New research published by University of Utah S.J. Quinney College of Law Associate Professor Jorge Contreras in the journal Science today proposes that universities currently holding CRISPR patents open their licenses to broader segments of the biopharma industry — a change that could potentially lead to important discoveries for human health and medicine.
“Because the potential for CRISPR as the engine for the creation of life-saving drugs and therapies is potentially compromised by the current licensing model, it should be corrected to improve the potential for enhancing public welfare,” said Contreras of his findings in Science, titled “CRISPR, surrogate licensing and scientific discovery: Have research universities abandoned their public focus?”
Contreras, along with co-author Jacob S. Sherkow of New York Law School, critiques the current “surrogate” licensing model for biopharma technology licensing and proposes a new model that would broaden the accessibility of the technology to others.
The call for a new licensing model has been prompted by the emergence of CRISPR-Cas9, a revolutionary technology that can be used to edit the DNA sequence of any living organism.
The technology has been mired in recent legal battles over patents. At issue is who owns what part of the technology —and who should be able to access the technology in the future.
The basic CRISPR technology was developed at several major research universities: the Broad Institute (a collaboration between Harvard and MIT); UC Berkeley and University of Vienna. These universities have each patented aspects of the basic CRISPR technology. Berkeley and Vienna, on one hand, and Broad (Harvard-MIT), on the other hand, have each licensed the use of their CRISPR patents for human therapeutics to a single company formed by the university and its principal CRISPR researchers. These two companies therefore control the use of this potentially valuable technology around the world.
Traditionally, broadly-applicable patents on research tools have been licensed on a non-exclusive basis, meaning that many companies can use them to discover and develop new drugs and therapies. But, contrary to guidance from the National Institutes of Health and a 2007 accord signed by the universities themselves, the use of CRISPR for all human therapeutic applications has been licensed exclusively to two companies.
“Because there is no way that these two companies, even with their commercial partners, can hope to explore all biomedical applications of CRISPR, this exclusivity has the potential to limit the number of life-saving drugs and treatments that can be developed,” said Contreras.