Human Gene Patents at the Supreme Court, and Slate Readers Tell Their Stories

Oral argument from the court.
April 15 2013 6:31 PM

Taking the Breast Cancer Test

Stories from Slate readers about human gene patenting, the Supreme Court topic of the day.

Protesters hold banners demanding a ban over human gene patents during a protest outside the Supreme Court in Washington on April 15, 2013.
Protesters hold banners demanding a ban over human gene patents during a protest outside the Supreme Court in Washington on April 15, 2013.

Photo by Mladen Antonov/AFP/Getty Images

As the Supreme Court hashed out the legality of human gene patenting this morning, Justices Antonin Scalia and Sonia Sotomayor got to the gist of the dispute. “Why would a company undertake massive investment if it cannot patent?” Scalia asked. That’s why governments give out patents: to reward and encourage the investment required for new inventions.

Emily Bazelon Emily Bazelon

Emily Bazelon is a staff writer at the New York Times Magazine and the author of Sticks and Stones

Sotomayor, however, pointed to the specifics of today’s case. The company in question, Myriad Genetics, secured its patents by locating and isolating the genes BRCA1and 2, which can mutate in ways that carry a high risk of breast and ovarian cancer. In doing so, said Sotomayor, the company had not actually invented anything new. The gene is “just nature sitting there,” she said. Chief Justice John Roberts said the company’s work on the gene was akin to merely “snipping” a string of molecules out of the body.

With its patents, Myriad controls all the testing for the BRCA genes. No one is allowed to develop an alternative test. The company’s monopoly has earned it the enmity of some patient groups—and some of the Slate readers I heard from when I asked for personal stories about gene patenting. One concern about Myriad’s monopoly is cost. Helen, who was diagnosed with breast cancer last February in California, says her genetic counselor suggested she should be tested, “to help with my decision making and to inform my sister, who if I tested positive would need to be watched carefully.” She says, “I spoke to my insurance company (Blue Cross/ Anthem) and they stated that the test would not be covered and the cost would be between $3,000 and $4,000.” Helen says she couldn’t afford that. “It is a horrifying feeling to be told you have a deadly disease and yet, a helpful and informative test will not be covered by your insurance company,” she writes. “I had to make a major health decision solely on financial reasons. Not a good feeling.”

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I emailed Ron Rogers of Myriad for a response, and he said that the BRCA tests are reimbursed by more than 95 percent of insurance plans, and that “patients on average pay less than $100 out of pocket.” He also said that Myriad has offered more than 5,000 free tests to low-income women without insurance in the last three years. Duke policy researcher Robert Cook-Deegan told me last week that Myriad’s offer of free testing applies in just 0.4 percent of cases. Rogers said he didn’t know what the percentage was.

Making it into the group of patients whose insurance covers Myriad’s tests can be a project. Another reader, Steven, wrote to me about his efforts to get the test covered for his wife, who died of breast cancer related to the BRCA 1 gene in 2009. When she was diagnosed, her doctor recommended testing. As in Helen’s case, this was for the benefit of family members as well as for her. To get the insurer to pay the $3,500 bill, Steven ended up on a telephone odyssey, getting passed from insurance reps to testing reps and back again. “From a patient/insured perspective, that process is a black box,” he wrote. “The insurance companies will not let you speak directly and the claims people say that they cannot contact them. The claims people can only regurgitate what the payment people write.” The calls took six weeks, “a pleasant diversion while one’s wife is sick from chemo,” Steven dryly remarked. He is a lawyer, and he wound up threatening to sue—and wondering how a patient without a law degree in the family would have fared. Here’s his conclusion: “On the patient level, Myriad has monopoly pricing, and they refuse to license it to any other lab. Besides the outrageous price, it is an insurance nightmare for patients.”

Mary, who was diagnosed with breast cancer last year at age 32, paid only $300 for her BRCA testing. Her insurance company picked up the rest without a problem. “The thing that was toughest for me about undergoing the test was how long it takes to get results,” she wrote. With the version of the test she took, she waited a month. “I needed to know my BRCA status in order to make a decision between bilateral mastectomy or much more minor breast-conserving surgery. And it was a week from my initial cancer diagnosis before I could get an appointment to see a genetic counselor for the test. Those five weeks were some of the longest, most stressful weeks of my life. I don't know if there's a procedural reason why it takes Myriad so long to produce test results, but as long as they're the only lab that performs the test, there's no incentive to get faster.” Rogers, of Myriad, said that patients receive their testing results in about a week. Apparently not all of them.

Mary concludes, “I have mixed feelings about the patent. On the one hand, I want companies to have financial incentives to develop these kinds of tests. On the other hand, I want as many scientists as possible to be able to participate in this important research.”

Myriad says that plenty of research has been done alongside the patent, and points out that it has spent $500 million developing the BRCA tests. According to the New York Times, the company made $405 million on testing just in its last fiscal year, “accounting for more than 80 percent of its revenue.” The patents run for 20 years, and in fact have almost run their course—they expire in the next two years.

That makes the case seem slow-moving. And as the NYT article discusses, some scientists say human gene patenting is generally waning in importance. As several Slate readers pointed out to me over email, it will soon be cheaper to sequence someone’s entire genome than to go for BRCA testing. One cancer researcher who emailed me, though, said the patents are still a stumbling block, because researchers are afraid of treading on patents when they work on therapeutic interventions. Maybe the court will block sweeping patents of human genes like Myriad’s with a ruling that is clear but narrow, so it doesn’t unsettle the biotechnology field all that much. As another reader suggested, the big question then will be this: Which kinds of inventions that are based on human genes—as opposed to the genes themselves—can you patent? That seems like the harder line to draw.

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