The scientific community is in the midst of a gold rush in new technological applications all made possible by the CRISPR/Cas9 system. CRISPR, short for “clustered regularly interspaced palindromic repeats” is quite possibly the biggest innovation in biological science since PCR was developed over three decades ago. This is literally life altering genetic innovation.
Scientists have been modifying genomes for years, so what’s the big deal behind this new technology?
In the past, prior to 2010, in order to modify the genome of a mouse, researchers would transfer embryonic stem cells into a mouse embryo containing the genetic mutation of choice. It would then take three generations to see the desired mutation and actually start utilizing the mutation for research purposes. This resulted in large amounts of time and money spent on breeding two unnecessary generations of mice without the guarantee of success. If a researcher wished to modify five genes of interest, this process would be repeated, you guessed it, five more times.
Taking this into account, CRISPR only needs one generation. This system is precise, efficient, and flexible, allowing for multiple mutations to be made all at once. Its efficacy has been proven time and time again in mice, monkeys, and recently in non-viable human embryos by a group of researchers in China, which proves its potential to treat ANY genetic disease.
As applications of this system are developed, many billion-dollar opportunities will arise. With this much money at stake along with world changing potential, rights to the invention are sure to create a heated patent battle at the USPTO, begging the question; who owns the technology anyways?
Professor Jennifer Doudna of UC Berkeley and Emmanuelle Charpentier from Umea University in Sweden filed on March 15, 2013 – one day before the first-to-file rule took effect – and claimed a priority date of May 25, 2012. On the other hand, Feng Zhang of the broad institute of MIT and Harvard in Cambridge, Massachusetts filed on October 15, 2013 under the accelerated examination program. The Broad Institute received patent No. 8,697,359 in April of 2014 claiming priority to a provisional application filed in December 2012.
As the Broad Institute continued to file applications for the technology, Doudna filed a Suggestion of Interference claiming that the Broad Institute Patents interfered with Doudna’s previous application. Pre AIA gives right to who created the invention first, unlike the first-to-file rules of today. An interference procedure is underway with oral arguments set for November 2016.
At stake are the rights to exclusively make, use, license, and sell the invention. The CRISPR/Cas9 system has the ability to completely alter how we treat genetic diseases, and may lead to the actualization of ‘designer babies’ – babies born with their traits hand picked by the parents. The discovery of a lifetime is up for grabs and it will be interesting to see who emerges with rights to the technology. Each party has issued liscences to large biotech companies ready to use the technology in grand-scale implication, however these projects have been delayed, pending the USPTO decision of this patent battle.