The US Supreme Court [official website] ruled [opinion, PDF] unanimously Thursday in Association for Molecular Pathology v. Myriad Genetics, Inc. [SCOTUSblog backgrounder] that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. The court also found that synthetically created DNA known as complementary DNA (cDNA) is patent eligible because it is not naturally occurring. Myriad Genetics [corporate website] patented two genes, BRCA1 and BRCA2 [NCI backgrounder], which are linked to increased risk of breast and ovarian cancer. The two genes are isolated genesdifferent from native genes because the process of extracting them changes their molecular structure but not their genetic code. In an opinion by Justice Clarence Thomas, the court held that the isolated genes are not patentable, but that synthetic cDNA is patent eligible:
cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. ... Petitioners concede that cDNA differs from natural DNA in that "the non-coding regions have been removed." ... They nevertheless argue that cDNA is not patent eligible because "[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician." ... That may be so, but the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a "product of nature" and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.The court affirmed in part and reversed in part the judgment [JURIST report] of the US Court of Appeals for the Federal Circuit. Justice Antonin Scalia filed a separate short opinion concurring in part and concurring in the judgment.
Gene patents remain a controversial issue around the world. In February the Federal Court of Australia [official website] ruled that Myriad could patent the BRCA1 gene [JURIST report] because the isolated gene is not natural, but rather the product of human intervention.