Among the most controversial issues in biotechnology over the last ten years has been the patenting of human DNA sequences as well as human genes. The medical, pharmaceutical along with economic interests at stake are huge, making investments in biotechnology firms involved in gene patenting highly volatile. Gene patenting is a relatively broad term and refers to the patenting of individual processes that involves the isolation of DNA or other associated material and also to any chemical substance that is related to DNA. The idea of gene patents has played a key role in the rapid growth of the biotech industry over the last two decades.
The earliest of the gene patents were obtained back in 1978. One of the biggest issues involving biotechnology and the law is the patenting of human genes. Because of advances in technology, it is relatively routine a procedure to isolate genes and determine their genetic sequence (Birren & Rommens 1999). With the recent completion of the Human Genome Project, we now know the entire genetic sequence of the human genome. All that remains is for science to determine which portions of the sequenced genome correspond to actual genes (Eisen & Laderman 2007).
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For these reasons, the United States Patent and Trademark Office witnessed a tremendous increase in the number of patent applications for human genes. The number of applications more than doubled in the last ten years, from approximately 16,000 applications in 1990 to 33,000 applications in 2000, and in the last twenty years, "the [PTO] 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 cases not known for the gene fragments being issued patents on.
Many questions have arisen over when, from the discovery to development into viable products, the exclusive right to genes may be claimed. This is important 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 right to exclude others from making, using, selling, or importing the patented invention in the United States "beginning on the date on which the patent issues and ending 20 years from the date on which the application for the patent was filed. "
The 300- to 500-base gene fragments which are better known as expressed sequence tags (ESTs), make up about 10 to 30% of the mean cDNA, while the genomic genes typically happen to be 10 to 20 times bigger than the cDNA. A cDNA molecule is made in the laboratory and is a version of the gene which only contains the information-rich (exon) regions; these molecules offer a way to researchers to fast-forward through the genome get to more biologically significant areas. The initial chromosomal locations as well as biological functions of the while genes identified by ESTs happen to be unknown in the majority of cases.
The patenting of genes has been a controversial area to say the least. The argument is that patenting such discoveries is not justifiable because the effort to find a certain EST is meager when compared with the work of isolating and characterizing a gene and gene product, finding out what it does, and developing a commercial product. They feel that allowing holders of such "gatekeeper" patents to exercise undue control over the commercial fruits of genome research would be unfair.
Similarly, allowing multiple patents on different parts of the same genome sequence --say on a gene fragment, the gene, and the protein-- adds undue costs to the researcher who wants to examine the sequence. Not only does the researcher have to pay each patent holder via licensing for the opportunity to study the sequence, he also has to pay his own staff to research the different patents and determine which are applicable to the area of the genome he wants to study. Some physicians believe that if a lot of genes receive patents, the genetic testing of patients could end up being prohibitively costly.
Even though the technological knowledge is there to develop such tests, a lot of work remains to produce 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, then this technology may never be exploited effectively in order to help patients. On the other hand, if protection is not offered to the industry, then R & D expenses may not be recouped, therefore reducing incentive for investment in the industry. The implications of gene patenting on R & D have been the subject of considerable debate.
Advocates say that gene patents like normal patents encourage the disclosure as well as dissemination of ideas by opening critical uses of gene sequences to the publicly 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 not allowed patent protection. Many argue that genes are not "inventions," but rather they are "discoveries" which do not require an inventive effort. Because the discovery of genes does not require an inventive effort, the PTO should not issue patents for genes (Hettinger 1995).
In the same regard, because genes are "discoveries" and not new "compositions," genes should not be patented because they are not "novel," as required by section 102. For example, human genes have existed as long as the existence of humanity; therefore, an inventor can 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 body 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 particular 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 system, an inventor's reward 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 intellectual curiosity, and as such, hardly qualifies as labor. Therefore, intellectual 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 difficult to envision why the law should distinguish the discovery of genes from other discoveries in this regard.
Another argument is that the patenting of genes discourages others from performing 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 gene's role in that disease, it may be difficult to design an experiment 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 waste 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 problem 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 might similarly impede scientific progress. Ethical arguments is the most difficult to marshal and address. As such, this author will briefly address only the two most common arguments against the patenting of genes. One of the most common ethical arguments is that the government should not issue patents on human genes because genes belong to all humankind, and therefore no single group should have the exclusive property right to exclude others from their use (Doll 2001).
However, gene patents are not owned in the same sense as property 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, often 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 society's 150-year prohibition on humans having property rights in another human being.
However, should a human gene qualify as a human being or a living entity? The U. S. Supreme Court has offered a potential framework for analyzing whether a gene should qualify as a living entity. In Roe v. Wade, 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 equate a woman's right to seek an abortion with an inventor's 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 life outside the mother's 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 fantasy (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 somewhat relaxes this policy by allowing one to "donate" certain bodily fluids, such as plasma, for money. The underlying concern for this ban on the sale of organs may be to protect those that are impoverished from sacrificing vital 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 cell (Overwalle 2007). Thus, a patentee that patents his or her own genes is not deprived 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 banned 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 fraction 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 scientists 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 structure 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 organize everything in the cell. Biotechnology and pharmaceutical companies with high stakes 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 Gene Patents: The Legal, Economic, and Social Implications of Licensing the Core of Life Could Alter the Current Patent System.
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