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Tuesday November 13 2018

The War for CRISPR

Science is often viewed as the embodiment of the good in humanity. Human progress, curiosity and selflessness are all revered principles within the scientific community, and the pursuit of truth is said to be held above all else. Unfortunately, the reality of academia often differs from these ideals.

This October, the Nobel Prize for Medicine and Physiology was awarded for the discovery of the molecular underpinnings of circadian rhythm.[1] Yet in the days leading up to this announcement, many in the scientific community believed that the award would be given to Emmanuelle Charpentier, Jennifer Doudna and Feng Zhang for their pioneering discovery of CRISPR-Cas9, allowing scientists to cheaply and accurately make changes to DNA.[2] However, the Nobel Prize committee has deferred on recognizing the contributions of CRISPR for years – despite clear evidence of its importance – in light of the ongoing patent war between Charpentier and Doudna’s team and Zhang’s team.

In 2012, Charpentier and Doudna, researchers associated with the University of California-Berkeley, discovered the mechanism underlying CRISPR-Cas9. In May of that year, the Berkeley team filed a patent for this technology to the United States Patent and Trademark Office (USPTO). Not long after, Feng Zhang from the Broad Institute of Harvard and MIT proved the applications of this new technique in eukaryotes, also submitting a patent for their work. Having submitted their patent later, the Broad Institute team elected to pay the patent office a fee to fast-track their patent and ultimately won the right to license the use of Cas9 in eukaryotic cells in April of 2014, before Berkeley received their patent.[3] Since the majority of CRISPR’s commercial applications, from medicine to agriculture, are expected to take place in eukaryotes, the patent won by the Broad Institute is expected to be extremely lucrative.[4]

Considering these high stakes, Berkeley requested a patent interference trial, claiming that Zhang’s patent significantly overlapped with their own. In February, the trial finally concluded in favour of the Broad Institute team.[5] The USPTO justified their decision by stating that the work done by Zhang’s team did not obviously follow from that of Charpentier and Doudna’s.[6] Charpentier and Doudna are currently appealing the decision by the UTPSO to uphold the Broad Institute’s patent.[7] In Europe, Berkeley was also granted the general rights to CRISPR, in both prokaryotes and eukaryotes, by the European Patent Office in March.[8]

Although conflicts between scientists over intellectual property are hardly new, the involvement of academic institutions in this dispute over CRISPR is hailed by many as a turn for the worse.[9] Since the introduction of the Bayh-Dole act in 1980, universities have been allowed to patent the results of publicly-funded research. This act was originally introduced with the aim of incentivizing innovation and giving private institutions access to government-funded research, largely untapped until this point.

Universities have historically been content to leave the commercial application of research to venture capitalists or scientists themselves, only beginning in earnest to acquire and license intellectual property recently.[10] Patent licensing has not been extremely profitable in the past. Only around 5% of patents held by universities end up being licensed, the rest costing money by accruing legal maintenance fees. This can potentially lead to intellectual properties being sold to patent auction houses and, in the worst case, to patent trolls. Of the 30,000 patents owned by Intellectual Ventures, a notorious patent troll, 500 were provided by universities.[11] Although some patents have the potential for large profit margins, such as CRISPR-Cas9, they are few and far between. Only 11% of technology-transfer offices (TTOs) at universities are profitable, with the majority of TTOs losing money.[12]

Increasing reliance on licensing for funding brings with it the risk of research becoming subservient to profit. If universities draw significant revenue from patent licensing, it is easy to imagine tenure committees placing more weight on patents compared to papers published, and resources being directed away from basic research to applied. Competition between universities may also discourage information-sharing. Universities should certainly have the option of supplementing their income with patent licensing, however they should approach this prospect cautiously. If possible, universities should seek to help researchers and startups develop intellectual properties, relying less on their technology transfer offices.


Written by: Kevin Zhao, Bachelor of Health Sciences (Class of 2021)

Edited by: Angela Dong, Bachelor of Health Sciences (Class of 2020) 


References:

[1] The Nobel Institute at Karolinska Institutet. Press Release. 2017. Available from: https://www.nobelprize.org/nobel_prizes/medicine/laureates/2017/press.html

[2] Kramer, K. Predictions for the 2017 Chemistry Nobel Prize. Chemistry World;2017. Available from: https://www.scientificamerican.com/article/predictions-for-the-2017-chemistry-nobel-prize/

[3] Ledford H. Bitter fight over CRISPR patent heats up. Nature. 2016;529: 265. doi:10.1038/nature.2015.17961

[4] Sherkow, J.S. How Much Is a CRISPR Patent License Worth? Forbes. February 21 2017. Available from: https://www.forbes.com/sites/jacobsherkow/2017/02/21/how-much-is-a-crispr-patent-license-worth/#378d0b0f6b77

[5] Cross, R. CRISPR patent dispute ends well for Broad Institute. Berkeley says: Not so fast. Chemical & Engineering News. February 20, 2017. Available from: https://cen.acs.org/articles/95/i8/CRISPR-patent-dispute-ends-well.html

[6] United States Patent and Trademark Office. The Broad Institute, inc. vs. The regents of the University of California. The Broad Institute. 2017. Available from: https://www.broadinstitute.org/files/news/pdfs/106048DecisiononMotions.pdf

[7] Sanders, R. Appeals board clears way for UC Berkeley to receive patent on CRISPR-Cas9 gene editing. Berkeley News. February 15 2017. Available from: http://news.berkeley.edu/2017/02/15/patent-office-determines-uc-broad-institute-patent-claims-on-crispr-cas9-genome-editing-are-separately-patentable/

[8] Doudna, J.A. et al. EP2800811 – Methods and Compositions for RNA-Directed Target DNA modification and for RNA-directed Modulation of Transcription. 13793997.1 (Patent). 2017.

[9] Lemley M.A. Are Universities Patent Trolls? Fordham Intellectual Property, Media and Entertainment Law Journal. 2008;18(3): 611-631. Available from: http://ir.lawnet.fordham.edu/cgi/viewcontent.cgi?article=1405&context=iplj

[10] University of Pittsburgh Innovation Institute. Bayh-Dole Act at a Glance. Available from: http://www.innovation.pitt.edu/resource/bayh-dole-act-at-a-glance/ [Accessed December 29 2017]

[11] Katz Y. Universities have turned over hundreds of patents to patent trolls. Medium. October 13 2016. Available from: https://medium.com/@yardenkatz/universities-have-turned-over-hundreds-of-patents-to-patent-trolls-99d5cdec1d8a

[12] Merrill D., Migliozzi B., Decker S. Billions at Stake in University Patent Fights. Bloomberg. May 24 2016. Available from: https://www.bloomberg.com/graphics/2016-university-patents/

 

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