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Can genes be patented?
URL of this page: https://medlineplus.gov/genetics/understanding/testing/genepatents/

Can genes be patented?

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 about the Supreme Court case. From the National Institutes of Health

The National Human Genome Research Institute (NHGRI) discusses Intellectual Property in Genomics.From the National Institutes of Health

Topics in the Genetic Testing chapter

  • What is genetic testing?
  • What are the different types of genetic tests?
  • What are the uses of genetic testing?
  • How is genetic testing done?
  • What is informed consent?
  • How can I be sure a genetic test is valid and useful?
  • What do the results of genetic tests mean?
  • What is the cost of genetic testing, and how long does it take to get the results?
  • Will health insurance cover the costs of genetic testing?
  • What are the benefits of genetic testing?
  • What are the risks and limitations of genetic testing?
  • What is genetic discrimination?
  • Can genes be patented?
  • How are genetic screening tests different from genetic diagnostic tests?
  • How does genetic testing in a research setting differ from clinical genetic testing?
  • What are whole exome sequencing and whole genome sequencing?
  • What are secondary findings from genetic testing?
  • What is noninvasive prenatal testing (NIPT) and what disorders can it screen for?
  • What is circulating tumor DNA and how is it used to diagnose and manage cancer?

Other chapters in Help Me Understand Genetics

The information on this site should not be used as a substitute for professional medical care or advice. Contact a health care provider if you have questions about your health.

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