Vernellia R. Randall
Professor of Law and
Web Editor
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Annotated Bibliography
Bridget Ammons
Health Care Law
The University of Dayton
Spring 2000
| Since 1980, the U.S. Patent and Trademark Office (PTO) have awarded patents on the cellular structure of living organisms.
Recently, the subjects of these patents have moved to human cells. Because of the personal nature of the human genetic material,
the issue of patenting genes has spawned a controversy.
Proponents of gene patenting claim such patents are justified as a reasonable reward for investor risk and the hard labor of the
researcher. Opponents of granting gene patents claim there is substantial difference between bio-patents and traditional subject
matter, because bio-technicians manipulate genes rather then invent them.
Whether the United States Patent Office should issue patents on gene sequences is a difficult question. It involves complex laws and
complex science, as well as a whole host of social, religious, and moral aspects. The question of whether genes should be patented is
one where the efforts of research scientists and the progress of science must be balanced against free access public knowledge of
their genetic heritage. One author has described this as a battle of universal heritage vs. reward for human effort.
Three principle arguments have been articulated against DNA sequence patents:
(1) Patents should only be granted to inventions not on something that is a discovery of nature. DNA sequences are a
discovery of nature and therefore, not patentable.
(2) DNA sequence patents potentially restrict research in particular areas and may inhibit progress in medical research in
the treatment of a disease.
(3) DNA sequences patents are morally objectionable because the patent creates a property right in the building blocks
that make up mankind.
(1) The effort involved in locating, characterizing, and determining the role genes play elevate the discovery of their
sequences to the status of an invention not merely a discovery.
(2) Discoveries of this nature are expensive, in terms or time and money; thus, obtaining a patent may be the only way that
companies or organizations can protect their investments.
(3) Patents may promote research and development because patents facilitate focusing of effort and inhibit duplication of
research. [5]
During my research, I learned of the concerns that minorities have about the genome project that I had not occurred to me
previously. For example, the concerns of African- Americans with the information produced from the Human Genome project are
far ranged from misrepresentations in taxonomy to defining minorities in a "biological underclass". Therefore, Howard
University launched the African- American Diversity Project, intending to bring African-Americans into mainstream genome
research and to ensure that genetic medicine does not pass by the African -American population.
Another project, called the
Human Diversity Project collected biological samples focusing on populations that have been geographically isolated or have
distinct culture and language. The material would be shared with scientists worldwide for research on human history and biology.
The information could be used to construct genealogical trees and may be used to answer the question: How much do individuals
vary from the composite "reference" sequence that will emerge from the human genome project. When researchers first developed
the HGDP, they misjudged how indigenous groups, which were listed, as relevant to the study, would perceive the idea. Groups
representing indigenous people, such as the World Counsel on Indigenous Peoples (WCIP), were outraged that specific populations
were being "targeted" without prior consultation and dubbed the HDGP the "vampire project." Others accused the researchers of
racism and "genetic colonialism."
Also During my research, the topic of gene sequence patents was very newsworthy. First, the government-funded Human Genome
project (HGP) and Celera Genomics decided such collaboration was impossible. The initial intent was to merge research, so that the
merged HGP/Celera Database would be more complete and more accurate. However, collaboration was found to be impossible, due
to HCP's responsibility to provide the public all information in its databases and Celera's responsibility to its shareholder's to
protect to intellectual property aspects of its databases Second, President Clinton and British Prime Minister Tony Blair issued a
joint statement regarding the HGP/Celera fiasco, saying, "Raw fundamental data on the human genome…should be freely available
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The following articles are included in this bibliography: |
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Annotated Bibliography
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· Department of Energy Office of Biological and Environmental Research, The Human Genome Program, (visited
April 5, 2000)
<http://www.ornl.gov/hgmis/faqs1.html/>
This site has everything you ever wanted to know about the human genome project as well as links to other sites, genome news,
articles, and papers. The site discusses the goals, progress, history, ethical, legal and social issues, benefits, and the science behind
the Human Genome Project. The Human Project's goal is discover all the genes within the genome (approximately 100,000 human
genes), make them accessible for further study, and to determine the complete sequence of the 3 billion subunits. This is quite a feat
considering that if the DNA sequence of the human genome were compiled into books, it would equal 200 volumes the size of the
Manhattan phonebook and would take 9.5 years to read aloud
The Human Genome Project is an international effort to sequence the human genome begun in October 1990. The project's
expected completion date is in the year 2003. The Human Genome Project is made up of the Department of Energy's Human
Genome Program and the National Institute of Health's National Human Genome Research Institute. Many laboratories around the
United States, numerous colleges, and universities receive funding from the Department of Energy or the Department of Energy to
do human genome research. Eighteen countries have established human research programs.
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Patent Law for non-lawyers: Patent Law for non-lawyers:
This section of the website covers the types of patents and requirements. This section is focused on patent laws applicable to genetic
engineering and biotechnology. A patent gives one the rights to prevent others from making, using, offering for sale, or selling an
invention in the United States or importing the invention in the United States. U.S. patents are only valid in the U.S. Utility patents
are granted to an individual who invents any new and useful process machine, manufacture, or composition of matter, or any new
and useful improvement thereof. There are three basic requirements for a utility patent; non-obviousness, novelty, and utility. After
the patent expires, the public can freely make use of the subject matter of the patent.
There are time limits for patents. First, one cannot patent subject matter that has
The website is a simplistic overview of patent laws but gives practical advice to
Genetic Engineering for non- scientists: Genetic Engineering for non-scientists:
The website defines genetic engineering as a heritable, directed alteration of an organism. The website describes genetic engineering
as the most powerful and least understood tool of biotechnology. The Human Genome project does not involve genetic engineering
but it is important in arguments concerning parenting. This website gives an easy to read explanation of basic genetics.
DNA is the building blocks of matter contained in all life. DNA is made up of genes that give us many of our physical
characteristics. All the DNA in our cells is contained in 46 chromosomes. Chromosome is basically a long piece of DNA coiled up.
Humans get 23 chromosomes from their mother and 23 chromosomes form their father. Thus, an egg cell will contain one each of
chromosomes 1- 22 and have one X-chromosome. A sperm cell will contain one each of chromosomes 1- 22 and either one X
chromosome or a Y chromosome.
DNA is a long double-stranded helix. Each stand of DNA in the helix is said to be complementary. Complementary is that one
strand of DNA determines the sequence on the other. DNA is a long ticker tape with written instructions or genes. Genes are
discrete units of information that tells the cells what to do. There are controls that ensure that the correct genes get expressed in the
correct tissues. There are systems in cells that read the DNA and translate it into proteins. DNA contain the instructions and
proteins carry these instructions out
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>Kristen Phillipkoski, "Celera: Genome Map Complete" (visited April 4, 2000)
<http://www.wired.com/news/technology/0,1282,35479,00.html>
The private company Celera made the announcement on April 4, 2000, officially beat the Human Genome Project in mapping the
human genome. The company finished the staggering task of located and mapped all 3 billion units of a human being's DNA. Celera
stated that they will publish the sequences on the Internet with no restrictions for researchers to use the information. To map the
genome, Celera used the largest civilian supercomputer and a "shotgun technique" [28] to put together the sequences. A Celera's
scientist developed the algorithm for the shotgun technique the company used to map the genome of the fruit fly. Celera has plans to
patent 500 genes. They had filed for 6,500 patents on gene sequences and submitted the paperwork on the genetic information but
will only follow through with the patents on genes that may have significant for drug development. The company's stock price
surged and was the volume leader on the New York Stock Exchange after Celera's announcement.
It is amazing that Celera finished the mapping the genome in such a short time. Mapping is only the first part of the objective of both
Celera and the Human Genome Project. Mapping the genome is just finding where the genes begin and where the end. The Human
Genome Project has not done accomplished this yet. The method that Celera used is controversial in the scientific community. The
Human Genome Project is using techniques that are more slow and common. Celera being finished mapping the genome does not
mean that they have not elucidated the actual sequences of all the genes. The sequences themselves are the most important part of
their objective. Although, this announcement may scare some people because a company will finish sequencing and "own" medically
important genes. This does not mean that Celera will be able to get a patent. That will be something for the U.S. Patent Office to
decide.
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· Patricia Kahn, Genetic diversity project tries again; Human Genome Diversity Project includes related article on
African-American project, 266 Science 726 (1994).
Human Genome Diversity Project:
Genetic researchers from Yale University and University of California at Berkeley developed the Human Genome Diversity Project
(HGDP). The primary purpose of HGDP was to study the genetic basis of disease susceptibility. HGDP's plan was to (1) prepare
cell lines and DNA from blood, hair or salvia samples taken from anonymous individuals in different populations and (2) prepare
databases of information accumulated about these cell lines and DNA.
The collection of samples was to be focused on
populations that have been geographically isolated or have distinct culture and language. The material would be shared with
scientists worldwide for research on human history and biology. The information could be used to construct genealogical trees and
may be used to answer the question: How much do individuals vary from the composite "reference" sequence that will emerge from
the human genome project.
Due to the controversy, the International Bioethics Committee of the United Nation's Educational, Scientific and Cultural
Organization (UNESCO) will set up a subcommittee and hold hearings to ensure that, if HGDP goes forward, all groups of
indigenous peoples will be able to speak on these issues and international guidelines for the project or projects similar to HGDP will
be defeated.
This article is interesting because it gets it set forth the controversy in detail and offers opinions from both researchers and
indigenous groups. The article also demonstrates how political and social issues are intertwined with scientific ones and points out
those researchers who ignore political and social issues do so at their peril. Perhaps, the initial errors in HGDP were a failure to
communicate and a failure to encourage participation from leaders of indigenous groups, from leaders of indigenous groups from
the beginning of the project. In that way, guidelines would be drifted and the HGDP, if agreed upon by all parties involved, would
be felt to be an example of international cooperation rather then colonial exploitation.
African-American Diversity Project:
Immunogenetist, Georgia Dunston, of Howard University launched the African- American Diversity Project, intending to bring
African-Americans into mainstream genome research. This project is to ensure that genetic medicine does not pass by the African
-American population. Dunston concern is based on the fact that virtually all-human genome research is done on samples from
Caucasian donors. This is particularly disturbing when scientists known that Africans are oldest and most genetically diverse people.
The lack of knowledge of the genetic information will have severe effects on medicine, such as tissue typing for organ transplants in
African-Americans. The key to knowledge is to have biological material from African- Americans to study and that is where
Dunston's African-American pedigree project (G-RAP) comes in. Dunston's project has as its primary objective the identification
and characterization of DNA polymorphic markers that will be useful in mapping genes underlying diseases or susceptibility of
diseases common in African-Americans.[24][24]The long-range goal of G-RAP is to improve the health of African-Americans through
research on DNA variability. This project also helps Howard University students to receive training and conduct research in genetics
thereby increasing the African American scientist participation in human genome research.
I think the Human Genome Project should ensure that researchers sample a diverse population of races so the composite genetic[24]The long-range goal of G-RAP is to improve the health of African-Americans through
research on DNA variability. This project also helps Howard University students to receive training and conduct research in genetics
thereby increasing the African American scientist participation in human genome research.
I think the Human Genome Project should ensure that researchers sample a diverse population of races so the composite genetic |
Karl Theif, "Celera and NIH's Doomed Romance" visited March 14, 2000)<http://www.doubletwist.com/news/>.
After recent discussions about how to potentially merge genomic databases, the government-funded Human Genome project (HGP)
and Celera Genomics decided such collaboration was impossible. The initial intent was to merge research, so that the merged
HGP/Celera Database would be more complete and more accurate. However, collaboration was found to be impossible, due to
HCP's responsibility to provide the public all information in its databases and Celera's responsibility to its shareholder's to protect
to intellectual property aspects of its databases.
These early discussions apparently envisioned an alliance similar to Celera and National Institute of Health's cooperative effort to
complete the fruit fly genome earlier this year, in which public data was compared to Celera's own work, merged and jointly
published. But the potential commercial value of the fruit fly data is insignificant to that of the human genome.
With respect to the human genome, Celera's data released for "pure research applications," [26] but would restrict any commercial
use of its proprietary data, whether it is by a databases provider or a drug company. The problem with the merging of the databases
is that it would involve the works of both the public and private efforts, so each group's interests would be inexorably tied up in the
work.
This conflict has served to enforce the growing stereotype of biotechnology companies as greedy corporations that have power to
deny the public rights to their own genetic make-up. President Clinton and British Prime Minister Tony Blair have issued a joint
statement regarding the HGP/Celera fiasco, saying, "Raw fundamental data on the human genome…should be freely available to
scientists everywhere." [27] Unfortunately, the message taken by investors, demonstrated by the recent plunge in the biotech stock
market, is that corporations having hampering the progress of science and the government intervention are coming quickly.
This article clearly sets forth the problems inherent in allowing patents based on human genome data. The way the system operates
today allows public information to come second to private stock profits.
Bridgid Quinn, "U.S. Patent Policy Unaffected by the US/UK Statement on Human Gene Sequence data" (visited on
March 20, 2000) <http://www.uspto.gov/web/offices/com/speeches/00-17.html>
This is the United States Patent Trademark Office reaction two days after the joint statement made by the United States and the
United Kingdom concerning human genetic sequences. The statement issued by President Bill Clinton and British Prime Minister
that urged "raw fundamental data on the human genome…should be made freely available to scientists everywhere." The Patent
Office stated that genes and genomic inventions remain patentable.
I think the impact that the joint statement between the U.S. and U.K. had on investors and the stock market was very reactionary.
The investors apparently believed that this statement meant that government were going to step in and render genes sequences
un-patentable and therefore, the biotech industry would no longer be profitable.
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