On February 28, 2022, the Patent Trial and Appeal Board (“PTAB”) issued a decision on priority in an interference proceeding between the Broad Institute, Inc., Massachusetts Institute of Technology, and President and Fellows of Harvard College (collectively, “Broad”) and the Regents of the University of California, University of Vienna, and Emmanuelle Charpentier (collectively, “CVC”), and held that Broad’s inventors were the first to invent the subject matter of Count 1 of the interference,[1] a CRISPR-Cas9 system with a single guide RNA able to cleave or edit DNA to affect gene expression in a eukaryotic cell. The Regents of the University of California v. The Broad Institute, Inc., Interference No. 106,115, Decision on Priority at 2, 4 (PTAB Feb. 28, 2022).

Count 1 recites claim 18 of Broad’s U.S. Patent No. 8,697,359 or claim 156 of CVC’s U.S. Patent Application No. 15/981,807. Id. at 6. The inventors listed on Broad’s patent are Feng Zhang, Ph.D., Le Cong, Ph.D., Fei Ran, Ph.D., Patrick Hsu, Ph.D., Randall Platt, Ph.D., and Neville Sanjana, Ph.D., and the inventors listed on the CVC application are Jennifer Doudna, Ph.D., Martin Jinek, Ph.D., Emmanuelle Charpentier, Ph.D., and Krzysztof Chylinski, Ph.D. Id. at 9, 50.

Broad, as senior party, was accorded benefit of its provisional filed December 12, 2012, and CVC, as junior party, was accorded benefit of its provisional filed January 28, 2013. Id. at 4. Both parties filed motions for judgment based on priority, arguing for dates of conception and reduction to practice of the invention of Count 1 earlier than their accorded benefit dates. Id. at 4. CVC also filed a motion arguing that Broad’s related patents and applications are unpatentable for failure to name the correct inventors and requested authorization to file a motion that Broad’s related patents and applications are unpatentable due to alleged inequitable conduct during prosecution. Id. at 4, 81. The PTAB denied CVC’s motions related to priority and inventorship and granted Broad’s motion based on priority. Id. at 82. The PTAB declined to consider CVC’s arguments related to inequitable conduct because the arguments were not directly related to the issue of priority. Id. at 81-82.

First, the PTAB denied CVC’s motion for priority because it was not persuaded of CVC’s asserted actual reduction to practice date of August 9, 2012, or its asserted conception date of March 1, 2012. An actual reduction to practice requires proving that the inventors constructed an embodiment of the count and determined the invention would work for its intended purpose. Id. at 9. CVC argued that the CVC inventors reduced the invention to practice by testing the CRISPR-Cas9 system in a zebrafish embryo experiment performed on August 9, 2012, by Dr. Florian Raible, a research group leader at the University of Vienna. Id. at 9, 24. Dr. Raible testified that he identified at least one zebrafish with the targeted mutation and informed inventor Dr. Chylinski about the results who then emailed another inventor, Dr. Charpentier. Id. at 11-13. The PTAB agreed with Broad that none of CVC’s evidence, including contemporaneous emails and testimony of witnesses, demonstrated that Dr. Raible or any of the inventors recognized or appreciated the results of the August 9, 2012 zebrafish experiment to be a success. Id. at 14, 23-24. The PTAB also found that given the alleged importance of the experiments that Dr. Raible was performing, Dr. Raible’s abandonment of the CRISPR-Cas9 zebrafish project by September 12, 2012, indicates that “he did not recognize any success in 2012.” Id. at 22-23. The PTAB found that because the inventors had not appreciated the success of the CRISPR-Cas9 system in Dr. Raible’s zebrafish experiment, the inventors had not actually reduced to practice the invention by August 9, 2012. Id. at 24.

Second, the PTAB was also not persuaded by CVC’s assertion that CVC inventors, Drs. Doudna and Jinek, had a complete conception of a CRISPR-Cas9 system in eukaryotic cells by March 1, 2012. Id. at 24. “Conception requires a ‘formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention’ . . . . ‘not just a general goal or research plan he hopes to pursue.’” Id. (citation omitted). “Conception is complete only when the idea is so clearly defined in the inventor’s mind that only ordinary skill would be necessary to reduce the invention to practice, without extensive research or experimentation.” Id. at 25 (citation omitted). To support conception, CVC relied on Drs. Doudna and Jinek’s testimony and related emails showing that prior to March 1, 2012, the inventors had planned experiments using CRISPR-Cas9 in mammalian cells. Id. at 27. CVC also relied on pages from Dr. Jinek’s lab notebook dated March 1, 2012, memorializing Drs. Doudna and Jinek’s ideas, including a schematic diagram of a CRISPR-Cas9 system. Id. at 27-28. CVC further relied on the inventors’ later experimental work using CRISPR-Cas9 in eukaryotic cells as evidence that the inventors were diligently working toward an actual reduction to practice of the March 1, 2012, conception. Id. at 33-37.

According to Broad, the CVC inventors lacked “a definite and permanent idea of the complete operative invention” and that the schematic in Dr. Jinek’s March 1, 2012 notebook page was only a “naked idea.” Id. at 37. Broad pointed to CVC’s multiple failures throughout 2012 using CRISPR-Cas9 in mammalian cells as indicating that CVC inventors were “merely guessing at solutions to fundamental problems” instead of having a definite and permanent idea of the invention by March 1, 2012. Id. at 41. The PTAB agreed with Broad that CVC failed to establish a March 1, 2012, date of conception. Id. at 49. The PTAB found that CVC inventors engaged in a “prolonged period of extensive research, experiment, and modification” following the alleged March 1, 2012, conception. Id. at 45 (citation omitted). The PTAB further held that “the communications surrounding the [failed] experiments reflect ‘uncertainty that so undermines the specificity of the inventor’s idea that it [was] not yet a definite and permanent reflection of the complete invention as it [would] be used in practice.’” Id. at 45-46 (citation omitted).

Third, regarding Broad’s motion for judgment based on priority, the PTAB held that Broad’s inventors achieved an actual reduction to practice of an embodiment of Count 1 by October 5, 2012. Id. at 71. Broad’s inventor Dr. Zhang testified that he learned of CRISPR systems as a tool for genome editing by February 7, 2011, and by July 17, 2012, had designed a plasmid map of a CRISPR-Cas system for use in eukaryotic cells. Id. at 50-53. Broad inventors Drs. Zhang and Cong testified that the CRISPR expression system was used to genetically modify mouse cells in experiments on July 17, 2012, the results of which were reported and memorialized in a manuscript submitted to the journal Science on October 5, 2012. Id. at 53-56. Broad asserted that Dr. Zhang’s submission of the manuscript to Science indicated that he recognized and appreciated that the results of using the CRISPR-Cas9 system to cleave DNA in a eukaryotic (mouse) cell were successful. Id. at 56-57.

CVC opposed Broad’s motion for priority by asserting that Broad’s inventors derived the CRISPR system of Count 1 from CVC. Id. at 64. But to prove derivation, CVC needed to establish that its inventors conceived of the subject matter of Count 1 before Broad’s inventors. Id. at 65. The PTAB rejected CVC’s derivation argument by focusing on CVC’s failed motion on priority, in which the PTAB found “the preponderance of the evidence presented by the parties demonstrates that the CVC inventors’ experimental failures reveal uncertainty undermining a definite and permanent idea of an sgRNA CRISPR-Cas9 system that edits or cleaves DNA in a eukaryotic cell.” Id. at 66. The PTAB held that without prior conception, CVC’s argument that Broad derived the system of Count 1 from CVC’s inventors failed. Id. at 71. The PTAB therefore granted Broad’s motion on priority and held that Broad’s inventors achieved an actual reduction to practice of the Count by October 5, 2012. Id.

Finally, the PTAB denied CVC’s motion for judgment that Broad’s patent is unpatentable for failure to name all the correct inventors. Id. at 71, 79. An inventorship determination requires (1) a construction of each asserted claim to determine the subject matter encompassed and (2) a comparison of the alleged contributions of each asserted co-inventor with the subject matter of the construed claim to determine correct inventorship. Id. at 72. CVC relied on a declaration submitted by Thomas Kowalski, one of Broad’s former patent prosecution attorneys, in a European Patent Office opposition proceeding regarding inventorship of Broad’s PCT application claims. Id. at 72. CVC asserted that the inventors and their alleged contributions for the PCT application set forth in the Kowalski declaration is inconsistent with the inventors named on the Broad patent, and therefore the inventorship on the Broad patent is incorrect. Id. The PTAB rejected CVC’s inventorship arguments because CVC did not perform the required inventorship analysis by comparing the alleged contributions of the asserted co-inventors with Broad’s patent claims. Id. at 73.

[1] An interference is a contest under pre-America Invents Act (AIA) 35 U.S.C. § 135(a) between a patent application and either another application or a patent to determine priority, meaning, which party first invented the commonly claimed invention. The “count” in an interference is the description of interfering subject matter. See MPEP 2301 and 2301.02.