CRISPR, the gene editing technique that became popular world over in 2012, is drawing the attention of researchers. This technique of genetic engineering offers revolutionary prospects encouraging researchers to improvise, develop and tame these breakthrough molecular scissors.
Amid the high stake patent battle between University of California and Broad Institute, scientific research in this domain continues to intrigue inventors and scientists. Universities and biotechnology companies in the U.S. are aggressively pursuing research on CRISPR. The widespread application of CRISPR in agriculture, therapeutics and medicine, and veterinary is multifold. However, the impact that this gene editing technology might have on mankind poses ethical hurdles and strict regulatory barriers.
While the world debates about the ethical usage of gene modification tools, China moved a step ahead by bringing the technology from labs to the hospital. A Chinese group has become the first to inject a person with cells that contain genes edited using CRISPR–Cas9 technique. In October 2016, a team led by oncologist Lu You at Sichuan University in Chengdu injected the modified cells into a person being treated for aggressive lung cancer as part of a clinical trial at the West China Hospital, Chengdu.
The first US human CRISPR trial is slated to begin this winter by the University of Pennsylvania, following an FDA regulatory approval last year. Scientists plan to genetically alter patients’ immune cells to attack three different kinds of cancer as part of this trial phase.
China, U.S. in a CRISPR race for IP assets
China, along with the U.S., has witnessed advances in CRISPR technology marked by active patenting activity. Of the 2,298 granted patents and applications filed globally, U.S. owns 19% of the global CRISPR patent portfolio while China owns 17%. Number of patent applications filed in China (410 granted patents and applications) and US (447 granted patents and applications) are comparable.
Ever since the publication of CRISPR as the potential gene editing technique by Jinek et.al in 2012, patenting activity has increased exponentially. Patent filing trends in the U.S. and China show a competing trend.
76% of Chinese patents have been filed by in-house Chinese universities and companies as compared to 81% of US patents filed by U.S. based companies and universities. In other words, China attracted 24% patenting activity from foreign companies, while US attracted only 19%. Interestingly, while Chinese universities and companies have restricted themselves from filing patents in the U.S. (2 patent applications), U.S.-based universities and companies have been safe guarding their IP in China (77 patents and applications). China has also attracted patenting activity from European players.
The reason might be multifaceted. Regulatory and ethical restrictions in China is not as strict as in the U.S., and hence provides early testing ground for human trials, which are essential to attain precision in using CRISPR for medical and therapeutics. Owing to the government sponsorship of CRISPR projects in China, Chinese universities are actively inventing various aspects of CRISPR technology. This propels U.S. assignees to notice the developments in China and also safe guard their IP.
Important assignees of CRISPR IP assets in the U.S.
Major patent assignees in CRISPR technology are Broad Institute, Dow Chemical, Du Pont and Harvard University. Of 214 IP assets (granted patents and applications) owned by Broad Institute, 14 IP assets are filed in China. Chinese Academy of Sciences makes it to the top 15 assignees with 26 IP assets.
China’s role in developing and commercializing CRISPR is well recognized by the world. A close competition between the USPTO and SIPO on CRISPR inventions has kept the world on edge. While the Chinese have already put this revolutionary gene editing technique to practice, U.S. is catching up by not only strengthening its research, but also seeking approvals for the first clinical trials.
(Featured image is for representational purpose alone. Image has been sourced from https://pixabay.com/en/man-dna-spiral-biology-merge-2125123/)