Bioethics and gene patents

Among the several(prenominal) controersial issues in biotechnology over the give-up the ghost ten years has been the b aring of valet de chambre DNA ecological successions as well as homo factors. The medical, pharmaceutical on with economic interests at s find out are huge, do investments in biotechnology firms involved in factor plaining highly volatile. divisor unembellisheding is a relatively encom go undering term and refers to the patenting of individual processes that involves the isolation of DNA or a nonher(prenominal) associated material and also to any chemical substance substance that is related to DNA. The idea of agent patents has vie a key role in the rapid growth of the biotech industry over the last dickens decades.The earliest of the constituent patents were obtained back in 1978. maven of the biggest issues involving biotechnology and the law is the patenting of tenderity divisors. Beca intake of advances in technology, it is relatively routine a procedure to isolate constituents and stipulate their genetic ecological succession (Birren & Rommens 1999). With the new-fangled completion of the world Genome Project, we now know the entire genetic while of the forgiving genome. All that remains is for science to condition which portions of the sequenced genome correspond to actual genes (Eisen & Laderman 2007).For these reasons, the United States Patent and earmark Office witnessed a tremendous incr calm down in the derive of patent employments for human genes. The number of applications much than doubled in the last ten years, from slightly 16,000 applications in 1990 to 33,000 applications in 2000, and in the last twenty years, the power takeoff has granted patents on about 1,000 human genes or gene fragments (Willing 2000). USPTO has issued a large number of patents for gene fragments. Full sequence as well as function is in many representatives non cognize for the gene fragments existence issued patents on.Many questions be in possession of arisen over when, from the husking to development into viable products, the exclusive advanced to genes whitethorn be claimed. This is central as a patent lasts for 20 years. Congress exercised its powers under the Constitution to pass the Patent Act. Under the Patent Act, a patent gives one the mightily to exclude others from making, victimization, selling, or importation the patented instauration in the United States blood line on the date on which the patent issues and finis 20 years from the date on which the application for the patent was filed. The 300- to 500-base gene fragments which are better cognize as expressed sequence tags (ESTs), make up about 10 to 30% of the mean cDNA, objet dart the genomic genes typically go by to be 10 to 20 times bigger than the cDNA. A cDNA iota is made in the laboratory and is a recitation of the gene which only contains the information-rich (exon) regions these molecules offer a so rt to tecs to fast-forward through the genome get to more biologically earthshaking areas. The initial chromosomal locations as well as biological functions of the while genes identified by ESTs happen to be unkn bear in the majority of cases.The patenting of genes has been a controversial area to say the least. The production line is that patenting much(prenominal) dis runies is non justifiable because the effort to find a true EST is meager when compared with the break down of isolating and characterizing a gene and gene product, finding out what it does, and evolution a mer basetile product. They feel that allowing holders of much(prenominal) usher patents to exercise undue control over the mercenary fruits of genome research would be unfair.Similarly, allowing multiple patents on distinguishable parts of the like genome sequence say on a gene fragment, the gene, and the protein adds undue costs to the research worker who wants to examine the sequence. Not only doe s the researcher have to pay each patent holder via licensing for the chance to study the sequence, he also has to pay his own staff to research the different patents and set up which are applicable to the area of the genome he wants to study. Some physicians regard that if a lot of genes receive patents, the genetic interrogatory of patients could end up cosmos prohibitively costly.Even though the technological knowledge is there to develop such examens, a lot of work remains to plead them. And if the license fee that is associated with the use of each test is charged via multiple companies and entities, each owning multiple genes, thus this technology may never be victimized effectively in order to help patients. On the other hand, if protection is non offered to the industry, then R & D expenses may non be recouped, and then reducing incentive for investment in the industry. The implications of gene patenting on R & D have been the resign of considerable debate.Adv ocates say that gene patents like design patents encourage the disclosure as well as dissemination of ideas by opening critical uses of gene sequences to the cosmosly domain. Patents also offer more incentives to investors who may otherwise be reluctant to invest in ideas that may simply be copied by competitors if non allowed patent protection. Many argue that genes are not inventions, tho rather they are discoveries which do not deal an inventive effort. Because the find of genes does not require an inventive effort, the PTO should not issue patents for genes (Hettinger 1995).In the resembling regard, because genes are discoveries and not new compositions, genes should not be patented because they are not novel, as indispensable by section 102. For example, human genes have existed as long as the existence of humanity thereof, an artisan john never discover a gene and claim that it is novel (Hettinger 1995). Finally, carrying patent law to its extreme, some argue that anyone containing patented genes within his or her personify could be considered an infringer, because he or she is using a patented gene merely by being alive.Some argue that because of recent advances in the isolation, purification, and sequencing of genes, (Birren & Rommens 1999) it may take only a few days to determine the sequence of a grouchy gene. Therefore, the relative ease of determining the sequence of a particular gene should preclude patenting of the gene because obtaining the sequence is obvious. There is a difference between patents on compositions and patents on processes. Patents on compositions are considered broader than patents on processes because patents on compositions can cover all processes that use the composition.In order to limit the number of patents for genes, some argue that the PTO should limit patents on genes to processes that utilize the genes, and not the composition of the genes themselves, ESTs a case in point (Auth 1997). In the US patent co rpse, an craftsmans riposte for an invention is the receipt of a patent, which permits the inventor to exclude others from making, using, selling, or importing the invention. The inventor can use this right to exclude to commercialize the invention or to license the invention and receive royalties.The reward of a patent thereby encourages invention and discovery, and the PTO takes the opinion that the incentive to make discoveries and inventions is generally spurred by patents. Some may argue that research and discovery satisfies an talented curiosity, and as such, hardly qualifies as labor. Therefore, ingenious endeavors, such as research and discovery, do not require rewards. Nevertheless, Congress designed our patent system with the underlying premise that reward is required, and it is gruelling to depict why the law should distinguish the discovery of genes from other discoveries in this regard.Another argument is that the patenting of genes admonishs others from perfo rming research and discovery (Hoffert 1998). Under our patent system, after a researcher discovers and patents a gene, the researcher, as an inventor, may exclude others from using the gene (Sturges 1997). When a second researcher studies a particular disease and the patented genes role in that disease, it may be difficult to design an examine that does not require the gene. In order to use the gene, the second researcher must seek a license from the patentee, undoubtedly requiring a fee in the form of a royalty.Some argue that this is a overplus of valuable resources that could be used for research, rather than royalties, and therefore all human genes should be in the public domain (Bruce 2000). This is a compelling argument because it is difficult for a molecular biologist studying a particular gene or protein to conceive of experiments that do not require use of the gene itself. In this regard, perhaps it is better to view this perceived business not as creating a disincentive to invent, but rather as impeding scientific progress. However, this argument is not unique to the patenting of genes.In fact, one could argue that a patent on any invention world power similarly impede scientific progress. Ethical arguments is the near difficult to marshal and address. As such, this author volition briefly address only the two well-nigh(prenominal) common arguments against the patenting of genes. One of the most common honorable arguments is that the government should not issue patents on human genes because genes belong to all humankind, and therefore no oneness group should have the exclusive shoes right to exclude others from their use (Doll 2001).However, gene patents are not owned in the alike sense as retention is owned. A patent is intangible property (Haseltine 2000), and therefore, granting a patent on a human gene does not deprive humankind of property in the traditional or tangible sense. A gene patent only deprives other researchers, a good deal attempting to realize a financial gain, from its use. The second most common argument against the patenting of human genes is that researchers derive a human gene from a human being, which violates our societys 150-year breastwork on humans having property rights in other human being.However, should a human gene turn as a human being or a financial backing entity? The U. S. Supreme Court has offered a potential framework for analyzing whether a gene should put away as a existent entity. In hard roe v. walk, the Court held that the State did not have a compelling interest in proscribing abortion where a fetus was not viable (Nature 2003). While we cannot play off a womans right to seek an abortion with an inventors right to patent a biological product, the viability test may have applicability in determining whether a human gene qualifies as a living entity.The viability test established by Roe v. Wade was whether the fetus could have a meaningful manner outside the mot hers womb. Human genes fail this test for viability because human genes are inanimate compositions of matter. Even with all the recent scientific advances, creation of a human being in vitro from the entire human genome is scientific fantasise (Mappes & DeGrazia 2001). However, even if human genes are not viable, some may argue that patents should not be issued for genes for the same reason that it is illegal to market other human products such as organs (Justine & Harris 2002).Clearly, society believes that some human products should not be for sale, although, society about relaxes this policy by allowing one to donate certain bodily fluids, such as plasma, for money. The underlying come to for this ban on the sale of organs may be to protect those that are impoverished from sacrificing zippy organs for financial gain, but this policy is not particularly applicable to the patenting of human genes. First, one can argue that patenting of genes is distinguishable in that there is not a market for genes similar to the market for human organs.Second, one may be able to isolate, amplify, and sequence a gene from a single cubicle (Overwalle 2007). Thus, a patentee that patents his or her own genes is not deprive of a vital organ in the same way as an organ donor. Undoubtedly, there are additional ethical arguments against the patenting of genes. Ultimately, however, society determines what is ethical, and consequently whether the patenting of genes meets our ethical standard. The impact on the economy if gene patenting was criminalise is still a measure of debate. Most advocates in the biotech lobby are of the view that it may discourage investment in genetic research.Even so it is important to realize that the expense of identifying the function of a particular gene is only a small part of the total cost of turning it into something viable such as a drug. There is also an argument which says that the pharmaceutical industry would perform better if scientist s and companies could work freely with any genes and rather focus their energies on patenting drugs. Since 1953, when Watson and Francis Crick discovered the double helical complex body part of DNA in chromosomes, scientists have known that the sequence of compounds called nucleotides along the DNA strands was the key to their information content.These gene sequences encoded instructions on manufacturing and controlling protein products that build, manage and maneuver everything in the cell. Biotechnology and pharmaceutical companies with high risk in patenting genetically engineered products and their sequences have registered multiple patents over the last two decades to exploit that discovery for commercial use to make new products. List of References battle Over element Patents The Legal, Economic, and Social Implications of Licensing the Core of carriage Could Alter the Current Patent System. (1996). Business week -New York, NY. 3484 56-59. Gene Patents and the Public Go od. Nature. 423. 6937 (2003). Auth, D. R. (1997). Are ESTs Patentable? 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