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Companies can't patent genes, US court rules

Amy Corderoy (via NYT/ SMH) | June 14, 2013
Decision hailed by Australian lawyers challenging the patent on 'breast cancer gene' BRCA1.

Human DNA: Not patentable.
A generalised DNA structure. Photo: Reuters

The highest court in the United States has ruled that human genes cannot be controlled by companies.

The decision could lead to the overturning of thousands of patents already granted on human genes and may have ramifications for a case currently under way in Australia challenging the patent on the so-called breast cancer gene, BRCA1.

Rebecca Gilsenan, the principal lawyer at the company fighting the Australian patent, Maurice Blackburn, said the US decision was exciting and encouraging.

"The Australian court is not bound by the what the US Supreme Court has decided, however, I expect that an Australian court will be very interested in what the Supreme Court has decided and the reasons it had, and will take notice of that," she said. "It's a very significant development by a very significant court."

In February, Maurice Blackburn lost an Australian Federal Court case challenging the ruling that a patent could be granted on a mutation in the BRCA1 gene that drastically increases a person's risk of cancer.

In August an appeal will be heard, in which the law firm will argue Federal Court Justice Nicholas erred in finding that simply isolating a gene outside the body constituted a form of new manufacture.

Ms Gilsenan said it was heartening that the Supreme Court had sided with the arguments being put forward by her firm in Australia.

"The US Supreme Court has held up the essence of the argument we have put forward in our case, that genes are a naturally occurring substance that are not patentable," she said.

She said final submissions on the appeal were due today, so the firm would be able to refer to the US decision.

The central question for the justices in the case, Association for Molecular Pathology versus Myriad Genetics, was whether isolated genes are "products of nature" that may not be patented or "human-made inventions" eligible for patent protection.

Myriad's discovery of the precise location and sequence of the genes at issue, BRCA1 and BRCA2, did not qualify, Justice Clarence Thomas wrote for the court.

"A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated," he said. "It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.

"Groundbreaking, innovative or even brilliant discovery does not by itself satisfy the criteria" for patent eligibility, he said.


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