INTRODUCTION
In the world of biotechnology, there is nothing that caused as much excitement as the invention of CRISPR Technology. This revolutionary gene-editing technique proved to have enormous developments in medicine, agriculture, and various other industries. Although this is a piece of exciting news for the science community, it has a complex legal wrangling in its backdrop. The battle to own the IP rights of the CRISPR technology has been humungous. This is due to the obvious reason that anyone who owns IP rights or commercial rights over this will get the opportunity to generate extremely high financial profits because several companies have made substantial investments totalling millions of dollars for CRISPR medical therapies.[1]Before delving into the complexities of the patent matter in question, it is necessary to know how the CRISPR technique came into existence.
WHAT IS CRISPR TECHNOLOGY?
CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a genetic engineering technique that allows cutting and editing of an organism’s DNA. It is known to be the most convenient and precise method of genome editing as compared to other techniques like Zinc finger nucleases (ZFNs) and Transcription activator-like effector nucleases (TALEN).
CRISPR was originally derived from bacteria; They were seen to play the role of an immune system against bacteriophages. They consist of sequences of genetic code and it serves as a genetic memory that detects and destroys invaders[2] It is an enzyme that binds the DNA of the targeted genes and cuts it off.
CRISPR as a tool
CRISPR is said to be the greatest tool of gene editing up to this date. Its applications range in various fields and industries, from poultry to medicine. In terms of medicine, CRISPR is an effective tool to treat monogenic and polygenic disorders. Genetic disorders are caused by certain DNA sequence variants that encode malfunctioning proteins. Through CRISPR, scientists can edit these DNA sequences.[3] For instance, in a recent case, a patient with sickle cell disease was treated with CRISPR.[4] Similarly, undesired genes like that of cancer can be cut off using this technology.
THE PATENT WAR
The array of CRISPR patents has caused a legal storm in the industry. The origins of the patent dispute can be traced to its roots in two prominent researchers; Doudna from the University of California, Berkeley, and the other one was Feng Zhang from the Board Institute. However, According to studies, a Swiss-based IP management consultancy, stated there are currently over 900 patent families asserting rights over various facets of CRISPR-Cas9 systems.[5]
This raises an important question as to who owns the patent for this technology. The crux of this dispute delves into the concept of inventorship and the interpretation of intellectual property laws.
The University of California the Board Institute of Massachusetts Institute of Technology (MIT) and Harvard were engaged in this fierce battle for ownership rights over the CRISPR technology. Initially, the 2020 Nobel Prize winners, Emmanuelle Charpentier and Jennifer Doudna highlighted the applications of CRISPR by using it to edit genes. Specifically, how Cas-9 (an enzyme in CRISPR) can cut these genes. This revelation was applied for patenting in May 2012. The team at Board Institute led by Feng Zhang then discovered that they had found a way to edit the genes of mammals just six months later. The Board first filed their application in December 2012.[6] The race towards winning the patent rights was about who invented it first and most importantly whose work contributed more. Moreover, awarding Emmanuelle Charpentier and Jennifer Doudna the Nobel Prize for the invention of the CRISPR technique stirred up various controversies as to whether they deserved the prize.
The USPTO (United States Patent and Trademark Office) granted the patent to the Board Institute in 2013. Unhappy with this decision, UC Berkeley initiated a patent interference procedure under the USPTO’s Patent Trial and Appellate Board (PTAB). In 2017, the PTAB held its decisions on the motions stating that the parties’ claims do not interfere and upheld the patent rights of the Board Institute. It reasoned that the Board Institute is claiming a patent for using CRISPR technology in eukaryotic cells. In contrast, UC Berkeley invented a CRISPR system for any environment in vitro or prokaryotic. UC Berkeley appealed this decision but lost the appeal.
Even after this, the battle yet continued as UC Berkeley once again filed before the PTAB in 2019 pitting different patents against the Board’s patents. The judgement was delivered in 2022 wherein the PTAB yet again upheld the Board’s patents. It was held that the Board’s use of CRISPR in eukaryotic cells was distinct from UC Berkeley’s use in test tube experiments. [7]
THE TRANSATLANTIC COMPLEXITY
Despite the 7-year-long case conflict, UC Berkeley claims that the PTAB has erred in their judgment. “The University of California is disappointed by the [tribunal]’s decision and believes the [tribunal] made several errors,”[8] a university press release read, and therefore wishes to file more patent claims for other aspects of CRISPR.
The complexity of the issue is heightened by the additional factor that both parties also submitted a patent application to the European Patent Office. When it comes to international patenting, any inventor can claim a “priority” of an early patent application. Accordingly, to protect their innovation beyond national borders, inventors must first file a patent application at their national office and then submit an international application under the Patent Cooperation Treaty (PCT).[9] Hence they opted to file it under EPO. Therefore, the question before the European Patent Office was whether the claim for a patent by UC Berkeley made the claim of the Board Institute narrowly worded and invalid.[10] Here, the decision was in favour of UC Berkeley as they were granted general patents over the CRISPR technology.
Therefore, although the United States PTAB favoured the Board Institute, UC Berkeley took the lead in Europe. This showcases the complexities involved. It also becomes difficult to determine where to obtain exclusive and commercial licenses for basic CRISPR patents. For Broad, Editas, a startup co-founded by Zhang, holds significant exclusive rights for human therapeutics. Caribou Biosciences, which was founded by Doudna, holds exclusive rights through UC’s licensee. Moreover, for human therapeutics, Caribou has granted an exclusive sublicense to another startup founded by Doudna, Intellia Therapeutics.[11] The private companies that are willing to invest further in CRISPR research will have to look into the different sources of these patent rights and will have to approach both the Board Institute and UC Berkeley for licensing rights.
CONCLUSION
Such legal complexities tend to hinder the progress of scientific inventions. This ground-breaking discovery, capable of saving millions of lives faces a setback due to the conflicts on patents. Although there is no restriction on the research of this technology ( it will not be considered patent infringement), the therapeutic or commercial usage of it will have to wait until all the legal issues are resolved. The most amicable manner to resolve this dispute would be to agree on a settlement since each party has something that the other party wants. The UC Berkeley team has exceptional clinical data whereas the Board Institute team has several patents.[12] By clubbing together and creating a CRISPR Patent pool, the scientific world will benefit from it.
Author(s) Name: Vaishnavi Kulkarni (Ramaiah College of Law)
Reference(s):
[1] Jon Cohen, “New CRISPR patent hearing continues high-stakes legal battle” (Scienceinsider, 2 Feb 2022) <https://www.science.org/content/article/new-crispr-patent-hearing-continues-high-stakes-legal-battle> accessed 9 February 2024.
[2] Board Institute, “ Questions and Answers about CRISPR” (Board Institute) <https://www.broadinstitute.org/what-broad/areas-focus/project-spotlight/questions-and-answers-about-crispr> accessed 10 February 2024.
[3] Fyodor Urnov, “CRISPR in Medicine” (Innovative Genomic Institute) <https://innovativegenomics.org/crisprpedia/crispr-in-medicine/ >accessed 9 February 2024.
[4] Rachel Jones, “ Conquering Sickle Cell with CRISPR: Victoria Gray’s Story” (National Press 13 Nov 2023) <https://nationalpress.org/topic/victoria-gray-first-sickle-cell-crispr-gene-therapy-portia-gabor-tv3-ghana/ >accessed 10 February 2024.
[5] Catherine Jewel and Vijay Shankar Balakrishnan, “The battle to own the CRISPR–Cas9 gene-editing tool” ( WIPO Magazine April 2017) <https://www.wipo.int/wipo_magazine/en/2017/02/article_0005.html >accessed 8 February 2024.
[6]Id.
[7]Regents of the Univ. of Cal. v. Broad Inst., Inc., 903 F.3d 1286 (Fed. Cir. 2018).
[8] Meher Bhatia, “Berkeley Loses the CRISPR War” (Cal Alumni Association 6 June 2022) <https://alumni.berkeley.edu/california-magazine/2022-summer/berkeley-loses-the-crispr-war>/ accessed 8 February 2024.
[9] World Intellectual Property Organization, “Protecting your Inventions Abroad: Frequently Asked Questions About the Patent Cooperation Treaty (PCT)” ( WIPO July 2022) <https://www.wipo.int/pct/en/faqs/faqs.html> accessed 9 February 2024.
[10] Felicia Lozon, Vincent M. de Grandpré, “Making sense of the battle for the CRISPR-Cas9 patent rights” ( Osler 18 Mar 2021) <https://www.osler.com/en/resources/critical-situations/2021/making-sense-of-the-battle-for-the-crispr-cas9-patent-rights#_edn15 >accessed 10 February 2024.
[11] Rai, A. K., & Cook-Deegan, R. “Racing for academic glory and patents: Lessons from CRISPR.” (2017). Science, 358(6365), 874–876. <https://www.jstor.org/stable/26400837> accessed 10 February 2024.
[12] Jon Cohen, “CRISPR’s Nobel Prize winners defeated in key patent claim for genome editor” ( Scienceinsider1 Mar 2022) <https://www.science.org/content/article/crispr-s-nobel-prize-winners-defeated-key-patent-claim-genomeeditor#:~:text=Patent%20rulings%20and%20scientific%20honors,many%20millions%20in%20licensing%20fees > accessed 10 February 2024.
