Interference proceedings for disputed patents relating to the gene-editing technique CRISPR – which  Nature recently called “the biggest biotechnology advance since the polymerase chain reaction (PCR),” — continued last week as the parties held an initial conference call with the three USPTO judges presiding over the case.[1]

CRISPR, an abbreviation for Clustered Regularly-Interspaced Short Palindromic Repeats, is a tool for genetic editing and has great potential for treating a wide range of diseases and genetic abnormalities.  A boon for genetic engineering with a seemingly limitless number of applications in humans, plants, and other animals, CRISPR technology is based on a bacterial defense system that, when modified, enables scientists to remove a gene from any organism more efficiently and accurately.

The patent dispute pits Feng Zhang of the Broad Institute against Jennifer Doudna and collaborator Emmanuelle Charpentier, of UC-Berkeley and the Max Planck Society, respectively. Zhang’s team at the Broad, which obtained the first of their 12 patents in April 2014, has been designated the junior party in the proceedings. While the UC team filed their first patent application before the Broad scientists filed theirs, the UC team has not been awarded any patents.  The Patent Trial and Appeal Board will use the “first to invent” standard for determining inventorship, as both parties filed prior to the adoption of the “first to file” system introduced by the America Invents Act.

The validity of these 12 issued patents, as well as the ownership of CRISPR for a myriad academic and therapeutic applications will be decided with this case. And a CRISPR patent could be a financial windfall for which ever institution ultimately obtains its rights: other blockbuster patents have brought in hundreds of millions of dollars through licensing, royalties, or sale.  All three developers of the technology have already started their own companies to harness CRISPR for gene therapy, and the ruling of the PTO’s proceedings will have enormous consequences on each biotech’s future commercial prospects. Editas Medicine, the company cofounded by Zhang, raised $94.4 million for its February IPO. Doudna’s Caribou Biosciences was issued another CRISPR-based patent, U.S. 9,260,752, last month. Charpentier cofounded a company, CRISPR Therapeutics, which formed a $350 million dollar partnership with Bayer in 2015.

Following the phone call, the USPTO will consider each parties’ list of proposed motions before instituting trial.[2]

[1] http://www.biologicsblog.com/wp-content/uploads/2016/01/Broad-Inst.-v.-Regents-of-Univ.-of-Cal..pdf
[2] https://www.arelaw.com/images/article/link_pdf-1-1415047685-ARElaw_Understanding_PTAB_Trials101414.pdf

– Jessica Miles and Anthony D. Sabatelli, PhD, JD

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