The Supreme Court ruling
The Supreme Court has long allowed patent protection for the creation of a new process or use for natural products. Whether "isolating" or "extracting" genes themselves qualifies for such protection became the central argument.
The justices took the position offered by the Obama administration -- DNA itself is not patentable but so-called "cDNA" can be.
Complementary DNA is artificially synthesized from the genetic template, and engineered to produce gene clones.
Use of this protein-isolating procedure, known as "tagging," is especially important in mapping and cataloguing the vast human genome.
"Genes and the information they encode are not patent-eligible under [federal law] simply because they have been isolated from the surrounding genetic material," said Justice Clarence Thomas, who wrote the 9-0 court opinion.
"Myriad did not create anything," said Thomas. "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."
But Thomas said, "cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments."
Reaction to the decision
The American Civil Liberties Union said the decision represents a major shift in patent law and overturns established policy.
"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."
Dr. Harry Ostrer, a professor at Albert Einstein College of Medicine and director of genetic and genomic testing at Montefiore Medical Center in New York, said the decision will not undermine the genetically engineered drug industry and expects the costs of tests to fall.
"I'm thrilled. We can offer BRCA 1 and 2 testing to low-income women without concerns about how it will be paid for," he said.
Jolie also hoped for a meaningful impact.
"I hope that this ruling will lead to more women at risk of breast cancer being able to get access to gene testing and to take control of their lives, not just in the U.S. but around the world -- whatever their means and whatever their background," she said.
Peter D. Meldrum, president and chief executive officer of Myriad, said in a statement the company believed the court "appropriately upheld our claims on cDNA"
The ruling, he added "underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward."
Investors in Myriad were pleased with the ruling with the stock soaring as much as 9% before settling back but still higher.
The case is Association for Molecular Pathology v. Myriad Genetics (12-398).