The Federal Circuit has vacated in part a patent interference ruling by the Patent Trial and Appeal Board (PTAB or Board), finding that the PTAB improperly conflated the distinct legal standards for conception and reduction to practice.
The case is The Regents of the University of California v. The Broad Institute, Inc.
The case involves an invention relating to the adaptation of “CRISPR” systems to edit eukaryotic DNA.
Scientists associated with the University of California and the University of Vienna, and Emmanuelle Charpentier (collectively “Regents”), claimed they invented the technology.
Scientists affiliated with The Broad Institute, the Massachusetts Institute of Technology (MIT), and Harvard College (collectively “Broad”) argued they were the true inventors.
The Board concluded that “Broad has priority over Regents with respect to a CRISPR-Cas9 system that contains a “singleguide” RNA that edits or cleaves DNA in eukaryotic cells.”
As the court explained,
CRISPR systems are immune defense systems in prokaryotic cells that naturally edit DNA. One of the “simplest” types of CRISPR systems, a “Type II CRISPR system,” uses an RNA sequence, “crRNA,” to guide a protein to a particular DNA sequence as part of the process of editing the DNA.
As Time noted, CRISPR technology gave the world the first COVID-19 vaccines.
As the court explained,
Every living organism is one of two types: prokaryotic or eukaryotic. Prokaryotes are single-celled organisms lacking a nucleus, such as bacteria, while eukaryotes are more complex organisms, such as animals and plants, whose cells possess a nucleus.
Scientists sought to use the natural editing capabilities of CRISPR systems to edit DNA in eukaryotic cells. Broad’s and Regents’ scientists both claimed that by 2011 or early 2012 they knew CRISPR Type II systems edit DNA using three components: mature tracrRNA, mature crRNA, and a protein called “Cas9.”
As the court noted,
Starting in March 2012, Regents’ scientists, directed by Charpentier, Jennifer Doudna, and Martin Jinek, planned experiments to show the single RNA CRISPR-Cas9 system could be used to edit eukaryotic DNA. On March 1, 2012, Jinek wrote a notebook entry and exchanged emails with Doudna in which they described the system and experiments using it in mammalian cells, to test if the system could successfully edit eukaryotic DNA.
After these initial plans, Regents filed its first provisional patent application on May 25, 2012.
After Regents’ scientists made public announcements in June 2012, describing the single RNA CRISPR-Cas9 system in a conference presentation at the University of California, Berkeley, scientists from other laboratories, including those associated with Broad, tried to use the system to edit DNA in eukaryotic cells.
As the court explained, “conception,” in patent law,
is defined as “the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.”…
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.
The Board had determined that Regents did not prove conception of the invention prior to Broad’s actual reduction to practice on October 5, 2012, because Regents’ scientists didn’t know their CRISPR-Cas9 system would produce the effects on genes in a eukaryotic cell recited in Count 1 of their patent application.
Regents argued that the Board erred by requiring Regents’ scientists to know that their invention would work. The Federal Circuit agreed that the Board legally erred by conflating the distinct legal standards for conception and reduction to practice.
As the court explained,
There are three stages to the inventive process: (1) conception, (2) reasonable diligence, and (3) reduction to practice. …At the conception stage, it is well-established that “an inventor need not know that his invention will work for conception to be complete.”
Thus, said the court, the PTAB erred “by requiring Regents’ scientists to know their invention would work to prove conception.”
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