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Supreme Court: Human genes cannot be patented

A technician loads patient samples into a machine

A technician loads patient samples into a machine for testing at Myriad Genetics in Salt Lake City. (June 13, 2013) Photo Credit: AP

In a unanimous decision, the U.S. Supreme Court ruled against patents on human genes Thursday in what critics of the practice are calling a landmark victory and proponents have labeled a "troubling departure."

The court ruled that isolated human genes cannot be patented, unraveling decades of exclusive corporate and institutional rights on human DNA. The highly controversial case involved Myriad Genetics, a Utah company, which has held patents for nearly two decades on a pair of genes related to breast and ovarian cancers.

Because of the patents, Myriad had a monopoly on the only screening available for the heritable cancers caused by mutations in the genes, BRCA 1 and BRCA 2. The test cost more than $3,500, which put it out of reach for many patients.

Myriad and other biotech companies will still be able to patent so-called cDNA -- complementary DNA -- genes that are produced synthetically in the lab, according to the ruling.

"If we had some champagne, we would break it out," said Dr. Daniel Budman, director of hematology and oncology for the North Shore-Long Island Jewish Health System.

"This is a wonderful decision for us from a medical standpoint," Budman said. "We really couldn't determine if a patient was at risk unless we ordered a horrendously expensive test. I've noticed today that the [price of the] test is already dropping."

Advocates for patients were also pleased with the high court's decision.

"Today we witnessed an important victory," said Karen Joy Miller, executive director of the Huntington Breast Cancer Action Coalition. "The U.S. Supreme Court has outlawed human gene patents and corporations can no longer own our genes."

'Groundbreaking moment'Hillary Rutter, director of the Adelphi University Breast Cancer Program, sees the decision as one that will benefit women -- and men -- at risk of hereditary cancers. "This is a groundbreaking moment in the history of biotechnology," Rutter said, "and a case that will surely rank among the most noteworthy biomedical decisions of our time.

"The overarching question -- which has been an ongoing controversy since 1997 when the U.S. Patent Office granted Myriad's patent of the two genes -- was whether genetic information, even newly discovered information, could be patented," Rutter said.

But Jim Greenwood, chief executive of the biotech trade group known as Biotechnology Industry Organization -- BIO -- said the court preserved the most important patentable molecules. He said "cDNA is the commercially most important form of DNA used in biotechnology."

Still, he thinks the court dealt the industry a blow.

"The Supreme Court's decision today represents a troubling departure from decades of judicial and Patent and Trademark Office precedent supporting the patentability of DNA molecules," he said.

Myriad had been challenged in lower courts for years by scientists and physicians represented by the American Civil Liberties Union in Manhattan.

Plaintiffs said Myriad's monopoly blocked them from developing more efficient and less expensive screenings for genetically linked cancers.

The BRCA genes were in the spotlight last month when actress Angelina Jolie announced that she had undergone a double mastectomy because she carries a BRCA 1 mutation.

Thursday, in a statement, Myriad said the Supreme Court decision was a victory because it upheld its patents on cDNA.

"We believe the court appropriately upheld our claims on cDNA . . . ensuring strong intellectual property protection for our BRACAnalysis test," said Peter Meldrum, Myriad's president and chief executive.

"More than 250,000 patients rely upon our BRACAnalysis test annually," Meldrum said.

But senior ACLU attorney Sandra Park noted that not only were medical costs steep for patients whose insurers refused to pay for the screening, doctors and scientists faced lawsuits from Myriad whenever they attempted to study the two genes.

"They had effectively locked up these genes from any other scientific investigation," Park said. She called the court's ruling "a landmark decision for scientific freedom and patient health."


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