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Thursday, June 13, 2013

SCOTUS Strikes Down Human Gene Patents

In yet another smack down to the increasingly patent crazy United States Court of Appeals for the Federal Circuit (Patent Court), the Supreme Court has ruled that the contents of the human genome are a discovery, not an invention, and so they cannot be patented:

Pronouncing what may seem like a patent truism, the Supreme Court ruled unanimously on Thursday that biotech researchers have to create something to get monopoly protection to study and apply the phenomenon. Because Myriad Genetics, Inc., “did not create anything,” the Court struck down its patent on isolating human genes from the bloodstream, unchanged from their natural form. Because Myriad did create a synthetic form of the genes, however, that could be eligible for a patent, the Court concluded.

The decision was a major blow to a company that believed it had a right to be the sole user and analyst of two human genes, mutations in which show a high risk, for women found to have them in their blood, of breast and ovarian cancer. But the ruling will give medical and scientific researchers, and family doctors, greater opportunity to help women patients discover their potential vulnerability to those types of cancer.

………

The scientific and legal key to the Court’s denial of patent protection to isolated, natural forms of DNA were these sentences: “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA.”

While that was not disputed, because the legal controversy focused rather on what Myriad claimed it did to locate and then isolate the forms of genetic DNA, those agreed-upon factors were enough to convince the Court that “Myriad did not create anything.” As Justice Thomas commented further: “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. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the [patent law] inquiry.”
I think that one of the reasons that this was a unanimous ruling was that it was a very narrow ruling, hence the caveats about their explicitly saying nothing about synthesized genetic material.

Still, it is a good ruling, and yet another much needed bitch slap to the Patent Court.

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