Earlier this week, Angelina Jolie wrote a heartfelt op-ed in The New York Times about her decision to undergo a preventive double mastectomy. She made the decision after doing a genetic test that showed she carries a gene that greatly increases her risk of developing aggressive breast and ovarian cancers.
What many people don't realize is that Angelina Jolie's cancer gene, BRCA1, is patented by a company called Myriad Genetics. The gene, and the company, are at the center of a pending U.S. Supreme Court ruling.
Patenting Human Genes: Association for Molecular Pathology v. Myriad Genetics
Myriad holds patents on the BRCA1 and BRCA2 genes. These patents allow the company to control research on the genes -- and to control the price of testing for these genes.
The ACLU and the Public Patent Foundation (PUBPAT) filed a lawsuit against Myriad, charging that patents on two human genes associated with breast and ovarian cancer, BRCA1 and BRCA2, are unconstitutional.
The U.S. Supreme Court heard arguments on the patentability of human genes last month. The highly anticipated decision will be out this summer.
Generally, you can't patent a "product of nature." To patent something, you need a process that involves "human ingenuity."
The ACLU thinks the BRCA1 and BRCA2 genes aren't patentable because they are made by nature, and were not created by Myriad.
Myriad, however, thinks their ability to isolate the genes outside of the human body is a form of "human ingenuity."
The Public Policy Debate
The goal of patent law is to encourage discovery and invention by allowing patent holders to keep exclusive rights over their invention.
At the heart of the human gene issue is a "finder's keepers" patent policy question: If you invested a boatload of time and money in finding and isolating something, does that make it yours?
The ACLU doesn't think so. They think Myriad's exclusive right over BRCA1 and BRCA2 testing gets in the way of innovation and genetic testing.
More specifically, they think the patents are pricing out women from diagnostic genetic tests. Currently, Myriad charges $3,000 to $4,000 for the test.
Especially repugnant to the goal of patent law, the ACLU thinks the gene patents are harming scientific discovery. This is because Myriad isn't letting many geneticists, pathologists, or other researchers study BRCA1 and BRCA2 for a cure or for alternative testing methods.
Regardless of which way the court rules, let's hope women come out as the real winners with affordable access.
On a side note, come January 2014, BRCA1 and BRCA2 tests have mandated coverage under the Affordable Care Act (aka Obamacare), regardless of grandfathered insurance plans or pre-existing conditions.
- Federal Circuit Still Says Genes Can Be Patented (FindLaw's Federal Circuit Blog)
- Breakdown of Oral Arguments in Myriad Gene Patent Case (FindLaw's Federal Circuit Blog)
- A Patent on Mother Nature? Court Invalidates Gene Patents (FindLaw's Decided)
- Brad Pitt, Angelina Jolie Engaged: 'Kids Are Very Happy' (FindLaw's Celebrity Justice)