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Supreme Court says no patent on natural DNA, upholds other Myriad patents

Published: Thursday, June 13 2013 1:05 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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SALT LAKE CITY — Bunny Sterin finds the notion that someone could prevent her from donating part of her genetic makeup to cancer research — or using it in other ways, for that matter — ridiculous.

She recently was diagnosed with breast cancer, had a lumpectomy and completed radiation. Along the way, Sterin, 58, also had genetic testing that found she does not carry a BRCA gene implicated in some breast cancers.

The BRCA1 and BRCA2 genes that prompted actress Angelina Jolie to undergo a double mastectomy in an aggressive effort to avoid breast cancer — and who controls those genes — had been hotly contested until Thursday, when the U.S. Supreme Court ruled DNA is part of nature and no one can patent it. The court's unanimous decision also determined that synthetic DNA can be patented.

The decision in the case Association for Molecular Pathology v. Myriad Genetics settled the question of whether researchers who identify segments of DNA can lay claim to them and control their use in research. The practical effect of the ruling, however, is unclear and may even prove to be somewhat symbolic, experts say.

Salt Lake-based Myriad Genetics identified and patented BRCA1 and BRCA2. Mutations in the two BRCA genes greatly increase the likelihood of developing certain cancers — to between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer. Myriad's patents have allowed it to control research on the genes and bar tests that compete with its own BRACAnalysis(R) genetic test.

"As we have recognized before, patent protection strikes a delicate balance between creating 'incentives that lead to creation, invention, and discovery' and 'imped(ing) the flow of information that might permit, indeed spur, invention,'” the Supreme Court wrote as it upheld part of a previous ruling and struck down another part.

Both sides called the ruling a victory.

"We actually think today's decision is positive for the company," Myriad Genetics spokesman Ron Rogers told the Deseret News. He said the company lost five patents on the genes themselves, but still has 500 claims that are "valid and enforceable" in 24 different patents related to the BRCA1 and BRCA2 genes. "I don't think today's decision will have any negative impact on our operations. It also doesn't change the strong patent protection for intellectual property for our (genetic) test."

AMP hailed the decision as a "great step forward in the field of molecular pathology, for genomic science and, most important, for our patients. We look forward to exciting future advancements in diagnostic testing and therapeutics that will accrue to the benefit of our patients and our field."

One of its spokesmen, Roger Klein, a molecular pathologist at the Cleveland Clinic, told the Deseret News the ruling would provide "better access to testing, likely at lower cost, more choice of providers and also encourage innovation."

The lawsuit, he noted, was "not us vs. Myriad, it was us vs. gene patents."

Competing claims

Those who oppose patenting genes, including the AMP, researchers, physicians and patients, said that granting such patents stifles research, raises the cost of genetic testing, can hamper the search for cures and limits access for patients who cannot afford the genetic testing.

Myriad maintained gene patents are needed to protect the costly investment companies and other researchers must make to reap significant biologically based discoveries. The biotech company countered the test-cost criticism by pointing out it provides testing at reduced cost or sometimes free to those who cannot afford it. More than 1 million women have used its test, including more than 35,000 at-risk patients who received free or reduced-cost testing, it said.

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