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Bio & Life Sciences Business

By Adrienne Jane Burke | June 13, 2013, 12:22 PM

“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” the Supreme Court has ruled today unanimously. The 20-page decision written by Justice Thomas added that synthetic DNA, also known as complementary DNA or cDNA, “is patent eligible because it is not naturally occurring.”

The landmark decision is a blow to the biotech and pharmaceutical industries, which have often claimed the need to hold exclusive rights to genes in order to justify the costly investment in drug and diagnostic development for specific diseases related to mutated genes. But it is welcome news to competitors and academic scientists who are now free to pursue such research. In particular, the cost for patients of diagnostics for breast cancers associated with the two mutated genes for which Myriad claimed patent rights are expected to drop.

According to the decision in Association for Molecular Pathology v. Myriad Genetics that was handed down this morning:

“Myriad Genetics, Inc., obtained several patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer. This knowledge allowed Myriad to determine the genes’ typical nucleotide sequence, which, in turn, enabled it to develop medical tests useful for detecting mutations in these genes in a particular patient to assess the patient’s cancer risk. If valid, Myriad’s patents would give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes, and would give Myriad the exclusive right to synthetically create BRCA cDNA. Petitioners filed suit, seeking a declaration that Myriad’s patents are invalid under 35 U. S. C. §101.”

Justice Thomas said for the Court, “laws of nature, natural phenomena, and abstract ideas are basic tools of scientific and technological work that lie beyond the domain of patent protection” and “Myriad’s DNA claim falls within the law of nature exception.” The Court said that the biotech company “did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 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.”

cDNA, on the other hand, is patentable, the Court said, because “Its creation 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.” Myriad will be able to retain those patents.

Ed. Note: While most headlines today declare that the Supreme Court has ruled that human genes cannot be patented, the Court did not restrict its ruling to humans, and the language of the decision makes clear that any genes that occur in nature are ineligible for patent.