Perspective from Rebecca Nagy, MS, CGC
Perspective from Beth Y. Karlan, MD
Perspective from Mark A. Sperling, MD
Perspective from Michael Tolentino, MD
Perspective from Sherry J. Bass, OD, FAAO
June 13, 2013
2 min read
Save

Supreme Court rules human genes cannot be patented

Perspective from Rebecca Nagy, MS, CGC
Perspective from Beth Y. Karlan, MD
Perspective from Mark A. Sperling, MD
Perspective from Michael Tolentino, MD
Perspective from Sherry J. Bass, OD, FAAO
You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

The U.S. Supreme Court has ruled unanimously today that genes and the information they encode are not eligible for patents.

The case involved patents held by Utah-based company Myriad Genetics for two genes, BRCA1/2, used to test if a woman has a greater risk for developing ovarian or breast cancer.

“Myriad did not create anything,” according to Justice Clarence Thomas, who wrote the court’s decision. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

The decision, however, leaves open the door for patents on synthetic versions of gene material because, the court wrote, “it is not naturally occurring.”

"Today, the court struck down a major barrier to patient care and medical innovation," said Sandra Park, senior staff attorney with the ACLU Women's Rights Project. "Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."

Mutations in BRCA1/2 genes can significantly increase an individual’s risk of developing breast and ovarian cancer. The court's decision in Association for Molecular Pathology v. Myriad Genetics pointed out that average American woman has a 12% to 13% risk for developing breast cancer. However, the risk can range between 50% and 80% for breast cancer and between 20% and 50% for ovarian cancer among women with certain genetic mutations.

Myriad emphasized that the decision left intact more than 500 "valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test."

“We believe the court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward," said Peter D. Meldrum, president and CEO in a written statement. "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."

Justice Antonin Scalia joined the overall judgment of the court, excluding some sections that delved into details of molecular biology. In a separate written opinion, Scalia said he was "unable to affirm those details on my own knowledge or even my own belief." But he affirmed that "having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state."