Work of The Human Genome Project
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Work of The Human Genome Project
Tune in to news programs regularly and you will probably become aware of the considerable debate over the patenting of genes. This controversy is fueled largely by the work of the Human Genome Project and the biotechnology industry.
Despite numerous meetings and publications on the subject, Congress has not used U.S. patent laws to shape a policy that allows maximum innovation from biotech inventions. The first gene patents, issued in the 1970s, were granted for genes whose full nucleotide sequence was known; the protein product was also known, and the protein’s function was well understood. Since that time, genome projects have produced new ways of finding genes.
Short sequences, only 25 to 30 nucleotides in length, called expressed sequence tags (ESTs) can be used to identify genes but provide no information about the entire gene, the product, the function of the product, or its association with any genetic disorder. Using gene-hunting software, researchers can take a short sequence of DNA and use it to search gene databases, turning up theoretical information about the sequence.
For example, the sequence may belong to a gene encoding a plasma membrane protein or may be similar to one in yeast that is involved in cell–cell signaling. At the present time, there are tens of thousands of ESTs and gene-hunting patent applications fi led at the U.S. Patent Office. The unresolved question at the moment is how much you need to know about a gene and its usefulness to
file a patent application. How should utility be defined? The diagnosis of disease certainly meets the
definition of utility. Many discoveries have identified disease-causing genes, such as those for cystic
fibrosis, fragile-X syndrome, breast cancer, colon cancer, and obesity. Many of these discoveries have patents based on diagnostic utility. An increasing number of patent applications are being fi led for discoveries of hereditary-disease-causing genes. These discoveries frequently lack immediate use for practical therapy, however, because gene discovery does not always include knowledge of gene function or a plan for developing a disease therapy.
The impact of a decision about gene patents is enormous. Pharmaceutical and biotech companies have invested hundreds of millions of dollars in identifying genes to be used in developing diagnostic tests and drugs. Without patents, it is unlikely that companies will invest in developing these drugs.
However, patenting genes can lead to royalty-based gene testing accompanied by exorbitant fees and licensing arrangements requiring payment to companies that own the patent on a particular gene. A case now before the courts about the patents on two genes used to test for breast cancer may determine much of the future of patented genes. As the results of the Human Genome Project redefine health care, these issues take on importance for everyone.
- What is a patent?
- Is patenting a gene different from patenting another product or invention? Should patents be awarded for genes under any circumstances? Explain.
- If patenting genes were not allowed, do you think it would slow gene research in a significant way
RUBRIC
Excellent Quality
95-100%
Introduction 45-41 points
The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned.
Literature Support
91-84 points
The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned.
Methodology
58-53 points
Content is well-organized with headings for each slide and bulleted lists to group related material as needed. Use of font, color, graphics, effects, etc. to enhance readability and presentation content is excellent. Length requirements of 10 slides/pages or less is met.
Average Score
50-85%
40-38 points
More depth/detail for the background and significance is needed, or the research detail is not clear. No search history information is provided.
83-76 points
Review of relevant theoretical literature is evident, but there is little integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are included. Summary of information presented is included. Conclusion may not contain a biblical integration.
52-49 points
Content is somewhat organized, but no structure is apparent. The use of font, color, graphics, effects, etc. is occasionally detracting to the presentation content. Length requirements may not be met.
Poor Quality
0-45%
37-1 points
The background and/or significance are missing. No search history information is provided.
75-1 points
Review of relevant theoretical literature is evident, but there is no integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are not included in the summary of information presented. Conclusion does not contain a biblical integration.
48-1 points
There is no clear or logical organizational structure. No logical sequence is apparent. The use of font, color, graphics, effects etc. is often detracting to the presentation content. Length requirements may not be met
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Work of The Human Genome Project