Supreme Court gene-patenting decision represents balancing act

A June 2013 Supreme Court ruling that human genes cannot be patented upholds the notion that “our common humanity cannot be owned” but also preserves incentives important for biomedical innovation, according to an article by Harvard School of Public Health (HSPH) researchers and colleagues.

The article was published online July 10, 2013 in the New England Journal of Medicine. HSPH co-authors included Michelle Mello, professor of law and public health, and Aaron Kesselheim, research associate, both in the Department of Health Policy and Management.

In the case Association for Molecular Pathology v. Myriad Genetics, all nine Supreme Court justices agreed that naturally occurring genes are not patentable “because they are products of nature,” the authors wrote. But so-called “complementary DNA” (cDNA)—a man-made copy—remains patentable.

The genes at issue in the Myriad case were BRCA1 and BRCA2, known as the “breast cancer genes.” Because Myriad Genetics held the patent on these genes, the company also held a monopoly on genetic testing for them, for which it was charging roughly $4,000.

Now, with the Court’s decision, the cost of testing for these breast cancer genes and other gene mutations will drop, the authors wrote. But the decision also “leaves undisturbed most of the intellectual-property rights on which the biotechnology industry depends.” Their conclusion: “Patient advocates and industry groups alike can find something to celebrate in this Supreme Court decision.”

Read the New England Journal of Medicine article