[Infowarrior] - SCOTUS: Genes can NOT be patented

[Richard Forno]

Justices rule human genes cannot be patented

Richard Wolf, USA TODAY 10:37 a.m. EDT June 13, 2013

http://www.usatoday.com/story/news/nation/2013/06/13/supreme-court-gene-breast-ovarian-cancer-patent/2382053/

WASHINGTON -- The Supreme Court ruled Thursday that human genes cannot be patented, a decision with both immediate benefits for some breast and ovarian cancer patients and long-lasting repercussions for biotechnology research.

The decision represents a victory for cancer patients, researchers and geneticists who claimed that a single company's patent raised costs, restricted research and sometimes forced women to have breasts or ovaries removed without sufficient facts or second opinions.

But the court held out a lifeline to Myriad Genetics, the company with an exclusive patent on the isolated form of genes that can foretell an increased genetic risk of cancer. The justices said it can patent a type of DNA that goes beyond extracting the genes from the body.

The complex scientific case was perhaps the most important on the high court's calendar other than its more celebrated cases involving same-sex marriage, voting rights and affirmative action.

And unlike those cases, which are expected to divide the court sharply along ideological lines, the controversial concept of gene patenting gave all nine justices something to agree on.

The decision was based on past patent cases before the high court in which the justices ruled that forces of nature, as opposed to products of invention, are not patent-eligible.

Since 1984, the U.S. Patent and Trademark Office has granted more than 40,000 patents tied to genetic material. Armed with those patents, Myriad has tested more than 1 million women since the late 1990s 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 that 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 that most patients pay only about $100.

Myriad and a broad array of industry trade groups argued that without patent protection, research and development would dry up. Doctors, geneticists, women's health groups and cancer patients contended that competition would lower prices, improve outcomes and lead to more discoveries.

The two sides had battled to a draw in lower courts: A federal district court in New York sided with the  patent's challengers, while a divided court of appeals that handles patent cases ruled for the company.

During oral argument in April, the court was presented with opposite interpretations of Myriad's contribution to genetic research. Christopher Hansen, the lawyer for the American Civil Liberties Union representing the patent's challengers, said Myriad had invented "nothing." Myriad's attorney, Gregory Castanias, said the company created "a new molecule that had never been known to the world."

The justices generally agreed that Myriad deserved credit for its process of isolating the gene and its use – but not for the gene itself. "In isolation, it has no value," Justice Sonia Sotomayor said. "It's just nature sitting there."

But the compromise that emerged Thursday was evident during that 65-minute debate. Several of the more conservative justices said a complete denial of patent rights could jeopardize investments by other biotechnology companies — and that could limit progress on a range of research, from agriculture to the environment.

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