Gene-editing technology needs a pass on patent minefields
A breakthrough gene-editing technology known as CRISPR is poised to deliver new medical therapies and agricultural and industrial advancements.
Although recent reports of its success in the laboratory are promising, the larger challenge confronting CRISPR may be access to the underlying patent rights. To develop CRISPR technologies, commercial developers must fight or license their way through an intellectual property labyrinth that is the definition of inefficiency.
The situation looks like an invitation to litigation or government intervention, either of which would put the technology’s vast potential at risk.
There is a solution. In the 1990s, when the consumer electronics industry adopted the seminal international digital video standard known as MPEG-2 used in HDTV, DVD, cable and satellite, industry leaders recognized that the technology would not achieve ubiquitous deployment and assure a successful transition to the digital age if product development were hindered by litigation or the inaccessibility of patent licenses.
Industry leaders decided to combine their intellectual property in a “patent pool” that provided commercial developers with worldwide access at a reasonable and transparent price. Such “one-stop shopping” allowed patent holders to realize a reasonable profit, while fostering the interoperability that helped digital video technologies create a trillion-dollar global business.
MPEG LA, which led that effort, has proposed that CRISPR patent holders follow a similar path, for which gene-editing technology seems ideally suited. Here’s why:
CRISPR, short for Clustered Regularly Interspaced Short Palindromic Repeats — is a naturally occurring tool in the immune system of bacteria. It can be reconfigured and introduced into human, animal or plant cells to “edit” genes, in effect by changing the way they are written or read. CRISPR, which is fast, cheap and relatively easy to use, is considered superior to previous gene-editing techniques.
CRISPR is already being used in agricultural research to develop hardier and more nutritious crops and in industrial biotechnology for green products such as biofuels.
The potential for human therapies is breathtaking. Currently, the Centers for Disease Control and Prevention estimate that three to four percent of American babies are born each year with a genetic birth defect. Consider a disorder such as Huntington’s, in which a seemingly inconsequential “stutter,” or repeated DNA sequence on a single gene, leads to violent mood changes, early onset dementia, paralysis and eventually death, beginning as early as age 30. Editing out the extra DNA sequences holds the prospect of not just forestalling the disease but eliminating it.
In recognition that CRISPR is too important to be left at risk of endless patent battles and splintered licensing regimes, key CRISPR patent holders including the Broad Institute of MIT and Harvard have responded affirmatively to a public call for the creation of a global pool license.
What’s missing now is the big boost in investment that will come when the full range of patent licenses is readily available to all. Companies the world over — and their customers — will reap great benefits from the transparency of a pool license and the ability to license the necessary patents in a single transaction on fair and predictable terms. At the same time patent owners will be rewarded for their innovation with the opportunity to maximize return and minimize risk on their investments by making their technology accessible to many rather than just a few.
A patent pool in which rights holders make these decisions in concert with the market is preferable to governmental or judicial intervention. It also appears to be their most practical option and one that would bring good will and responsible stewardship to biotechnology innovation.
The situation looks like an invitation to litigation or government intervention, either of which would put the technology’s vast potential at risk.