Instructions:Step 1: Read the article found in section 9A: Biochemical Connections: Law in your digital book. (attached) Using the Concorde’s Online Library, your digital material, and other scholarly websites, discuss the following:What are your feelings regarding the article?Describe, in detail, what the following statement means, “What can be patented is purified DNA containing the sequence of the gene and techniques that allow the study of the genes.”How do you see the patenting of genes/DNA impacting science and medicine over the next 30 years?Do you believe this trend is ethical? Why/why not?Step 2: Compile your thoughts & research and write a 3-5 page paper addressing the topics and questions above.Step 3: Once complete, save your file and submit.You are required to have at least two outside resources, at the scholarly level. Wikipedia is not acceptable. You are encouraged to use Concorde’s Online Library: Gale Resources (Links to an external site.)Assignment Submission:The use of outside resources is required and all papers must be cited and written in APA format.Once you have completed the assignment, click the Submit Assignment option in the menu to the right and select a format for submitting your assignment.Click the Submit Assignment button when you are ready.
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9ABiochemical Connections: Law
Who Owns Your Genes?
“There is a gene in your body’s cells that plays a key role in early spinal cord
development. It belongs to Harvard University. Incyte Corporation, based in
Wilmington, Del., has patented the gene for a receptor for histamine, the compound
released by cells during the hay fever season. About half of all the genes known to be
involved in cancer are patented.”
Following the explosion in information that
came from the Human Genome Project (see Biochemical Connections 9B),
commercial firms, universities, and even government agencies began to look for
patents on genes, which began a long philosophical and legal battle that continues to
this day. Human cells have about genes, which are the blueprint for the trillion cells
in our body. About percent of the human genome has been patented. As of 2006,
Incyte Corporation owned about percent of all known human genes.
So the question that comes to mind is, “how can a company patent a biological
entity?” Well, clearly they cannot actually patent you or your genes, at least not the
ones you carry around. What can be patented is purified DNA containing the
sequence of the gene and techniques that allow the study of the genes. The idea of
patenting information began with a landmark case in 1972 when Ananda M.
Chakrabarty, a General Electric engineer, filed for a patent on a strain
of Pseudomonas bacteria that could break down oil slicks more efficiently. He
experimented with the bacteria, getting them to take up DNA from plasmids that
conferred the clean-up ability. The patent office rejected the patent on the grounds
that products of nature and live organisms cannot be patented. However, the battle
was not over, and in 1980 the Supreme Court heard the appeal in the same year that
the techniques of molecular biology and recombinant DNA technology really began
to take off. Chief Justice Warren Burger declared arguments against patenting life
irrelevant by stating, “anything under the sun that is made by man” could be
patented. The ruling was close, only in favor of Chakrabarty, and the ramifications
continue to this day. Patents have been issued for gene sequences, whole organisms
such as specific bacteria, and cell types like stem cells. A patent on a clone gene or
the protein it produces gives the owner exclusivity in marketing the protein, such as
insulin or erythropoietin. As of 2005, the largest holder of scientific patents was the
University of California, with more than patents. The U.S. government was second
with , and the first commercial enterprise on the list, Sanofi Aventis, came in third
at (Figure 9.7).
Figure 9.7
This map of the chromosomes offers an indication of how often genes have been
patented in the United States. Each colored bar represents the number of patents in
a given segment of a chromosome, which can contain several genes. Patents can
claim multiple genes, and one gene may receive multiple patents. As a result, the
number of patents indicated for each chromosome does not necessarily match the
sum of the values represented by the colored bars.
(Laurie Grace)
There are many issues stirring the controversy. Proponents for the patent system
point out that it takes money to drive research. Companies will not want to invest
hundreds of thousands to millions of dollars in research if they cannot get a tangible
gain. Allowing them to patent a product means they can eventually recover their
investment. Opponents believe a patent on what amounts to information stifles
more research and even prevents the advancement of medicine. If a company holds
the patent to a gene known to be involved in a disease, then others cannot study it
effectively and perhaps come up with better or cheaper treatments. The latter point
of view has come under intense scrutiny recently because patents on diagnostic
genes inhibit both research and clinical medicine. At the heart of the conflict are
patents for two genes related to breast cancer, BRCA 1 and BRCA 2, both owned by
Myriad Genetics, Inc., of Salt Lake City. In 2009 a group of patients, doctors, and
research professionals brought a suit to invalidate those patents. They argued that
the two genes are “products of nature” and should never have been patented in the
first place. The long-term effects of such a suit are important enough that the
American Civil Liberties Union has joined the plaintiffs.
Opponents of gene patents claimed a big victory in March 2010 when Federal Court
Judge Robert Sweet ruled against Myriad in the suit of BRCA 1 and BRCA 2, stating
the human genes cannot be patented. So who owns your genes? At the moment, you
do. See the Hot Topic on breast cancer at the end of this chapter for more about
BRCA 1 and 2.
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