Biology
The Legal Challenges of Patenting Genetic Sequences
Quick fact
In 2013, the US Supreme Court ruled that a naturally occurring piece of DNA cannot be patented, even if isolated from the body, but synthetic complementary DNA (cDNA) can be patented.
Why this is interesting
You know that companies can patent drugs, but can they own the rights to your genes? It sounds futuristic, but until recently, scientists had patents on human DNA – and the battle to decide who owns your genetic code is far from over.
Read the full explanation
Understanding The Legal Challenges of Patenting Genetic Sequences
Imagine you discover a new mineral in the earth. You might own the land, but you cannot patent the mineral itself because it's a natural product, not an invention. Similarly, genes are found in nature, and for a long time, companies and universities patented specific genes they had isolated. These patents gave them exclusive rights to use those genes for diagnostics and therapies, which could block others from working on them. The key legal question is: does isolating a gene make it an invention? The courts have said no for natural DNA, but yes for synthetic DNA that doesn't exist in nature.
A deeper explanation
The fundamental issue is the 'products of nature' doctrine in patent law: you cannot patent something that exists naturally; you must create something new and non-obvious. When researchers isolate a gene, they are not creating it—they are extracting it from the genome. The Supreme Court in the Myriad case clarified that while the chemical structure of isolated DNA is identical to natural DNA, it is not patent-eligible. However, cDNA, which is made in the lab from messenger RNA, has a sequence that does not naturally occur in the genome, making it a human invention and thus patentable. This distinction attempts to balance incentives for research with preserving access to genetic information. In practice, this means that patents on particular naturally occurring sequences are invalid, but companies can still patent modified or synthetic sequences. The challenge continues because as we develop new technologies like gene editing, the question of what is 'natural' becomes blurrier, and the patent system struggles to keep up.