Emily Prieur is an IPilogue Writer and a 3L JD Candidate at Queen’s University Faculty of Law.

 

Introduction

In 2020, the Royal Swedish Academy of Sciences awarded the Nobel Prize in Chemistry to Drs. Emmanuelle Charpentier and Jennifer A. Doudna for “the development of a method for genome editing” otherwise known as CRISPR gene editing.

CRISPR’s discovery was a revolutionary breakthrough that has the potential to end various human diseases like cancer and facilitate the discovery of novel drug targets. CRISPR has been widely discussed within the scientific community for years for both its scientific and ethical implications.

But in late February 2022, CRISPR entered the news for an entirely different reason. After a decade-long dispute, the United States Patent Trial and Appeal Board (“PTAB”) decided that Drs. Charpentier and Doudna were not the rightful owners of the CRISPR-Cas9 patent, concluding that the gene editing technology belonged to Dr. Feng Zheng and his team of scientists at the Broad Institute of MIT and Harvard.

What is CRISPR?

CRISPR is an acronym for “clustered regularly interspaced short palindromic repeats” and Cas9 is short for “CRISPR-associated protein 9”. CRISPR are specialized repeats of genetic information (i.e., DNA). Cas9 is a protein that cuts the DNA and binds a guiding RNA to the DNA to add the desired sequence. The protein that is added to the DNA does not have to be Cas9; however, it is the protein that is most often used by scientists when employing this technique. In essence, the technology generally involves finding a “bad” piece of DNA, removing that bad piece, and then correcting the DNA sequence by inserting a new gene.

The Patent Dispute History

Drs. Charpentier and Doudna from the University of California-Berkeley (“UCB”) showed the genius of the CRISPR editing method in their Science paper in 2012, specifically on gene-editing in test tubes. Dr. Zhang and his group at the Broad Institute of MIT and Harvard also published in Science in 2013, showing the promise of CRISPR/Cas9 in humans.

Following the scientists’ publications, the United States transitioned from a first to invent patent system to a first inventor to file system, which became effective in March 2013. This is relevant as all patent disputes between the scientists revolved around the issue of who invented CRISPR, and, more specifically, who was able to prove CRISPR’s application in humans, first.

In 2014, the United States Patent and Trademark Office (“USPTO”) granted U.S. Patent No. 8,697,359 to Dr. Zhang and his group at the Broad Institute of MIT and Harvard. There were two interferences at the PTAB, in 2015 and 2019, both triggered by the UCB through request and application. For the first interference, the PTAB ruled that there was no interference because of the invention’s applications in different cell environments (i.e., eukaryotic human cells versus non-human cells in a test tube). For the second interference, UCB requested that the PTAB reverse the prior first instance decision and conclude that successful experiments in human cells is not necessary to successfully obtain the patent.

The PTAB’s Decision

Following the scientists’ oral arguments on February 4, 2022, the PTAB concluded that Dr. Zheng and his team at the Broad Institute of MIT and Harvard were the rightful owners of the patent. UCB was unable to prove that their invention was applicable in human cells prior to the Broad Institute’s invention in 2013.

Conclusion

The battle may not be over. Drs. Charpentier and Doudna, along with the University of California Berkley, have the option to appeal to the U.S. Court of Appeals Federal Circuit. In a statement, the University of California Berkley said it was considering "various options" to challenge the PTAB decision, making an appeal even more likely. In addition to UCB, Dr. Zheng and his colleagues at the Broad Institute of MIT and Harvard are also embroiled in two other pending interferences at the PTAB involving two different companies (ToolGen, Inc. and Sigma-Aldrich Co. LLC).