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Can medical companies patent human genes? Supreme Court hears key case. (+video)

The US Supreme Court on Monday takes up a case with widespread implications for scientific innovation and health care in the US. The question: Are human genes patentable?

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At the center of the case is whether the process developed by Myriad is a man-made invention or just recognition of a natural process, a law of nature.

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Patent protection is authorized by federal law and the US Constitution. Article I, Section 8 empowers Congress to “promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”

The idea is to offer a strong incentive for individuals or companies to undertake the difficult work of innovation and discovery.

Modern research firms must convince investors that their labor will eventually bear fruit – and profits.

But to qualify for patent protection, the innovation must be a product of human ingenuity rather than merely a product of nature.

That’s the essence of the dispute in Association for Molecular Pathology v. Myriad Genetics (12-398).

Myriad says its process uses a newly-created chemical composition that does not occur in the natural world. The company “isolates” the targeted DNA molecule in a way that permits the identification of the mutation on the gene that researchers say is predictive of a higher incidence of breast or ovarian cancer.

Hansen disputes this. “Myriad defends its [patent] claims on the grounds that a gene becomes a human invention when removed from the human body (‘isolated’),” he said.

“Under this rationale, a kidney ‘isolated’ from the body would be patentable, gold ‘isolated’ from a stream would be patentable, and leaves ‘isolated’ from trees would be patentable,” he said in his brief.

He said the company’s argument defied common sense and violated the prohibition on issuing patents to protect claimed innovations demonstrating nothing more than the laws of nature.

In a friend of the court brief, a research scientist at the University of Illinois, Ananda Mohan Chakrabarty, argued that there was a substantial difference between “isolated” kidneys, gold, and leaves and Myriad’s system of molecular diagnostics.

“A human kidney that has been removed (isolated) from the body does not have any utility apart from that which existed in nature,” Mr. Chakrabarty said in his brief. “Neither does a polished diamond, nor gold taken from a stream, nor a leaf snapped from a tree.”

“But the Myriad patents… allow for genetic testing and drug screening for a permanent cure for cancer that would be impossible with non-isolated mutation-harboring DNA as it exists in the genome of a vulnerable woman,” he said. “For that reason, they should be patent-eligible.”

Chakrabarty said courts examining patents granted for gene research should weigh whether the innovation provides “specific, substantial, and credible utility” different from what is found in nature.

Chakrabarty speaks from experience. In 1980, the US Supreme Court upheld the patent for his discovery of how to increase the ability of a bacterium to help degrade crude oil. The innovation held great promise to speed cleanup after environmentally-devastating oil spills.

“Even though I had used natural materials to build my invention, the court found it patent-eligible based on its new, significant utility,” he said.

Hansen of the ACLU said in his brief that offering patent protection for Myriad’s process of isolating DNA “ties up all basic uses of the BRCA1 and BRCA2 genes, foreclosing more future innovation than the underlying discovery could reasonably justify.”

“The patents exclude using the genes for research, clinical genetic testing, and the development of therapies,” he said. “And these fears are not hypothetical; in practice, Myriad has used it patents to shut down clinical care and impede research.”

Hansen added that unjustified patent protection raises First Amendment issues. “Such restrictions on an entire field of knowledge give control over thought and pure information, in violation of the Constitution,” he said. 

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