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Will the Supreme Court accept a UC Berkeley Appeal of the Sep. 10th, US Court of Appeals for the Federal Circuit decision to uphold the patent filed by the Broad Institute on CRISPR/Cas9 gene editing?

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on June 6, 2019

Several companies were founded on the initial CRISPR IP rights granted to various individuals and institutions. These companies include Intellia Therapeutics and its parent company, Caribou Biosciences (Berkeley), CRISPR Therapeutics and ERS Genomics (Emmanuelle Charpentier), and Editas Medicine (Broad) as well as the Broad Institute itself. Anyone aiming to commercialize CRISPR technology must obtain licenses from one or more of these companies. However, Broad and Berkeley have followed the long-standing recommendations that federally funded academic institutions grant non-exclusive licenses to university researchers and nonprofits.

ERS Genomics also offers non-exclusive licenses for research purposes and the commercialization of certain services and products, including, specifically, synthetic biology. Additionally, the Broad Institute offers non-exclusive licenses for companies selling reagents and other genome editing tools and for in-house commercial research. But they are clear they only offer exclusive licenses for human therapeutics. Editas holds most of the Broad’s IP rights for therapeutics but companies can potentially obtain licenses through what the Broad calls their “inclusive innovation” model.

If all of that weren’t complex enough, there are certain overlaps between the patents. For example, Editas, CRISPR Therapeutics, and Intellia all offer licenses to treat human diseases. But ERS Genomics specifically excludes a therapeutics option. Meanwhile, both Editas and Intellia offer licenses for stem cells, CAR-T cells, and Alpha-1 antitrypsin while Caribou Biosciences and the Broad Institute do not. In short, navigating the CRISPR IP thicket can be extremely confusing. And, unfortunately, it is likely to become even more so.

Image credit: Labiotech  and Science News.

While Berkeley’s notice of allowance does help put out the flames, until recently, most of the fights have centered on the Cas9 protein. But, in the last several years, research has shown that the CRISPR-Cpf1 protein, also known as Cas12a, is potentially more effective than Cas9. Companies like Mammoth Biosciences have already been founded off of Cas12a technology. Patents involving the Cas12a-RNA complex are already pending on behalf of Berkeley and the Broad Institute.

SOURCE

https://synbiobeta.com/with-the-recent-patent-news-who-owns-crispr-now/

On 2018, Sep. 10^th, the US Court of Appeals for the Federal Circuit agreed to uphold the patent filed by the Broad Institute on CRISPR/Cas9 gene editing in organisms with complex cells – UC Berkeley team can appeal this decision to the US Supreme Court, it is unclear whether the Supreme Court will accept this case.

According to Appeal and Interference Statistics 11/30/2016

https://www.uspto.gov/sites/default/files/documents/Appeal%20and%20Interference%20Statistics%20November%202016.pdf

In recent years, more than half of PTAB’s decisions have been upheld. “The Federal Circuit heard three appeals of interferences in 2016,” said intellectual property expert Jacob Sherkow of New York Law School. “All three were at least affirmed in part. It’s completely unclear whether that’s meaningful — it’s an N of 3–but there you go.” Overall, on 155 appeals since PTAB was created in 2012, the Federal Circuit affirmed 120 on every issue, dismissed or reversed 21 on every issue, and issued partial decisions (that is, upholding parts of a PTAB decision and reversing others) in the other 14.

SOURCE

https://www.scientificamerican.com/article/disputed-crispr-patents-stay-with-broad-institute-u-s-panel-rules/

Based on

Appeal and Interference Statistics 11/30/2016

https://www.uspto.gov/sites/default/files/documents/Appeal%20and%20Interference%20Statistics%20November%202016.pdf

I recommend UC, Berkeley to Appeal to the Supreme Court the Sept 10th Decision.