Could CRISPR Patent Pools Foster Biomedical Innovation?
The CRISPR/Cas 9 bioengineering tool has received increased attention in the molecular biology and biomedical worlds, as innovations in this procedure have raised hopes that human cells may eventually be bioengineered to potentially cure a range of genetic diseases including, for instance, muscular dystrophy.[1] By replacing disease-causing mutations in cells, an individual can theoretically be cured of the associated disease.[2]
On February 15, 2017, the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) issued a decision between the Broad Institute and the Regents of the University of California relating to a claim by the latter concerning potential interference with its CRISPR/Cas9 patent territory.[3] The PTAB held that since the Broad Institute’s CRISPR system was reserved for eukaryotic cells, the University of California was not interfering with its application of CRISPR to other types of cellular environments, such as that of prokaryotic cells.[4] The decision relied on the ordinary skill standard, stating that “the evidence shows that the invention of such systems in eukaryotic cells would not have been obvious over the invention of CRISPR/Cas9 systems in any environment, including in prokaryotic cells or in vitro, because one of ordinary skill in the art would not have reasonably expected a CRISPR/Cas9 system to be successful in a eukaryotic environment.”[5] Though the PTAB struck down their interference claim, the University of California is in the process of appealing the decision.[6] University of California claims that the PTAB did not factor in findings of the degree of obviousness of their patent in eukaryotic environments.[7]
Meanwhile, other institutions, including the Broad Institute (a party in the interference case), MIT, Harvard and Rockefeller University, have entered a patent pool, which essentially allows each of these respective institutions to enter into a joint expedited licensing process.[8] So far twenty-two patents have been proposed for inclusion in the patent pool.[9] The licensing firm responsible for developing the patent pool, MPEG LA LLC, believes that this system will make it easier for medical research institutions to innovate, rather than spend resources attempting to maneuver around patent legality issues.[10] Based on whether the University of California wins the appeal in its case against the Broad Institute, it may or may not enter this materializing patent pool.[11] If the institution holds the sole patent right to a significant portion of CRISPR technology, then it may be reluctant to pool its resources.[12]
The Supreme Court has defined patent pools as the “linking of the right to use patents issued to more than one patentee.”[13] The use of patent pools allows patentees to contribute and receive certain mutual patent rights.[14] According to several analyses, patent pools do typically generate innovation, but this is largely contingent on several factors such as how exactly innovation is accounted for, the type of patents involved, and potential competitive and antitrust matters that might arise.[15]
Pools are generally more effective when the patents involved are more robust, since this mitigates the legal ambiguities surrounding their use.[16] The PTAB decision regarding the University of California’s CRISPR patent might suggest that the lack of interference indicates the existence of more robust patents in the CRISPR field.[17] However, the fact that there was a case to begin with could also signify a degree of ambiguity. While a CRISPR pool might lead to an increased rate of patents, the relationship with innovation in the actual technology and its potential biomedical benefits is not necessarily a direct correlation, since some of those patents might just have readily been grouped as one.[18] Moreover, if institutions develop monopolies over certain patented technologies through use of a pool, this could lead to decreased competition by other less well-resourced institutions, and possibly a decline in overall innovation.[19]
Thus, some scholars do not believe that a CRISPR patent pool would lead to the desired result of expediency and innovation.[20] Since it is so expensive to innovate CRISPR technologies, New York Law School’s Jacob Sherkow and the University of Utah’s Jorge Contreras believe that this might prove detrimental to a pool since the original innovators would not have sole rights to their patented technology and the make-up costs associated with ownership of those sole rights.[21] Sherkow argues that the non-exclusive nature of the CRISPR patent pool would make it economically unfeasible.[22]
Nevertheless, whether or not patent pools can ultimately foster CRISPR innovation, there is already rapid advancement in the field. Any proposed legal methodology will need to help facilitate that continued growth to lead to better medical treatment for individuals.
Footnotes
