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CRISPR & BIOPIRACY: A LEGAL CIRCUS WHERE PATENTS MEET PIRATES

April 1, 2025

*Mr. Shivam Jaiswal

INTRODUCTION

In 2012, CRISPR-Cas9 exploded onto the scientific scene which revolutionized genetic technology and biomedical research. CRISPR is short for “clustered regularly interspaced short palindromic repeats” and is basically a biotechnology that allows scientists to alter the DNA of living organisms. But the real controversy began, when UC Berkeley and Broad Institute got into a legal dispute over who “invented”CRISPR, specifically in respect of “eukaryotic gene editing”.

OWNERSHIP OF CRISPR: THE CRISPR-Cas9 EUKARYOTIC PATENT WAR

Two Nobel-laureates, Dr. Doudna and Dr. Charpentier, associated with UC Berkeley, first published their research on CRISPR-Cas9 related to prokaryotes in June 2012, and filed for a patent. Later, Dr. Zhang and his team published their research on the use of CRISPR-Cas9 in eukaryotes, and applied for a patent. Both these patents were filed before the US adopted a first-to-file approach in 2013, letting go of its earlier, “first-to-invent” approach.

The United States Patent & Trademark Office (USPTO) and the Federal Circuit Court oversaw a legal game of tag between UC Berkeley and the Broad Institute, resulting in the Broad Institute winning the patent for CRISPR-Cas9 technology in respect of eukaryotic cells. The dispute was complicated by multiple companies using the technology, and they had taken licenses from either UC Berkeley, or the Broad Institute.

Being able to patent this technology would mean to use it, the medical centers and institutes would have to license it from the patent-owners, who could charge a hefty sum to give such licenses, and given the widespread possible application of this technology, this legal battle, might not just be for recognition.

With appeals and cases still pending in US courts and Patent offices, this legal battle has cleared one thing, that even microbes, that are invisible to the naked eye, can spark billion-dollar patent wars.

BIOPIRACY: APPROPRIATION OF TRADITIONAL KNOWLEDGE THROUGH PATENTS

Biopiracy is the “unauthorized extraction of biological resources and/or associated traditional from developing countries, or the patenting of spurious inventions based on such knowledge or resources without compensation.” It is the art of patenting nature.

The Enola Bean Fiasco is a good example of this. What happened here was that a U.S. firm patentedMexico’s yellow bean in 1999, and then sued the Mexican farmers for infringing upon their patent by selling it in the U.S. Though it lost the battle a decade later, much damage had already been done by then. Around 22,000 farmers had been affected economically. And what did it cost the firm? A lifetime supply of schadenfreude.

Biopiracy is like plagiarism, but with more lawyers, less apologies, and better PR. Add CRISPR to this, and you get a turbocharged loot-fest by editing indigenous species into corporate property.

The Nagoya Protocolwas supposed to stop biopiracy by forcing companies to share profits with source countries. However, it serves as a global “ask before stealing” pact, whose compliance is as reliable as a screen door on a submarine, with ambiguous interpretations and lack of proper enforcement mechanism.  To add to this, we have entered the legal loophole of the century, the “Digital Sequence Information” (DSI).

It is basically a generic data that is digitally available and accessible. It also includes the DNA & RNA of an organism. Due to this DSI, companies can now mine DNA databases and use CRISPR to genetically modify and then patent genes without actually touching a single cell. It’s like biopiracy, but digital. Further, the protocol regulates “genetic resources”. But CRISPR-edited genomes are synthetic. So, there is a loophole in the current international framework.

The World Intellectual Property Organization (WIPO) in May 2024 did adopt a treaty regarding IP, genetic resources and traditional knowledge. This new treaty introduced “disclosure requirements” for patent applicants whose inventions were based on genetic resources and/or associated with traditional knowledge.

CRISPR X BIOPIRACY: BIOPIRACY 2.0

There is a scope of Biopiracy 2.0 being brought in by the CRISPR. Traditional biopiracy involved stealing biological resources. Therefore, CRISPR would now let corporates “improve” these very resources, and claim ownership over them. For example, a biotech firm uses CRISPR to tweak an Amazonian plant, a biological resource associated with traditional knowledge, patents it and sells it to the rest of the world for hefty sum. Something that the Amazonian Tribes would have been using for millennia.

If there can be a Biopiracy 2.0, why not a Colonialism 2.0?

  • Step 1: Take traditional knowledge (e.g., medicinal plants).
  • Step 2: CRISPR-edit the plant to “enhance”.
  • Step 3: Patent the “invention.” Profit.

CRISPR: Making biopiracy great again, since 2012.CRISPR blurs the line between discovery and invention, by enabling synthetic alteration to the biological materials, complicating the ownership.

The TRIPS Agreement requires members to patent biotech. Developing countries must comply with the same, or else they would have to face consequences. Now, CRISPR patents constitute 92.2% for the U.S., China and Europe combined. The CRISPR revolution thereby creates a risk of new wave of genetic appropriation, unless international law changes accordingly.

GENE OWNERSHIP AND CRISPR

So, who owns your genetic information actually? CRISPR’s IP chaos means your genes could be the next NFT (Non-Fungible Token.).A 2013 U.S. Supreme Court judgment in the case of Association for Molecular Pathology v. Myriad Genetics, Inc., held that human genes could not be patented in the U.S., because, DNA was a product of nature. The court noted that since DNA was natural, there was nothing “novel” in the gene discovery process, meaning there was no intellectual property to safeguard, and thus patents could not be issued.

The court however did allow that lab-manipulated DNA to be eligible for patent protection, because these genes were not found in nature. The court specifically mentioned a special type of DNA, known as complimentary DNA or cDNA, that could be patented. When we talk about CRISPR, it has the ability to alter/modify human genetic information, thus creating something new and unnatural, which could thus be patented.

Consider the case of the legendary, and the first immortalized line of cells, called HeLa cells back from 1951, which were taken during the treatment of Henrietta Lacks, a cervical cancer patient. According to the Myriad Genetics lawsuit, these HeLa cells would have been considered as genetically transformed and hence a novel discovery, therefore they might have been patented if they had been found today using CRISPR.

Given that different medical and research institutions would thus have been required to get licenses in order to use these cells for their studies, it would have been quite fascinating to see how the many medical advancements, that this immortalized HeLa line of cells contributed to, such as the COVID and polio vaccines, as well as the study of AIDS and cancer, would have been discovered in the present day.

Another case that brings into spotlight the issue of rights over one’s own genetic material is the case of Moore vs. Regents of the University of California, where the Supreme Court of California, while ruling in favor of the Regents of the University of California, observed that an individual (in this case, Moore), did not have any rights over his genetic material, and they could be used by the University for further purposes without having to pay such individual any compensation. This created another, rather ‘infamous’line of cells, the Mo Cells.

Today, CRISPR could turn a person’s spleen into a patent. And their compensation? A “thank you”, maybe? Their DNA would become like their Netflix password. Used by everyone, paid for by none.

THE NEED FOR CHANGE

This CRISPR-biopiracy is a legal grey area, that needs regulations, as modern as these technologies themselves. It is a dystopian sitcom, where it’s the corporations that sit behind the screens, invisible to everyone and laugh, while it’s the indigenous tribes, the possessors of traditional knowledge and the protectors of biological resources, who are getting laughed at, and it’s the general public, that has to pay to enjoy all this, since the corporations’ genetically modified work is patented. The intersection of CRISPR and biopiracy emphasizes the need for modern, inclusive and enforceable legal frameworks so that genetic innovation does not come at the cost of justice, especially for the indigenous and marginalized communities.

To prevent this, certain steps could be taken, such as, –

  • Nagoya Protocol 2.0 Needed: There is a need to regulate DSI and synthetically modified genetic material. Talks related to these however, are not coming to fruition anytime soon.
  • CRISPR Licenses: Mandate profit-sharing for edits based on traditional knowledge. Think of it as “cultural royalties.”
  • Indigenous IP Rights: Let communities patent their own biodiversity.

CONCLUSION

The interaction of CRISPR and Biopiracy demands urgent attention to update the international legal framework, ensuring equitable treatment of biological elements and traditional knowledge. With the changing technologies, our legal and ethical standards must also evolve to safeguard against exploitation and for an equitable innovation in genetic research.

REFERENCES

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  • Gene Quinn, A Brave New Patent World: First to File Becomes Law, IPWATCHDOG (Mar. 16, 2013, 1:12 PM), https://ipwatchdog.com/2013/03/16/a-brave-new-patent-world-first-to-file-becomes-law/.
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  • Alok K. R. et al., CRISPR-Based Techniques for Genome Editing: A Comprehensive Review, 15 Nat. Commun. 2182 (2024).
  • Jacqueline Martin-Laffon, Marcel Kuntz & Agnès Ricroch, Worldwide CRISPR Patent Landscape Shows Strong Geographical Biases, 37 Nat. Biotechnol. 613 (2019), https://doi.org/10.1038/s41587-019-0138-7.
  • NAT'L LIBRARY OF MED., https://medlineplus.gov/genetics/understanding/testing/genepatents/ (last visited May 12, 2025).
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  • Rohini Nott, Moore v. Regents of the University of California (1990), EMBRYO PROJECT ENCYCLOPEDIA (Nov. 18, 2020), https://embryo.asu.edu/pages/moore-v-regents-university-california-1990/ (last visited May 12, 2025).

Author:
* Mr. Shivam Jaiswal
3rd Year, B.A. LL.B. (Hons.) Student, Hidayatullah National Law University, Raipur

Disclaimer: The opinions expressed in the article are the personal opinions of the author. The facts and opinions appearing in the article do not reflect the views of the Alliance Centre for Intellectual Property Rights (ACIPR) and the Centre does not assume any responsibility or liability for the same.