After battling breast cancer in 2008, Lisbeth Ceriani took on a whole new challenge. She joined a lawsuit against a biotechnology company she believed was blocking her ability to make informed decisions about her ongoing treatment.
Myriad Genetics was awarded patents in the 1990s on two isolated genes called BRCA 1 and BRCA2 as well as diagnostic methods. Women with mutations in those genes are at a much higher risk for breast and ovarian cancer. Because of the patent, Myriad is the only place to go for testing, and it sets the $3,340 price tag.
Ceriani's problem was that even though her doctors recommended she get the test to make an informed decision about future risks (ovarian in particular) she could not afford it. She was stunned to learn that the patents give Myriad the right to prevent others from doing commercial testing.
"I think my genes are mine," she says. "Myriad thinks they are not mine."
On Monday, the Supreme Court will hear a challenge to Myriad's patents originally brought by scientists, researchers and patients who believe the patents stand in the way of further research on the genes and limit the availability of testing. The ACLU is representing the groups and argues that the Court should invalidate the patents because they cover a product of nature and not an actual invention.
The case has huge ramifications for biotechnology companies racing to create personalized tests and treatments tailored to a person's genetic make-up.
Myriad says that the patents have been essential to the development of diagnostic tools to help patients and doctors assess the risks of cancer. The company rejects the notion that it somehow owns someone's genes. "Each individual's DNA is theirs," says Mark Capone, the company's president. He says that what his scientists did was identify, define and isolate the genes out of the human body, which led to a momentous scientific advancement. The company says it spent over $500 million and that it took 17 years to recoup the capital investment. Without protection from a strong patent system, Myriad argues it won't have the incentive to charge ahead.
Capone says over one million women have been tested and that 95% of patients in the U.S. have access to the testing through private insurance and other coverage. "For the first time they have been given the opportunity to identify why these cancers have ravaged their family histories."
Dan L. Burk, a law professor at the University of California, Irvine, believes the Court should uphold Myriad's patents. "The patent doesn't cover anybody's genes in their body. The patent only covers isolated molecules that are outside the body. It is against patent office policy and against patent law to own a human being or anything in the human body."
But Sandra Park, a senior attorney with the ACLU, says, "The patents are framed as covering and claiming the isolated genes. What that means is that the moment the gene is removed from the cell, Myriad owns it. The scope of the patent is incredibly broad."
In court papers lawyers for the ACLU write, "Under this rationale, a kidney 'isolated' from the body would be patentable, gold 'isolated' from a stream would be patentable, and leaves 'isolated' from a stream would be patentable".
They argue that although Myriad has not exercised its authority to stop all research, it has a monopoly on clinical testing in the U.S., and the ability to discourage research because laboratories are dissuaded from pursuing scientific work that requires using patented genes.
Lori B. Andrews, a professor from Chicago-Kent College of Law who has filed an amicus brief on behalf of the American Medical Association and others, says, "Patents on human genes impede the provision of health care, thwart public health objectives, shackle innovation and violate ethical tenets."
The United States government has filed a brief arguing that patents on certain types of isolated genes are invalid. Solicitor General Donald B. Verrilli writes, "The mere act of culling a natural product from its environment to exploit its preexisting natural qualities—however useful those qualities may be—should be treated as insufficient to create patent-eligible subject matter."
Ceriani says that after "pestering" Myriad for more than a year and a half over a dispute with her health insurance company, she was finally able to get testing done through test kits donated by Myriad. It turned out she was at an increased risk for ovarian cancer.
"There are so many genes in our body," she says. "It's part of nature, it seems very contradictory to me that a company could say, that a piece of the inside of my body is only theirs to look at and not mine."
But Marylee Jenkins, head of the New York Intellectual Property Group of Arent Fox LLP, worries that such a statement oversimplifies the challenge in front of the Supreme Court.
"You have bio tech companies that have spent years and tens of millions of dollars in research and development and patent protection for their inventions with the general public not understanding the complexities of the patent system and protecting innovation in this country. You hope that the Supreme Court gets this right without negatively impacting the definition of patent-eligible subject matter under our U.S. patent system. Unfortunately or fortunately, innovation is often not as simple as we would like."