Patents on two human genes linked to breast and ovarian cancers are being challenged in court by the American Civil Liberties Union, which argues that patenting pure genes is unconstitutional and hinders research for a cancer cure.
"Knowledge about our own bodies and the ability to make decisions about our health care are some of our most personal and fundamental rights," said ACLU Executive Director Anthony D. Romero. "The government should not be granting private entities control over something as personal and basic to who we are as our genes."
Myriad and the research foundation hold patents on the pair of genes -- known as BRCA1 and BRCA2 -- that are responsible for many cases of hereditary breast and ovarian cancers.
The ACLU contends that patenting the genes limits research and the free flow of information, and as a result violates the First Amendment. The lawsuit also challenges genetic patenting in general, noting that about 20 percent of all human genes are patented -- including genes associated with Alzheimer's disease, muscular dystrophy and asthma.
"It is absolutely our intent that upon victory this will rend invalid patents on many other genes," said Dan Ravicher, executive director of the Public Patent Foundation and a patent law professor at Yeshiva University's Benjamin N. Cardozo School of Law. "We just had to pick one case as our case."
Myriad's patents give it exclusive right to perform diagnostic tests on the genes -- forcing other researchers to request permission from the company before they can take a look at BRCA1 and BRCA2, the ACLU said. The patents also give the company the rights to future mutations on the BRCA2 gene and the power to exclude others from providing genetic testing.
The company also charged $3,000 a test, possibly keeping some women from seeking preventive genetic testing, the ACLU says.
At least one expert said the ACLU should focus more on getting the patents reversed than arguing whether they are constitutional.
"I doubt they're going to get far with argument that the patent is unconstitutional," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.
"A better argument would be that they were wrong when they granted the patent," he added referring to the patent office.
Caplan said patents are privileges, not "carved in stone." He noted that the defendants may have identified the genes, but didn't actually work on them. So, the government could reverse the patents on the genes.
"It's like trying to patent the moon," he said. "You didn't do anything to create it, just discovered something that already existed. You can't patent things that are publicly available, that anyone can find. You have to create something, make something, do something with the thing."