In his book Next , popular writer Michael Crichton created the evil biotechnology company BioGen that was sued by a man who lost ownership of his own cells during cancer treatments. After the court decided in BioGen's favor, the company asserted its right to harvest his cell line, including those of his daughter and grandson.
Crichton, who also authored Jurassic Park , included an essay in Next titled "Stop Patenting Genes" in which he wrote, "When Myriad patented two breast cancer genes, they charged nearly three thousand dollars for the test, even though the cost to create a gene test is nothing like the cost to develop a drug."
Myriad is Salt Lake City-based Myriad Genetics, which a couple of weeks ago lost a major court ruling after a coalition of researchers, professional medical organizations, health advocates and women who had suffered breast or ovarian cancer had sued to overturn parts of patents it holds that are related to two human genes. The ruling has the potential to undermine part of the foundation of the nation's biotechnology industry.
That Myriad also was singled out by Crichton may help explain why, among thousands of entities that hold patents related to human genes, it was the company named in the lawsuit. Myriad is a pioneer in creation of gene-related diagnostic tests, but during its aggressive marketing it became for many the evil BioGen, deservedly or not.
The hunt for genes » Frustrated with inadequate funding to pursue research, University of Utah researcher Mark Skolnick allied with a venture capital group to found Myriad Genetics in 1991. They poured millions of dollars into research to pinpoint the location of two genes linked to breast and ovarian cancer, and to develop commercial tests to detect mutations.
In 1994, researchers from Myriad and other institutions that included the University of Utah identified the location of the gene labeled BRCA1 and patented it (or acquired other rights through licenses, including from the U., which is a lawsuit defendant). A year later, the company applied for patents on the BRCA2 gene, setting the stage for others in biotech to follow suit.
Both patents, though, raised the ire of researchers over three key questions:
» Who was really responsible for the discoveries?
» Should public monies have been used for discoveries that wound up in private hands.
» Whether genes, as products of nature, should be patented in the first place.
From the very beginning, there was "a degree of hostility toward Myriad due to the way the scientific race had proceeded," an associate professor of law at McGill University in Montreal wrote in a 2008 study of Myriad.
Going forward, Myriad's aggressive commercialization campaign, what some considered its ham-handed interactions with researchers and health officials, and the company's failure to counter widely held but largely mistaken views about it cast Myriad in an unfavorable light that led to a negative portrayal in the media. It also got caught in the political battles over women's health issues and whether aspects of medicine such as genes should be turned over to for-profit companies.
"They were a good target for this lawsuit to make some political points," said McGill's Richard Gold, co-author of the Myriad study.
Health care costs » The authors assert that Myriad also stumbled when it made commercial forays into Canada and Europe, where health care systems are government run or financed. The Utah company failed to understand "and perhaps even respect the nature of public health care," offering "gold standard" diagnostics that could raise health care costs when what administrators wanted were cost-effective methods, the authors wrote.
"The worry was the precedent that would be set: that Myriad's BRCA test represented just the first of a new wave of genetic tests expected to hit the market that, collectively, could dramatically increase health care costs."
The company compounded those fears by not communicating effectively with health officials in Canada and Europe, the authors argued.
Gold pointed to the company's attempt to reach an agreement with the Canadian government. After not hearing back from the ministry six months after the meeting, the Myriad sent a cease-and-desist letter that "provoked a reaction of, 'Well, Myriad just doesn't want to talk to us,' " said Gold. In reality, officials in the office dealing with the gene issues was small and had not had time to come up with a policy before Myriad sent the letter, he said.
"They wanted to provoke the government to negotiate, but it was misunderstood, and Myriad did nothing to fix the problem."
In the United States and elsewhere, Myriad's patents and exclusive testing also ran up against the "highly charged political issue" of breast cancer, the second-leading cause of cancer deaths for U.S. women. Its diagnostic tests raised gender and equality issues in the U.S. and elsewhere.
"In this climate, few patients or policymakers would consider such a test as just another product; rather, they would have seen it as raising important questions of availability and accessibility, two issues rendered problematic by Myriad's business model," the study's authors said.
Research continues » For all its perceived missteps, Gold contends that Myriad did not shut off scientific research into the two genes, as many in the scientific and the public came to believe.
It regularly allowed research into the two genes, not even demanding a license to do so. It provided at-cost tests for other researchers, and contributed its own findings to a public database, said Richard Marsh, Myriad's executive vice president and in-house legal counsel. There have been thousands of papers published on the genes, he added.
"The notion that we have inhibited research is just ridiculous."
Marsh said the company and its backers poured more than $200 million into research, development and promotional activities to locate the genes, create tests and get them to doctors.
It took the company about 10 years to earn back its investment, he said. The money generated by the patents accelerated research and test development beyond what could have been accomplished by academic researchers working on limited budgets, he said.
"In my mind I just cannot fathom the time, effort and cost it took us to try to get the testing to where it is today," he said. "Most of the plaintiffs in this case are academic centers, and I just cannot see an academic center spending hundreds of millions of dollars employing a thousand people all to try to promote the science. Yeah, they'll have a center of excellence, but in order to reach the public, it's just not going to happen."
Enforcing the patents » The lawsuit was led by lawyers from the American Civil Liberties Union and the Public Patent Foundation.
Sandra Park, an attorney with the ACLU Women's Rights Project, said Myriad was singled out because it had actively tried to enforce its patents, including through a cease-and-desist letter to the University of Pennsylvania. The perception was that other companies that held patents on other genes were not trying to aggressively enforce their rights in connection with research, she said.
"Myriad on some level was choosing to exercise the patents exclusively and pursued a strategy, I think, of being the sole genetic testing provider in the United States," said Park.
Myriad's actions provoked concerns in the scientific community, and the issue of breast cancer also elevated opposition to Myriad's patents, she said.
"We talked to patients and physician groups, and because breast and ovarian cancer are such concerns, the patents on the BRCA genes were of deeper concern than perhaps some patents on genes that are associated with more rare diseases," Park said.
Marsh takes Park's point, but thinks Myriad also was the lawsuit focus because the company held the exclusive patents on diagnostic tests that centered on potentially frightening aspects of women's health.
"If our patents were on toe fungus, I guarantee we wouldn't have been the target," he said.
A court ruling » On March 29, U.S. District Judge Robert Sweet in New York City invalidated parts of seven patents Myriad held related to BRCA1 and BRCA2.
He followed the plaintiffs arguments in ruling that genes are products of nature and that some derivatives from them cannot be patented under U.S. law.
Dr. Robert Cook-Deegan, director of the Center for Genome Ethics, Law & Policy at the Duke Institute for Genome Sciences & Policy, said the ruling's effect will fall differently on different companies in the biotechnology industry.
"This ruling encourages some companies' models and it discourages other models," he said. "I think the companies that are likely to be most adversely affected are those that rely on exclusive licensing of university-based patents and become the sole provider using intellectual property as their tool."
The losers could include institutions such as the University of Utah, which Marsh said had received "tens of millions of dollars" in licensing fees as a result of the patents. Representatives of the U. declined to answer questions for this story.
Kenneth Chahine, a visiting professor at the S.J. Quinney College of Law at the University of Utah, wonders whether Sweet's ruling will have much effect on Myriad, given it preserved most of its patents that, in any case, begin to expire in 2014.
But it might have a greater impact on startup companies that conceivably will not have the level of patent protection Myriad once enjoyed, and will have to "get creative" to preserve the profit-potential of gene-related products, he said.
Chahine said Sweet's ruling will go before a "savvy" group of judges when Myriad appeals it to the U.S. Circuit Court of Appeals in Washington, D.C., which has exclusive jurisdiction over patent cases.
"Ultimately it's a big enough case that I don't see either Myriad or the ACLU dropping it before it gets to the Supreme Court."
» Myriad Genetics says it will appeal a ruling that its patents related to two human genes are invalid.
» The Federal Circuit Court of Appeals in Washington, D.C. has exclusive jurisdiction over patent appeals.
» Some believe the ground-breaking issues in the case will eventually end up before the U.S. Supreme Court.