Can genes be patented?

A gene patent grants exclusive rights to a specific DNA sequence, though a landmark Supreme Court ruling has significantly limited the ability to patent human genes in the United States.

Overview

A gene patent is the exclusive right to a specific sequence of DNA (a gene) granted by a government to the individual, organization, or corporation that claims to have first identified it. Once a patent is granted, the holder dictates how the gene can be used in both commercial settings, such as clinical genetic testing, and noncommercial settings, including research, for 20 years from the date of the patent. Historically, gene patents have often resulted in companies having sole ownership of genetic testing for patented genes.

The Supreme Court Ruling

On June 13, 2013, in the case of the Association for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court of the United States ruled that human genes cannot be patented in the U.S. because DNA is a "product of nature." The Court determined that because nothing new is created when discovering a gene, there is no intellectual property to protect.

Prior to this ruling, more than 4,300 human genes were patented. The Supreme Court's decision invalidated those patents, making the genes accessible for research and commercial genetic testing.

Exceptions for Lab-Manipulated DNA

The Supreme Court's ruling allows for the patenting of DNA manipulated in a lab, as DNA sequences altered by humans are not found in nature. The Court specifically noted the eligibility of complementary DNA (cDNA). This synthetic DNA is produced from the molecule that serves as the instructions for making proteins, known as messenger RNA.