The case in question was over whether Myriad Genetics’ patents for the BRCA1 and BRCA2 genes were legal. The company obtained several patents after discovering the location and sequence of the two genes, mutations of which can increase the risk of breast and ovarian cancer. This knowledge allowed Myriad to detect mutations in the genes and therefore assess a patient’s cancer risk.
A group of medical researchers, associations and patient advocates, however, sued Myriad in 2009 claiming that the patents were invalid because human genes, even synthetically produced material related to them, were naturally occurring. A federal judge ruled the patents invalid but an appeals court said they were valid, which is why the Supreme Court took the case.
Supreme Court Decision
The Supreme Court’s carefully worded ruling found that although “Myriad’s DNA claim falls within the law of nature exception” and that its “principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes,” the company’s exclusive right to synthetically create BRCA cDNA “does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.”
Myriad stock is now up more than 10 percent on the news.
The creation of cDNA, the Court said, “results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.”
But the Court also qualified those statements with the claim that, “This case, it is important to note, does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.”