In a unanimous 9-0 decision, the Supreme Court of the United States ruled that companies cannot hold patents on naturally occurring human genes, though synthetic versions of those genes may be protected by patent.
The case centers around a lawsuit between the American Civil Liberties Union and Myriad Genetics Inc., a genetic testing company based out of Utah. The lawsuit sought to settle the question of whether or not genes could ever be patented for a period of time.
Myriad Genetics argued genes ought to be patentable, claiming that billions of dollars worth of genetic and medical research is at stake. The company is credited with isolating two natural genes in particular - BRCA1 and BRCA2 - which are believed to contributed to breast and ovarian cancer. Myriad claimed it had exclusive rights to test on BRCA1 and BRCA2. Other labs seeking to test on those genes would have to get permission from Myriad first.
The ACLU, however, argued those genes occur naturally, and therefore cannot be patented. The civil liberties group also argued such patents have the potential of creating a chilling effect on research, and would interrupt the free flow of information. Such a situation, they argued, would violate the First Amendment. The group also argued that synthetic genes shouldn't be patentable by law.
"Genes and the information they encode are not patent-eligible under [federal law] simply because they have been isolated from the surrounding genetic material," Justice Clarence Thomas said in the majority opinion.
The ACLU praised the court's decision, saying patients will have better access to genetic test as a result, and that researcher won't have to operate in fear of being sued.
While the decision seems clear-cut in favor of the ACLU, Myriad did walk away with a significant victory: synthetic genes such as cDNA, a synthetic version of DNA, is patentable by law.
"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, president and CEO said in a prepared 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 healthcare costs."
The decision, as The Washington Post notes, could have a ripple effect on pharmaceuticals and agriculture as well as medical and genetic research, though its effects will take some time to be felt.
