In other words, although the Broad team filed their patent application after the University of California team, the Broad team acquired rights to the patent drawn to this gene editing technique.

The Leahy-Smith America Invents Act (“AIA”) went into effect on September 16, 2012. This Act brought changes to the United States Patent and Trademark Office (“USPTO”) system of granting rights to a patent by allowing an inventor “who filed first” rather than the one “who invented first” to acquire rights to a patent. However, in this case, since several key elements of these patents were filed before the AIA went into effect, the USPTO granted University of California’s request for a patent interference proceeding against the Broad team. During this proceeding, a panel of USPTO judges hears evidence from both the sides to determine which team invented this technique and should be granted rights to the patent . The University of California team has been designated as the “senior party” in this case because it filed the patent application first. While it may take a long time before this issue is resolved, Bob Yirka has pointed out a minor detail in this case, which could turn things in Broad’s favor. According to him, the patent application filed by University of California team was more general while the patent application filed by the Broad team was more specific regarding how the technique could be used. As the scientists and legal minds wait to see how this dispute is resolved, the likelihood of success for a party to acquire rights to a patent will hinder in the details disclosed within the specification of the application.