U.S. Supreme Court Invalidates BRCA Patent

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July 3, 2013

On June 13, 2013, the U.S. Supreme Court unanimously decided that naturally occurring human genes are not protected by patent. The act of discovering and identifying the location and sequence of a specific gene without any alterations to the gene cannot be patented, said the court. The case arose from a patent held by Myriad, a commercial molecular diagnostics laboratory, for the BRCA1 and BRCA2 genes, in which mutations are associated with a substantially increased risk for breast cancer. The laboratory had discovered the location of the genes and subsequently developed a test to detect BRCA mutations.

Because it held the patent on the BRCA genes, only Myriad could perform tests for these genes. Other labs could not develop alternative tests for the genes and researchers were limited in studying the genes. The decision also invalidates patents currently held on other naturally occurring genes. It does not, however, affect patents on laboratory tests developed by companies to evaluate genes.

Some scientists interested in the case say the decision will increase availability and lower the cost of the tests while generally promoting further genetic research. Others say that without protection from patents, companies will be reluctant to fund the research necessary to find similar breakthroughs. It remains to be seen what impact the decision will have on the future of genetic testing.

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NOTE: This article is based on research that utilizes the sources cited here as well as the collective experience of the Lab Tests Online Editorial Review Board. This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Any new sources cited will be added to the list and distinguished from the original sources used.

(June 14, 2013) Young, Kelly. U.S. Supreme Court: Human Genes Can't Be Patented. Physicians First Watch. Available online at http://www.jwatch.org/fw107613/2013/06/14/us-supreme-court-human-genes-cant-be-patented through http://www.jwatch.org. Accessed July 1, 2013.

(June 13 2013) Liptak, Adam. Justices, 9-0, Bar Patenting Human Genes. New York Times. Available online at http://www.nytimes.com/2013/06/14/us/supreme-court-rules-human-genes-may-not-be-patented.html?_r=2& through http://www.nytimes.com. Accessed July 1, 2013.

(June 13, 2013) Wolf, Richard. Justices rule human genes cannot be patented. USA Today. Available online at http://www.usatoday.com/story/news/nation/2013/06/13/supreme-court-gene-breast-ovarian-cancer-patent/2382053/ through http://www.usatoday.com. Accessed July 1, 2013.