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Can genes be patented?

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

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 decided that because nothing new is created when discovering a gene, there is no intellectual property to protect, so patents cannot be granted. Prior to this ruling, more than 4,300 human genes were patented. The Supreme Court’s decision invalidated those gene patents, making the genes accessible for research and for commercial genetic testing.

The Supreme Court’s ruling did allow that DNA manipulated in a lab is eligible to be patented because DNA sequences altered by humans are not found in nature. The Court specifically mentioned the ability to patent a type of DNA known as complementary DNA (cDNA). This synthetic DNA is produced from the molecule that serves as the instructions for making proteins (called messenger RNA).

For more information about gene patenting and the Supreme Court ruling:

Read the Supreme Court rulingP D F fileThis link leads to a site outside Genetics Home Reference. against gene patenting.

The National Institutes of HealthThis link leads to a site outside Genetics Home Reference., the American College of Medical Genetics and GenomicsP D F fileThis link leads to a site outside Genetics Home Reference., and the American Medical AssociationThis link leads to a site outside Genetics Home Reference. voice their support for the Supreme Court’s ruling on gene patents.

The Genetics & Public Policy Center at Johns Hopkins University summarizes the impactThis link leads to a site outside Genetics Home Reference. of the Supreme Court’s ruling on gene patenting.

The National Human Genome Research Institute discusses the relationship between Intellectual Property and GenomicsThis link leads to a site outside Genetics Home Reference.


Next: How does genetic testing in a research setting differ from clinical genetic testing?

 
Published: December 16, 2014