Trouble with the Global Patent System?: The European Patent Office’s Revocation of the CRISPR Patent
A patent is an exclusive right granted for an invention that is novel, useful, and non-obvious. However, patents are territorial rights, which only apply in the country in which a patent has been filed and granted.[1] With the increasing interconnectivity of the world, the territorial nature of patent rights create potential for critical inconsistencies in protection that could undermine the incentives on which the patent system is founded.
CRISPR (Clustered Regularly Interspaced Short Palindromic Repeat) was initially discovered in 1987 as a naturally occurring DNA sequence in E.coli. In 2007, it was hypothesized that the CRISPR-Cas9 system was part of an adaptative immune system to cut bacterial phage DNA into small fragments, thereby protecting the organism from the infiltrating foreign DNA.[2] CRISPR-Cas 9 was first harnessed for genome editing by Feng Zhang and the Broad Institute of MIT and Harvard in 2013.[3]
CRISPR-Cas9 technology is a revolutionary gene-editing tool with many possible applications.[4] This tool has the potential to affect dozens of therapeutic areas and hundreds of diseases.[5] Among the diseases CRISPR-Cas9 could cure are cancer, blood disorders, blindness, AIDS, cystic fibrosis, muscular dystrophy, and Huntington’s disease.[6] The gene-editing tool also has useful non-medical applications, including the potential to eliminate pests, increase the efficiency of biofuel production, and accelerate crop engineering.[7]
After a long patent battle in the United States between the Broad Institute and UC Berkeley over the first to “reduce to practice,” the Broad Institute utilized the Paris Convention and filed in Europe.[8] The Paris Convention is an international treaty that grants a right of priority to a patent filed in one country to a subsequent patent filed in a participating country. In this case, the European patent benefits from the priority date of the U.S. patent. This benefit provides for uniform patent protection across countries.[9] The Broad Institute patent was granted in Europe in 2018 based on the Paris Convention and the original U.S. patent filings.[10]
However, on January 16, 2020, the European Patent Office (EPO) revoked the CRISPR gene-editing technology for lack of novelty. This lack of novelty existed because an omitted applicant failed to transfer his rights to the remaining applicant and the Patent Cooperation Treaty application was considered invalid, resulting in an intermediate prior art.[11] The issue stems from the earliest U.S. patent, filed in 2012, which lists Professor Luciano Marraffini of Rockefeller University as an inventor, while later U.S. and Europe patents do not include him. Essentially, the patent laws in the U.S. and Europe differ as to the requirement of listing inventors, and so the Paris Convention no longer protects priority.
Ultimately, this ruling is expected to affect nine of the 21 CRISPR-Cas9 patents in Europe,[12]and revocation of the patent will likely make it easier to commercialize CRISPR-Cas9 technology in Europe.[13] The Broad Institute has spoken out in disagreement of the decision and stated that instead of concerning the scientific merits of the patent application, the decision focuses on the interpretation of the law.[14]
While the effects of this decision are likely to be limited since the majority of the Broad Institute’s CRISPR-Cas9 patents in Europe are not affected by this decision,[15] the ruling does lead to some uncertainty: How will this decision affect the relationship between the U.S. and European patent systems going forward? How will this decision affect the ongoing research on CRISPR-Cas9? How will this decision affect the patenting process of the next breakthrough technology?
Footnotes
