The Supreme Court unanimously ruled on June 13 that normal human genes cannot be patented. Writing for the court, Justice Clarence Thomas explained: "A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated." In Association for Molecular Pathology v. Myriad Genetics, No. 12-398, the Court ruled that manipulating a gene to create a synthetic version, however, makes it eligible for patent protection.
The genes at the heart of the case were BRCA1 and BRCA2, which have been linked to an increased risk of breast and ovarian cancers. The actress Angelina Jolie recently helped elevate the profile of BRCA1, a gene that she carried that was behind her decision to have a protective mastectomy.
While Myriad did isolate a useful gene, the act of isolating it from "surrounding genetic material is not an act of invention," explained Justice Clarence Thomas.
The decision marks a departure from the findings of the Federal Circuit, which ruled twice that DNA sequences are in fact patentable.
Over the past three decades, U.S. patents have been granted to more than 4000 human genes.
Before the ruling, the biotechnology industry predicted that a decision against Myriad would put in jeopardy billions of dollars in investment. Still, the company's president and CEO Peter Meldrum remains optimistic. In a statement, he explains that the company believes "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."
Conversely, ACLU proclaimed in a statement: "VICTORY! Supreme Court Decides: Our Genes Belong to Us, Not Companies." The ACLU claimed that arrangement was a hurdle making difficult the investigation of human genes.