Breaking Down the CRISPR Patent Dispute
Patents play a crucial role in safeguarding investments into biotechnology experimentation.[1] Developing just a single product costs a large amount of money, and generally the technology produced does not provide any return on the investment.[2] Patents give inventors the right to exclude others from profiting from the invention for a certain period of time.[3] This helps inventors to make a profit on an investment before competitors saturate the market, which is important for promoting innovation.[4]
What is CRISPR?
The introduction of CRISPR-Cas9 (“CRISPR”) technology in 2012 was “revolutionary,” because it is a precise, low cost, and usable innovation that has transformed genetic research.[5] CRISPR technology can be used to edit genes by finding a specific DNA sequence in a cell and altering that gene.[6] This is important because many diseases stem from a mutation in the DNA[7], so having the ability to alter these mutations could treat and possibly prevent diseases that currently do not have a cure.[8] For example, a clinical trial using CRISPR to treat sickle cell disease was proposed.[9]
The CRISPR Patent Dispute
In May 2012, researchers from the University of California Berkeley (“UC”) filed patents for the CRISPR technology in the United States, while researchers from the Broad Institute (“Broad”) filed patents in the United States for CRISPR in December 2012.[10] UC sought patents using CRISPR in any environment, while Broad’s patents sought to use CRISPR in plant and animal cells.[11]The Broad patents were granted first because, although they were filed later, they were sought on an expedited basis.[12] After Broad was awarded the patents, the United States Patent and Trademark Office (“USPTO”) instituted an interference between Broad’s patents and UC’s patents.[13] An interference proceeding “is designed to determine which of two sets of inventors was the first to invent a technology and should be issued patents”.[14] Broad argued that the claims were distinct because UC’s patents did not show that CRISPR would work in plant and animal cells.[15] The Patent Trial and Appeal Board (“PTAB”) determined that there was no interference because of the differences in the types of cells that the institutions relied on in their patents.[16]
UC appealed the PTAB’s decision, and the Court of Appeals for the Federal Circuit affirmed.[17] The appeals court did not discuss the issue of which party was the first to invent the technology, as they held that UC and Broad applied for distinct patents.[18] The court explained that the patents were distinct because “a skilled artisan would not reasonably expect that UC’s patent claims on CRISPR technology would work in plant and animal cells”.[19] Because the court did not rule on the validity of the patent claims, it did not preclude UC from pursuing future litigation to establish that it invented CRISPR use in eukaryotic cells.[20]
In 2019, the USPTO issued a second interference proceeding regarding UC and Broad’s patents and applications.[21]This proceeding was the result of 10 additional patent applications submitted by UC detailing the use of CRISPR in plant and animal cells and will be compared with the same Broad patents at issue in the first proceeding.[22] Because the UC applications and the Broad patents are both based on the use of CRISPR in plant and animal cells, the issue of first invention will be decided.[23] The PTAB has not yet issued a decision on this proceeding.[24]
Implications of the Dispute
Because CRISPR could be successful in providing human therapies, the market could be worth billions of dollars per year.[25] Developments over the years, however, have lowered the value of the initial patents discussed above.[26] When the UC and Broad patents were filed, “it was unclear whether enzymes other than Cas9 [(the enzyme patented by UC and Broad)] would have the same efficacy”, but over the years researchers have discovered a multitude of other enzymes that are efficient when paired with CRISPR.[27] Even so, the patent is estimated to be worth around one hundred million dollars over its life.[28] Whoever wins the PTAB case will have rights to the patent and the money it generates.[29]
It is worth noting that in 2020, Emmanuelle Charpentier and Jennifer A. Doudna, the team from UC, won the Nobel Prize for CRISPR.[30] With this, it is plausible to consider the possibility that both UC and Broad continue to fight for the patent rights to CRISPR not for the now slim monetary gain, but for the recognition of inventing this revolutionary technology. While Broad retains the patent for plant and animal cells for now, only time will tell what the final outcome will be.
Footnotes
