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Gene Patents and the U.S. Patent Code:
A Turn for the Worse
Khanh M. Ensign
Academic affiliation: Oklahoma State University
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At its beginning, the patent was a powerful tool that could protect inventions and ideas from being stolen and help inspire creative people to develop unique machines that they had formulated in their minds. The basic idea behind patent laws was to protect these inventions and ideas from would-be thieves. These thieves could possibly make a profit from these stolen ideas at the expense of another's hard work. Somewhere between then and now, the U.S. Patent Code has changed from protecting inventions to protecting non-inventions such as genes. In "Who Owns This Body?" Wil S. Hylton writes about the dramatic change in the U.S. Patent Code that took place without much notice from the public. There are several arguments for and against the patenting of genes. The arguments that support the patenting of genes state it could help find cures, while arguments against the patenting of genes state that it would hinder the process of finding cures. Should people, companies, and organizations be able to patent things they did not invent and then restrict access to those items? Obviously, patents have already been granted, but what these people, companies, and organizations do with the patents after issue are immoral and undermines the U.S. Patent Code's original intent.

The patenting of genes and other life forms has twisted the original intent of the U.S Patent Code. The idea of a patent on genes and animal species seems faulty on the basis that these patent holders did not invent these things. They might have discovered them, however, discovering and inventing are two completely different concepts. Wil S. Hylton wrote: "There's never been a vote by Congress to approve the patenting of human or animal life, there's never been an executive order by any president, and there's never been a decision by the U.S. Supreme Court on the patenting of any animal larger than a microorganism. In fact, just twenty-five years ago, you couldn't patent any of it: genes, cells, blood, marrow, even a clipped fingernail" (110). How is it that people, companies, and organizations can now have these patents? Was there some sort of loop-hole that allowed these patents? If people, companies, and organizations can patent genes, what will be patented next? Breeds of animals? People? In the absence of an inventor, Congressional votes, executive orders, or court decisions, the patenting of genes has clearly deviated from the original intent of the U.S. Patent Code and the U.S. Constitution.

The patenting of genes further undermines the original intent of the U.S. Patent Code with the idea that these patent holders can make money for something that they did not create. For example, there is a gene called BRCA1, which is the gene for breast cancer. Myriad Genetics is the patent holder for BRCA1. Would you want to know if the gene BRCA1 was in your body? One would think that it would be fairly simple and straight forward test and therefore, somewhat inexpensive. However, that is not case: "So if you want to know whether you have the gene for breast cancer, you're going to have to call somebody for permission. Then you're going to have to pay for the cost of the doctor's visit, plus a $2,500 fee to Myriad Genetics just to access its gene, the gene inside your body" (Hylton 109). Myriad Genetics did not create that gene, it is something that was already present in the body. Theoretically, an individual could get a patent on a body part and charge another for using their body part on day to day activities. The idea of having to pay any amount of money to have access to a gene contained in ones own body seems utterly ridiculous. However, it might be understandable to be required to pay for access if the gene was unique and was stored at some remote laboratory miles away. Nevertheless, the patenting of a gene that is in another's body is immoral.

However, money is not the only issue with gene patenting. Gene patenting will also minimize the number of laboratories that can perform certain tests. Patent holders can give exclusive licensing to a particular laboratory or testing facility, which can present problems. In a Professional Issue's article, "Gene patents raise concerns for researchers, clinicians," Vida Foubister writes, "Second opinions, a long-standing medical practice, can be difficult to obtain when there are only a handful of laboratories (perhaps only one) licensed to perform the test" (11). With something as serious as health related issues, second opinions are essential. With few or even one laboratory conducting the test, the questions of accuracy and quality of the results become a major concern. Another concern with exclusive licensing is medical training for certain test would be limited. For example, Vida Foubister quotes Jonathan F. Talt, MD, PhD, who suggests: "The way physicians learn about how to use tests is to actually see tests and do tests and interpret them and study them," and "So if all the testing in the country is sent to one particular laboratory, then the people who are in training are denied the ability to participate directly in training and learn from it" (12). With the patenting of genes and exclusive licensing, when a patient was struck with a potentially deadly disease, the patient would not be able to get a second opinion or have great difficulty obtaining one. The patient's gene sample would then be sent to an exclusive laboratory, where a test (the level of accuracy of the test is unknown) would be conducted. The questionable results of the test would then be sent back to the doctor. If the results of the test are just a bunch or numbers or levels, will the doctor be able to interpret the results? Not if the doctor have been denied the training. With all these issues in mind, does gene patenting really sound right and moral?

Laboratories that want to conduct research are also affected by gene patenting. Patent holders are not limited on the amount that they can charge to give access to their patented gene. Vida Foubister writes: "Even if the patent holders do give laboratories the option of buying a license to offer tests, they're free to set the terms. Labs are usually charged both an upfront usage fee and a per test fee, often at rates that small diagnostic laboratories cannot afford." and "If a [company] offers nonexclusive licenses but it sets royalty term unreasonably high, it can shut out other labs," said Jonathan F. Talt, MD, PhD, associate professor and director of the Molecular Diagnosis laboratory at the University of Washington, Seattle (11). A lot of laboratories and research facilities are on limited budgets. Therefore, the possibility of high license fees can deter a potential laboratory from even considering the start of research of a cure to a particular disease. This strengthens the idea of the U.S. Patent Code going radically astray.

The issuing of patents on genes gives too much power to the patent holder. Patent holders do not just end up with a possible tool to cure a disease, patent holders essentially end up owning the entire disease. Having control over the access to a gene hinders other researchers from doing any studies. Vida Foubister also writes: "Jon F. Merz, PhD, an assistant professor of bioethics at the University of Pennsylvania, Philadelphia, has preliminary data showing that about 20% of more than 100 laboratories surveyed last summer did not develop a test for hemochromatosis in part because the gene was patented" (11). As stated earlier, some of the arguments in favor of gene patenting are that it aides in researching cures for diseases. The previously stated statistics suggest otherwise. If the idea is to aid or increase research, then it would make sense to give access to a gene to as many laboratories and researchers as possible. By patenting genes, it merely gives the patent holders the luxury of working at their own pace to find a cure. Patenting genes also gives the patent holders the security that if another laboratory or researcher finds the next big cure with their patented gene, that they will own that process and reap the benefits as if they had discovered the cures themselves. With this in mind, there is no motivation for other laboratories and researchers to find a cure for diseases. The potential exorbitant fees that laboratories will have to pay to access and research the patented gene and the thought of a cure not belonging to them but some patent holder after they have put in all of the hard work and effort to find that cure are just strong deterrents not motivators. Controlling access to a certain gene and hindering research for a possible cure to a disease is immoral. Access to genes for disease research should not be restricted.

Concepts and thoughts behind the U.S. Patent Code have obviously changed. The concept of patents on inventions changing to patents on practically anything to include genes and animal species. The thought of protection from someone stealing your ideas changing to being able to charge for access to a gene. Some can argue that genes are patented so that research can be done to cure diseases. Although this argument can probably be supported, could there be a better ways to find cures for diseases? Should the process for patenting genes be examined? Should there be special stipulations to the U.S. Patent Code in reference to special areas such as genes? There are many more questions that should be asked to find possible solutions to the problems associated with gene patenting. Perhaps, instead of patenting genes to conduct research, the research should be conducted and the discovered cure should be patented.

Works Cited

Hylton, Wil S. "Who Owns This Body?" Speculations An Anthology for Reading, Writing, and Research. Landrum, Jason, Matthew Wynn Sivils, and Constance Squires, eds. Dubuque: Kendall/Hunt, 2003. 107-124.

Foubister, Vida. "Gene patents raise concerns for researchers, clinicians" Professional Issues 43. 7 (2000): 9-12.

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