U.S. Appeals Court Rules on CRISPR Gene Editing Patent Challenges

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Harvard University and the University of California at Berkeley have been at odds over gene-editing patent technology. The patent dispute concerns who owns the rights to Clustered Regularly Interspaced Short Palindromic Repeats (“CRISPR”) technology, which allows scientists to specifically target genes and cut parts of the gene out or even the entire gene itself.   The CRISPR gene technology revolves around an enzyme found in bacteria that naturally occurs as a response to virus threats. Specifically, the CRISPR-Cas9 protein is the one at issue in this dispute, though other CRISPR proteins appear to be coming to market soon. In regards to the dispute at hand, the U.S. Patent and Trademark Office had originally ruled that Harvard University’s affiliated Broad Institute may keep its technology on gene-editing patents regarding CRISPR. Previously, Harvard had been locked in a dispute with Berkeley over intellectual property rights that include attribution, reputational credit, and financial profits that would result from the gene-editing patent technique.

Dispute Over Coverage of the CRISPR Gene Patent

The patent dispute arises from the fact that Berkeley argues that they were first to file a patent to cover all uses of the CRISPR gene in 2012. Harvard, on the other hand, argues that the Berkeley patent only covers use of the CRISPR gene in a test tube, whereas the Harvard patent covers use of CRISPR in plants, animals, and humans.

Another wrinkle that arises from the dispute is the different journeys the patent applications took before the Patent Office. For example, in this case, Harvard had paid extra fees to have their patent applications reviewed on an expedited timeline, while Berkeley’s application still remains before the Patent Office on a more traditional timeline. When Berkeley later heard of Broad Institute Inc.’s applications, Berkley filed motions to have Broad’s patents canceled, specifically arguing that their own patents already covered the use of the CRISPR gene in animals.

In their ruling, the U.S. Patent Office found that both groups could hold patents to the CRISPR gene technology because the applications covered different aspects and applications of the gene technology. On appeal, the Federal Circuit agreed with the U.S. Patent Office’s findings, stating that there was “substantial evidence” to support such a holding.

In the meantime, Berkeley had said that it is considering its options after the latest decision; and may file a petition for the Federal Circuit to review its decision, or may even appeal to the U.S. Supreme Court to hear its case. In such an appeal, Berkeley may be counting on the U.S. Patent Office’s initial finding that the applications did overlap, which eventually led to a later hearing before the board to hear further evidence on the subject.

Third Parties Utilizing Dual Licensing Agreements for CRISPR gene

While the decision remains up-in-the-air, third parties that use the CRISPR gene generally have licensing agreements with both Berkeley and Harvard in order to cover their licensing uses. Similarly, experts who have been following the case have noted that the actual court rulings do not provide a true finding about which party is actually entitled the credit for the initial discovery of the CRISPR gene technology. Likewise, other experts note that the Federal Circuit’s holding that the claims are patentably distinct does not render a judgment on the validity of either party’s claims.

As such, it would behoove patent attorneys and gene specialists alike to follow California v. Broad Institute Inc. as it winds its way through the federal court system to stay up to date on the validity of the patents and to find out who will ultimately be credited with the discovery of the groundbreaking gene-editing technique.

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