Patenting genes: Justices tackle big health issue in case with Utah ties

By Jesse J. Holland

Associated Press

Published: Monday, April 15 2013 5:40 p.m. MDT

The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years, but opponents of Salt Lake City-based Myriad Genetics Inc.'s patents on two genes linked to increased risk of breast and ovarian cancer say patent protection should not be given to something that can be found inside the human body.

Alex Brandon, Associated Press

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WASHINGTON — The Supreme Court seemed worried Monday about the idea of companies patenting human genes in a case that could profoundly reshape the multibillion-dollar biomedical industry and U.S. research in the fight against diseases like breast and ovarian cancer.

Justices argued not only about snipping DNA strands but also about chewing the leaves of Amazonian jungle plants, the shaping of baseball bats and the ingredients of chocolate chip cookies as they tried to figure out whether companies can gain government protection — and profits — for their work with human genes.

The ability to claim control of genetic information found inside every American could hang on the nine justices' decision later this summer, a ruling that could affect the intersection of science and the law for years to come.

"The issue here is a very difficult one," Justice Samuel Alito said.

Abstract ideas, natural phenomena and laws of nature cannot be awarded patents, the legal protection that gives inventors the right to prevent others from making, using or selling a novel device, process or application. The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years, but opponents of Myriad Genetics Inc.'s patents on two genes linked to an increased risk of breast and ovarian cancer say such protection should not be given to something that can be found inside the human body.

"Finding a new use for a product of nature, if you don't change the product of nature, is not patentable," said lawyer Christopher Hansen, arguing against the patents. "If I find a new way of taking gold and making earrings out of it, that doesn't entitle me to a patent on gold. If I find a new way of using lead, it doesn't entitle me to a patent on lead."

Several organizations, including the American Civil Liberties Union, the Association for Molecular Pathology, a number of doctors and researchers and some people at risk for hereditary breast and ovarian cancer, have challenged the patents.

But Myriad argues — and the patent office and a federal appeals court have agreed — that the company's genes can be patented because the DNA that Myriad isolated from the body has a "markedly different chemical structure" from DNA within the body.

"What was 'merely snipped' out of the body here is fundamentally different in kind from what was in the body," Myriad lawyer Gregory A. Castanias said. "The most important reason it's different in kind is that it cannot be used in the body to detect the risk of breast and ovarian cancers."

The company has used its patent to come up with its BRACAnalysis test, which looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer. Women with a faulty gene have a three to seven times greater risk of developing breast cancer and also a higher risk of ovarian cancer.

Myriad sells the only BRCA gene test. Opponents of its patents say the company can use its patents to keep other researchers from working with the BRCA gene to develop other tests.

In such matters, companies can have billions of dollars of investment and years of research on the line. Their advocates argue that without the ability to recoup their investment through the profits that patents bring, breakthrough scientific discoveries to combat all kinds of medical maladies wouldn't happen. That concerned several justices.

"Why shouldn't we worry that Myriad or companies like it will just say, 'Well, you know, we're not going to do this work anymore?'" Justice Elena Kagan asked.

Hansen said that a company could get recognition for its work and that money for research would always be available, a statement that Justice Anthony Kennedy said wasn't sufficient.

"I don't think we can decide the case on, 'Don't worry about investment. It'll come,'" Kennedy said.

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