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Should Genes Be Patented?

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Should Genes be Patented? Patenting genetic discoveries have proven to be controversial throughout the years. There are now patents that are associated with many of the genes within the human genome. Patents are issued to encourage innovation and protect those investing in genetic research the opportunity to maximize profit. During this period, another party can use the discovery to develop a product only with a licensing agreement; however, basic researchers can use it freely. Some argue that this period of exclusivity fosters commercial development of the discovery by discouraging competition. Yet the patenting of genes is not without controversy. Some reject the entire concept of patenting, while others have objections to the patenting of only specific types of DNA sequences. It has also been argued that patents inhibit or limit biomedical research all together. The patenting of human genetic material raises complex social, ethical, and policy issues such as the potential for discrimination in access to healthcare services or employment, and the implications for ongoing research and access to services. The patentability of inventions concerning human genetic material is determined by the US Patent and Trademark Office (USPTO). To obtain a patent, the invention must meet four criteria. The invention must be “useful” in a practical sense, “novel” (not known or used before filing), “nonobvious” (not an improvement easily made by someone trained in the relevant area), and the invention must be described in detail to enable one skilled in the field to use it for the stated purpose, which is sometimes called the “enablement” criterion (“Human Genome Project Information”). In a general sense, raw products of nature are not patentable; DNA products usually become patentable once they’ve been isolated, purified, or modified to produce a unique form not found in nature. Although credit should be given to the researchers who discover specific genes known to cause certain diseases, the patenting of these genes slows down future innovations in patient care that are cost-effective and therapeutic to provide the best care for patients. The main purpose of patenting genes is to provide an incentive for full disclosure so that others can learn about the gene, use it after patent expiration, and/or try to discover new genes using the patented gene as a starting point for discovery. According to William A. Haseltine, “the patent system is thus structured and administered to assure the rapid and open dissemination of new knowledge, encourage innovation, and promote commerce.” Discovering and developing new gene-based medicine requires years of commitment and immense capital resources. According to University of Melbourne professor Andrew Christie, “if we ban the patenting of genes, we will remove the incentive for people to invest.” Without the possibility of regaining investment that is offered by patents, no biotechnology company would be able to raise the financing necessary to develop vital products. With this being addressed, many believe allowing genes to be the subject of patents will not stifle research or prevent beneficial therapies from reaching the general public. Allowing genes to be protected under patent law is believed to encourage private investment in bringing therapies to market, and with the acceleration of this science, inventive steps should increase and lead to a precisely defined process to patent genes. Debate will continue over the patent status of gene sequences, but the arguments will most likely be about utility and claims rather that inventiveness.
The main issue with gene patents is that on average, a patent costs about $10 million per patent, takes about five years to process, and ultimately inhibits future developments in medicine (“Intellectual Property and Genetics”). As the risks to infringe existing patents grow, pharmaceutical industries are forced to specialize in particular fields, therefore increasing costs for litigation concerning the patents and impeding research activities. Although some would argue that not patenting genes would prevent new drugs from being created, there are patents that could be placed on formulating the proteins or synthesizing variations once they are discovered instead of the gene itself (“Patenting Life”). By doing this the gene would not need to be patented, and in turn the cost of the drugs could be kept at a lower rate because there would be less licensing fees that would need to be paid for. However, if this is not considered, a price increase would result. This price increase can prevent the drugs from spreading to the public by creating high rates of return since most people will be unable to afford the increase in price, regardless of how vital the drug is to them or a family member. If this occurs, a serious road block to innovations in drug discovery research would result; this would ultimately lead to a higher mortality rate, higher morbidity from diseases, and slow down or cripple innovations in personalized medicine. Furthermore, patent holders have the right to ask that drugs be withdrawn if they feel that the drugs are infringing their patent rights, even if the drugs are widely used. As more information is gathered about the human genome, questions continue to be raised about the extent to which “ownership” via patent protection should be conferred on human genetic information. Although the government has generally been supportive of intellectual property protection for genetic material, the issue of how much one must know about a gene before intellectual property rights are conferred has come into question. To address some of the general concerns about gene patents, Representative Lynn Rivers introduced two bills. Rivers stated that her goal is to “carve out some limited exceptions to the applicability of gene patents.” According to Rivers, “these exceptions are designed to minimize some of the negative impacts of patents on the practice of medicine and the advancement of science.” The first bill states that scientists would have to consult with the National Science and Technology Council so all levels of intellectual property are addressed, and the second bill states that certain sequencing information can be used without a license as long as this information is disclosed to the public ("Genomic Research and Diagnostic Accessibility Act of 2002"). With this being addressed, legislation regarding gene patenting is unlikely to take priority until issues surrounding genetic patenting start to affect health care costs and consumer groups get involved. The government has generally argued that patents are good for all types of technology, and that there should not be discrimination against any particular field or area of potential patenting. This would make it difficult to carve out criteria specific to gene patents. The existing problems with this technology and patenting cannot be solved until stricter regulation is put into place and followed by all research institutions. Since each genetic sequence and patent application is different, no fixed line can be drawn. Rather, the effort to define patentability is an administrative process that has been ongoing and will ultimately continue in the future. Unfortunately, setting aside the issue will not make it more sensible. Gene patents cannot be considered true inventions; rather these are discoveries made possible through other technological and scientific inventions. Most importantly, unprecedented innovations are warranted to establish the usefulness of genes for the invention of novel therapeutic drugs that may provide clinical and economical benefits to patients. Current patent laws are clearly insufficient and need to be reconsidered in this respect. That is not suggesting that innovations in genetics cannot be patented and that companies should not be rewarded for their efforts. What needs to be put into place is something more sensible. As the science of genetics continues to develop and developments in medicine occur, it is important to maintain an optimal balance. A balance between the use of patents to protect and encourage genuine invention needs to occur so the value of genetic information remains high and benefits humanity as a whole. A patent policy that works to defend the rights of biotechnology companies should be created, but not at the expense of scientific inquiry and the public interest.

Bibliography
"DNA Patents Create Monopolies on Living Organisms." Action Bioscience. The Council for Responsible Genetics, n.d. Web. 14 Mar 2013.
Goozner, Merrill. "Patenting Life." American Prospect. 18 Dec 2000: 1-4. Print.
Haseltine, William A.. "The Case for Gene Patents." MIT Technology Review. Human Genome Sciences, n.d. Web. 4 Apr 2013.
"Human Genes Can't Be Patented, Supreme Court Says." Huffington Post. N.p., 26 Mar 2012. Web. 13 Mar 2012.
"Intellectual Property and Genetics." National Human Genome Research Institute. National Institutes of Health, 21 May 2012. Web. 4 Apr 2013.
Johnson, Steve. "Patenting Genes: Looking Into The Pros and Cons of Genetic Patents." The American Legal Journal. N.p., 09 Dec. 2011. Web. 14 Mar 2013.
Kevles, Daniel. "Can Your Genes Be Patented?." The New York Review of Books. N.p., 07 Mar
2013. Web. 13 Mar 2013.
Nelson, Roxanne. "Supreme Court to Hear Challenge to BRCA Gene Patents Again." MedScape News. N.p., 25 Jan 2013. Web. 13 Mar 2013.
"Patenting of Genes: A Personal View." Encyclopedia of the Human Genome. Chicago: 2005.
Resnik, David. "Scientists Should Be Allowed to Patent Human Genes." Opposing Viewpoints. Center for the Advancement of Ethics, n.d. Web. 13 Mar 2013.
Rose, Danny. "Gene patents ban 'would hit biotech'." The Sydney Morning Herald 05 Nov 2009, n. pag. Web. 4 Apr. 2013.
United States. Office of Legislative Policy and Analysis. Genomic Research and Diagnostic Accessibility Act of 2002. Washington, D.C.: , 2002. Print.
Zuhn, Donald. "Gene Patenting Debate Continues." Patent Docs. N.p., 17 Dec. 2009. Web. 14 Mar 2013.
Zwahlen, Roy . "Debunking the Myth: Your Genes Are Patented." BIOtechNow. N.p., 03 Jun 2011. Web. 14 Mar 2013.

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