Introduction: The Gene Ownership Dilemma
Imagine being told that a naturally occurring part of your very body—a gene sequence that makes you who you are—was actually owned by a corporation. This isn't science fiction. For decades, private companies, universities, and research institutions have held patents on human genes, creating an ethical and legal landscape as complex as our DNA itself.
Key Insight
The controversy came to a head when Myriad Genetics, which held patents on the BRCA1 and BRCA2 breast cancer genes, forced women to pay thousands of dollars for genetic testing and prevented them from seeking second opinions.
The journey of gene patenting reflects a fundamental tension between rewarding innovation and protecting access to fundamental knowledge. On one hand, patents provide the financial incentive necessary for costly biomedical research. On the other, they can create barriers to healthcare and scientific progress. As new gene-editing technologies like CRISPR burst onto the scene, this debate has become more urgent than ever.
Innovation Incentive
Patents drive investment in costly research and development
Access Concerns
Patent monopolies can limit availability and increase costs
What Exactly is a Gene Patent?
Before delving into the controversy, it's important to understand what we mean by "gene patents." Contrary to popular belief, these patents don't typically claim genes as they exist naturally in our bodies. Instead, they cover isolated or purified versions of genes that have been removed from their natural environment and processed through human intervention 7 .
Claims to the isolated DNA or RNA sequences themselves
Methods for testing for specific genetic variations associated with disease
Applications such as producing therapeutic proteins or determining drug responses
To qualify for patent protection, an invention must meet three key requirements: it must be new, non-obvious, and useful. For gene patents, the critical legal question has centered on whether isolating a gene transforms it enough from its natural state to be considered a human invention rather than a discovery of nature 3 7 .
Gene Patent Timeline
1982
First gene patent granted for a recombinant DNA vector containing the human growth hormone gene 7
1990s
Rapid expansion of gene patenting with advances in sequencing technology
2013
Landmark Supreme Court decision in AMP v. Myriad Genetics
The Myriad Experiment: A Natural Test Case
The most significant real-world experiment in gene patenting unfolded not in a laboratory, but in courtrooms across the United States. The case of Association for Molecular Pathology v. Myriad Genetics became the definitive test of whether human genes could be patented, with implications that would reverberate throughout the scientific and medical communities.
Myriad Genetics, having identified and sequenced the BRCA1 and BRCA2 genes linked to hereditary breast and ovarian cancer, obtained patents covering both the isolated DNA sequences and the diagnostic methods for testing them 7 9 .
The company enforced its patent rights aggressively, creating a diagnostic monopoly by requiring that all testing be performed exclusively in its laboratories 5 9 .
When researchers tried to develop alternative tests or conduct further studies on these genes, they faced legal barriers 4 9 .
In 2013, the U.S. Supreme Court delivered a unanimous decision: naturally occurring DNA sequences, even when isolated, cannot be patented 8 .
The Court reasoned that Myriad's discovery of the BRCA genes was a "groundbreaking, innovative, and brilliant" achievement, but that separating a gene from its surrounding genetic material didn't alter its fundamental nature—that of a product of nature 7 .
Impact of Myriad Decision on BRCA Testing
| Aspect | Before Myriad Decision | After Myriad Decision |
|---|---|---|
| Cost of Full BRCA Sequencing | Over $3,000 | Dropped to under $1,000 |
| Testing Availability | Exclusive to Myriad Genetics | Multiple laboratories |
| Second Opinions | Not available | Readily available |
| Research Freedom | Restricted | Expanded |
The Global Pendulum: How Different Countries Regulate Gene Patents
The Myriad decision represented a significant swing of the pendulum in the United States, but the approach to gene patenting varies considerably across international borders. This disparity highlights how the same technology can be treated very differently depending on national policies and values.
| Country/Jurisdiction | Patentability of Isolated Genes | Key Legal Standard |
|---|---|---|
| United States | Not patentable (natural phenomenon) | Supreme Court ruling in AMP v. Myriad (2013) |
| European Union | Patentable with restrictions | Rule 29(2) of European Patent Convention |
| Australia | Patentable | Federal Court upheld Myriad's BRCA patent |
| China | Patentable | Moving toward broader protection for NGT innovations 1 |
United States Approach
Following the Myriad decision, naturally occurring genes are not patentable, representing a significant shift in U.S. patent policy.
European Approach
The Biotechnology Directive allows patenting of isolated genes but requires disclosure of industrial application.
Diverging International Approaches
Meanwhile, China is moving toward broader patent protection for gene-related innovations, particularly in the agricultural sector, as part of a strategic effort to stimulate research and commercial breeding 1 . This divergence in international approaches creates a complex landscape for researchers and companies operating globally.
The Scientist's Toolkit: Key Technologies in Modern Genetic Research
The field of genetic research has evolved dramatically from simply identifying and sequencing genes to actively editing them. This progression has required parallel advances in the tools and reagents that enable cutting-edge genetic science.
CRISPR-Cas9
Precise gene editing using RNA-guided DNA cutting
Lipid Nanoparticles
Delivery system for genetic material into cells
TAL Effector Nucleases
Targeted DNA cutting enzymes
Patent Landscape for Genetic Technologies
Unlike the gene patents of the past, modern genetic tool patents typically don't claim natural substances but instead protect engineered molecular machines—such as guide RNAs and modified Cas proteins—that function as genetic editors. This distinction may place them on firmer legal ground than the earlier generation of gene patents.
CRISPR Licensing Example
The ongoing patent battle among early CRISPR pioneers has seen millions of dollars in legal fees and complex licensing agreements, such as the one between Editas Medicine and Vertex Pharmaceuticals that involved a $50 million upfront fee plus annual payments until patent expiration 6 .
New Frontiers: Gene Editing and the Patent Landscape
As genetic technology has advanced from reading genes to rewriting them, the patent system has faced new challenges. The emergence of CRISPR gene-editing technology has created one of the most hotly contested areas in biotechnology intellectual property, with billions of dollars in potential therapeutic applications at stake 6 .
The CRISPR patent landscape illustrates how the pendulum continues to swing, but in different directions for different types of genetic inventions.
In 2025, we're seeing this play out in real-time as companies navigate this crowded IP landscape. For instance, ToolGen has sued Vertex Pharmaceuticals in the UK Patents Court for alleged infringement of its CRISPR-Cas9 patent in relation to Casgevy®, the first CRISPR-based therapeutic approved for sickle cell disease 6 .
"Notably, ToolGen stated that the lawsuit isn't aimed at restricting patient access but at securing compensation through licensing—potentially signaling a more collaborative approach to patent enforcement than characterized earlier gene patent controversies."
Evolution of Patent Focus
These developments highlight a crucial evolution: the focus has shifted from patenting genetic discoveries to protecting genetic engineering technologies—a distinction that may align better with the traditional purpose of the patent system to reward human ingenuity rather than natural discoveries.
The Future of Gene Patenting
The pendulum of gene patenting has unquestionably swung away from the broad protection of isolated natural genes that characterized the early decades of biotechnology. However, it hasn't swung toward a complete prohibition on genetic inventions. Instead, we're seeing a more nuanced approach that distinguishes between discoveries of nature and human-engineered inventions.
New Genomic Techniques
The debate has largely shifted from isolated genes to NGTs—ultra-precise genetic tools that make tiny, targeted edits 1 .
Licensing Practices
There's growing recognition of the importance of licensing practices in determining technology accessibility 5 .
Transparency Tools
Platforms like Cambia's PatSeq tools help researchers navigate the complex IP landscape 8 .
Current Trajectory
The current trajectory suggests several key trends for the future. Perhaps the most promising development is the emergence of more sophisticated approaches to intellectual property that recognize the need for both incentive and access. As one researcher noted, the solution lies in designing "appropriate IP mechanisms, such as licensing platforms, breeders' exemptions, and effective coordination between patent law and plant-variety rights, that promote innovation while keeping new breeding tools and stacked traits widely accessible" 1 .
Conclusion: A Pendulum in Motion
The story of gene patenting is far from over. What began as a gold rush to claim pieces of the human genome has evolved into a more mature conversation about how to balance innovation with access, profit with public good. The pendulum has indeed swung away from the patenting of naturally occurring genes, but it continues to oscillate as science advances into new territories like gene editing and synthetic biology.
The Myriad case represented a significant correction—a recognition that some things are too fundamental to human existence to be owned. But the subsequent explosion of investment and innovation in gene editing technologies demonstrates that the patent system continues to play a vital role in motivating and rewarding genetic research.
As consumers of healthcare and members of society, we all have a stake in how this balance is struck. The question is no longer simply whether genes should be patented, but what system will best promote the development of life-saving treatments while ensuring they remain accessible to those who need them. The pendulum will likely continue to swing, but perhaps with decreasing extremes as we collectively learn to navigate the complex intersection of nature, science, and law.