The CRISPR Patent Landscape: Past, Present, and Future

Abstract

The development of CRISPR depends, in part, on the patents-past, present, and future-covering it. As for the past, the origins of the CRISPR patent landscape predate its use as a gene editing technology. Fundamental patents covering CRISPR-Cas9 as a genomic editing system did not first arise until 2012; they sparked the now canonical dispute between the University of California and the Broad Institute. The present dispute has not stopped widespread licensing of critical patents, however, bringing with it an explosion of research from both academic and commercial sectors. Whether this broad availability will persist in the future remains uncertain. The ease and reliability of CRISPR threatens many future patents as being ''obvious.'' Nor is it clear how academic scientists and technology transfer offices will respond to the patent dispute. Like the technology itself, the future of the CRISPR patent landscape depends on researchers and their institutions.

CRISPR: Challenges to South African biotechnology law

“…Despite the ongoing patent litigation, the University of California and the Broad Institute, the Massachusetts Institute of Technology (MIT) and Harvard University have all proceeded to grant broad exclusive licences to use their respective CRISPR technologies commercially; [19] the Broad Institute, MIT and Harvard state that academic and nonprofit use shall not require licences. [20] For example, the Broad Institute employs an 'inclusive innovation model' wherein the surrogate company Editas is a primary licensee of exclusive licences, but after an initial period, other companies may be granted licences for the CRISPR technology.…”

“…[20] For example, the Broad Institute employs an 'inclusive innovation model' wherein the surrogate company Editas is a primary licensee of exclusive licences, but after an initial period, other companies may be granted licences for the CRISPR technology. [20] Sherkow [19] voices the concern that this may prevent other smaller companies from innovating using CRISPR-Cas9 technology, and suggests that co-operative patent licensing should be encouraged, as opposed to exclusivity and patenting thickets. The University of California and the Broad Institute have announced that they are working on a patent pool and other mechanisms to enhance access to CRISPR technology, but this requires foundational patent owners, [21] which include the company Šikšnys and other agricultural companies such as Monsanto, DuPont Pioneer, Caribou Biosciences, and ERS Genomics.…”

“…The University of California and the Broad Institute have announced that they are working on a patent pool and other mechanisms to enhance access to CRISPR technology, but this requires foundational patent owners, [21] which include the company Šikšnys and other agricultural companies such as Monsanto, DuPont Pioneer, Caribou Biosciences, and ERS Genomics. [19] Apart from the issue of access to technology, there is also the issue of whether down-the-line inventions using CRISPR technology would even be patentable. Sherkow [19] questions whether there is any non-obvious application of CRISPR-Cas9, with obvious negative consequences for patentability.…”

“…[19] Apart from the issue of access to technology, there is also the issue of whether down-the-line inventions using CRISPR technology would even be patentable. Sherkow [19] questions whether there is any non-obvious application of CRISPR-Cas9, with obvious negative consequences for patentability. [19] The process itself has already been patented, and it may be possible that future patents will include the use of the technique in claims to the genome-edited end products.…”

“…Sherkow [19] questions whether there is any non-obvious application of CRISPR-Cas9, with obvious negative consequences for patentability. [19] The process itself has already been patented, and it may be possible that future patents will include the use of the technique in claims to the genome-edited end products. However, what is debatable is: (i) whether these gene-edited end products are patentable subject matter, as they may be regarded as products of nature, [22] a debate predating genome editing; (ii) whether these gene-edited end products, if they are homologous to corrected genes present in a normal healthy population, fulfil the novelty criterion of patentability; [22] and (iii) whether the production ARTICLE of the edited genes introduces a non-obvious step that is required for patent eligibility.…”