[Update, June 13, 2013: In a ruling that seemingly had something for both parties, the U.S. Supreme Court handed down a decision on June 13 declaring that human genes cannot be patented.
Observers predicted the ruling would open the door to competition against Myriad Genetics in the arena of diagnostic testing for breast and ovarian cancer. Company officials hailed the ruling for maintaining the patent eligibility of a type of synthesized DNA, saying it left several Myriad patents in place.]
KANSAS CITY, Kan. – In its pursuit of cutting-edge treatments, the biotech industry balances a complex web of competing scientific and business interests.
But officials at regional institutions, such as the University of Kansas Medical Center, could have a clearer landscape in which to operate within a month.
That’s the expected timeframe for a U.S. Supreme Court decision in a case challenging patents on two genes linked to breast and ovarian cancer. The company holding the patents is Myriad Genetics Inc., of Salt Lake City, which has research ties to KU Med.
But to some, the decision has implications far beyond cancer care. Patent law extends across many areas of scientific inquiry, including to genomics work at Children’s Mercy Hospitals and Clinics in Kansas City, Mo.
“It is going to impact us here, but not just in (cancer),” said Jennifer Klemp, a genetic counselor and director of cancer survivorship at the KU Cancer Center. “This has a bigger frame to it.”
Some skeptics, including Patrick Woolley, who leads the science and technology practice at the Polsinelli law firm in Kansas City, contend the potential landmark status of the Myriad case has been overhyped.
Klemp and others, however, argued the case could affect regional issues like life sciences entrepreneurism, the cost of patient care, and the breadth of clinical research.
A woman who has inherited a harmful mutation in BRCA1 or BRCA2 is about five times more likely to develop breast cancer than a woman who does not have such a mutation, according to the National Cancer Institute.
Myriad’s patents on the two genes date back to the late 1990s, according to a detailed discussion of the context of the case published in 2010.
Myriad contends that it rightly holds patents on its work because its discoveries represent “new chemical matter with important utilities which can only exist as the product of human ingenuity,” as the company chief executive put it after the appeals court victory.
In May 2009, the American Civil Liberties Union and the Public Patent Foundation filed a lawsuit contending the U.S. Patent and Trademark Office should never have issued the patents for BRCA1 and BRCA2.
Among the organizations’ arguments, as outlined on the ACLU website, is that granting gene patents that “limit scientific research, learning and the free flow of information violates the First Amendment.” The suit also contends genes are “products of nature” that cannot be patented.
At Children’s Mercy, scientists at its Center for Pediatric Genomic Medicine have tested and diagnosed patients for more than 600 single-gene childhood diseases. Children’s Mercy also has a bioethics center that explores issues like the appropriateness of screening newborns for genetic diseases.
Dr. John Lantos, a board-certified pediatrician, is the director of the bioethics center.
He said the Supreme Court decision in the Myriad case could remove some of the uncertainty that researchers at Children’s Mercy operate under now.
By some estimates, the federal government has issued patents for approximately 20 percent of human genes, and Lantos said it’s possible that Children’s Mercy is encroaching on patents in doing its genetic work.
“It’s unclear a) whether patent holders will seek to enforce those patents against programs like the one we have here, and b) whether they’d win if they did,” Lantos said, “so everybody is now sort of living in a legal limbo.”
From an ethical point of view, Lantos said he found it “deeply problematic” that Myriad’s lock on the genes has essentially given it a monopoly on testing for the mutations, which critics have said makes the test more expensive than it would be in a competitive marketplace.
Various accounts have pegged the cost of the test at between $3,000 and $4,000, though Myriad says that most patients have insurance coverage and that plans typically pick up about 90 percent of the cost.
Klemp argued the cost of the test would probably drop to less than $500 with more competition.
Andrew K. Godwin, director of molecular oncology at KU Med and deputy director of the KU Cancer Center, said he has a colleague at the Dana-Farber Cancer Institute in Boston who says he could do the test much less expensively with a sufficient volume of samples.
Godwin also said that Myriad’s patents on the two genes have a chilling effect on research into other genes that scientists have linked to breast and ovarian cancer. Researchers can now put together panels to study 20 genes at a time, he said.
“But you can’t really do those studies because all those studies would require using BRCA1 and 2,” Godwin said. “We could do the test now in my clinical lab at KU, but we won’t be doing it until this is decided upon whether they have the total monopoly towards testing a gene or two genes.”
Klemp and Godwin also praised Myriad for supporting clinical research, such as the work KU Med researchers are doing around “triple negative” breast cancer. That form of the disease can be particularly aggressive and derives its name from the absence of three receptors that doctors usually target to treat breast cancer.
Godwin said Myriad is doing the testing for free.
As much as Klemp sees how patients and researchers would benefit from a Supreme Court ruling against Myriad, she also worries about what such a decision would mean to life sciences entrepreneurs. She is chief executive of Cancer Survivorship Training, a company that spun out of her research at KU Med. The company provides online education courses for health care professionals in the area of cancer survivorship.
Entrepreneurs have to know they can recoup their investment and make money, she said, particularly in the area of pharmaceuticals.
“So how do we encourage smart folks who go ahead and take intellectual property and do tests and build new drugs, if we don’t have any incentives for that?” she said.
But Woolley, the Polsinelli attorney, said researchers have several ways to protect an idea that has business potential.
For instance, he said, if it’s a diagnostic tool, the spin-out company can maintain the confidentiality of its procedures by having customers send samples to the company for testing.
And as far as the Myriad case substantially altering the legal landscape, Woolley said he has his doubts.
“There is a case like this every two to three years, that either impacts software or something, and it’s always going to be, ‘This is it, this is going to change things as we know it forever,’ and that doesn’t happen,” he said.
“Typically people just have to be smarter about what they are doing or figure out where the true innovation is, or we have to advise our clients on other ways to protect themselves.”