Last week, the United States Supreme Court ruled that genes cannot be patented because they are naturally-occurring and have not been “created” by the patent holder. Prior to this ruling, companies could patent genes and DNA segments, preventing other companies from conducting genetic testing on these genes. The ruling makes the existing patents invalid, and clears the way for increased scientific research and more affordable testing. Synthetically created or altered genes are not affected by the ruling and can be patented.
The specific case that prompted this change is a suit against Myriad Genetics, the company that discovered the specific location and sequence of the genes, BRCA1 and 2. The discovery was important because mutations of these genes are linked to increased risk of breast and ovarian cancer, but only Myriad could legally provide testing services for the mutations because they held the patent on the genes. Myriad had argued that locating and isolating these specific genes was a creative act and therefore able to be patented. The Supreme Court, in a unanimous decision, disagreed. Justice Clarence Thomas, the author of the Supreme Court’s decision stated, “…Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”
The Decision also states, “We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” Under the Patent Act, products of nature are not able to be patented. The Court cited the following in its ruling:
“Laws of nature, natural phenomena, and abstract ideas are not patentable. Rather, they are the basic tools of scientific and technological work that lie beyond the domain of patent protection. As the Court has explained, without this exception, there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and thereby ‘inhibit’ future innovation premised upon them.”
The Myriad patent was for human genes, but the decision applies to all genes, including animal and plant. Animal Genetics has always been of the opinion that the mere discovery and isolation of a particulate fragment of DNA was not in itself enough to fulfill the requirements of Section 101 of the Patent Act. The Supreme Court’s ruling will be beneficial for genetic research going forward, and will reduce the cost of genetic testing as more companies are able to offer these services without fear of patent infringement.
The full Supreme Court Decision can be found here: