The human gene cannot be patented.
According to a unanimous decision of the U.S. Supreme Court released Thursday, isolation of a human gene is ineligible for protection under federal patent law because it amounts to the discovery of a natural phenomenon.
Lori B. Andrews, a professor of law at IIT-Chicago Kent College of Law and director of that law school's Institute for Science, Law, and Technology, told Minnesota Public Radio that the decision prevents biotechnology companies from being "unreasonably enriched."
The financial implications of the decision are likely to be significant, starting with the likelihood that patients will have more choices of providers of tests to determine whether they carry mutations of two genes implicated in breast and ovarian cancers.
The genes at issue in the dispute are known as BRCA 1 and BRCA 2. Myriad had obtained patents on the location and DNA nucleotide sequence of both genes. Being the owner of the patents, Myriad was in a position to be the exclusive source for diagnostic tests aimed at determining whether a patient's genome included the mutations of one or both genes that would, in turn, indicate risk for cancer.
A federal district court invalidated the patents in 2010, but the U.S. Court of Appeals for the Federal Circuit reinstated them in 2012.
Justice Clarence Thomas' opinion for the Supreme Court explained that, because Myriad did not actually create the genes on which it had obtained patents, the grant of those patents violated a basic premise of patent law requiring the invention or discovery of something more than "laws of nature, natural phenomena, and abstract ideas."
Myriad did not, however, suffer a total loss at the Supreme Court because the justices also decided that the firm was eligible for a patent on synthetic DNA isolated in its laboratories.
A company executive asserted Thursday that this aspect of the decision will help to preserve Myriad's ability to market its unique form of genetic testing to women concerned about their susceptibility to cancer.
"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," Peter D. Meldrum, Myriad's president and chief executive officer, said.
The case is Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398.