Enough with Patenting the Breast Cancer Gene

To date, about 20 percent of the human genome has been patented, including genes for Alzheimer’s, asthma, colon cancer, and perhaps most famously, breast cancer. This means pharmaceutical companies, scientists, and universities control what research can be done on those genes, and how much resulting therapies and diagnostic tests will cost. That is why, three years ago, a woman named Genae Girard couldn’t get a second opinion on a test showing she carried the breast cancer genes. Her doctor couldn’t help her, because Myriad Genetics holds the patent on the genes, and forbids other doctors or companies from testing for them.

This week, the ACLU, several breast cancer survivors [2], and professional groups representing more than 150,000 scientists, sued Myriad Genetics [3] over their breast cancer gene patents. Those genes, mutated forms of BRCA1 and BRCA2, are responsible for most cases of hereditary breast and ovarian cancer. They’re also very lucrative, because Myriad has created something of a monopoly. It charges $3,000 per test, which often isn’t covered by insurance. No one else can offer the test, and researchers can’t develop new or cheaper ones (or new therapies for that matter) unless they get permission from Myriad and pay a steep licensing fee. So women have no choice about who performs their tests, and they can’t seek those second opinions. That is no small thing. Tests aren’t 100 percent accurate, and results sometimes come back inconclusive. Women with the BRCA1 and BRCA2 mutations have a 40 to 85 percent chance of developing breast cancer, so a positive result helps them decide whether to have their breasts and ovaries removed to prevent future cancer. But with its lawsuit, the ACLU isn’t just fighting Myriad’s patent—it hopes to end the practice of gene patenting entirely on the grounds that it’s illegal, unconstitutional, and interfering with science.

“If genes are patented...there can be a serious and negative effect on diagnosis and treatment of disease,” the ACLU wrote in its complaint. [4] “The effect of the patents has been to stifle clinical practice and research on the genetic predispositions to breast and/or ovarian cancer. The public, and, in particular, women, have suffered unnecessarily as a result.”

In a survey done a few years ago [4], 53 percent of laboratories had stopped offering or developing a genetic test because of patent enforcement, and 67 percent felt patents interfered with medical research. It costs $25,000 for an academic institution to license the gene for researching a common blood disorder, hereditary haemochromatosis, and up to $250,000 to license the same gene for commercial testing. At that rate, it would cost anywhere from $46.4 million (for academic institutions) to $464 million (for commercial labs) to test a person for all currently-known genetic diseases.

Though patent law says “products of nature” can’t be patented [4], genes have long qualified because they’re “isolated from their natural state and purified.” The first ruling allowing for the patenting of a life form came in 1980, in the landmark case of Diamond v. Chakrabarty [5]. Ananda Mohan Chakrabarty, a scientist working for General Electric, had created a bacterium genetically engineered to consume oil with hopes that it could help clean oil spills. When the patent office denied his application citing the law against patenting anything naturally occurring, Chakrabarty sued, and won. His lawyers argued that the bacterium could be patented because it had been altered using human ingenuity.

Since Chakrabarty, there’s been a long history of legal battles [6] over the ownership of human cells and tissues taken from patients during biopsies (including one case in which a man’s cells were patented and licensed for millions of dollars without his knowledge). The first lawsuit over a gene patent involved a couple [7] who’d donated tissue samples and money to help a researcher find the gene for their children's rare disorder. The researcher patented that gene without telling them, and they sued in 2003 for fraudulent concealment of the patent, lack of informed consent and unjust enrichment. The case settled out of court for an undisclosed amount. But across the board, rulings in similar cases have upheld claims of ownership by scientists, arguing that to do otherwise would eliminate incentive to do research, and inhibit the progress of science.

Here’s a case that may prove the toughest legal precedent for the ACLU group: In 1986, a company called Metabolite patented a medical fact. If you have increased levels of the amino acid homocysteine in your blood, it means you have a vitamin B deficiency. Because of Metabolite’s patent, it’s illegal to test for, write, publish, or (in theory) even think about that fact without a license from the company (which isn’t cheap). Metabolite sued LabCorp, a company that tested for the deficiency without licensing it, and the court ordered LabCorp to pay $9.5 million for patent infringement and fees. LapCorp appealed all the way to the Supreme Court, and everyone who cared about such things thought, oooooh, this could be the big case that changes the future of biological patents. A ruling against Metabolite would have called into question thousands of other patents on medical tests and genes. So scientists, patient advocacy groups, lawyers, ethicists and pharmaceutical companies fought for and against Metabolite with a flood of briefs [8]. But in 2006, the Supreme Court refused to hear the case. [9]

Now the Myriad suit has come along with a strategy that’s bigger than any before it. The ACLU’s suit is the first to claim that gene patenting violates the no-products-of-nature rule. It’s also the first to evoke the First Amendment and challenge biological patents for inhibiting freedom of thought. Through its patent, Myriad owns the fact that mutations in the normal BRCA1 and BRCA2 genes make them cancerous. So it’s technically a patent violation to make that connection, even in your head. “Freedom of speech means nothing if you don’t have freedom of thought,” an ACLU spokesman said.

It’s a new and interesting approach. Still, the ACLU’s suit faces big legal hurdles. Nearly all previous rulings in this country point to a loss. (And Myriad has already successfully appealed a ruling revoking its patents in Europe.) But there is one case that could set a precedent in ACLU’s favor. Nearly a decade ago, surgical procedures were patented similarly to genes—if you went to the hospital needing, say, a certain kind of appendicitis surgery and your doctor hadn't licensed the procedure, he couldn't operate without risking a lawsuit. After one case successfully challenged that practice [10], the House of Representatives decided that doctors weren't required to license surgical patents for treating patients.

There is one more thing the ACLU suit may have going for it. It’s the first case of its kind with plaintiffs that include a long list of scientists from top institutions. They claim that gene patenting has inhibited their research. Their very presence in the suit challenges the standard argument that ruling against biological patents would interfere with scientific progress.

Photo from Photodisc.