Myriad's patent on parts of naturally occurring human genes is a disgrace. Millions of women suffering from breast and ovarian cancer are affected by Myriad's patents. The fight is not over!
The patent system, as currently designed, imposes untold social costs, and also fails to maximize innovation - as Myriad’s gene patents demonstrate. After all, Myriad did not invent the technologies used to analyze the genes. If these technologies had been patented, Myriad might not have made its discoveries. And its tight control of the use of its patents has inhibited the development by others of better and more accurate tests for the presence of the gene. The point is a simple one: All research is based on prior research. A poorly designed patent system - like the one we have now - can inhibit follow-up research.
That is why we do not allow patents for basic insights in mathematics. And it is why research shows that patenting genes actually reduces the production of new knowledge about genes: The most important input in the production of new knowledge is prior knowledge, to which patents inhibit access.
Fortunately, what motivates most significant advances in knowledge is not profit, but the pursuit of knowledge itself. This has been true of all of the transformative discoveries and innovations - DNA, transistors, lasers, the Internet, and so on.
A separate legal case has underscored one of the main dangers of patent-driven monopoly power: corruption. With prices far in excess of the cost of production, there are, for example, huge profits to be gained by persuading pharmacies, hospitals, or doctors to shift sales to your products.
The U.S. attorney for the Southern District of New York recently accused the Swiss pharmaceutical giant Novartis of doing exactly this by providing illegal kickbacks, honoraria, and other benefits to doctors - exactly what it promised not to do when it settled a similar case three years earlier. Public Citizen, a consumer advocacy group, has calculated that, in the United States alone, the pharmaceutical industry has paid out billions of dollars as a result of court judgments and financial settlements between pharmaceutical manufacturers and federal and state governments.
Money talks ...
Sadly, the U.S. and other advanced countries have been pressing for stronger intellectual-property regimes around the world. Such regimes would limit poor countries’ access to the knowledge that they need for their development and would deny life-saving generic drugs to the hundreds of millions of people who cannot afford the drug companies’ monopoly prices.
The issue is coming to a head in ongoing World Trade Organization negotiations. The WTO’s intellectual-property agreement, called TRIPS, originally foresaw the extension of 'flexibilities' to the 48 least-developed countries, where average annual per capita income is below $800. The original agreement seems remarkably clear: The WTO shall extend these 'flexibilities' upon the request of the least-developed countries. While these countries have now made such a request, the U.S. and Europe appear hesitant to oblige.
Intellectual property rights are rules that we create that are supposed to improve social well-being. But unbalanced intellectual-property regimes result in inefficiencies -including monopoly profits and a failure to maximize the use of knowledge - that impede the pace of innovation. As the Myriad case shows, they can even result in unnecessary loss of life.
America’s intellectual property regime - and the regime that the US has helped to foist upon the rest of the world through the TRIPS agreement - is unbalanced.
The Supreme Court Case in which Myriad Genetics was challenged because they had a patent on our human BRCA genes should have never gotten that far in our courts. This patent allowed them to be the only ones to do this gene test which kept other researchers and companies from conducting research for better tests that would help women with treatment decisions by knowing if they are at high risk of developing this genetic form of breast and ovarian cancer. While Myriad held the monopoly on the test, other companies were prevented from developing better and less expensive tests and more research into other genes.
The case originally in 2009 brought together many diverse plaintiffs in New York Federal Court that included the ACLU, the Association for Molecular Pathology, the American College of Medical Genetics, individual researchers; women’s health and breast cancer advocacy groups, including Breast Cancer Action and Our Bodies Ourselves; and women who have breast and ovarian cancer. Originally they ruled against Myriad but the case was overturned a year later in an appellate court. Absent from the list of plaintiffs was the Susan G. Komen Foundation who lists Myriad Genetics as a donor to their organization.
One of the plaintiffs, Breast Cancer Action is a national grassroots education and advocacy organization working to end breast cancer. They do not accept any donations from companies, corporations or anyone who profits from breast cancer.
The Supreme Court got it right when it ruled against Myriad Genetics by ruling that companies cannot patent parts of naturally occurring human genes. The ruling was complex and at the heart of it was the patent, which would help doctors, pathology labs, research, breast and ovarian cancer patients and those at high risk for the disease and would have also made the test more affordable. The test was very expensive (over $4000.00) and many women were uninsured, and those who carried insurance while doing the test were sometimes denied payment or had very high co-pays for the test. There is already a genetics testing company based in Houston that said it would offer the test for $995.00 called DNATraits. To see the decision go to: The Association for Molecular Pathology et al. vs. Myriad Genetics .
Breast cancer and ovarian cancer patients cheered the decision of the Supreme Court. Thank you to the breast cancer patients, patient advocates, doctors, legislators, organizations, bloggers that are working every day to help other patients, make the public aware about the realities of this disease, get more funding for research especially for patients who are metastatic and doing difficult treatments every day to stay alive, and finally work to develop a vaccine that will prevent this horrible disease in the first place.
The Supreme Court's ruling which was overturned by an appellate court:
Human genes may not be patented, the Supreme Court ruled unanimously. The decision had the potential to reduce the cost of genetic testing for some health risks, and it would have discouraged investment in some forms of genetic research.
The case concerned patents held by Myriad Genetics, a Utah company, on genes that correlate with an increased risk of hereditary breast and ovarian cancer. The patents were challenged by scientists and doctors who said their research and ability to help patients had been frustrated.
After the ruling, at least three companies and two university labs said that they would begin offering genetic testing in the field of breast cancer.
"Myriad did not create anything," Justice Clarence Thomas wrote for the court. "To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention."
The course of scientific research and medical testing in other fields would have been shaped by the court’s ruling, which drew a sharp distinction between DNA that appears in nature and synthetic DNA created in the laboratory. That distinction would have altered the sort of research and development conducted by the businesses that invest in the expensive work of understanding genetic material.
The decision tracked the position of the Obama administration, which had urged the justices to rule that isolated DNA could not be patented, but that synthetic DNA created in the laboratory - complementary DNA, or cDNA - should be protected under the patent laws. In accepting that second argument, the ruling on provided a partial victory to Myriad and other companies that invest in genetic research.
The particular genes at issue received public attention after the actress Angelina Jolie revealed in May that she had had a preventive double mastectomy after learning that she had inherited a faulty copy of a gene that put her at high risk for breast cancer.
The price of the test, often more than $3,000, was partly a product of Myriad’s patent, putting it out of reach for some women.
That price "should come down significantly," said Dr. Harry Ostrer, one of the plaintiffs in the case, as competitors wanted to offer their own tests. The ruling, he said, "will have an immediate impact on people’s health."
In a statement, Myriad’s president, Peter D. Meldrum, said the company still had "strong intellectual property protection" for its gene testing.
The central question for the justices in the case, Association for Molecular Pathology v. Myriad Genetics, No. 12-398, was whether isolated genes are "products of nature" that may not be patented or "human-made inventions" eligible for patent protection.
Myriad’s discovery of the precise location and sequence of the genes at issue, BRCA1 and BRCA2, did not qualify, Justice Thomas wrote. "A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated," he said. "It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes."
"Groundbreaking, innovative or even brilliant discovery does not by itself satisfy the criteria" for patent eligibility, he said.
Mutations in the two genes significantly increase the risk of cancer. Knowing the location of the genes enabled Myriad to develop tests to detect the mutations. The company blocked others from conducting tests based on its discovery, filing patent infringement suits against some of them.
"Myriad thus solidified its position as the only entity providing BRCA testing," Justice Thomas wrote.
Even as the court ruled that merely isolating a gene is not enough, it said that manipulating a gene to create something not found in nature is an invention eligible for patent protection.
"The lab technician unquestionably creates something new when cDNA is made," Justice Thomas wrote.
He also left the door open for other ways for companies to profit from their research.
They may patent the methods of isolating genes, he said. "But the processes used by Myriad to isolate DNA were well understood by geneticists," Justice Thomas wrote. He added that companies may also obtain patents on new applications of knowledge gained from genetic research.
Last year, a divided three-judge panel of a federal appeals court in Washington ruled for the company on both aspects of the case. All of the judges agreed that synthesized DNA could be patented, but they split over whether isolated but unaltered genes were sufficiently different from ones in the body to allow them to be protected. The majority, in a part of its decision reversed by the Supreme Court, said that merely removing DNA from the human body is an invention worthy of protection.
"The isolated DNA molecules before us are not found in nature," Judge Alan D. Lourie wrote. "They are obtained in the laboratory and are man-made, the product of human ingenuity."
Long passages of Justice Thomas’s opinion read like a science textbook, prompting Justice Antonin Scalia to issue a brief concurrence. He said the court had reached the right result but had gone astray in "going into fine details of molecular biology."
How sad that the Supreme Court's ruling was overturned by an appellate court.
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