Gene patenting is the practice of claiming intellectual property rights over specific DNA sequences, giving the patent holder exclusive control over the use of that genetic information for a set period. For decades, companies and researchers filed patents on human genes and other organisms’ DNA, treating isolated genetic material as a patentable invention. At its peak, roughly 20% of human genes were covered by patents. The practice has been significantly curtailed in the United States since a landmark 2013 Supreme Court ruling, but it remains a complex and evolving area of law worldwide.
How Gene Patents Work
A gene patent functions like other patents: it grants the holder exclusive rights to make, use, or sell the patented material for approximately 20 years. In the context of genetics, this meant a company could patent a specific DNA sequence it had identified and isolated from the human body. Once patented, no other laboratory, hospital, or researcher could work with that sequence without the patent holder’s permission, which typically required paying licensing fees.
The key legal argument behind gene patents was that isolating a gene from the body required significant technical effort and investment. Patent applicants argued that a gene removed from its natural chromosomal context and purified in a lab was fundamentally different from the gene sitting inside your cells. Patent offices in the U.S. and elsewhere accepted this reasoning for years, treating isolated DNA as a manufactured product rather than a discovery of nature.
Gene patents could cover diagnostic tests (using a gene sequence to screen for disease risk), therapeutic applications (using the gene in treatment development), and the sequence itself. A single gene could be covered by multiple overlapping patents held by different entities, creating a thicket of intellectual property claims that researchers and clinicians had to navigate.
The Scale of Gene Patenting
By the early 2010s, patents had been granted on an estimated 4,000 to 5,000 human genes, roughly 20% of the entire human genome. These patents were held by a mix of biotechnology companies, universities, government agencies, and individual researchers. The U.S. Patent and Trademark Office had been granting gene patents since the 1980s, following a 1980 Supreme Court decision (Diamond v. Chakrabarty) that allowed patents on living organisms, specifically a genetically engineered bacterium designed to break down crude oil.
That decision opened the floodgates. Throughout the 1990s and 2000s, as the Human Genome Project mapped our DNA, patent filings surged. Companies raced to identify genes associated with diseases, then locked down exclusive rights to test for or develop treatments around those genes. The commercial logic was straightforward: gene discovery required enormous investment, and patents provided the financial incentive to pursue that work.
The BRCA Gene Controversy
The most prominent gene patenting dispute centered on Myriad Genetics, a Utah-based company that held patents on two genes called BRCA1 and BRCA2. Mutations in these genes dramatically increase the risk of breast and ovarian cancer. Because Myriad held the patents, it was the only company in the United States that could offer diagnostic testing for BRCA mutations. No other lab could legally analyze those genes, even using different testing methods.
This monopoly had real consequences. Myriad charged over $3,000 for its test, putting it out of reach for many patients. Women who received results couldn’t get a second opinion from an independent lab because no other lab was allowed to examine those gene sequences. Researchers studying breast cancer genetics faced restrictions on using the BRCA sequences in their work. The situation crystallized the tension at the heart of gene patenting: the company argued its patents rewarded the investment that identified these critical genes, while critics argued that no one should own a piece of human biology that people need access to for their health.
In 2009, the American Civil Liberties Union and a coalition of patients, researchers, and medical organizations sued Myriad Genetics. The case, Association for Molecular Pathology v. Myriad Genetics, spent four years working through the courts.
The 2013 Supreme Court Decision
In June 2013, the U.S. Supreme Court ruled unanimously that naturally occurring DNA sequences cannot be patented, even when they have been isolated from the body. The Court held that Myriad did not create anything by identifying the BRCA genes. Finding an important gene and separating it from surrounding genetic material was a discovery, not an invention, and discoveries of nature are not eligible for patent protection.
The ruling drew an important distinction, though. While natural DNA sequences lost patent protection, the Court allowed patents on complementary DNA (cDNA), which is a synthetic form of DNA created in the lab that contains only the protein-coding portions of a gene. This preserved some intellectual property protections for biotechnology companies working with engineered genetic material.
The practical impact was immediate. Within days of the ruling, several companies began offering BRCA testing at lower prices, and competition drove costs down further. Researchers gained freedom to study previously patented genes without licensing barriers.
Arguments For and Against Gene Patents
Supporters of gene patenting have consistently pointed to the economics of biotech research. Identifying a gene’s function, developing a reliable diagnostic test, and bringing genetic therapies to market requires years of work and hundreds of millions of dollars. Patents provide a temporary monopoly that allows companies to recoup those costs and generate profit, which in turn funds further research. Without patent protection, the argument goes, private investment in genetic research would dry up because competitors could simply copy discoveries without bearing any of the development costs.
Opponents raise several counterpoints:
- Genes are products of nature, not inventions. No company created the BRCA genes or any other human DNA sequence. Patenting them is more like claiming ownership of a mineral deposit than inventing a new machine.
- Patents restrict access to medical care. When one company controls a diagnostic test, patients face higher prices, fewer options, and no ability to seek independent confirmation of results.
- Research suffers. Gene patents can block academic researchers from studying patented sequences, slowing the pace of scientific discovery. Some researchers reported abandoning projects or redirecting their work to avoid patent conflicts.
- Broad patents stifle innovation. Overlapping patent claims on genes and genetic techniques created legal minefields that deterred new companies from entering the field, the opposite of what the patent system is designed to encourage.
Gene Patenting Outside the United States
The legal landscape varies significantly by country. The European Patent Office has generally allowed patents on isolated gene sequences, though European Union directives require that patent applications clearly state the industrial application of the genetic material. Simply sequencing a gene without demonstrating a use for it is not sufficient for a European patent.
Australia followed a path similar to the United States. In 2015, Australia’s High Court ruled that isolated naturally occurring DNA is not patentable, echoing the reasoning of the U.S. Supreme Court. Canada has taken a more restrictive approach overall, with its courts generally skeptical of gene patents. Meanwhile, some countries with emerging biotech sectors have adopted patent frameworks that are more permissive, hoping to attract investment.
What Can Still Be Patented
The 2013 ruling did not end all genetic intellectual property. Several categories of genetic innovation remain patentable in the U.S. and most other jurisdictions. Synthetically created DNA sequences, including cDNA and entirely novel genetic constructs, are eligible for patent protection. Methods and processes for analyzing genes, such as specific new techniques for sequencing or interpreting genetic data, can be patented as long as the patent covers the method rather than the underlying gene. Applications of genetic information, like a novel therapeutic that uses gene editing to treat a specific disease, also remain patentable.
Gene editing technologies like CRISPR have generated their own intense patent battles, but these disputes center on the tools and techniques for modifying DNA rather than on ownership of naturally occurring sequences. The distinction matters: you can patent a new way to cut and edit a gene, but you cannot patent the gene itself.
The shift away from gene patents on natural DNA has not slowed the pace of genetic research or commercial development. The biotechnology industry has adapted, building intellectual property portfolios around applications, methods, and engineered sequences rather than raw genetic information. Genetic testing has become dramatically cheaper and more widely available, with direct-to-consumer companies now offering broad genomic screening at a fraction of what a single-gene test cost during the patent era.