Supreme Court skeptical of patent on breast cancer gene

10:44 PM, Apr 15, 2013   |    comments
(Photo: Karen Bleier, AFP/Getty Images)
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By Richard Wolf, USA TODAY

WASHINGTON -- The Supreme Court expressed grave doubts Monday about the legality of a company's exclusive patent on the genes that can identify an increased risk of breast and ovarian cancer.

Using analogies ranging from baseball bats to chocolate chip cookies, a majority of justices said Myriad Genetics' isolation of the breast cancer genes was largely a force of nature, not invention.

At the same time, the justices indicated a compromise could be in the works, siding with the company on its patent for a type of DNA that goes beyond merely extracting the BRCA1 and BRCA2 genes from the body.

If the court strikes down the broader patent, it would be a victory for a coalition of doctors, geneticists, researchers, women's groups and cancer patients who have fought for four years to open up research into the genetic markers for breast and ovarian cancer.

How much that decision would hinder research and development by the biotechnology industry remains in doubt, depending on whether the court finds a compromise that allows some of Myriad's work to be considered patentable.

At its most basic level, the question before the court was: Can genes be patented?

Since 1984, the U.S. Patent and Trademark Office has granted more than 40,000 patents tied to genetic material. Armed with those patents since the late 1990s, Myriad has tested more than 1 million women for mutations that often lead to breast and ovarian cancer.

Most women who want testing must pay its price - $3,340 for the breast cancer analysis and $700 for an additional test, called BART, which picks up a genetic link in about 10% of women who test negative the first time. Myriad officials say about 95% of its patients receive insurance coverage, often without co-payments, so most patients pay only about $100.

Justice Sonia Sotomayor likened Myriad's claim to a patent on the ingredients used to make chocolate chip cookies, such as sugar and flour. Chief Justice John Roberts said it was not akin to patenting a baseball bat extracted from a tree, since considerable work is involved in making the bat.

"You have to invent it," Roberts said of the baseball bat. When it comes to the isolated gene used to find mutations that can cause breast or ovarian cancer, he said, "You just have to snip it off."

The parade of analogies extended from plants in the Amazon to organs in the body as the justices - experts in the law, but not science - attempted to determine how much ingenuity was involved in Myriad's nearly 20-year-old discovery. The general conclusion was that Myriad deserved credit for the process of isolating the gene and its use - but not the gene itself.

The justices seemed to align themselves with the position taken by the Department of Justice, which split with the government's patent office -- labeled "patent-happy" by Justice Elena Kagan. Solicitor General Donald Verrilli sided with the patent's challengers, coordinated by the American Civil Liberties Union, but indicated a lesser portion of Myriad's claim would be acceptable.

"The patent law is filled with uneasy compromises," said Justice Stephen Breyer, the court's patent expert and author of its most recent case invalidating a patent on the basis that it involved a law of nature. While the process and use of natural phenomena often can be patented, he said, a patent is more difficult to get for "the thing itself."

Some of the court's most conservative justices appeared to support Myriad's claim. Justice Samuel Alito said isolated DNA "has a very different function" from DNA that exists in nature. He and Justice Antonin Scalia worried that without the benefit of a patent, companies would not conduct valuable research.

But a majority seemed to agree with Justice Sonia Sotomayor's description of the breast cancer gene isolated by Myriad. "In isolation, it has no value," she said. "It's just nature sitting there."

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