The long running patent dispute between two leading players in the development of the genome editing CRISPR-Cas9 (CRISPR) technology has finally reached the Federal Circuit. On April 30, 2018, the University of California, Berkeley (UC) and the Broad Institute of MIT (Broad) met at the court to argue inventorship rights in foundational patents on methods for the use of CRISPR technology.
Briefly, the first-filed UC patent application to Jennifer Doudna, Emmanuelle Charpentier and their colleagues is directed to methods for the use of CRISPR in all cells. A later-filed application by Feng Zhang and his colleagues at the Broad resulted in an issued patent for the use of CRISPR in eukaryotic cells (includes human and animal cells). Between these two rivals, the UC scientists were first to publish on the CRISPR technology in the scientific literature.
Historically, U.S. patent law, requiring the issuance of a patent to the first inventor, has had a mechanism for identifying the first inventor where two separate applicants file for a patent on overlapping subject matter, known as an interference proceeding. The 2011 America Invents Act (AIA) instituted a first inventor to file regime, which largely eliminated the need for interferences. These CRISPR patent applications were filed before the effective date of the AIA in 2013, and are thus subject to the older regime. Thus, the patent rights to one of the most important advances in biotechnology are being sorted out according to the now-discarded first inventor paradigm of U.S. patent law. UC requested an interference proceeding from the U.S. Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (PTAB), believing that the Broad application covered the same subject matter as their own patent application and was therefore not valid (asserting that eukaryotic cells are a subset of all cells, and fall within the scope of the UC patent). The
UC argument is that their patent application is prior art to the Broad
patent, and provided enough information to allow other scientists to use
CRISPR in eukaryotic cells with a “reasonable expectation of success.”
UC asserted that the Broad subject is therefore obvious and not patentable. The PTAB declared an interference in 2016 (more background here).
In early 2017, the PTAB ruled that there were no conflicting patent rights (no interference) between the pending UC patent application and the already issued Broad patents. According to the PTAB, the Broad patent was not obvious in view of the UC patent application. Therefore, the existing grant of patents to the Broad for the use of CRISPR in eukaryotic cells was upheld, and the UC application for the use of CRISPR in all cells could continue prosecution. Effectively, this was a win for Broad. UC then appealed the PTAB decision to the Federal Circuit.
In the oral argument at the Federal Circuit on April 30th, the dispute centered on whether the PTAB applied the correct evidentiary standard to the determination of nonobviousness, and whether it properly considered all available evidence in its review. The PTAB had found that there was enough uncertainly about the technology in the 2012 time frame that the Broad scientists had no “reasonable expectation of success” and its work in eukaryotic cells was nonobvious; UC argued that the PTAB misapplied the obviousness standard.
It appears that the Federal Circuit may be likely to affirm the ruling of the PTAB. Looking forward, it is possible that the coexistence of a UC patent (upon issuance) and the Broad patents could require licenses from both patent holders for the use of CRISPR in eukaryotic cells by third parties, and cross-licenses between the patent holders for such use. The fate of patent rights to one of the most important biotechnologies in decades could soon be clarified. Depending on the ruling, a Supreme Court appeal could follow; however, it is unlikely that the Court would take the case.