The court unanimously ruled that isolated and purified DNA was a product of nature and therefore not eligible for patent protection under Section 101. But it said that synthetically created complementary DNA (cDNA) can be patented because it is not a naturally occurring substance.
The case, Association for Molecular Pathology v Myriad Genetics, revolved around Myriad’s US patents covering the isolation and detection of the BRCA1 and BRCA2 genes, which can be used to screen for certain types of cancer. Testing, which could only be carried out by Myriad because of the patents, cost around $3,000.
The case sharply divided supporters and opponents of patents on human genetic material. Public interest organisations including the American Civil Liberties Union (ACLU) and the Public Patent Foundation filed amicus briefs in support of AMP, arguing that Myriad’s patents had caused “a proven chilling effect on research” into the genes.
Others, including Biotechnology Industry Organization (BIO) which filed an amicus brief in support of Myriad, argued that a ruling against the biotech company could disincentive investment in research and development in the field.
AIPLA took a neutral position on Myriad's specific claims, but in general supports patent eligibility for genetic material.
In their ruling, the justices said patent protection must strike “a delicate balance” between creating incentives for innovation and impending the flow of information that might spur further inventions.
“Myriad did not create or alter either the genetic information encoded in the BCRA1 andBCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.”
But they said that with regard to complementary DNA, “the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.”
The decision affirmed in part and reversed in part a July 2012 decision by the Federal Circuit, which reversed a previous district court ruling that Myriad’s composition claims covered patent-ineligible products of nature.
The Federal Circuit had initially ruled on the case in July 2011, but after an appeal to the Supreme Court was filed the case was returned to the Federal Circuit following the Supreme Court's decision in Mayo v Prometheus in March 2012.
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