Biomedical Engineering Reference
In-Depth Information
Patenting
Cloning babies is not likely to be the most immediate or widespread use
of genetic engineering in the biotech industry. Already, genetic informa-
tion is being put to use to carry out genetic tests on humans, to improve
drugs' performance by tailoring them to a variety of diseases, and to
splice genes across species of plants and bacteria. All of these techniques
are ostensibly aimed at great benefit for humans and the relief of suf-
fering, and all are or have the potential to be highly profitable.
The gateway to profit is the patent. A patent gives its holder the right
to exclusive use of an invention for twenty years, during which time roy-
alties are charged for licenses to use the patented information, either for
a marketable application or further research. Although patent laws vary
nationally and regionally, an international regime of patent law has been
established by means of the World Trade Organization's (WTO) require-
ment that member nations respect intellectual property rights as defined
according to North American and European standards. Adherence to the
1995 Trade Related Aspects of Intellectual Property Rights (TRIPS)
agreement is part of the price of entry into the global economic market,
and noncompliant members will be placed on trade “watch lists” that
threaten eventual trade sanctions and discourage investment even in the
short term. At least in theory, patents can only be obtained for inven-
tions, not discoveries in nature; and patentable inventions must have
clear and specific utility. Enforcement of these criteria has been ques-
tionable in practice. Patent applications have been filed for genes and
segments of genes, even though these are not inventions, and no useful
process or product based on them has yet been proposed in any detail.
As of 2000, according to a U.S. Department of Energy report, over three
million gene-related patent applications had been filed, mostly in the
United States, Europe, and Japan.
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In the emergent global market, patented drugs are big international
business. It is now clear that the number of functional human genes is
much smaller than once anticipated, which may mean that pharmaceu-
tical companies will be able to produce genetically engineered drugs more
quickly, even though there may turn out to be fewer of them to produce,
and production may depend on further study of the proteins genes code
for, not just a knowledge of genes themselves. Human Genome Sciences,
based in Rockville, Maryland, already has drugs in clinical trials.
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