Race, Health Care and the Law

Speaking Truth to Power!

Who owns the Human Genetic Code

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Vernellia R. Randall Annotated Bibliography

Professor of Law and
Web Editor
Bridget Ammons
Health Care Law
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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
What's New the human genetic material, the issue of patenting genes has spawned a
Awards and Recognitions controversy.

Proponents of gene patenting claim such patents are justified as a reasonable

Chapters reward for investor risk and the hard labor of the researcher. Opponents of
granting gene patents claim there is substantial difference between bio-
Health Status
Organization and Financing
patents and traditional subject matter, because bio-technicians manipulate
Access to Health Care genes rather then invent them.
Quality of Health Care
Health Care Research
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 Health Care Research Whether the United States Patent Office should issue patents on gene
Bio-ethical Issues
Health and Human Rights sequences is a difficult question. It involves complex laws and complex
International Issues science, as well as a whole host of social, religious, and moral aspects. The
The Health Care Challenge question of whether genes should be patented is one where the efforts of
Eliminating Disparities 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.

Syllabi Three principle arguments have been articulated against DNA sequence
AIDS patents:
American Health Care Law
Bioterrorism (1) Patents should only be granted to inventions not on something that is a
Health Care Malpractice
Tobacco discovery of nature. DNA sequences are a discovery of nature and therefore,
Violence and Public Health 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.
Surveys
(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
Favorite Poetry genes play elevate the discovery of their sequences to the status of an
Invictus invention not merely a discovery.
The Bridge Poem
Still I Rise (2) Discoveries of this nature are expensive, in terms or time and money;
No Struggle No Progress
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

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 (3) Patents may promote research and development because patents
Related Websites facilitate focusing of effort and inhibit duplication of research. [5]
Race and Racism
Gender and the Law During my research, I learned of the concerns that minorities have about the
Legal Education
Personal Homepage 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."

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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
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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
The following articles are included in this bibliography:
A bitter battle over insulin gene; University of California loses patent suit
against Eli Lilly
Celera and NIH's Doomed Romance
Celera: Genome Map Complete
Genetic diversity project tries again; Human Genome Diversity Project,
includes related article on African-American project
Genome Research: Fulfilling the Public's Expectations for Knowledge
and Commercialization
Genomic sequence information should be released immediately and
freely in the public domain
Patent Law and Human Genomics
Patent law for non-lawyers and genetic engineering for non-scientists
Religion and Gene Patenting: rift between scientists and religious
leaders
Human Genome News, Should the Public-Minorities in Particular- Be
Concerned About the Human Genome Project?
The Human Genome Program
The patenting of DNA; concerns that may impede innovation and
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cooperation.
Universal Heritage v. Reward for Human Effort
U.S. Patent Policy Unaffected by the US/UK Statement on Human Gene
Sequence data
Annotated Bibliography
· 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
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Department of Energy or the Department of Energy to do human genome
research. Eighteen countries have established human research programs.
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.
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 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

· >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
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 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.

· Patricia Kahn, Genetic diversity project tries again; Human Genome

Diversity Project includes related article on African-American project, 266
Science 726 (1994).
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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
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 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.

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 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
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 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)
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 <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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 Contact Information:
Professor Vernellia R. Randall
Institute on Race, Health Care and the Law
The University of Dayton School of Law
300 College Park
Dayton, OH 45469-2772
Always Under Construc tion! Email: randall@udayton.edu

Last Updated:
03/10/2010

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since Sept. 2001

Copyright @ 1993, 2008. Vernellia R. Randall

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