Tue, 03/02/2021
This post is a summary of Episode 9 of The Nebraska Governance & Technology Center’s Podcast Series, Tech Refactored. Hosts Gus Hurwitz, Menard Director of the Nebraska Governance and Technology Center (NGTC) and Christal Sheppard, NGTC Distinguished Fellow and Adjunct Professor at the University of Nebraska College of Law were joined by Samantha Zyontz, Research Fellow in Intellectual Property at Stanford Law School and Jake Sherkow, Professor at the University of Illinois College of Law.
Ever since CRISPR (“Clustered Regularly Interspaced Short Palindromic Repeats”) gene editing was demonstrated to be a viable way of efficiently modifying the genomes of organisms in 2013, it has resulted in a paradigm shift in numerous scientific fields; from agronomy, to pharmaceuticals, to gene therapy. As Sherkow put it, “the possibilities for CRISPR lie almost entirely in the imagination of scientists, and the limits, if there are any, are biological; things genes can or cannot do, not technical things that are difficult to do in the lab.”
As our panel noted, for many people the idea of genetic engineering conjures up assumptions based on the Hollywood blockbuster Gattaca, where eugenics achieved through genetic engineering results in a rigid class system and proscribed roles for everyone in society. Although we are a long way from that genetic dystopia, the genetic engineering of embryos has already moved from the realm of science fiction to science fact. Although the genetic engineering of human embryos is banned in most countries, that nevertheless failed to prevent a Chinese scientist from announcing in 2018 that he had used CRISPR to genetically modify the genomes of a pair of embryos in order to make them resistant to HIV. The embryos were implanted in a mother, and ultimately two baby girls were born.
While the genetic modification of embryos capable of subsequently passing on their genetic modifications remains highly controversial, the high-profile example of the “CRISPR babies” has managed to rob the spotlight from several very-positive studies that have used conventional CRISPR gene-therapy to open up avenues for the treatment of muscular-dystrophy and sickle-cell anemia. Conventional gene-therapy differs from the genetic modification of embryos (so-called germline gene therapy) in that the modifications it makes to the recipient's genome are not passed down to the next generation and therefore don’t implicate the permanent artificial modification of the human genome in the same way as germline gene therapy.
The implications of CRISPR extend well beyond human health; as Zyontz notes, CRISPR has been used to create drought-resistant and blight-resistant crops, leading to higher, more predictable crop yields. These resistant breeds are also better able to tolerate the extreme weather fluctuations that are becoming increasingly common as a result of climate change, helping to mitigate the catastrophic food shortages that often attend extreme weather events in the developing world.
The process of patenting CRISPR technology was so dynamic that it has led to its own cottage-industry of books discussing the events and personalities that are still competing to have their patent claims recognized internationally. Sherkow notes that, in part because of the unique set of circumstances surrounding the initial patenting of CRISPR technology, and in part because of the tremendously significant implications of CRISPR for a variety of areas of science and technology, there are currently an outsized number of complex CRISPR patent disputes winding their way through the courts. Hurwitz asked whether the number and breadth of CRISPR patent disputes is common to the patent industry, and if so, is that degree of litigation an inefficient, undesirable feature? Sheppard noted that patents that come under dispute are the vast, vast exception, “probably .001%” of the patents ever issued.
Interestingly, in the case of CRISPR, scientists have been incentivized to invent “around” existing patents, in a way that allows them to functionally “use” the innovation without interfering with the patent. This method is possible because there are a number of other nucleases (essentially enzymes capable of cutting genetic code) that can be employed using the CRISPR system in order to achieve similar results to the “Cas9” nuclease method that has been at the heart of the high-profile patent litigation. In fact, according to Zyontz’s most recent research, there have been “over 4,000 patent families” that have been registered in the last eight years that deal with different versions of CRISPR, mainly as a means of avoiding interfering with the Cas9 interference dispute. Just as genes evolve to find their way around existing barriers, so to do the methods of genetic modification developed by scientists.
As Zyontz puts it:
“To borrow a little from Jurassic Park, ‘Life finds a way.’”
Tags: Tech Refactored Review
