We hear about it in the news: innovative scientific research shows X causes Y, which means that a new treatment has been found for Z disease. It seems that every day, medical research has led to some breakthrough that is revolutionizing the pharmaceutical field. We assume it is done to benefit the general public, because it is, theoretically. But what happens when, somewhere between the research and the new beneficial medication, something gets in the way?
That is the question the United States federal government is trying to answer with its stance on gene patenting and its legality. The patenting of genes has sparked controversy for many years but has always been legally allowed by the US Patent and Trademark Office. A recent case brought by the Public Patent Foundation and the ACLU has reignited the public debate over whether or not to allow the patenting of gene sequences, and the US Justice Department has gotten involved.
The case, presided over by Judge Robert W. Sweet of the United States District Court in Manhattan, involved a lawsuit challenging patents held by Myriad Genetics and the University of Utah Research Foundation. The patents in question are for two genes, BRCA1 and BRCA2. The genes indicate that someone is at risk for breast or ovarian cancer, and testing for them can give a person vital information about whether she is at risk. The issue that the ACLU, the Public Patent Foundation, and others have with these patents is that since Myriad has a patent on BRCA1 and BRCA2, they are the ones who have developed the tests necessary to find the genes. And they give the test to people who need it—sometimes.
With their patent, Myriad can choose with which health insurance providers they contract; only those providers are allowed to administer the genetics test for BRCA. This, Judge Sweet ruled in March, should be illegal under the United States patent system. His ruling against Myriad said that because the company isolated but did not invent the genes, Myriad should not be able to patent those genetic sequences. The ACLU agreed with this idea, saying that patents should be reserved for when a gene has been modified, or a test or drug has been developed based on a gene. Sandra Park, a lawyer for ACLU, said that, “that’s what actually happens in much of biotech, they’re actually patenting things they’re creating,” as opposed to discovering.
In response to these ideas, the US Department of Justice filed a “friend of the court” brief concerning gene patenting. The brief stated, “chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds.” The federal government’s position is that genes that are simply isolated should not be patented, though genes that have been altered should be allowed patents.
Myriad is appealing the case since gene patents are what keeps their investors willing and their companies profitable. After the ruling, Myriad’s general counsel, Richard Marsh, said, “This [case] really goes to the fundamental question of ‘Does the U.S. patent system work?’… we spent hundreds of millions of dollars until we broke even before we got [the test] out, to fund the research.” Without a gene patent, Myriad researchers and investors would not have the incentive to put in massive amounts of time and money. The patent offers the company security that their work won’t be duplicated elsewhere, and that it will ultimately be profitable since there is no competition.
But who benefits from gene patents and who suffers? In the biotechnology field, gene patents are a positive force. Researchers dedicated to working with certain genes are rewarded for their efforts, and can profit from their patents, funding future research. Also, no one wastes time or money working on the same product. There is less of a competitive attitude among researchers, and no secrecy involved after something has been invented—everyone has access to it. Companies have an incentive to put money into their research if they know they can get something out of it.
On the other side of the debate are those hurt by gene patenting: us. From a purely principled standpoint, not having ownership of our genetic code seems like a limit to human identity. Women wanting to get tested for a potentially life-threatening gene combination face beauracratic red tape when attempting to read their genetic code. This results in potentially life threatening consequences.
Gene patenting also greatly increases the pharmaceutical companies’ ability to raise prices on their products due to a monopoly. If a gene is patented, there is a much smaller chance that a pharmaceutical company will want to develop products or treatments based on it, since creating said products or treatments is incredibly expensive. The expenses increase further when something called “patent stacking” occurs, which is when a single gene sequence can be patented in multiple ways. For example, one sequence can have separate patents as a gene, an “expressed sequence tag,” or sub-sequence, and an SNP (single nucleotide polymorphism).
Gene patenting, especially patent stacking, equals much greater costs for third parties working with the genes than if the patents did not exist. And if a third party, like a pharmaceutical company, has to pay more, that means consumers will also have to pay more.
Thus, the questions stands: what happens when gene patents hurt those they are supposed to help? In the Myriad case, what happened was that the patents were declared invalid. But this one case does not even come close to solving the many issues surrounding gene patenting. No doubt, gene patents lead to better, broader, and more research in the field of biotechnology. But theoretically, isn’t all this research being done for the good of the public? If we can’t even afford to use the products that result from the new research, then what is the point? It seems that, in this ongoing debate, the questions just keep coming, and the answers are few and far between.