March 28, 2017
A Tale of Two CRISPR’s: The battle for the IP behind one of the most important scientific discoveries of the century
To understand the significance behind the fight for CRISPR (technically the CRISPR-Cas9 system), its best to explain its significance first. Simply put, CRISPR is a genome editing tool that is much more precise, quicker, and cheaper than anything that has come before it. CRISPR is essentially a pair of molecular scissors that allows scientists to accurately delete and insert specific gene segments. This allows for a variety of things – genetically engineered plants, cures for genetic diseases, etc. Eventually, this editing could extend to curing certain types of cancer, hepatitis B, and other forms of genetically inherited diseases. Although these germline edits, which would be passed to subsequent generations, present their own legal and ethical dilemmas, the CRISPR system stands to potentially be worth billions.
However, the ownership of the CRISPR patent is in question. There are two parties disputing ownership: on one side is Jennifer Doudna of the University of California; on the other side is Feng Zhang of MIT. Both claim that they were the first to “invent” CRISPR. However, the filing was done under the (somewhat confusing) “first-to-invent” system. Although the U.S. transitioned to a “first-to-file” system in March of 2013, any filings before that date must be reviewed under first-to-invent laws. Although Doudna was first to file, Zhang filed under an expedited decision program that allowed his patent to be reviewed first. In April, 2014, Zhang received his patent for CRISPR.
There were also some differences in claims between the two patents. Zhang took a narrower approach when drafting his claims, covering only eukaryotic cells (cells with membrane-bound organelles) while Doudna covered both eukaryotic and prokaryotic cells. While Zhang has the current patent, Doudna’s may prove more valuable if he is able to beat Zhang in court.
The fight over CRISPR is somewhat uncommon in the world of academics. Although research institutions generate enormous amounts of patents every year, it is rare that a patent dispute reaches this level of magnitude. On the other hand, it isn’t every day that something as groundbreaking as CRISPR comes along. The enormous stakes in this case – billions of dollars is probably a conservative estimate – could have long term effects on how universities conduct their business when it comes to intellectual property. Its possible that under a first to file system, universities will push researchers to expedite the patent process before their inventions are entirely complete.
However, Zhang and Doudna are under the first to invent system. Under this system, the court must attempt to find who actually invented the system first. To do so under 35 U.S.C 102(g), the court looks to see that:
“(1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.”
Essentially, the court is looking for two steps: (1) conception of the invention, and (2) reduction to practice of the invention. Assuming that both parties conceived of CRISPR independently, it really comes down to who actually made it work first.
The process for determining this is as hard as it seems—requiring extensive evidence including lab journals, depositions, and records to determine who really reduced CRISPR to practice first. Its possible that whoever wins control of this multi-billion dollar invention will simply be the person who kept the best records.
Either way, it makes one pretty happy that the U.S. has switched our system to a first-to-file like the rest of the world.