A unanimous Supreme Court decision yesterday that genes, being a product of nature, are not patentable when isolated from the body is mixed news for Myriad Genetics, which hoped to continue its monopoly of the market for testing whether women have a genetic tendency to develop breast and ovarian cancer. But it should be a boon for biotech research -- and patients -- across the board, most observers seem to be saying.
“The decision should have ‘an immediate impact’ on public health, allowing rival companies and laboratories to enter the market on genetic testing,” Harry Ostrer, a physician at Yeshiva University's Albert Einstein College of Medicine in the Bronx, N.Y., tells the Wall Street Journal’s Jess Bravin and Brent Kendall. “‘Costs should come down considerably,’ and greater competition should ‘improve the quality of genetic testing overall,’” he says.
Ostrer is among the researchers, medical groups and patients that were represented by the American Civil Liberties Union and the Public Patent Foundation, which challenged Myriad’s right to completely block competition to its BRACAnalysis test that screens for hereditary breast and ovarian cancer.
About 5 to 10% of breast cancers are thought to be due to bad BRCA genes; mutations in one of them can give a woman up to an 87% risk of developing breast cancer and up to a 54% risk for ovarian cancer, the Associated Press’ Marilynn Marchione reports. The tests “cost $3,000 to $4,000, and insurers only cover them for women thought to be at high risk,” she writes.
“VICTORY! Supreme Court Decides: Our Genes Belong to Us, Not Companies,” reads the headline on a blog post by Sandra S. Park, a staff attorney with the ACLU Women's Rights Project. “Seems like common sense, right? But over the last 30 years, the U.S. Patent Office has issued patents on thousands of human genes, including genes associated with colon cancer, Alzheimer's disease, muscular dystrophy, and many other devastating diseases,” she writes.
“The court gave Myriad a partial victory,” points out the AP’s Jesse J. Holland, “ruling that while naturally occurring DNA was not patentable, synthetically created DNA [known as cDNA] could be patented ‘because it is not naturally occurring.’”
“We believe the court appropriately upheld our claims on cDNA and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward,” says Myriad's president and CEO Peter D. Meldrum in a statement that points out that the company has “500 valid and enforceable claims in 24 different patents conferring strong patent protection” for the test. “More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples' lives and lowering overall healthcare costs.”
The market will no doubt help see to the latter.
“Within hours of the decision, the University of Washington and Ambry Genetics, a closely held company in Aliso Viejo, Calif., said they would immediately offer expanded testing that included the BRCA1 and BRCA2 genes, which Myriad has had under patent since the late 1990s,” Bloomberg’s Robert Langreth and Shannon Pettypiece report.
Ambry’s website declares: “Your Genes Have Been Freed.” In addition, Quest Diagnostics will begin to sell testing for the genes later this year, according to Langreth and Pettypiece.
And the Salt Lake Tribune’s Tom Harvey reports that “just after the decision was released, DNATraits, a division of Houston-based Gene By Gene Ltd., announced it would offer testing for the BRCA1 and BRCA2 genes in the United States for $995.”
Myriad’s stock initially rose to an historic high after the decision was announced but closed down 5.6% after competition emerged from the shadows, Barron’s Johanna Bennett reports.
“In a way, the ruling was a silent tribute to screen actress Angelina Jolie, who recently gained huge notoriety not for her acting but for voluntarily having her breasts surgically removed after discovering that she had the threatening mutations in her body,” writes Lyle Denniston on the SCOTUSblog. “She, of course, was able to pay the high cost of that test; now, women of less means will be able to afford it, and that was a key motivation for challenging Myriad’s patent right.”
But the impact of the decision will be much broader.
“Before the Supreme Court ruled Thursday that companies cannot own exclusive rights to human genes, leukemia patients at NewYork-Presbyterian Hospital often waited days for the blood test results that might tell them how long they could expect to live” Jen Wieczner reports on MarketWatch. “Now, doctors at that hospital say they are free to perform the genetic test in-house, which would make it faster and cheaper and could potentially extend the lives of patients.”
“We celebrate the Court's ruling as a victory for civil liberties, scientific freedom, patients, and the future of personalized medicine,” the ACLU’s Park blogs -- or, as someone else once wrote, for “life, liberty and the pursuit of happiness.”