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Patients, industry both winners in Supreme Court DNA ruling

NBC's Pete Williams shares details on the Supreme Court's unanimous decision that says human genes cannot be patented, but Synthetic DNA is patentable.

Patients, researchers and industry all claimed victory Thursday when the Supreme Court ruled that human DNA cannot be patented, opening the door for dozens of scientists and others trying to market newer and better tests to tell people about their risks for a range of illnesses from cancer to heart disease.  

But the unanimous ruling left in place protections for the biotechnology industry and methods used to make drugs based on engineered DNA.

The ruling clearly invalidated Myriad Genetics' most controversial patents on tests for mutations in the BRCA1 and BRCA2 genes that raise the risk of breast, ovarian and other cancers. But it did not go so far as to remove patents on artificial DNA, which is not widely used in genetic testing, but is used in other biotechnology applications.

“We just are so glad that women and our genes are not being held hostage by a private corporation any more,” said Lisbeth Ceriani, a Massachusetts breast cancer survivor who is one of the plaintiffs in the suit.

The researchers whose lawsuit prompted the decision were also celebrating. They say it will make genetic tests cheaper and far more widely available in the future.

“I think it changes everything,” Dr. Harry Ostrer, a genetics expert at Albert Einstein College of Medicine in New York and one of the main plaintiffs in the case, told NBC News.

“I think this is a green light for us to go ahead with our testing.”

Patients will benefit, said Dr. Ossama Tawfik an expert in breast cancer pathology at the University of Kansas Medical Center and a member of the American Society for Clinical Pathology. “I know the costs of these tests will be considerably lower without patent protection, allowing more women at risk to be tested,” Tawfik said in a statement.

The American Civil Liberties Union, which backed Ostrer in the suit, said many more patents on genetic tests may also fall. “Obviously, we are thrilled with the decision, “ said the ACLU’s Sandra Park.

“This ruling is a victory,” Park told reporters in a conference call.

Ostrer, the ACLU and others sued Myriad Genetics over the company’s strict enforcement of its patents on BRCA1 and BRCA2.  Ostrer said the company’s legal threats have kept researchers like himself from making and distributing DNA tests that can test multiple genes at a time to tell someone their cancer risk.

“You won’t need to get prior approval from Myriad Genetics to have the BRCA1 and 2 results reported,” Ostrer said.

The Court ruled that natural DNA cannot be patented, and that no matter how clever Myriad was in finding the particular gene mutations it did, or in removing and copying that DNA to make a test, it cannot claim a patent on the DNA itself.

The unanimous ruling makes a point of saying Myriad’s patent was on a product, not a method.  “Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent,” reads the ruling, written by Justice Clarence Thomas. But it used well-known and reported methods.

Ostrer says what the ruling does is protect other aspects of the biotech industry -- those that use artificial and engineered DNA to make drugs, for instance. “The biotech industry had expressed a lot of concern that they would lose out,” Ostrer said.

Myriad claimed victory, also, saying the court’s ruling on artificial DNA upheld the company’s claims. “Following today's decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test,” the company said in a statement. Myriad also disputed that the test was too expensive.

"As a result of the Affordable Care Act, the vast majority of at-risk patients can receive BRCA analysis testing with no out-of-pocket costs — meaning no co-pays or deductibles. Additionally, more than 35,000 at-risk patients in need have participated in Myriad's patient assistance programs that provide free tests or other financial assistance," the company said.

The 2010 health care law says health insurance companies must pay for cancer screening without charging patients any co-pay.

The researchers say the ruling does leave others free to develop their own tests for breast cancer risk, however. Since the Myriad tests came out, researchers have found dozens of other genes that influence breast cancer risk, as well as the risk for other cancers.

Myriad's earliest patents were set to run out over the next year or so and the company has been preparing for this. Wall Street investors have also taken this into account, and Myriad's share rose after the decision was handed down.

Kevin Noonan, a partner at Chicago law firm McDonnell Boehnen Hulbert & Berghoff LLP, who specializes in the biotechnology industry, says many gene tests don’t look at the entire gene anyway, any more. Newer tests can look at small bits of the the gene, just looking for the important mutations that affect cancer or other disease risk.

“If you don’t get the whole gene isolated in a test tube, you don’t infringe the claim,” Noonan said.

Other companies have patented human genes, and those patents could be challenged one by one. “Perhaps a quarter or even more of human genes have been patented,” Ostrer said.

But Roger Klein, of the Association for Molecular Pathology, another one of the plaintiffs in the suit, said it’s more likely that researchers will just ignore the patents, knowing the companies won’t be able to enforce them.

“This testing is very, very important. People make extremely important, life-changing  decisions based on the testing,” Klein said.

Among them was actress Angelina Jolie, who made headlines in May when she said she’d had both breasts removed and would have her ovaries removed soon because of her high genetic risk of both cancers.

“Having gone through the devastating experience of making life-altering decisions based on the results of one test, I believe that the Supreme Court’s decision is a victory for everyone who believes that a company cannot patent parts of our body,” said U.S. Rep. Debbie Wasserman Schultz, a Florida Democrat who was diagnosed with breast cancer in 2007.

“Despite the fact that we’re all born with these genes, a private company had patented them. These patents had broad practical ramifications, preventing competition in testing for the gene mutations, second opinion testing, and restricting access to data on testing results for other researchers.”


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