Human Stem Cell Medical - Term Paper

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This bill was sent to the U.S. Senate and set for vote mirroring a bill previously passed by the House during the Summer of 2003 which failed to pass the Senate because of vehement disagreement that was even "within the parties over the prohibition of therapeutic cloning.(National Legislation Concerning Human and Reproductive Cloning, 2004; paraphrased) As of the date of the report on legislation eight U.S. states had passed laws that explicitly prohibited reproductive cloning using human embryos and another five U.S. states have placed a prohibition on cloning for any purpose whatsoever with 22 other U.S. states introducing bills outlawing the reproductive cloning of humans. (Ibid; paraphrased) Patenting laws for genetics allow inventors to patent genetics but only specific genetic factors may be patented and inventors are required to:

1) Identify novel genetic sequences;

2) Specify the sequence's product, 3) Specify how the product functions in nature --i.e. its use; and 4) Enable one skilled in the field to use the sequence for its stated purpose.

The USPTO issued out patents relating to gene fragments due to the fact that the full sequence and function of the gene is not known. The gene fragments are 300 to 500 base and are referred to as sequence tags (ESTs) which represent only about 10 to 30% of the cDNA while the genomic genes may be often ten to twenty times larger than the cDNA. The cDNA is a molecule that is laboratory manufactured version of a gene with only the information rich regions and it is these that provide the capability for researchers in the genome field to go forward to the important areas of the biology. There has been much controversy among scientists and with most scientists urging the USPTO that the broad patenting of the human genome should not be done at this state of research.

I. Implications of Diamond v. Chakrabarty (1980)

Diamond v. Chakrabarty was decided by the Supreme Court and was a case dealing with man-made, genetically-engineered bacteria capable of breaking down crude oil and having significant value in the treatment of oil spills. The Patent Office allowed method claims for producing the bacteria and for a combination of a floating carrier and the bacteria, but it rejected claims for the new bacteria itself. According to the examiner's decision statutory subject matter does not govern living things and the bacteria were living things and not subject under Section 101. Accompanying the 1952 act are the Committee Reports that inform the reader that the statutory subject matter intended by Congress to be included was: "anything under the sun that is made by man." The same year as the case Diamond v. Chakrabarty, 1989) the Bayh-Dole Act was passed in order that patent rights be granted to universities and other recipients of grants and other receiving or using federal funds.

IV. Implications of Later Cases

The case that followed Chakrabarty was Diehr's Rubber Molding. In this case Diehr and Lutton were inventors of a method used in operation of molding presses manufacturing rubber items such as car tires. The method that they used "produced properly cured rubber articles by ensuring that the articles remained in the press for the proper time so that they were not either over-processed or under-processed. It did this by continually monitoring the actual temperature in the mold and repeatedly calculating the cure time using a well-known formula, the Arrhenius equation." (Legal Protection of Digital Information, 2006) The claim was rejected by the examiner because he believed that the men were stating a type of computer programming claim. However the CCPA reversed and held that a claim that is staked upon a process or method does not depend on gaining validity under 35 USC 101 because if the claim is drawn upon 'subject matter' it does not become non-statutory simply because a computer is part of the execution process. If the rejection of a claim is solely due to the fact a computer program is involved this is not supported in law due to the broadness of the issue. The court ruled that this must be reversed because it did not have its basis in the law." (Legal Protection of Digital Information, 2006; paraphrased)

V. Free Market System Impacts

Impacts to the free market are positive in that "Gene patents are allowed because of the benefits that these patents can provide to the patentee. One of these benefits is that gene patents can be seen as an incentive to encourage research by scientists.

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The research required to conduct studies is expensive, and researchers need a way to make up for the expenses lost in conducting their research. Patents and licensing fees provide a way for companies and researchers to regain the funds spent on studies. Some believe that researchers would be less likely to invest in research if there was not a way to regain some of the money spent on the research (Hill, 2003, "Patents, Medicine," 2002). In this way patents can help to protect against market failure and foster innovation (Walpole, Dawkins, Sinden, O'Leary, 2003). Also, funds generated by patents can be reinvested in future research." (Koporc, nd)

Koporc,. further states: "Gene patents are also widely defended as a means of free enterprise ("Patents, Medicine," 2002). As a researcher puts his or her time and effort into creating something, he or she may deserve to reap the benefits from such a discovery. This argument would support licensing fees and restrictive access to the invention. In this understanding of the role of gene patents, research and drug development is similar to any other business, which is encouraged to make a profit from its endeavors. This view may seem harsh when considering that the inventions being patented can directly impact human health, but it is a principle found throughout the business world and is highly valued in the United States today.

Koporc states that: "Another argument that supports gene patenting states that patents are important because they encourage the sharing of information and innovations (Walpole et al., 2003, Hill, 2003, "Patents, Medicine," 2002). Once a patent is granted for an innovation, that innovation becomes available to the public ("Patents, Medicine," 2002). This required sharing of information would prevent researchers from hoarding information for their own benefit. This requirement could provide other companies and researchers with databases of relevant information and the potential to research that product further." There is a dilemma presented in the patenting of the human stem cell in that much of the stem cell application is technological which if protected by patent would bar the release of the information and effectively bar research or use by any other than those who could afford to pay the patentee. (Caulfield, 2003) reveals that there are concerns in relation to patenting of stem cells. The patent to the "Primate Embryonic Stem Cell" is retained by the Wisconsin Alumni Research Fund. In the U.S. where government policy state that research is only to be done on stem cell lines already in existence these stem cell lines are important and they are valuable. The owners of the stem cell lines effectively have a monopoly because new stem cells are now lawful at this time for collection. (Caulfield, 2003

VI. What Ways Do Patents Objectify Human Dignity?

Because of the potentiality of human stem cell research in radical science and eugenics groups the human dignity factor is objectified in view of the ethnic cleansing goals of some in society, although let it be noted that not all who forge the path in eugenics are completely radical and it is said that many of those who study eugenics do not believe in any type of force or coercion. Another problem is with the factor of 'ownership' of human stem cell lines and specifically of the human embryo by corporations, organizations, or individuals in that 'ownership' of any part or whole of a human being is inherently believed by most to be wrong. The Human Genetics Alert publication in the article entitled: "Why Should I be Concerned About Human Genetics" states that:

It is hard to see how creating embryos purely as a source of biological raw material (ES cells) is compatible with respect: it seems part of the trend of turning human life into a commodity. (2006)

Further stated is that:

The commercialization of human biological samples has also led to the exploitation of indigenous peoples. Several cell lines from indigenous tribes have been patented by U.S. government institutions, without the consent of the people from whom the samples were derived, although some of these patents were withdrawn, following protests by the tribespeople. Concern over such 'biopiracy' has led countries such as India to try to restrict foreign scientists' access to their wealth of human genetic diversity."

VII. Is there a just way of thinking about intellectual property law?

According to the Hugo Ethics Committee statement on Stem.....

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