Abstract
The idea that genes can be patented has been a constant, controversial issue from the very beginning. Today, patents are granted for DNA sequences that have been obtained from genes that have been removed from the human body and purified. This then becomes something that has been man-made and not a product of nature, therefore making it patentable.
Biochemical Connections: Law
The ongoing issue of gene patents has long been an emotional and controversial one. Gene patenting is an exclusive right to a specific purified gene or technology and techniques regarding that gene. There are a wide range of pros and cons that have been argued regarding gene patenting, but after reading the article, Biochemical Connections: Law, I believe that companies should not be allowed to patent genes I personally find it morally wrong. The arguments against gene patenting have been followed largely with expert testimonies and research. While those who favor patenting of genes argue that it provides opportunities for investment in research and development without having to fear competition, it greatly inhibits innovation and adversely affects healthcare. I feel that the negative outcomes of gene patenting greatly outweighs any benefit it may provide and companies should not be able to patent genes.
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The statement, “What can be patented is purified DNA containing the sequence of the gene and techniques that allow the study of the genes” means that companies are not able to patent a biological entity or product of nature. However, removing a specific gene from the human body, isolating and purifying it and then obtaining its DNA sequence is how biotech companies are able to successfully argue that they created something not found in nature and therefore making it a patentable invention. This argument was found to be very persuasive by the U.S. Patent Office. As for those who are opposed to the idea of gene patenting argue that genes are parts of our bodies and can be identified not invented. Biotech and pharmaceutical companies like Mylan argue that without the protection offered by patents, they would have zero incentive for research and development of diagnostic tests and products. Which is fair, but I feel like it gives them more opportunities to conduct other research that is irrelevant to diagnostic tests and products.
The patenting of genes is a debatable topic because it is taking away the property of others, which are their genes. The patent of the EpiPen is one example of how gene patenting has negatively affected the lives of so many. The EpiPen is a patented injectable device that delivers a dose of epinephrine and is worth about one dollar. Over the past nine or so years, the owner of the EpiPen patent, pharmaceutical company Mylan, has increased the patented device from $100 to $600. The increase in price has caused a strain on those who rely on the device and are unable to afford it. The high cost has also forced individuals to rely on expired models which can hinder the potency of the medication. It is the society who suffers such negative consequences as high healthcare costs rise and opportunities for research and development are limited by these licensed companies. Another major disadvantage associated with gene patenting is the high demand of money spent on repeat experiments. Gene patenting limits the other companies from developing similar technologies without having to pay fees and deal with legal actions which then results in slowing down or declining the further research of biotechnology.
Several ethical concerns have also been raised about the effects of gene patents on clinical medical practice as well as on the associated research and development. The impact of such patents will make it more difficult to perform research in the future, therefore delaying or impeding discoveries and development of diagnostics and medical practices. According to Chandrasekharan and Cook-Deegan, contrary to industry claims that gene patents are necessary to bring test and products to market, such patents actually are detrimental to patient health and researchers access to genetic information (Chandrasekharan and Cook-Deegan, 2009). Gene patent holders often use their control to charge excessive fees for diagnostic testing and prevent other researchers from utilizing specific genes or techniques associated with specific genes towards research. This hinders advancement in research and high costs in the future. A survey involving genetic labs was conducted and found that over 53 percent of these labs had stopped doing research due to concerns about patented genes, and that there has been a significant decline in published material on patented genetic information (Chandrasekharan and Cook-Deegan, 2009). With the patenting of genes, the future of personalized medicine may be crushed by the weight of licensed gene biotech and pharmaceutical companies because of the permission that must be obtained from hundreds of patent holders to scan a single patient’s genome. Gene patents lock-in our knowledge on DNA sequences like those of the BRCA breast cancer mutations, to only their potential correlation to a disease and prevent others from looking at how that gene may interact with other genes or the outside environments.
While opponents of gene patenting believe it may give companies the time to study the genes without competition, due to the patenting of genes patent holders reserve the right and have exercised their exclusive rights to shut down and prevent other clinical laboratories from performing tests. This has then prevented the clinical laboratories from offering tests that may broaden the availability of testing. Although there are benefits of gene patenting, I believe the risks and associated negative outcomes from this topic are far greater and have a substantial impact.
References
- Can genes be patented? - Genetics Home Reference - NIH. (n.d.). Retrieved from https://ghr.nlm.nih.gov/primer/testing/genepatents.
- Chandrasekharan, S., & Cook-Deegan, R. (2009). Gene patents and personalized medicine - what lies ahead?. Genome medicine, 1(9), 92. doi:10.1186/gm92
- Pollack, A. (2010, October 30). U.S. Says Genes Should Not Be Eligible for Patents. Retrieved from https://www.nytimes.com/2010/10/30/business/30drug.html.
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