The commercialization of genome-editing technologies

Abstract The emergence of new gene-editing technologies is profoundly transforming human therapeutics, agriculture, and industrial biotechnology. Advances in clustered regularly interspaced short palindromic repeats (CRISPR) have created a fertile environment for mass-scale manufacturing of cost-effective products ranging from basic research to translational medicine. In our analyses, we evaluated the patent landscape of gene-editing technologies and found that in comparison to earlier gene-editing techniques, CRISPR has gained significant traction and this has established dominance. Although most of the gene-editing technologies originated from the industry, CRISPR has been pioneered by academic research institutions. The spinout of CRISPR biotechnology companies from academic institutions demonstrates a shift in entrepreneurship strategies that were previously led by the industry. These academic institutions, and their subsequent companies, are competing to generate comprehensive intellectual property portfolios to rapidly commercialize CRISPR products. Our analysis shows that the emergence of CRISPR has resulted in a fivefold increase in genome-editing bioenterprise investment over the last year. This entrepreneurial movement has spurred a global biotechnology revolution in the realization of novel gene-editing technologies. This global shift in bioenterprise will continue to grow as the demand for personalized medicine, genetically modified crops and environmentally sustainable biofuels increases. However, the monopolization of intellectual property, negative public perception of genetic engineering and ambiguous regulatory policies may limit the growth of these market segments.

[1]  Darryl Macer,et al.  Universal Declaration On The Human Genome and Human Rights , 1997, Nursing ethics.

[2]  Who owns CRISPR-Cas9 in Europe? , 2014, Nature Biotechnology.

[3]  S. Rosenberg,et al.  Cancer Regression in Patients After Transfer of Genetically Engineered Lymphocytes , 2006, Science.

[4]  J. Doudna,et al.  The new frontier of genome engineering with CRISPR-Cas9 , 2014, Science.

[5]  Jacob S. Sherkow.  Who Owns Gene Editing? Patents in the Time of CRISPR , 2016 .

[6]  Jeffrey D Wolt,et al.  The Regulatory Status of Genome‐edited Crops , 2015, Plant biotechnology journal.

[7]  Jacob S. Sherkow.  Patents in the time of CRISPR: Who owns gene editing? , 2016 .

[8]  Neville E. Sanjana,et al.  Genome-Scale CRISPR-Cas9 Knockout Screening in Human Cells , 2014, Science.

[9]  Jacob S. Sherkow.  CRISPR: Pursuit of profit poisons collaboration , 2016, Nature.

[10]  Gang Bao,et al.  CRISPR/Cas9 systems have off-target activity with insertions or deletions between target DNA and guide RNA sequences , 2014, Nucleic acids research.

[11]  Ying Sun,et al.  CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes , 2015, Protein & Cell.

[12]  L. Yueh,et al.  Patent laws and innovation in China , 2009 .

[13]  Emily Waltz,et al.  Gene-edited CRISPR mushroom escapes US regulation , 2016, Nature.

[14]  Jin-Soo Kim,et al.  Analysis of off-target effects of CRISPR/Cas-derived RNA-guided endonucleases and nickases , 2014, Genome research.

[15]  William Bains,et al.  Wasting cash—the decline of the British biotech sector , 2009, Nature Biotechnology.

[16]  Yaojin Peng.  The morality and ethics governing CRISPR–Cas9 patents in China , 2016, Nature Biotechnology.

[17]  N. Patron,et al.  Induction of targeted, heritable mutations in barley and Brassica oleracea using RNA-guided Cas9 nuclease , 2015, Genome Biology.

[18]  D. Go,et al.  The Impact of CRISPR/Cas9-Based Genomic Engineering on Biomedical Research and Medicine. , 2016, Current molecular medicine.

[19]  Kiran Musunuru,et al.  Expanding the genetic editing tool kit: ZFNs, TALENs, and CRISPR-Cas9. , 2014, The Journal of clinical investigation.

[20]  B. Wiedenheft,et al.  The history and market impact of CRISPR RNA-guided nucleases. , 2015, Current opinion in virology.

[21]  V. Iyer,et al.  Efficient genome modification by CRISPR-Cas9 nickase with minimal off-target effects , 2014, Nature Methods.

[22]  Sara Reardon,et al.  Chinese scientists genetically modify human embryos , 2015, Nature.