Human Genes May Not Be Patented, Rules the Supreme Court


Key Points

  • The Supreme Court ruled unanimously that isolated human genes may not be patented. However, artificially constructed genes are eligible for patents because they are inventions and do not exist in nature. The decision concerned patents on BRCA1 and BRCA2 genes held by Myriad Genetics.
  • Costs for genetic testing for BRCA1 and BRCA2, which currently average more than $3,000, may now come down as other companies develop their own tests for these genetic mutations, making them affordable to more women.

The U.S. Supreme Court ruled unanimously on Thursday that isolated human genes may not be patented. However, the creation of synthetic forms of DNA, known as complementary DNA (cDNA), is eligible for patent protection. The decision resolves the question brought before the Supreme Court justices in the case Association for Molecular Pathology et al v Myriad Genetics, Inc, et al, which concerned patents on BRCA1 and BRCA2 genes held by Myriad Genetics.

Writing for the court, Justice Clarence Thomas said, “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.… To be sure, [Myriad] found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.… Laws of nature, natural phenomena, and abstract ideas are not patentable.”

The patents were challenged by scientists and health-care professionals concerned that their ability to help patients and conduct research had been undermined.

In a statement posted on Myriad's website, Peter D. Meldrum, President and CEO of Myriad, responded favorably to the Court’s decision, saying, “We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection of our BRACAnalysis test moving forward. More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall health-care costs.”

Price for Genetic Testing May Be Reduced

Currently, the Myriad genetic test for BRCA1 and BRCA2 mutations costs more than $3,000 and is not always covered by insurance. Now that the Supreme Court has ruled that Myriad’s patents are no longer valid and other companies will be allowed to develop their own tests for these genetic mutations, prices may come down, making them affordable to more women at high risk for breast and ovarian cancers.

“Competition drives innovation. The cost of genetic sequencing has been coming down since 1994, but the price for doing BRCA1 and BRCA2 testing has been going up because there has been no competition,” said Olufunmilayo I. Olopade, MD, FACP, Walter L. Palmer Distinguished Service Professor of Medicine and Human Genetics and Director of the Center for Clinical Cancer Genetics at the University of Chicago Medicine. “The Supreme Court decision is a victory for genetic justice. The Court got it right by supporting the most vulnerable of all: people with genetic burden whom we need to support and not burden unnecessarily because they can’t afford the genetic test.”

Praise for the ruling also came from Francis S. Collins, MD, PhD, Director of the National Institutes of Health, who said in a statement, “The decision represents a victory for all those eagerly awaiting more individualized, gene-based approaches to medical care. The right to control exclusively the use of a patient’s genes could have made it more difficult to access new tests and treatments that rely on novel technologies that can quickly determine the sequence of any of the estimated 20,000 genes in the human genome. Such approaches form the cornerstone of the rapidly emerging field of personalized medicine, in which diagnostic, therapeutic, and preventive strategies can be tailored to each person’s unique genetic makeup.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.