Jewish Ethics and Biotech Innovation Clash in Supreme Court's BRCA Gene Case

Should Company Be Permitted to Patent 'Breast Cancer' Gene?

‘My DNA’: Lisa Schlager addresses protesters outside the Supreme Court. Many Jewish women may owe their lives to innovative new tests that uncovered their risk of breast cancer. But they strongly feel companies should not be allowed to patent genes.
courtesy of lisa schlager
‘My DNA’: Lisa Schlager addresses protesters outside the Supreme Court. Many Jewish women may owe their lives to innovative new tests that uncovered their risk of breast cancer. But they strongly feel companies should not be allowed to patent genes.

By Anne Cohen

Published April 18, 2013, issue of April 26, 2013.
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Lisa Schlager waited with hundreds of other women outside the Supreme Court in Washington on April 15, hoping to hear arguments over a private company’s effort to patent a human gene that is linked to breast cancer, especially in Ashkenazi women.

Schlager, 46, has a huge stake in the controversial case, as do thousands of Jewish women.

After testing positive for the BRCA1 gene at the center of the case, Schlager underwent ovarian and breast surgery to avoid an almost nine-in-ten chance of developing cancer. Like some so-called “pre-vivors,” Schlager opposes Myriad Genetics Inc.’s patent on the gene, which is under challenge in the Supreme Court case.

“God created my DNA,” said Schlager, an official with FORCE: Facing Our Risk of Cancer Empowered, an organization that seeks to promote awareness of hereditary cancers. “No company should have the right to patent what occurs naturally in my body.”

Not all Jews agree. Some point out that if pharmaceutical companies don’t have the financial incentive provided by the patent system, they simply won’t perform the kind of lifesaving research that Myriad did in isolating the mutated versions of BRCA1 and BRCA2 genes, which occur much more frequently in Ashkenazi Jewish women.

“If you want to promote the technology, what’s the best way to do that?” asked Rebecca Eisenberg, the Robert and Barbara Luciano Professor of Law at the University of Michigan. “I think this is an area where patents are important.”

For the Supreme Court, the case hinges mostly on the narrow question of whether the genes are naturally occurring and therefore not subject to patents, or if they are the product of human ingenuity, in which case they can be patented.

The American Civil Liberties Union and the Public Patent Foundation filed the lawsuit against Myriad in 2009, challenging the seven patents held by the company on the two genes. A federal judge ruled that the patents were invalid, a decision that was later overruled by an appeals court.

Justices cited more mundane products like baseball bats to argue into which category the gene mutations should fall. Both Justice Samuel Alito and Chief Justice John Roberts seized upon the suggestion made by Myriad’s attorney, Gregory Castanias, that a baseball bat doesn’t exist until it’s isolated from the tree.

In the case of a baseball bat, Roberts pointed out that “you have to invent it” and not just “cut it off” from the tree, a remark that seemed directed at Myriad’s cutting away the gene from strands of human DNA.

The top court, as is customary, did not indicate which way it would rule, and observers predicted that the justices might seek a middle ground that does not definitively allow or ban patents on genes.

For Jewish ethicists, of course, there are quite different issues at stake.

Rabbi David Teutsch, director of the Levin-Lieber Program in Jewish Ethics at the Reconstructionist Rabbinical College, said Jewish values dictate a balancing act between opportunity for individuals and healing for the community as a whole.

Teutsch said the Myriad case starkly poses the question, “How do we provide enough profits to researchers while guaranteeing open access to the results of that research?”

The two goals should be weighed against each other. But ultimately, Teutsch asserted, access to healing should trump private profit.

“If a very narrow interpretation of patented property rights is applied here, we’re not going to fulfill the value of maximizing healing,” he said. “The desire to maximize profits should not be allowed to trump maximizing healing.”

Arthur Caplan, head of the Division of Bioethics at New York University’s Langone Medical Center, asserts that the patent on the BRCA gene has done more harm than good when it comes to research.

“People have found more mutations, other genes have been found that influence cancer risk, but much more slowly than would have happened had there not been this patent,” Caplan explained.

He said Myriad may have a stronger case in its claim for a patent on the test for the BRCA gene than for the gene itself.

Caplan compared the genetics company to Galileo, who invented the telescope that he then used to see the moon and stars. The Renaissance scientist would have every right to a patent on the telescope, which he created, Caplan said, but not the celestial objects, which were there all the time.

William A. Haseltine, who is a former CEO of Human Genome Sciences and was one of the first people to file for a patent on a gene, agreed with Caplan. He said patents should be granted only in cases where companies have invented a specific test or method, not simply discovered a gene like Myriad did.

“The variant itself is not an invention, but a discovery,” he said.

Haseltine asserted that the Myriad case is “very different from other uses of genes” in which patents have been granted.

“For example, if you use a gene for gene therapy, you’ve taken it out of its natural context and shown that it can be used for health purposes,” he said. “It depends on how you’re using the invention.”

Eisenberg countered that the top court should consider the impact of the ruling on future research. She pointed out that the purpose of the patent system is to incentivize innovation, which can ironically restrict the ability of others to duplicate that innovation.

“It is surely the case that gene patents promote investments in bioresearch, and it is also the case that they have provided an obstacle to research and certain kinds of testing,” said Eisenberg, who has lectured extensively on the role of intellectual property in biopharmaceutical research.

Amid the legal and ethical arguments, Jewish women are left in the middle.

On the one hand, many may owe their lives to the research that Myriad performed to isolate the BRCA genes. One in 40 Ashkenazi women carries this gene mutation, a much higher percentage than in the general population.

“I feel blessed that I was given this knowledge and ability to be proactive with my health,” Schlager said.

But they also may not accept that a private company should control access to the genes and the lifesaving tests to discover them.

“In some ways I do understand private industry’s desire to protect their investments,” said Schlager, whose organization contributed an amicus brief to the Supreme Court arguing against Myriad. “But at the same time, I have to say that DNA are naturally occurring in nature. It’s a natural part of my body. Myriad didn’t create my DNA.”

Myriad has also spurred acrimony with what some see as its failure to cooperate with the scientific community about BRCA. Myriad has sole access to a database of BRCA sequences that documents the minute variations that can make a change in the DNA of a BRCA gene dangerous. In 2004, Myriad stopped sharing that data with Breast Cancer Information Core, a breast cancer database run by the National Institutes of Health.

Chani Wiesman, a genetic counselor with Yeshiva University’s Program for Jewish Genetic Health and the Albert Einstein College of Medicine, said patent holders do not always choose to restrict who can use the patent. In the case of BRCA, Myriad limits how others perform the test for the gene and charges hefty royalties to those who do.

Wiesman says simple economics dictates that without the patents, the price of the tests would come down.

“If these genes were no longer under a patent, then more places would be able to do testing and it would be easier for patients to access this testing,” she said.

The issue of cost is no small matter. According to Sue Friedman, Executive Director of FORCE and a breast cancer survivor, the full panel of tests to detect the various and potentially dangerous mutations of the BRCA1 and BRCA2 genes can cost up to $3,400. The specific test that targets the mutations commonly found in Ashkenazi Jews is cheaper, running at roughly $500. Neither test is necessarily covered by insurance, leaving many women unaware of their status.

“As a hereditary breast cancer survivor, I am offended by that,” Friedman said.

Joanna Rudnick is a filmmaker whose 2008 documentary “In the Family” documented her efforts to grapple with difficult decisions after testing positive for the BRCA gene at age 27. She falls within the small group of Ashkenazi Jews whose BRCA1 mutation couldn’t have been detected as part of the traditional and cheaper test for common mutations. She was lucky enough to gain access to the full test that also looked for less common mutations. Otherwise she wouldn’t have been able to know she was at risk and to make the necessary decisions about her health.

She called Myriad’s patent on the BRCA gene a threat to scientific progress on a health threat looming over the entire Jewish community.

“There has been a chilling effect on many generations of Jewish families,” she said.

Outside the Supreme Court, Schlager was joined by her 12-year-old daughter, Rachel. The girl is working on breast cancer awareness as a mitzvah project for her upcoming bat mitzvah, emphasizing her own family history as well as the importance of the issue for the larger Jewish community.

Though Rachel is aware of her potential risk, testing for the BRCA gene isn’t recommended before a girl turns 18. And in any case, Schlager said she’s reluctant to get her daughter tested before she’s out of college.

“It’s a heavy piece of information for a young person,” she said. “She knows it runs in our family, and she knows that that’s why I’m involved, but she’s still developing, and I don’t want her to be fearful of her body. I want her to have some carefree years.”

Contact Anne Cohen at cohen@forward.com


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