Patrick Waller: Lawyer with the biotechnology group at Wolf Greenfield.
If you’ve been following the news this week, you might have heard that Angelina Jolie elected to have a double mastectomy. Jolie made her decision after a test revealed she had a mutation of the BRAC1 gene, which heightens her risk for breast cancer.
Jolie explained her choice in a New York Times op-ed, saying, “I wanted to write this to tell other women that the decision to have a mastectomy was not easy. But it is one I am very happy that I made. My chances of developing breast cancer have dropped from 87 percent to under 5 percent.”
But while you might have read Jolie's compelling argument, you may not know that the test that revealed Jolie’s mutation is patented by a private company, Myriad Genetics. Myriad first filed the patent in the 1990s, and since then it has been the only company that can conduct tests determining whether a patient has a mutation in their BRAC1 or BRAC2 genes that makes them more susceptible to breast and ovarian cancers — it even has a patent on the genes themselves.
Genes for Sale
So should companies be able to own pieces of our genetic code? The Supreme Court is currently debating the constitutionality of Myriad’s patent. But Dr. Aubrey Milunsky, founder of the Center for Human Genetics, says no.
“There’s been a rapid escalation of the patenting of genes, and it’s really bothersome, because ultimately, under the patent law, the key word is ‘invention,’” Milunsky explains. “And of course no one … would believe that their genes had been invented.”
Myriad defends the patent by arguing that it invested heavily in developing the diagnostic test. As a result, the company feels it has a right to recoup its investment by having exclusive rights to the test. But this exclusivity can be problematic for the patient.
“You cannot get a second opinion. You can’t check the quality. You can’t query the findings,” Milunsky says. “That’s a real worry — nobody can check it. No one can do research. The costs are frequently double [that of a comparable medical test].”
The high price of the Myriad test — around $3,400 dollars — is especially concerning to Milunsky, as it places potentially life-saving information beyond the reach of many low-income patients.
“[A patient with a BRAC1 or 2 mutation] might opt to have both their breasts removed and their ovaries removed as an elective option,” he explains. “People without the economic ability were deprived of this opportunity of basically saving their lives.”
However, in correspondence with Innovation Hub, Myriad Genetics noted that "BRACAnalysis is covered by nearly all private health insurance insurers, Medicare, and 70% of the individuals on Medicaid, so the vast majority of patients have insurance reimbursement... Additionally, Myriad will test for free any patient who lacks insurance and can’t afford the test for income levels up to two times the poverty level or $47,100 for a family of four. We provided free tests to more than 5,000 qualified patients through our assistance program in just the past several years."
Protecting the Patent
But despite these concerns, Myriad holds this patent worldwide. According to Patrick Waller, a lawyer at Wolf Greenfield, they have been aggressive in protecting their ownership.
“They have made people aware that they have patent rights, and in the process, essentially put people on notice,” Waller says. “They’ve clamped down a lot of the potential market for second opinions that they could have allowed, which is really a business decision on their part.”
The Supreme Court has not yet issued a decision in the Myriad Genetics case. But both Waller and Milunsky predict that the patent will be overturned — at least in part.
“I think that the Supreme Court is unlikely to leave the status quo, to leave it the way it is,” Waller says. “However…it’s unlikely to settle it once and for all. It may mean that we’re faced with further legal challenges.”
For patients and health care providers, resolution may be a long wait.