Earlier this week, the Patent Trial and Appeal Board (PTAB) set the stage for what is expected to be an epic battle over who owns the intellectual property rights to “the biggest biotech discovery of the century.” On January 11, 2016, the PTAB declared an interference to decide who was first to invent the use of the groundbreaking gene-editing technique known as CRISPR in eukaryotic cells.
CRISPR, which stands for Clustered Regularly Interspaced Short Palindromic Repeats, is a technique allowing scientists to “edit” gene sequences much more easily and precisely than ever before. The technology has captured the attention and the imagination of those in the field as well as the popular press. Predictions of CRISPR’s impact range from research and treatment of complex genetic diseases to engineering more nutritious and disease-resistant crops. Everyone agrees that the technology promises to be immensely lucrative for whoever receives patent protection.
Jennifer Doudna and her team at the University of California Berkeley first published a paper in June 2012 detailing their success in editing the gene sequences of bacterial cells using the CRISPR technique. In February 2013, Feng Zhang and his team at MIT and the Broad Institute first published their landmark studies using the CRISPR technique to edit eukaryotic cells, human and mouse cells. Doudna’s team filed their first provisional patent application in May 2012, more than six months before Feng Zhang filed his first provisional application in December 2012. But Zhang requested accelerated examination of his patent applications, and was granted the first patent claiming CRISPR techniques, U.S. Patent No. 8,697,359, in April 2014, followed by many additional patents. Zhang argued, and the PTO agreed, that the published international counterpart of Doudna’s patent application (which claimed priority to the May 2012 provisional application) was directed to CRISPR’s application in bacterial cells only, and thus it did not anticipate or render obvious Zhang’s application of the technique to much more complex eukaryotic cells.
In April 2015, Berkeley filed a “suggestion of interference,” asking the PTAB to declare an interference between Doudna’s patent application and twelve of Zhang’s patents. The PTAB eventually agreed, instituting the current proceeding. Because Doudna’s team was the first to file, the PTAB designated Doudna’s team as the “Senior Party,” which places the burden of proof on Zhang, the “Junior Party”, to prove that he was the first to make the claimed invention. Whichever party ultimately prevails will receive patent protection and the potential of billions of dollars in licensing income, but the interference will undoubtedly take years to complete, and any decision is appealable to the Federal Circuit.
Of course, had these patent applications been filed after March 2013, there would be no interference. The America Invents Act (AIA) eliminated these proceedings for applications filed after March 2013. But an application filed prior to March 2013 is subject to the “first-to-invent” regime rather than the AIA’s “first-to-file” provisions. Because the CRISPR applications claim priority dates before March 2013, the old “first-to-invent” regime governs and an interference proceeding is available.
Administrative Patent Judge Deborah Katz both declared and is managing the CRISPR interference, No. 106,048. The interference involves twelve of Zhang’s patents, 8,697,359; 8,771,945; 8,795,965; 8,865,406; 8,871,445; 8,889,356; 8,895,308; 8,906,616; 8,932,814; 8,945,839; 8,993,233; 8,999,641, and Doudna’s patent application, 13/842,859. The parties’ list of motions is due on March 3, 2016.
The CRISPR proceeding may be one of the last great biotech interferences. The claims at issue are viewed by many as the “holy grail” for correcting and curing human genetic diseases and interferences will ultimately become obsolete under the AIA.