All day long, on the main floor of the Credit Valley Hospital in Mississauga, Ont., people ask Morag Bell for details on their family that they’ve never had a chance to know. They hope to find out what exactly led to their great- grandfather’s death or what illness may one day befall their new daughter. They want to make sense of what’s ailing them and what might have caused their disease.
Like a medical genealogist, Bell searches through their roots looking for cancer predispositions or neurological conditions that might exist within their family tree. Her tools, though, aren’t history books and family interviews. She uses some well-placed questions, sure, but most of her answers are found through blood samples and medical testing. Bell is a genetic counsellor; she finds her answers in her patients’ genes, helping them determine what illnesses might linger in their DNA.
“As the area of genetics is expanding, so is the idea of more conditions having subtler genetic components,” says Bell.
Today, thanks to the Human Genome Project, all of the human body’s genes have been identified, and genetics is a thriving sector of medicine and the biotech industry. But, as is the case with many new sciences, genetics comes with its own ethical and legal questions.
One of those questions is this: who should own your DNA? Right now, companies and researchers all over the world (including Canada) own at least 20 percent of the almost 24,000 genes in the human body. They hold patents on the chemical material within those genes, and as is the case with most patents, they hope that ownership will lead to financial returns.
“It feels like commercializing a life,” says Cindy Pearson, executive director of the National Women’s Health Network based in Washington, D.C. She compares human gene patents to selling a kidney. “There are some things we do say are wrong. Even if you could make a fully informed decision, we say selling parts of your body is wrong.”
Yet patents on genes have been allowed in the United States since 1980, when the Supreme Court permitted a patent on a biological organism (a genetically engineered bacterium that could break down crude oil); two years later, a similar court case in Canada made gene patenting legal in this country as well. Industry groups and biotech companies say that the patents drive investment on research into diagnostic tests and therapies that might be developed from those genes. Those who oppose them suggest just the opposite; not only do they argue that no one should own such an elemental piece of human life as its DNA, but they believe patents stagnate open research and make it harder and more expensive for patients to get the genetic tests they need.
Pearson and the National Women’s Health Network — a grassroots organization involved in women’s health issues — got interested in patents because of two specific genes: BRCA1 and BRCA2, mutations of which have been associated with hereditary predispositions for breast and ovarian cancer. According to the Canadian Cancer Society, the genes are a factor in five to 10 percent of all breast cancers. Myriad Genetics, based in Utah, owns the patents on the BRCA genes and has exclusive rights for 20 years from the time of filing to create any commercial uses from them, including any related diagnostic testing like the kind that Bell prescribes.
Myriad and the BRCA genes are currently at the centre of an ongoing court case that could change the practice of human gene patenting altogether. In a New York City court- room last year, the American Civil Liberties Union and a long list of plaintiffs (including the Association for Molecular Pathology, the American College of Medical Genetics and various researchers and cancer patients) challenged Myriad and its partner, the University of Utah Research Foundation, on several of their BRCA-related patents.
Behind the bench, making the decision for the Myriad case, was United States district court Judge Robert W. Sweet. In what was a surprising twist for many in the know, Judge Sweet ruled against Myriad and invalidated the challenged claims (affecting seven of Myriad’s 23 BRCA-related patents). In his judgment, Sweet determined that genes are a product of nature and therefore unpatentable — a ruling that if upheld could reverberate through the entire biotech industry.
Myriad appealed Judge Sweet’s decision, and the case will make its way to the Federal Circuit Court of Appeals early this year. Already, in October — after Myriad filed for appeal — the U.S. Department of Justice took a stand on the matter, issuing a statement to the court saying that isolating DNA is not an invention and therefore should not be patentable. The issue could go as far as the Supreme Court, suggests Sandra Park, attorney for the American Civil Liberties Union. “There have been a lot of patent cases that the court has been looking at in recent years, and I think our legal challenge is, on some level, part of that. [We’re] really asking if we’ve gone too far with patents in terms of what has been patentable,” she says.
U.S. patent law, after all, insists that products of nature or laws of nature are ineligible for patent protection. Canada has a similar distinction. It was this particular point that Judge Sweet brought out when making his decision on the Myriad case. Myriad’s objection — and that of the biotech industry as a whole — relies on the scientific procedures currently required to make a gene patentable.
A quick explanation: to patent a gene, that gene needs to be isolated and reproduced outside the body. The “junk DNA” — the parts of genes that scientists, as of yet, have found no use for — has to be cleared away, and researchers need to identify how the isolated gene is used to determine its potential functions. What’s left, say industry insiders, is something chemically different from the original DNA — and that’s what gets patented.
“You claim it in a form that is unnatural,” says Hans Sauer, deputy general counsel for intellectual property at the Biotechnology Industry Organization, an industry group in the United States. “You’ve taken something from nature, and you now make it available in a new form for applications or uses that aren’t possible in a natural thing.”
If you ask Judge Sweet or the plaintiffs in the Myriad case, however, isolated DNA is not different enough from what’s found in nature. Yann Joly, a lawyer and assistant professor of human genetics at Montreal’s McGill University, explains: “It’s kind of a legal fiction, in a way. Because how different is that from the gene as found in nature? It’s not very different. It’s just the same thing reproduced outside of the human body, with a specific use to it that’s been found.”
In many Canadian provinces, the BRCA patents have been simply and systematically ignored. To cut costs, most provincial health-care plans have chosen to conduct BRCA tests in non-Myriad Canadian labs, where they reportedly cost in the range of $1,000, compared to the more than $3,000 Myriad charges. Myriad has contested the practice to limited effect, but as of yet has chosen not to sue the provinces in an effort to uphold its patent rights. “There’s the negative publicity that this kind of lawsuit would bring Myriad — and there’s already been a lot of negative publicity,” says Joly.
If you ask Richard Marsh — executive vice-president and general counsel for Myriad — he’ll tell you that the negative publicity has been largely undeserved, that Myriad has been targeted not because of anything specific it has done, but because of the high-profile nature of the BRCA genes. He believes Myriad has become something of a “test case” in a much larger issue: the escalating debate on whether owning patents on isolated DNA is appropriate or not. That’s a decision that Marsh believes should be decided by federal bodies like the U.S. Congress, not the courts. He also believes that Judge Sweet and those who oppose gene patents aren’t considering the role that patents play in innovation, not just in the case of human DNA but in the agricultural and livestock industries as well.
Patents allow fledgling companies to find the money they need to take a gene and do something with it, he says. Take Myriad, for example: the company formed in 1991 and got its first BRCA-related patent in 1994. Over the following years, says Marsh, the company developed its BRACAnalysis test to detect genetic predispositions for breast and ovarian cancer. In total, he adds, the company spent $300 million to $400 mil- lion developing that test and educating physicians on its use. The patents alone can cost up to $10,000 each in every country where the patent is held, with dollar figures that can reach into the millions for court fees if those patents need to be defended along the way.
It took 10 years for Myriad to simply break even on its investment. “There’s no commercial entity that would have done all that we did . . . if they did not have the patents,” Marsh says. “The patent system encourages people to spend money now, to develop the technology with the promise that you’ll get back your investment down the road.”
Even with patents in place, gene research doesn’t always pan out and investments lead to nowhere, says Peter Brenders, president and CEO of BIOTECanada, another biotechnology industry organization. Patents at least give investors exclusive rights when they do prove profitable, and they allow the time and money necessary to develop commercial products that are meant to help patients like the ones Bell sees at Credit Valley. “The brilliance of the market that we’ve built, in terms of the value of patents, is what has led to the introduction of new therapies, new treatments and new diagnostics. In a world where these don’t exist, you don’t have the advances in that area,” says Brenders.
Park doesn’t believe that, though. She thinks that a different system would allow for a more competitive environment where choices would be available and tests like Myriad’s BRACAnalysis would be less expensive for patients, insurance companies and government health agencies like those in Canadian provinces. While she admits that “Myriad has a really good reputation in the testing that they do offer,” she says a more open research environment would also bring more minds to the table and perhaps lead to new findings. “Scientists would have more of an incentive to collaborate because there would be data all over the place.”
One proposed solution to the debate is to restrict patents: don’t patent the genes, but patent the scientific methodology employed in gene research and testing such as the methods used in Myriad’s BRACAnalysis test. The United Methodist Church made a similar argument in a 1992 resolution on genetic science, in which they reiterated a church declaration that genes should be “part of the common heritage of all peoples.” The resolution stated, “While patents on organisms, cells, and genes themselves are opposed, process patents — wherein the method for engineering a new organism is patented — provide a means of economic return on investment while avoiding exclusive ownership of the organism.”
Back at Myriad, Marsh says that while you can patent the methodologies around a test, the results aren’t the same as when you patent the gene itself. “Methods aren’t very strong patents. Everyone can have a different workaround,” he says.
Even if Judge Sweet’s decision in the Myriad case is upheld at the court of appeals, Joly doesn’t believe that patents on human genes will stop altogether in the near future. What the case might do, the McGill professor says, is raise the bar, allowing only the most innovative and useful patents. The biggest hurdle, he adds, will obviously be the biotech industry itself — the private, commercial entities like Myriad that rely on the patent system as is and won’t let it change without a fight.
If you ask Park, though, she’ll tell you that a free system — if the biotech industry could accept it — might mean scientific steps forward that are even now hard to imagine. “I was at a conference recently where they were talking about new technologies where you can sequence your whole genome, and that they predict that ultimately that type of test should only cost $100. Maybe that is true when you look at how much it costs to run the test, but when you factor in the patents on the genes, I seriously question whether you would be able to get permission from all the different patent holders.”
This story first appeared in The United Church Observer’s January 2011 issue with the title “Genes for Sale.”