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Court’s patent ruling could lower prices of genetic tests

A technician loads patient samples inmachine for testing Myriad Genetics 2002. The Supreme Court ruled Thursday thMyriad cannot patent BRCA

A technician loads patient samples into a machine for testing at Myriad Genetics in 2002. The Supreme Court ruled Thursday that Myriad cannot patent the BRCA genes, which are tested to check a woman’s risk for breast and ovarian cancer. | AP

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Updated: July 17, 2013 6:52AM

In a decision that is expected to make it cheaper for people to get genetic tests for disease, the Supreme Court unanimously ruled Thursday that naturally-occurring human genes cannot be patented by companies.

The high court’s judgment reverses three decades of patent awards by government officials. But it also gave a partial victory to the biotechnology industry by allowing legal protections on synthetically produced genetic material.

The decision threw out patents held by Utah-based Myriad Genetics Inc. on an increasingly popular breast cancer test brought into the public eye recently by actress Angelina Jolie’s revelation that she had a double mastectomy because of one of the genes involved in this case.

Justice Clarence Thomas, who wrote the court’s decision, said that Myriad’s assertion — that the DNA it isolated from the body for its proprietary breast and ovarian cancer tests were patentable — had to be dismissed because it violates patent rules. The court has said that laws of nature, natural phenomena and abstract ideas are not patentable.

“We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Thomas said.

However, the court gave Myriad a partial victory, ruling that while naturally-occurring DNA was not patentable, synthetically-created DNA could be patented. The court said that synthetically created DNA, known as cDNA, can be patented “because it is not naturally occurring,” Thomas said.

Patents are the legal protection that gives inventors the right to prevent others from making, using or selling a novel device, process or application.

Opponents of Myriad Genetics Inc.’s patents on the two genes – BRCA1 and BRCA2 -- linked to increased risk of breast and ovarian cancer argue that such protection inhibits some women from being tested for those genes because of the price of Myriad’s BRACAnalysis test, often more than $3,000. The price is partly a product of Myriad’s patent.

Women with a faulty gene have a three to seven times greater risk of developing breast cancer and also have a higher risk of ovarian cancer.

Dr. Olufunmilayo I. Olopade, director of the Cancer Risk Clinic at the University of Chicago Medicine, said she expects the ruling to mean lower prices for testing like this, because “now more labs will be able to compete to offer a test.”

And ideally, oncologists will be able to give these tests to more women who can now afford it, giving them a better sense of risk assessment for breast or ovarian cancer, said Olopade, who is also a professor of medicine and human genetics at U of C.

“If you just tell every woman go and get your mammogram when you get to 40 it doesn’t help the woman like Angelina Jolie who has lost her mother and her aunt to breast cancer that could have been prevented if they knew they had the genetic mutation,” she said.

Not only will the decision benefit patients, but also researchers, Melody Perpich, license genetic counselor at the Creticos Cancer Center of Advocate Illinois Masonic Medical Center, said.

“Researchers now have the ability to work with these two genes more closely outside of Myriad and not be worried about the threat of litigation,” Perpich said. “It’s going to allow more information to come out about the impact of these gene mutations.”

The decision will stop the practice of the U.S. Patent and Trademark granting patents to companies that isolate DNA but will allow patents for firms that build DNA from its basic chemicals

Companies have billions of dollars of investment and years of research on the line in this case. 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.

But not everyone is worried about that.

Most biotech companies have already moved on from trying to patent isolated DNA, instead looking at synthetic options and other ways of protecting their multimillion-dollar investments, said Matthew McFarlane of Robins, Kaplan, Miller & Ciresi L.L.P.

“On a day-in and day-out basis, I don’t see this changing that part of the industry,” McFarlane said. “Isolated DNA itself is not something that companies seek to protect anymore.”

Source: Associated Press

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