Lana El-Etr, Contributing Member 2024-2025
Intellectual Property and Computer Law Journal
I. Introduction
Can one really put a patent stamp on life built from lab grown DNA? In 2016, researchers at the J. Craig Venter Institute—a nonprofit research organization focused on genomics and synthetic biology- unveiled the first self-replicating synthetic organism built entirely from a minimal genome, one stripped to the mere genes necessary for life.[1] These “minimal cells” denote a revolutionary step in synthetic biology, pushing the boundaries of what it means to be alive; but it is the patenting process—rather than their mere existence—that questions who has the right to own life itself.
This article summarizes the milestones in minimal bacterial genome research and analyzes the legal gray area surrounding the patentability of fully synthetic minimal cells. Decisions like Diamond v. Chakrabarty and AMP v. Myriad Genetics lay the groundwork for understanding the intersection of biotechnology and intellectual property law, but they stopped short of addressing wholly synthetic life forms created by computer modeling, gene design, gene synthesis, and Clustered Regular Interspaced Short Palindromic Repeats (CRISPR) technology.[2] As a result, what remains is a patchwork of outdated standards of review attempting to control or regulate technologies that did not exist when those decisions were made.[3]
Moreover, this piece addresses the broader policy implications of issuing patents to organisms that do not exist in nature. Existing law that currently governs biotechnology does not adequately address these novel entities, and underlying questions remain about what constitutes patentable subject matter when the “product of nature” doctrine is applied to synthetic biology. To address these ambiguities, lawmakers should (1) update patent eligibility regulations to include specific criteria for synthetic life forms; (2) create protections against overbroad claims that could chill future research; and (3) provide licensing frameworks that allow equitable access to medical and public health uses of synthetic biology innovations.
Part II provides an overview of synthetic minimal cell development. It traces the scientific evolution from bacterial genome research to the creation of JCVI-syn3.0 and illustrates the role of CRISPR and gene synthesis technologies. This section also outlines how advancements in gene editing technologies and high-throughput DNA synthesis techniques have dramatically expanded the boundaries of biological and legal possibility. Part III discusses whether current patent law sufficiently addresses the unique legal status of fully synthetic life forms by exploring doctrinal gaps, corporate monopolization risks, and ethical concerns. Part IV concludes by arguing for a refined patent framework that distinguishes between synthetic and naturally derived biological inventions, calling for policy reforms that promote both innovation and public interest.
II. Background
The Journey to Creating a Minimal Cell
The idea behind a minimal cell is simple: a stripped-down organism brought down to its bare genetic basics, with just enough to keep it alive.[4] For scientists, figuring out what those key elements are is like solving a biological jigsaw puzzle with substantial commercial potential and opportunities for profit in the biotech industry. In order to survive, minimal cells require genes for DNA replication, transcription, and translation; systems for genome maintenance and repair; pathways for energy production and biosynthesis of key molecules; a functional cell membrane with transport proteins; machinery for cell division; and basic stress response and regulatory systems to maintain internal stability and function.[5] Minimal cells may be easier to study, more predictable to engineer, and ideal for making drugs, studying diseases, or cleaning up toxins.[6]
Building a minimal bacterial cell has been a scientific dream since the 1930s, but the journey to develop a synthetic minimal cell truly began in the mid-1990s.[7] The sequencing of parasitic bacteria Haemophilus influenzae and Mycoplasma genitalium full genomes to find the minimum number of genes necessary for life—a method known as the comparative genomic approach, which directly addressed the ‘minimal gene set’ question of how many genes are necessary for a cell to live and reproduce.[8] Research on the Mycoplasma genitalium, the smallest self-replicating natural cell known at the time, led to the discovery of many non-essential genes.[9] The concept of the ‘minimal genome,’ defined as the smallest set of elements needed for a free-living cellular organism, was documented in 1999 by Russian computational biologists Arcady Mushegian and Eugene Koonin.[10]
Synthetic minimal cells are not the product of genetic artificial selection or even genetic engineering in itself.[11] Instead, they are a revolutionary rethinking of cellular life because they act as simplified platforms to study gene function without the distraction of unnecessary genetic material.[12] Research on Mycoplasma genitalium soon revealed that natural genomes contain redundancies and genes of unknown purpose and thus are not appropriate as models for minimal life.[13] Until the invention of gene synthesis and high-throughput DNA assembly, researchers were unable to break through these constraints.[14]
Since the 1930s, researchers worked towards creating a bare cell with just enough genes to sustain life.[15] This abstract model was made experimentally feasible in the mid-1990s, when the sequencing of Haemophilus influenzae and Mycoplasma genitalium brought comparative genomics to a position where it could identify the “minimal genome.”[16] Mushegian and Koonin compared orthologs – genes in different species that evolved from a common ancestral gene through lineage splitting and generally have identical functions— between the two genomes of M. genitalium and Haemophilus influenza, determining a set of 256 genes that coded for the core functions of a minimal cell.[17]
By 2003, synthetic biology research evolved to a point where bacterial genomes could be constructed from pools of overlapping short segments of DNA or RNA—also known as oligonucleotides— in weeks, without the constraints of traditional cloning.[18] The work reached its zenith in 2010, when the Venter Institute transferred a fully synthetic genome into a host cell to give rise to JCVI-syn1.0, the first organism derived from a genome designed and made by humans.[19]
However, natural minimal genomes often contain redundancies and genes of unknown function, making them imperfect models for true minimal life.[20] This is important because when scientists try to understand what’s absolutely essential for a cell to live and function, unclear or unnecessary genetic material gets in the way.[21] Without a clean, stripped-down model, it’s harder to design cells for specific tasks like producing medicine, cleaning pollutants, or studying diseases.[22]
To address this obstacle, scientists attempted to find more precise methods for understanding and identifying the minimal set of genes required for an organism to survive. In 1999, a revolutionary method of transposon mutagenesis was introduced, which involved inserting transposons—segments of DNA that can move around a cell’s genome— into the M. genitalium genome, which disrupts the function of the gene at the insertion site.[23] This approach enabled researchers to systematically disrupt individual genes and observe whether the cell could survive without them. [24] Importantly, this technique provided the first comprehensive functional map of a minimal genome and laid the foundation for improved genome reduction strategies, ultimately guiding the design of synthetic cells with only the required genes .[25]
Concurrently with studies aimed at assessing gene indispensability, gene synthesis technology also revolutionized.[26] Most notably, high-throughput DNA assembly tools were changing the game.[27] With automated platforms, which are systems that carry out tasks or processes without human intervention, entire bacterial genomes could be synthesized from oligonucleotides—short, custom-designed DNA sequences used as units for assembling larger genetic models— avoiding the limitations of conventional cloning.[28] This provided the capability to design, construct, and test synthetic genomes at previously unimagined scales.[29] In 2003 alone, scientists used a pool of nearly 260 overlapping oligonucleotides to synthesize an entire bacterial genome in under two weeks.[30] These advances reached their culmination in the successful construction of large, functional chromosomes, like those subsequently employed in the development of JCVI-syn1.0.[31]
After a few years and numerous experimentations, in 2008, the Venter Institute created the largest man-made DNA structure using 582,970 base pairs of the M. genitalium DNA.[32] This was accomplished through the use of homologous recombination, a process cells use to repair their chromosomes when damaged.[33] In 2010, approximately 40 million dollars and countless hours later, scientists at the Venter Institute synthesized the genome of a different bacteria called Mycoplasma mycoides and transplanted it into a recipient cell, creating the first synthetic cellular organism.[34] This revolutionary organism, named the JCVI-syn1.0, signified the ability of a synthetic genome to control the functions of a living cell.[35] JCVI-syn1.0 raised ethical and legal issues about the boundary between invention and life. Though biologically equivalent to a native organism, its genome was formed entirely from chemically synthesized DNA, a difference that stirred debate and controversy about whether such life forms should or could be patented.[36]
Utilizing this foundational work, in 2016, researchers designed and synthesized JCVI-syn3.0, a bacterium with a genome of only 531,490 base pairs and 473 genes.[37] This was the first time an organism contained all the essential genes required for life under laboratory conditions.[38] Additional refinement led to JCVI-syn3A, a minimal cell with 543,000 base pairs and 493 genes.[39] While having an objectively larger genome, this cellular model provided a more comprehensive and versatile blueprint for studying the basics of life, with enhanced growth characteristics and stability because it allowed for increased efficiency in cellular functions.[40]
While early efforts at reducing the genome significantly relied on transposon mutagenesis and synthesis-directed assembly, the advent of CRISPR- Cas9 brought a more precise platform for genome engineering.[41] CRISPR allowed researchers to modify existing genomes with unprecedented preciseness, and thus have more precise control over what genes to knock out, insertions, and altering of regulatory elements.[42] While CRISPR wasn’t used in the initial assembly of JCVI-syn3.0, its ability to install, reconfigure, or remove interchangeable genetic “modules” allow it to be used as an editing tool tailored to a specific environment or application.[43]
These developments also contain a strong public interest component. The potential uses of minimal cells also extend to precision medicine, biosensing, and vaccine delivery.[44] Precision medicine is a newer approach for disease treatment and prevention that factors in individual variability in one’s genetics, environment, and lifestyle.[45] Biosensing refers to the process of combining biological molecule and a detector to create a measurable signal, most commonly exemplified in pregnancy tests and glucose monitoring sensors.[46] Monopolization of such life-critical technologies without open licensing models can broaden inequalities in access to healthcare around the world.[47] Policymakers should consider not just whether synthetic cells are patentable, but how to regulate their use and control to promote innovation while advancing the public interest.
Relevant Legal Frameworks
Existing patent laws, specifically under 35 U.S. C. § 101, allow for the patenting of any new and useful “process, machine manufacture, or composition matter.”[48] This standard has encompassed a wide range of biotechnological inventions. In Diamond v. Chakrabarty, the Supreme Court interpreted this statute broadly, holding that genetically modified organisms engineered by humans are patentable.[49] This opened the door to patents on everything from modified bacteria to gene-editing tools. However, in Association for Molecular Pathology v. Myriad Genetics clarified that naturally occurring DNA sequences, even when isolated, are not patentable.[50] However, synthetic complementary DNA, which is a reverse transcribed DNA copy of an RNA molecule, is patentable because it’s a product of human that does not occur in nature.[51]
III. Discussion
The availability of man-made minimal cells like JCVI-syn1.0 and JCVI-syn3.0 has revealed the limitations of patent law for regarding a class of inventions that fall between biology and technology. The Supreme Court’s Diamond v. Chakrabarty and Association for Molecular Pathology v. Myriad Genetics established the standard for biotech patents by validating the patenting of genetically modified organisms and complementary DNA (cDNA), respectively.[52] However, each decision is founded on a distinction between the naturally occurring and the product of human genius, a distinction that begins to be blurred with the creation of fully synthetic organisms.[53]
The creation of a minimal gene raised immediate questions: if the organism is biologically indistinguishable from its natural counterpart, but completely designed and assembled in a laboratory, is it man’s invention or nature’s product? In the landmark Diamond v. Chakrabarty case, the U.S. Supreme Court ruled that a genetically modified bacterium, created through human intervention, could be patented, reasoning that a living organism created by human ingenuity could be considered a ‘manufacture’ or ‘composition of matter’ under U.S. patent law.[54] However, Association for Molecular Pathology v. Myriad Genetics clarified that merely isolating a naturally occurring gene does not make it patentable, as the gene in its natural state is not a human-made invention.[55] JCVI-syn1.0, having been constructed de novo, approximates natural organisms to a high extent in both form and function, challenges both rulings.[56]
While a minimal cell is biologically similar to naturally occurring organisms, its creation through a completely artificial process raises the question of whether it can be patented like Chakrabarty’s genetically modified bacterium.[57] At the same time, its reliance on synthetic biology to create a novel organism tests the limits set by Myriad. In essence, JCVI-syn1.0 tests whether the boundaries of patentability should extend to organisms that are not merely altered versions of natural organisms but are entirely reengineered from scratch. The advancement of genome-editing technologies such as CRISPR-Cas9 has only complicated the answer to such a question.[58]
The CRISPR-Cas9 genome editing tool has revolutionized synthetic biology by giving scientists a precise way to edit genes—like using a word processor to cut, paste, or rewrite DNA.[59] Even though CRISPR was not initially used in developing JCVI-syn3.0, it enabled the tailoring of minimal cells for specific industrial, pharmaceutical, or environmental use.[60] The ability to design cut-and- and paste- cellular platforms with precise gene circuits, all of which can be CRISPR-edited, further distances these innovations from naturally occurring biology.[61] Existing laws, such as 35 U.S. C. § 101, risk granting overly broad control to companies over essential biological functions. Such patents could stifle future research applications of this novel area of biotechnology.[62]
Despite the limitations in Myriad, current law still permits synthetic genomes, gene circuits, and engineered organisms to be patented so long as they are “markedly different” from nature.[63] This has led to the awards of broad patents, such as those filed by the J. Craig Venter Institute on synthetic minimal genomes.[64] These patents were controversial because they not only cover the synthetic sequence itself, but also means of constructing and using entire organisms, essentially granting companies full possession over underlying biological platforms.[65] With synthetic cells becoming tools for everything from drug manufacturing to environmental remediation, these patents pose the risk of monopolizing basic biological process vital to scientific progress and public welfare.[66]
Without more specific statutory or judicial limits, companies are able to obtain broad patents that exclude others from inventing or improving upon core synthetic biology technologies. This jeopardizes the potential for “patent thickets”—conflicting intellectual property claims that pose legal and financial obstacles for researchers, universities, and small biotech companies.[67] Thus, while patent law stimulates and encourages innovation, its current structure risks granting disproportionate control over essential cellular functions that are nearly identical to their natural counterparts but have been synthetically recreated.
IV. Conclusion
Synthetic minimalist cells, such as JCVI-syn3.0, open a new field of biological engineering. These cells, designed through computer-based genome modeling and synthetic biology, mark a fundamental departure from traditional genetic manipulation. While they offer potential historic opportunities in biotechnology and medicine, they create new legal questions, most importantly in the field of patent law. Current U.S. patent law is not capable of meeting the challenge of these entirely synthetic forms of life and therefore it is unclear if they qualify for patent protection.[68]
As synthetic biology continues to advance, the gap between scientific advancement and legal regulation widens. Rulings such as Diamond v. Chakrabarty and AMP v. Myriad Genetics established early guidelines for patent eligibility but could not foresee synthetic organisms engineered from digital blueprints. [69] They are not very useful when applied to life forms created solely from synthetic DNA, and new legal standards that lay out what is novel and non-obvious when it comes to man-made organisms are needed to address this new area of biotechnology.
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[4] R.Z. Moger-Reischer et al., Evolution of a Minimal Cell, 620 Nature 122 (2023), https://www.nature.com/articles/s41586-023-06288-x, [https://perma.cc/W7WC-KYWE].
[5] James F. Pelletier et al., Genetic Requirements for Cell Division in a Genomically Minimal Cell, 184 Cell 2430 (2021), https://doi.org/10.1016/j.cell.2021.03.008.
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[8] Eugene V. Koonin, How Many Genes Can Make a Cell: The Minimal-Gene-Set Concept, in Annual Reviews Collection (2002), https://www.ncbi.nlm.nih.gov/books/NBK2227/#:~:text=genitalium%2C%20and%20Mycoplasma%20pneumoniae.,essential%20but%20functionally%20uncharacterized%20genes [https://perma.cc/J2RU-GRMR].
[9] Eugene V. Koonin, How Many Genes Can Make a Cell: The Minimal-Gene-Set Concept, in Annual Reviews Collection (2002), https://www.ncbi.nlm.nih.gov/books/NBK2227/#:~:text=genitalium%2C%20and%20Mycoplasma%20pneumoniae.,essential%20but%20functionally%20uncharacterized%20genes [https://perma.cc/J2RU-GRMR].
[10] Arcady R. Mushegian & Eugene V. Koonin, A Minimal Gene Set for Cellular Life Derived by Comparison of Complete Bacterial Genomes, 93 Proc. Nat’l Acad. Sci. U.S. 10268, 10268–73 (1996), https://doi.org/10.1073/pnas.93.19.10268.
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[12] J. Craig Venter et al., Synthetic Chromosomes, Genomes, Viruses, and Cells, 185 Cell 2709, 2712–13 (2022), https://doi.org/10.1016/j.cell.2022.06.046.
[13] Id. at 10273.
[14] Jeffrey Marlow, Assembling a Genome, Piece by Piece, Wired (Mar. 31, 2015), https://www.wired.com/2015/03/assembling-genome-piece-piece/ [https://perma.cc/CZ8R-MC27].
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[16] Arcady R. Mushegian & Eugene V. Koonin, A Minimal Gene Set for Cellular Life Derived by Comparison of Complete Bacterial Genomes, 93 Proc. Nat’l Acad. Sci. U.S. 10268, 10268–73 (1996), https://doi.org/10.1073/pnas.93.19.10268.
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[20] Id.
[21] Arcady R. Mushegian & Eugene V. Koonin, A Minimal Gene Set for Cellular Life Derived by Comparison of Complete Bacterial Genomes, 93 Proc. Nat’l Acad. Sci. U.S. 10268, 10268 (1996), https://doi.org/10.1073/pnas.93.19.10268.
[22] Xin Xu et al. Trimming the genomic fat: minimising and re-functionalising genomes using synthetic biology. Nat Commun 14, 1984 (2023). https://doi.org/10.1038/s41467-023-37748-7, [perma.cc/U42D-S2CQ].
[23] Id.
[24] Id.
[25] Id.
[26] John I. Glass et al., Minimal Cells—Real and Imagined, 9 Cold Spring Harb. Perspect. Biol. a023861 (2017), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5710109/ [https://perma.cc/S82L-LMRA].
[27] Id.
[28] J. Craig Venter et al., Synthetic Chromosomes, Genomes, Viruses, and Cells, 185 Cell 2709, 2712 (2022), https://doi.org/10.1016/j.cell.2022.06.046.
[29] Id.
[30] Id. at 2709.
[31] Id. at 2712.
[32] Clyde A. Hutchison III et al., Design and Synthesis of a Minimal Bacterial Genome, 351 Science 1414 (2016), https://cba.mit.edu/docs/papers/16.04.minimal.pdf.
[33] Daniel G. Gibson et al., One-Step Assembly in Yeast of 25 Overlapping DNA Fragments to Form a Complete Synthetic Mycoplasma genitalium Genome, 105 Proc. Nat’l Acad. Sci. U.S. 20404 (2008), https://www.pnas.org/doi/10.1073/pnas.0811011106. [https://pubmed.ncbi.nlm.nih.gov/19073939/].
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[35] Id.
[36] J. Craig Venter et al., Synthetic Chromosomes, Genomes, Viruses, and Cells, 185 Cell 2709, 2713 (2022), https://doi.org/10.1016/j.cell.2022.06.046.
[37] John I. Glass et al., Minimal Cells—Real and Imagined, 9 Cold Spring Harb. Perspect. Biol. a023861 (2017), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5710109/ [https://perma.cc/S82L-LMRA].
[38] Id.
[39] Marian Breuer et al., Essential Metabolism for a Minimal Cell, 8 eLife e36842 (2019), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609329/ [https://perma.cc/QL5L-GZ5H].
[40] Id.
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[42] Id.
[43] Ersin Akinci et al., Using CRISPR to Understand and Manipulate Gene Regulation, 148 Development dev182667 (2021), https://doi.org/10.1242/dev.182667.
[44] Kira Sampson et al., Preparing for the Future of Precision Medicine: Synthetic Cell Drug Regulation, 9 Synth. Biol. ysae004 (2024), https://doi.org/10.1093/synbio/ysae004.
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[46] Nikhil Bhalla et al., Introduction to Biosensors, 60 Essays Biochem. 1 (2016), https://doi.org/10.1042/EBC20150001, [perma.cc/8X2S-7DCQ].
[47] Sarah McGraw, The Double-Edged Sword of Medical Patents: How Monopolies on Healthcare Products Disparately Impact Certain American Populations, 5 U. Cin. Intell. Prop. & Comput. L.J. 1, 17 (2021), https://scholarship.law.uc.edu/ipclj/vol5/iss1/3.
[48] 35 U.S.C. § 101 (2018).”
[49] Diamond v. Chakrabarty, 447 U.S. 303 (1980).
[50] Carl Franzen, Supreme Court Rules That Natural Genes Aren’t Patentable, but Synthetic Ones Are, THE VERGE (June 13, 2013), https://www.theverge.com/2013/6/13/4426490/scotus-rules-natural-genes-not-patentable-synthetic-are [https://perma.cc/XKV3-N7XZ].
[51] Copy DNA (cDNA), Nat’l Hum. Genome Res. Inst., https://www.genome.gov/genetics-glossary/copy-DNA-cDNA (last visited May 1, 2025), [https://perma.cc/X6TA-2QZR].
[52] Diamond v. Chakrabarty, 447 U.S. 303 (1980); Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).
[53] Manual of Patent Examining Procedure § 2105, U.S. Patent & Trademark Office (Rev. 01.2024, Nov. 2024), https://www.uspto.gov/web/offices/pac/mpep/s2105.html, [perma.cc/CWE2-LR3X].
[54] Diamond v. Chakrabarty, 447 U.S. 303 (1980).
[55] Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).
[56] J. Craig Venter Inst., First Minimal Synthetic Bacterial Cell, https://www.jcvi.org/research/first-minimal-synthetic-bacterial-cell (last visited Apr. 18, 2025) [https://perma.cc/5DEA-ATDE].
[57] J. Craig Venter Inst., Press Release, First Self-Replicating, Synthetic Bacterial Cell Constructed by J. Craig Venter Institute Researchers (May 20, 2010), https://www.jcvi.org/media-center/first-self-replicating-synthetic-bacterial-cell-constructed-j%C2%A0craig-venter-institute [https://perma.cc/K5BJ-ZLAJ].
[58] Osler, Hoskin & Harcourt LLP, Making Sense of the Battle for the CRISPR-Cas9 Patent Rights, Osler (Feb. 2, 2022), https://www.osler.com/en/insights/updates/making-sense-of-the-battle-for-the-crispr-cas9-patent-rights [https://perma.cc/G2ER-QPU8].
[59] Doudna, Jennifer A., and Emmanuelle Charpentier, “The new frontier of genome engineering with CRISPR-Cas9,” Science, vol. 346, no. 6213, pp. 1258096 (2014), https://doi.org/10.1126/science.1258096.
[60] Ersin Akinci et al., Using CRISPR to Understand and Manipulate Gene Regulation, 148 Development dev182667 (2021), https://doi.org/10.1242/dev.182667.
[61] Id.
[62] Diamond v. Chakrabarty, 447 U.S. 303 (1980).
[63] Diamond v. Chakrabarty, 447 U.S. 303 (1980); Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).
[64] U.S. Patent No. 11,085,037 B2 (issued Aug. 10, 2021).
[65] Id.
[66] Arti K. Rai & Jacob S. Sherkow, The Changing Landscape of Patent Law for the Life Sciences, 34 Nat. Biotechnol. 360, 361 (2016).
[67] Jorge L. Contreras & Jacob S. Sherkow, Patent Pledges, 47 Ariz. St. L.J. 543, 577–78 (2015).
[68] Bao Tran, How Patent Law Addresses Innovations in Synthetic Biology, PatentPC (Apr. 15, 2025), https://patentpc.com/blog/how-patent-law-addresses-innovations-in-synthetic-biology, [perma.cc/GM8M-RHXK].
[69] Diamond v. Chakrabarty, 447 U.S. 303 (1980); Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).
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