When the Supreme Court decided on June 13 that unaltered human DNA cannot be patented, it was more than a victory for cancer patients and corporate rivals in the field of genetics; it was a reason to celebrate for Dr. Wayne Grody, a professor at UCLA School of Medicine who assisted in the case that the American Civil Liberties Union (ACLU) brought against Myriad Genetics.
“I’ve been involved with this case for about five years, since the beginning, and I’ve been giving lectures on it,” said Grody, 61, director of the Diagnostic Molecular Pathology Laboratory within the UCLA Medical Center.
“Actually, I was about to start another lecture on this [in Portland], when I got to the podium and about 10 people held up their iPhones to show me that the decision had been reached. I was blindsided and had to improvise the rest of the evening. Maybe the timing wasn’t great, but the news absolutely was.”
The court’s unanimous decision overturned U.S. Patent and Trademark Office policy and invalidated current patents on genes, thereby ending the monopoly of certain genetic tests, including those for types of breast cancer and ovarian cancer that affect a disproportionately large percentage of Ashkenazic women.
Until this decision, roughly 20 percent of human genes were patented, according to the U.S. Patent and Trademark Office. This meant that the holder of the patent could effectively prevent anyone from studying, testing or looking at the gene, which caused great concern among many in the medical community, according to Grody.
“We never felt comfortable with this idea and tried for many years to get around it — receiving numerous cease-and-desist letters from companies unhappy that we were doing medical genetic tests on genes they had patented,” he said.
When a company patents a gene and has an exclusive right to a test related to it, not only can it set the cost of the test as high as it wishes, but it makes it impossible for someone to get a second opinion. Patients must rely on a single test and hope it is done correctly.
“Many people don’t even know you could patent genes and were shocked when they found out it was possible,” Grody said.
This particular Supreme Court case was filed against Myriad Genetics, a company based in Utah. The genes and tests in question were mutation-location tests on the BRCA1 and BRCA2 genes, which act as significant markers for the likelihood of developing certain types of aggressive breast cancer and ovarian cancer.
Because the Ashkenazic gene pool is less varied than that of the general population, due to the historical pattern of marrying within the faith, three mutations within the BRCA1 and BRCA2 genes are nearly five times more likely to appear in Ashkenazic women than in the general population, according to the National Cancer Institute.
Grody, an Ashkenazic Jew himself who was an expert scientific witness in the Supreme Court case and helped craft various aspects of the ACLU’s legal argument, said Myriad Genetics wasn’t targeted because of any problems within its testing record.
“They’re a first-rate lab. We chose Myriad because breast cancer is such a highly visible disease,” Grody said. “However, the price for the full mutation screening is between $3,500 and $4,000 without insurance. Even if you only have to pay 20 percent, it’s still too much for some people. And until recently, they had no other choice but to test through Myriad.”
Often, the tests are used to decide whether a woman will take prophylactic measures to avoid getting cancer — drastic medical procedures such as a double mastectomy (like the one actress Angelina Jolie underwent recently) and removal of one’s ovaries. Both procedures are irreversible, so many women would like to be able to pursue a second opinion.
Now they can.
Although it will take many years for companies to build the kind of extensive genetic database that Myriad Genetics has, it’s the beginning of a new era for the genetic testing market — one that’s been decades in the making.
“By the end of the trial, which I had the honor of being able to attend, I felt like the justices really felt uncomfortable with the idea of patenting genes,” Grody said. “And although I was relatively confident that they’d rule in our favor, it was a relief to know that, yes, they did truly understand.”
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