1
LEGAL ASPECTS OF MANAGING
TECHNOLOGY
4th Edition
Biotechnology: Patent Issues
and Other Policy Matters
Lee Burgunder
INTRODUCTION
Most business analysts acknowledge that biotechnology could very well be the most important investment
frontier in the 21st century. In very simplified terms, biotechnology refers to the use of biological processes
and materials to help solve problems and satisfy needs. Biotechnology is nothing new. The brewing of
beer, for instance, which dates back thousands of years, relies on yeast for fermentation. Recent advances
in understanding the building blocks of life, however, have been truly remarkable. These discoveries,
coupled with significant improvements in computer technologies, have caused the field to advance at an
exponential rate. Just think of all the diverse ways in which biotechnology is now being used, especially in
the health care industry and in agriculture. It seems that almost every day now, leading newspapers
prominently report on biotechnology milestones in animal cloning, genetic testing, pest-resistant crops, and
potential new gene therapies. Even notions that only a few years ago were merely the creations of
imaginative science fiction writers, such as biological machines and computers, now seem within the realm
of reality.
Rapid technological change often breeds substantial social distrust. Society depends on established
norms and rules that govern the patterns of life. New technologies, though, often challenge the accepted
social frameworks, leading to resistance from powerful groups who fear the consequences that may result
from revised ways of doing things. The Internet, for instance, has stirred a hornet’s nest of legal and
regulatory opposition on a wide variety of matters, such as piracy, privacy, and pornography. Likewise, the
revolution in biotechnological developments has been beset by social opposition in almost every corner.
Indeed, the intensity of the debates has proven to be particularly emotional, perhaps because the subjects
are no longer merely social and economic, but rather involve decisions about the very essence of life itself.
This chapter reviews many of the important emerging issues and public debates that have accompanied the
biotechnology revolution. A brief description of how genetic engineering works and how it can be used is given
first. In this regard, the chapter highlights the importance of the Human Genome Project as well as advances in
cloning. Next, the chapter moves to patent issues. As you can probably imagine, biotechnology raises a host of
concerns in this regard, especially since, with a patent, one is essentially talking about human ownership of
living things. The chapter then proceeds to discuss other controversial matters raised by biotechnological
developments, such as food production and labeling, biological diversity and safety concerns, stem cell
research, gene testing and discrimination, gene therapies, and criminal responsibility.
BASICS OF GENETIC ENGINEERING
All living thing are comprised of cells, which are the fundamental engines of life. Cells need instructions to
regulate what they actually do, and these instructions come from a molecule called deoxyribonucleic acid,
or DNA. Interestingly, the DNA of every organism is made up of the same four nucleotides, which are
commonly identified by their bases (called A, T, C, and G)1 and which are physically arranged in pairs, as
1
The structure of the four types of nucleotides is the same except for differences in the bases. The base letters stand for Adenine, Thymine, Guanine,
and Cytosine.
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depicted in Exhibit 1. What makes living things different are the ways in which the base pairs of
nucleotides are organized and arranged. For instance, the DNA in humans is arranged in 24 separate
chromosomes that vary in length from about 50 million to 250 million base pairs. The sequence of the base
pairs in all humans is essentially the same, differing only in relatively small ways that account for the
individual differences among human beings. So, although you may think that you are very different from
others around you, in the grand scheme of nature, you really are not. Thus, there is, in effect, a human
genome, which consists of the complete set of DNA effectively shared by all human beings. As mentioned,
different kinds of organisms are different because their genomes have distinct DNA sequences. The
genomes also vary in size. For instance, some bacteria have as few as 600,000 DNA base pairs, whereas,
for mice and humans, the number is closer to 3 billion.
The manner in which DNA controls the operation of cells is very complex, and scientists are only
beginning to understand the dynamics involved. Researchers have known for some time that there are
sequences of base pairs within DNA that provide instructions for cells to make proteins. These sequences
are called genes. Without getting too technical, a cell obtains instructions from a gene through an
intermediate molecule called messenger RNA, or simply mRNA. In effect, mRNA is like a template that
uses the information from the DNA to instruct ribosomes in the cell to build amino acids into a specific
protein. It is really the resultant proteins that are most critical, because they determine how the cell
functions and contributes to the organism. As an example, insulin is one protein that is produced by cells
through this process.
EXHIBIT 1
The Structure of DNA
•
The structure of the four types of nucleotides in DNA is the same except for differences in the four
bases:
Adenine
Thymine
Cytosine
Guanine
A G C A T A A G C C G T . . . Nucleotide bases
+ + + + [weak bonds] + + + +
T C G T A T T C G G C A . . . Nucleotide bases
•
DNA is a double-stranded molecule held together by a weak bond between pairs of nucleotide
bases (“base pairs”):
•
In nature, A only pairs with T; G only pairs with C. Thus, the base sequence of each DNA strand
may be deduced from its partner.
•
The DNA sequence is the order of the nucleotide base pairs.
The link between genes and proteins provides opportunities for scientists to potentially manipulate
basic life processes in ways that might benefit individuals and mankind. For example, if scientists can
locate the gene that encodes cells to make insulin, then they might employ techniques that utilize the gene
to efficiently produce substantial quantities of the protein for use as a drug by diabetics. One possibility is
to remove that gene and then introduce it into the DNA of a bacterium, which will allow the bacterium to
make the protein. The beauty of this process is that bacteria multiply rapidly, so that each new cell also will
contain the gene that produces the desired protein. Thus, by genetically engineering a new form of bacteria,
you end up with what is essentially a protein factory, which in this case provides substantial quantities of
insulin. As we will explore in this chapter, there are many other possible ways to use genes once they have
been located. For instance, one might take a gene associated with a pest-resistant protein and incorporate it
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
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into a particular crop, thereby allowing it to deter bugs without having to apply insecticides. Also, knowing
the “correct” sequence and function of important genes makes it possible for doctors to recognize when
genes are defective and what harms might result. Such an understanding might enable scientists to develop
tests to identify the defective genes, which not only has predictive value, but also creates opportunities to
prevent medical problems at their source.
Of course, all of these useful techniques depend on two vital pieces of information: (1) being able to
identify gene sequences within the DNA and (2) knowing what functions the genes instruct the cells to
perform. One enormous problem is that most of the base pair sequences in DNA are not components of
genes. For instance, scientists now believe that only 2% of the human genome actually includes genes.
What the rest does is still a mystery. Some of it may be “junk” that has no function, but scientists surmise
that other parts may have purposes that only further study will uncover. Nonetheless, consider the daunting
task of sifting through the 3 billion base pairs of the human genome to find one of the 25,000 genes, having
an average length of around 3,000 base pairs.2
Clearly when one is dealing with so much information, it would be nice to have some kind of “map” to
help one locate particular pieces of data. The most important goal is to formulate an accurate map of the
human genome, but deriving maps of other organisms is important also. For instance, if scientists
understand the genome for certain bacteria, parasites, or mosquitoes, they may be able to formulate
measures to prevent the transmission of diseases. Also, other organisms may produce unique proteins that
might have useful applications within genetically modified organisms or for the development of
pharmaceutical products. As with humans, knowing that organism’s genome will facilitate efforts to devise
beneficial products and processes.
Determining the genome of other organisms also can help scientists understand the human genome.
For one, other organisms often have genomes that are shorter and simpler than the human genome.
Therefore, they may be simpler to decipher. In addition, it is far easier and ethically acceptable to
undertake experiments with nonhuman organisms. These experiments may allow researchers to
recognize gene sequences within the other life forms and to understand their functions. If scientists
then find similar DNA sequences within the human genome, they may be able to gain some valuable
insights. Genome researchers already have mapped complete sequences for, among other things, a
bacterium, a parasite, yeast, a fruit fly, a mosquito, and a roundworm. However, in 2002, they were
most excited by the virtual completion of the genome map for a mouse, since the mouse is expected to
share many characteristics with the human genome. Scientists hope that by conducting further studies
on mice, they may now be able to learn vital information about genetic functions within the human
genome.
THE HUMAN GENOME PROJECT
In 1986, the U.S. Department of Energy (DOE) announced that it was formulating a plan, known as the
Human Genome Initiative, to determine the reference sequence of DNA in human beings.3 During the next
couple of years, the DOE along with the National Institutes of Health (NIH) jointly developed a course of
action. In 1990, the agencies embarked on what they expected would be a 15-year endeavor to decipher the
genetic code of human beings. Logically, the effort was termed the Human Genome Project.4
The procedures used to decipher the sequence of the 3 billion base pairs are extraordinarily complex.
Looking at the process from an extremely simplified level, essentially two routes are used to unlock the
mysteries of the DNA code. With one method, scientists essentially “cut” the DNA into short fragments
and use sophisticated analytic techniques to determine the sequences of the fragments. The fragments of
sequenced data are then pieced together by finding overlapping segments within them. Although computers
can be used to automate some of the process, the overall procedure is extremely tedious and time
consuming. Nonetheless, it does provide a very accurate mapping of the human DNA sequence. This
process by itself, though, provides little information about what functions the sequences might have. In
particular, it does not specifically hone in on the segments that constitute genes. Other research methods,
therefore, must be used to make these determinations.
2
The largest known gene is 2.4 million base pairs.
All human beings would have some slight differences from the reference sequence. However, the genome of every individual human is practically
the same as the reference, sharing well over 99% of the reference DNA map.
4
The official website for the Human Genome Project is at http://www.doegenomes.org. The project was completed in 2003.
3
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
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The other technique used to sequence human DNA does not provide information about the entire
human genome. Rather, its intent is to find the genes, and determine their sequences as efficiently as
possible. Because genes represent just 2% of the entire human genome, a process that focuses attention
only on these regions substantially reduces efforts in sequencing data. In the end, through this method, one
obtains a map that is far from complete, but that does indicate the sequences and locations of the vital
genes. Thus, to some, this method provides the most bang for the buck.
You should be wondering how scientists might be able to recognize the relevant DNA sequences that
make up the genes. One trick is based on the role of mRNA, which carries instructions for producing proteins
from the genes to the cell. In a sense, mRNA in cells already has found the genes and carries information
derived from them. Thus, if researchers can isolate mRNA and translate its information back into its original
genetic code, then they would learn the sequence of a gene—at least that portion of the gene that the cell uses
directly to make a protein. Scientists have achieved this goal by placing mRNA into an enzyme—derived from
a virus—that reverses the genetic process and turns the mRNA into a copy of the original genetic code. This
segment is logically called complementary DNA or cDNA for short. The relatively short cDNA segment now
can be sequenced using the methods described earlier. In this way, one knows the sequence of a gene,
although without understanding that gene’s function or its location within the entire genome. Scientists have
found ways, though, to find the position of the gene. For example, one method is to take small uniquely
identifiable portions of the cDNA, called expressed sequence tags or ESTs, and use them as probes for
locating and mapping the gene.
In 2001, the Human Genome Project and a private company, Celera Genomics,5 each published
substantially complete maps of the human genome sequence. By using sophisticated computer technologies
and novel techniques, such as ones utilizing cDNA, the researchers were able to advance their work so rapidly
that they easily beat the initial goals set out in 1990. The value that this work will contribute to future research
EXHIBIT 2
Information Learned from the Human Genome Project
•
•
•
•
•
•
•
•
•
•
•
The human genome contains 3.1647 billion nucleotide base pairs.
The average gene consists of 3,000 base pairs, but sizes vary greatly. The largest known gene is
2.4 million base pairs.
The total number of genes is between 20,000 and 25,000.
About 2% of the genome consists of genes, which encode instructions for the synthesis of proteins.
Some DNA that does not code for proteins may yet be an important determinant of chromosomal
structure and dynamics. It also may play a role in the development of new genes over time.
The order of almost all (99.9%) base pairs is exactly the same in all people.
The functions of more than 50% of the genes are unknown.
The human genome has “urban centers” that are dense with genes. These are composed
predominantly of bases G and C. There also are gene-poor “deserts” that are rich in the bases A
and T.
Genes are concentrated in random regions along the genome, with vast expanses of noncoding
DNA between. In contrast, the genes of many other organisms are more uniform, with genes spaces
more evenly throughout.
Chromosome 1 has the greatest number of genes (2,968), and the Y chromosome has the
fewest (231).
Scientists have identified 1.4 million locations where there are variations in a single base pair in the
genome. These are called single nucleotide polymorphisms (SNPs). Discovery of SNPs may lead to
a greater understanding of the differences among human beings, including susceptibility to
diseases.
Source: U.S. Department of Energy Human Genome Program, Genomics and Its Impact on Science and Society: The
Human Genome Project and Beyond, available at http://www.doegenomes.org. Click on Genomics Primer.
5
For information on work achieved by Celera, go to http://www.celera.com. In 2005, Celera ended its private subscription service to access its
genome databases, and instead dedicated them to the public domain. The data include information not only on the human genome, but also on certain
animals, such as mice and rats.
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
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is immeasurable. Indeed, the initial findings alone have led to some startling discoveries (see Exhibit 2). For
instance, before the Human Genome Project got well under way, scientists believed that the human genome
must contain more than 100,000 genes. However, it is now clear that the actual number of genes is somewhere
between 20,000 and 25,000. This total is surprisingly low, given that a roundworm has 19,100 genes and a
fruit fly has 13,600. Indeed, according to scientists at Celera, the human genome may only have around 300
genes that do not have similar counterparts in the mouse genome. This raises a fundamental question: If genes
are not the source of what makes humans so much more complex than other species, then what is?
The answer is that proteins are the real building blocks of life. Because genes provide the codes for
cells to produce proteins, scientists once thought that there must be a different gene for every protein found
in the human body. However, the genome map demonstrates that the number of proteins far exceeds the
number of genes, meaning that more complex processes must be at work. Scientists surmise that genes may
be less like blueprints and may be more akin to building material lists. These lists essentially are given to
cells, which may make use of them in different ways. Some may make lots of one type of protein, some
may make none, and some may make weak or defective proteins. In addition, cells may form hybrid
proteins by splicing the instructions from different genes. For instance, a cell may use instructions from
gene A and gene B to make not only protein A and protein B, but other forms as well, such as protein AB
and protein ABB. For these reasons, scientists are beginning to believe that sequencing the human genome,
although extremely important, may soon be yesterday’s triumph. The new and perhaps more critical
frontier may be devising a dynamic model that explains the constellation of human proteins, known as the
human proteome.
CLONING OF ORGANISMS
ANIMAL CLONING
In 1997, the world was struck by the announcement that biotechnology research scientists at the Roslin
Institute in Scotland had successfully cloned an adult sheep. The birth of the lamb, which was given the
name Dolly, was greeted with both tremendous excitement and enormous fear. Beyond sheer intrigue, the
public quickly became aware that the ability to successfully clone higher life forms may result in
substantial public benefits in food production, medicine, and other applications. On the other hand, once a
sheep has been cloned, it does not stretch the imagination to begin considering the possibility that scientists
soon would understand how to clone human beings. And from this there emerge all the worries that
heretofore were simply the wild notions of science fiction authors, such as multiple duplications of sinister
leaders, creations of master races, and impersonal baby factories.
In the context of biotechnology, a clone is an exact replica of biological material. One element of
cloning that is not very controversial simply involves the duplication of genes or other pieces of
chromosomes so that they can be efficiently used in other applications. As noted before, a gene may be
spliced into the chromosome of a simple bacterium, which then will make multiple exact copies of the gene
(and its proteins) as it naturally divides. Not only can scientists use this process to produce useful proteins
for drugs and other applications, but they also can harvest the replicated genes and use them to create
transgenic plants and animals. The more intriguing form of cloning, however, involves the duplication of
whole organisms through a process called somatic cell nuclear transfer.6
Traditional gene-splicing methods used to create transgenic animals are frustrating because they are
extremely inefficient. Only about one-tenth of 1% of the animals born with these techniques assimilate the
desired genetic characteristics. For instance, assume that the goal is to create cows that produce milk
containing a particular useful nutrient. This may be achieved by splicing the appropriate gene into the
cow’s DNA during the fertilization process, but very few of the resultant animals actually will grow up and
provide the desired milk. Given how statistically difficult this is, wouldn’t it be nice if you could take the
occasional successful cow and then simply duplicate it? This surely would be a faster and cheaper way to
create an entire herd of cows providing especially nutritious milk.
6
The Department of Energy provides information on cloning on its website dedicated to the Human Genome Project. Go to
http://www.doegenomes.org and click on Human Genome Project Information. Click on Ethical, Legal and Social Issues and look for information
on Cloning. Another site providing information on cloning is http://www.howstuffworks.com. Click on Science Stuff and under Life Science, click on
Cloning.
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
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The goal with cloning is to create new cows that have the exact same DNA as the identified mature
cow. Fortunately, every cell in an organism’s body (except a red blood cell) contains the organism’s
complete set of DNA. Somatic cell nuclear transfer takes advantage of this in the following way. First,
scientists use a cell from the desired animal—perhaps a skin cell from the cow’s udder. They remove the
nucleus from that cell, which contains the entire strand of DNA. An egg cell is then removed from a
different cow and its nucleus is replaced with the nucleus from the desired cow. That egg is then implanted
into a surrogate mother cow, which will bear a clone of the desired cow if the pregnancy comes to a
successful term.
The major difficulty with this process is that cells become specialized as the organism grows from an
embryo, and the DNA adjusts to the differentiated cell environments by making unnecessary genes
inactive. To make a successful clone, one needs a way to essentially alter the nucleus from the
differentiated cell so that it reverts back to its nonspecialized embryonic state with all of the genes turned
back on. Prior to 1997, scientists did not believe this was possible, but the Roslin scientists discovered a
method to make this happen.7 The amazing result was the birth of Dolly.
The scientific and business communities are enormously excited by potential applications of animal
cloning. Genetic engineering already has made tremendous inroads in agriculture, and cloning furthers the
progress by enhancing predictability and efficiency.8 For instance, bioengineers have created cows that
provide leaner meat and produce more milk. They also have experimented with developing pigs that make
their own omega-3 fatty acids, which help prevent heart disease. In addition, it is now possible to introduce
into the embryos of farm animals genes that trigger the production of useful human proteins in controlled
locations such as in mammary glands. When these animals mature, they can be used for pharming—the
derivation of drug proteins from animal milk supplies. After the success with Dolly, it did not take
scientists long to transfer the techniques to other livestock, such as cows and pigs, and by 2001, farmers
had begun raising duplicates of prized animals. The Food and Drug Administration, though, indicated in
2002 that it considered the animals to be “experimental” and that numerous safety issues had to be
evaluated before food products derived from the clones could be sold.
When we look at animal patents, we will see that genetically engineered animals have numerous useful
applications in medical research. To further these ends, scientists have demonstrated that they can use
cloning techniques to duplicate rats, rabbits, and monkeys, among other animals. Medical researchers also
are beginning to look seriously at the possibilities of transplanting organs from bioengineered pigs to
humans to help alleviate the critical shortage of suitable human organs. Scientists are interested in pigs
because many of their organs are similar in size to those in humans. However, rejection of the very foreign
organs is a substantial hurdle. Nonetheless, through genetic engineering, scientists may be able to reduce
the likelihood of organ rejection. For example, in 2002, researchers blocked out a gene in pigs that is
responsible for making a sugar substance that triggers immune-system rejection in humans. In addition,
scientists produced four clones of one of those pigs in that same year.
Yet other applications of animal cloning techniques are possible. For instance, cloning may offer ways
to preserve endangered animal species or perhaps even restore extinct ones. As an example, in 2000,
scientists collected skin cells from an endangered gaur that had recently died and fused nuclei from those
cells into egg cells from a cow. These were then implanted into surrogate cows. Although there were many
miscarriages, one of the cows did give birth to a gaur, which was named Noah. The fact that a different
species can act as the mother is an intriguing development, one that offers tremendous potential benefits
but also one that some find ethically disturbing.
By 2005, scientists reported that they had successfully cloned cats and an Afghan dog.9 These results,
of course, raise the specter that people someday might be able to clone a beloved pet. Relatedly, scientists
reported in 2005 that they had successfully cloned a horse. Again, this may give individuals a way to
preserve a favorite animal friend or polo pony. In addition, professional sports organizations may now have
to consider whether they need to regulate breeding practices to prevent cloning of prized race horses or
olympic jumpers.
7
The Roslin Institute provides substantial information on its work with cloning at http://www.roslin.ac.uk. Click on Public Interest and then
Cloning.
8
Information about biotechnology in agriculture, including cloning, can be found at http://www.agbiotechnet.com.
9
For an excellent article describing these efforts, particularly the difficulties with cloning the dog, see Gina Kolata, “Beating Hurdles, Scientists
Clone a Dog for a First,” The New York Times (August 4, 2005), at A1.
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
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Although there have now been several successes with cloning animals, there have also been huge
setbacks that raise substantial questions about the future of the practice. For one, a large percentage of
the implanted embryos do not survive the gestation period. Also, many of the animals that are born have
birth defects. But maybe the most troubling news is that even the most celebrated success, Dolly, ended
up having an unusual disorder, for her cells seemed to prematurely age so that by the time she was just
one year old, she had the cellular makeup of a six-year-old sheep. Indeed, Dolly developed arthritis when
she was just five years old. Some fear that it may not be possible to turn back the cellular time clock when
cloning takes place, limiting the utility of current techniques. Nonetheless, scientists report that more
recently cloned cows do not seem to suffer from the same difficulties. Thus, all that can be said at this time
is that serious questions remain regarding potential health effects that result from animal cloning.
HUMAN REPRODUCTIVE CLONING
As mentioned, many see animal cloning as part of a slippery slope that inevitably leads to human cloning.10
There are two primary reasons why one might consider engaging in human cloning. The more obvious
concerns adults who want to raise children that are exactly the same in terms of genetic makeup as they are.
This notion is called human reproductive cloning. The other rationale is to employ cloning to create
embryonic cells—called stem cells—that scientists believe may have tremendous therapeutic benefits.
Logically, this practice is termed therapeutic cloning.
Although laws and regulations are based somewhat on political dynamics, they usually rest on rational
foundations as well, so that the social benefits they provide outweigh the costs. The concept of human
reproductive cloning faces tremendous public opposition because the benefits are not recognized as being
very high, while the social and ethical costs seem significant. For instance, human reproductive cloning
may help infertile couples bear children who are biologically related, while avoiding some of the ethical
issues resulting from current practices. However, the kinds of problems that have arisen with animals seem
that much more repulsive in the context of human babies. Even if these problems are someday corrected,
the whole notion of duplicating human beings raises substantial moral issues that the public will be slow to
overlook unless the benefits are more compelling. Thus, there currently is little controversy in the United
States that human reproductive cloning should be outlawed. Notwithstanding these objections,
Dr. Panayiotis Zavos, a U.S. fertility doctor, published a controversial article in 2003 titled “Human
Reproductive Cloning, The Time Is Near.”11 At that time, Dr. Zavos reported that he had prepared a cloned
embryo in an overseas lab for the purpose of human reproduction, and that he had several other patients
seeking reproductive clones. The U.S. reactions to this announcement, especially from religious and
political circles, were fast and furiously opposed. As of early 2006, several states had banned the practice
of human reproductive cloning, and the federal government was debating legislation that would forbid it
nationwide. In addition, the FDA had not yet approved any human reproductive cloning experiments in the
United States on safety grounds.
The public debates over human therapeutic cloning are much more intense than those about
reproductive cloning because the potential benefits to human health make the cost/benefit balance more
difficult to evaluate. The controversy took center stage in U.S. politics in 2001 when President Bush
spearheaded new government policies regarding stem cell research. This episode is discussed later in this
chapter, so further discussion of therapeutic cloning is deferred until that section. However, note that the
real holdup in passing a federal ban on human reproductive cloning is not because there is any question
that reproductive cloning should be prohibited.12 Rather, the question is whether legislation should outlaw
all human cloning or only reproductive human cloning. Also, some other countries, such as Great Britain,
have already passed laws prohibiting human reproductive cloning, but permitting experiments with
therapeutic cloning.
10
The American Journal of Bioethics provides information about the ethics of human cloning at http://bioethics.net. The Council for Responsible
Ethics also provides information at its website at http://www.gene-watch.org. Substantial information about reproductive technologies and bioethics
can be found at http://ethics.acusd.edu.
11
Information on Dr. Zavos and his work with reproductive cloning can be found on his website at http://www.zavos.org.
12
Since 1996, federal law has prevented the use of federal funds to further research that destroys embryos.
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
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BIOTECHNOLOGY PATENT ISSUES
As technology moves to new frontiers, it inevitably raises questions about the suitability of patent
protection for unforeseen discoveries. Nowhere is this debate more heated than in the realm of biological
and genetic engineering. The fundamental question is whether it is morally and economically appropriate
to grant an inventor exclusive rights to new life forms. Or, in short, should one be able to obtain a patent on
living things? The issue is not altogether new. Congress has addressed it previously in the context of
plants. But now the issues have risen to higher plateaus—to microorganisms, to strands of human DNA,
even to new types of animals. The Supreme Court set the stage for the new revolution in biotechnology
with its landmark decision in Diamond v. Chakrabarty.
DIAMOND V. CHAKRABARTY
United States Supreme Court, 1980
FACTS: In 1972, Chakrabarty filed a patent
application that claimed a human-made,
genetically
engineered
bacterium,
capable of breaking down multiple
components
of
crude
oil.
Chakrabarty’s patent claims were
of three types: first, process claims
for the method of producing the
bacteria; second, claims for an
inoculum composed of a carrier material
floating on water—such as straw—and the
new bacteria; and third, claims to the bacteria
themselves.
The patent examiner allowed the claims that
fell into the first two categories but rejected the
claim to the bacteria. His decision rested on two
grounds: (1) that microorganisms are “products
of nature” and (2) that as living things
microorganisms are not patentable subject matter
under Section 101. Chakrabarty appealed to the
Patent Office Board of Appeals, which affirmed
the patent examiner’s rejection. Chakrabarty
appealed to the Court of Customs and Patent
Appeals (today, such an appeal would go to the
Federal
Circuit),
which
reversed.
The
Commissioner of Patents and Trademarks
appealed to the Supreme Court.
DECISION AND REASONING: The question
before this Court is a narrow one of statutory
interpretation, requiring us to construe Section 101 of
the Patent Act. Specifically, we must determine
whether Chakrabarty’s microorganism constitutes a
“manufacture” or a “composition of matter” within the
meaning of the statute.
In cases of statutory construction, we begin with
the language of the statute. Unless otherwise defined,
words will be interpreted according to their ordinary
meaning. And courts should not read into the patent
laws limitations and conditions the legislature has not
expressed. In choosing such expansive terms as
“manufacture” and “composition of matter,” modified
by the comprehensive “any,” Congress was
contemplating that the patent laws would be given
wide scope.
The relevant legislative history, too, supports a broad
construction. The Patent Act of 1793 embodied
Jefferson’s philosophy that ingenuity should
receive liberal encouragement. The
committee reports that accompanied the
1952 amendments to the act inform us
that Congress intended statutory subject
matter to “include anything under the sun
that is made by man.”
This is not to suggest that Section 101 has no
limits or that it embraces every discovery. The laws
of nature, physical phenomena, and abstract ideas have
been held not patentable. Thus, a new mineral discovered
in the earth or a new plant discovered in the wild is not
patentable subject matter. Likewise, Einstein could not
patent his celebrated law that E = mc2; nor could Newton
have patented the law of gravity. Such discoveries are
manifestations of nature—free to all persons and
reserved exclusively to none.
Judged in this light, Chakrabarty’s microorganism
plainly qualifies as patentable subject matter. His claim
is not to a hitherto unknown natural phenomenon,
but to a nonnaturally occurring manufacture or
composition of matter: a product of human ingenuity
having a distinctive name, character, and use. A
previous case underscores the point. A scientist
discovered six naturally occurring root-nodule bacteria
that could be mixed into a culture and used to inoculate
the seeds of leguminous plants. This court denied
patentability, ruling that what was discovered was only
the handiwork of nature. The combination of species
produced no new bacteria, no change in the six species
of bacteria, and no enlargement of the range of their
utility. Their use in combination did not improve in
any way their natural functioning. They served the
ends nature originally provided, and they acted
independently of any effort by the scientist.
Here, by contrast, Chakrabarty has produced a new
bacterium with markedly different characteristics from
any found in nature and one having the potential for
significant utility. Chakrabarty’s discovery is not
nature’s handiwork but his own. Accordingly, it is
patentable subject matter under Section 101.
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
(continues)
9
(continued)
The commissioner argues that microorganisms cannot
qualify as patentable subject matter until Congress
expressly authorizes such protection. Its position
rests on the fact that genetic technology was
unforeseen when Congress enacted Section 101. The
commissioner argues that the legislative process is best
equipped to weigh the competing economic, social, and
scientific considerations involved and to determine
whether living organisms produced by genetic
engineering should receive patent protection. In
support of this position, the commissioner relies on this
court’s recent statement that the judiciary must proceed
cautiously when asked to extend patent rights into
areas wholly unforeseen by Congress.
It is, of course, correct that Congress, not the
courts, must define the limits of patentability, but it is
equally true that once Congress has spoken, it is the
province and duty of the judicial department to say
what the law is. Congress has performed its role in
defining patentable subject matter in Section 101; we
perform ours in construing the language Congress has
employed.
Broad, general language is not necessarily
ambiguous when congressional objectives require broad
terms. This court frequently has observed that a statute
is not to be confined to the particular applications
contemplated by the legislators. This is especially true in
the field of patent law. A rule that unanticipated
inventions are without protection would conflict with the
core concept of the patent law that requires novelty
for patentability. Congress employed broad, general
language in drafting Section 101 precisely because such
inventions are often unforeseeable.
To buttress their argument, the commissioner and
others point to grave risks that may be generated by
research endeavors such as Chakrabarty’s. Their briefs
present a gruesome parade of horribles, suggesting that
such research may pose a serious threat to the human
race. It is argued that this Court should weigh these
potential hazards in considering whether Chakrabarty’s
invention is patentable. We disagree. The grant or
denial of patents on microorganisms is not likely to put
an end to genetic research or its attendant risks.
Legislative or judicial fiat as to patentability will not
deter scientific minds from probing into the unknown
any more than King Canute could command the tides.
Whether Chakrabarty’s claims are patentable may
determine whether research efforts are accelerated by
the hope of reward or slowed by want of incentives,
but that is all.
The choice we are urged to make is a matter of
high policy for resolution within the legislative process
after the kind of investigation, examination, and study
that legislative bodies can provide and courts cannot.
Whatever their validity, the contentions now pressed
on us should be addressed by the Congress and the
executive, but not the courts. Congress is free to amend
Section 101 so as to exclude from patent protection
organisms produced by genetic engineering or to craft
a statute specifically designed for such living things.
But until Congress does, the Court must construe
Section 101 as it stands. And that language embraces
Chakrabarty’s invention.
Accordingly, the judgment of the lower court is
Affirmed.
Chakrabarty received a patent on the genetically engineered bacterium in 1981. However, by 1992, the
organism had yet to be used in a commercial application. This is not for want of a practical use, however.
Recent studies have shown that living microbes, such as Chakrabarty’s, may effectively break up oil by
releasing soap-like surfactants that emulsify oil into droplets small enough for bacteria to convert into
carbon dioxide and water. This, of course, could be extremely useful for major oil-spill cleanup efforts,
such as that needed after the Exxon Valdez spilled its cargo in Alaska. Indeed, the microbes may be less
toxic and more biodegradable than traditional methods using chemicals. But the stumbling block for this
technology, as with most biotechnology concerns, is fear.
Whenever living organisms are introduced into new environments, public anxiety buttons are pushed.
This is true even when living things that have been developed by nature are taken from their natural habitat
and moved into new regions. One only has to consider what happened when a few African killer bees were
shipped to South America or when the Mediterranean fruit fly made its way to California. Clearly, the
balance of nature is a delicate and complex matter well beyond the total grasp of human understanding.
Any human action that would serve to upset the natural chain of life in a region, therefore, is rightly met
with concern, hostility, and scrutiny. And obviously, the reaction will be many times as strong when the
issue is not simply the displacement of natural life, but rather the introduction of new life forms not yet
contemplated in the natural scheme of Earth. For a simple illustration, consider the widespread negative
public reaction that emerged in 1999 when a laboratory study indicated that pollen from bioengineered
pest-resistant corn might also be toxic to monarch butterflies. Although harms to butterflies do not directly
cause widespread damage to humans, and although the dangers had not yet been proven in the field, the
study nonetheless mobilized a coalition of national environmental groups to request greater government
oversight of biotechnological applications in agriculture.
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
10
Opponents of genetic engineering find recent research initiatives to be even more frightening. For
instance, scientists have begun to study the possibility of genetically engineering insects to help fight
diseases, among other goals.13 Research has already begun in creating a mosquito that is genetically
incapable of transmitting malaria. If these specially designed mosquitos were released in the wild, they
might naturally pass these genes to all other mosquitos through mating, thereby eradicating the spread of
the dreaded disease. However, this benefit must be weighed against the possibility that these mosquitos
might become ecologically fitter and, in turn, transmit other kinds of fatal diseases. Likewise, scientists are
studying the creation of honeybees that are resistant to pesticides and parasites, and insects that can inject
vaccines with every bite. As always, the potential beneficial effects have to be weighed in light of the law
of unintended consequences. For example, scientists conducting lab studies of a small freshwater fish
engineered with a salmon growth hormone gene noted that it not only grew faster and had a mating
advantage over its natural cousins, but that it also unexpectedly had a higher mortality rate. They estimated
that if just 60 of these fish had ever escaped or had been released into a wild population of 60,000 fish, that
this would have caused local extinction within 40 generations of that fish species.14
For these reasons, the difficult issues pertinent to patent protection for living things, of which there are
many, may be only the beginning of the frustrations for biotechnology enterprises. Beyond typical patent
concerns regarding the propriety and extent of legal control, biotechnology inventions must bear additional
social, ethical, and political burdens. Thus, a biotechnology business that successfully navigates the
extremely uncertain waters of patent protection typically has only begun its journey through the legal and
public policy process. This is particularly true when the newly engineered life forms will be released into
the open environment as opposed to being controlled in a laboratory setting. For instance, field tests for
evaluating genetically altered crops often engender stiff resistance from environmental groups and require
oversight from government regulators. Companies involved with biotechnology therefore must be prepared
to contend with regulations from a myriad of administrative agencies, even after a patent is granted.
PATENTS FOR HIGHER LIFE FORMS
As the science of biotechnology advances, the patent issues become increasingly contentious and complex.
A primary concern is just how far up the ladder of life should proprietary rights through patents be
allowed. It is one thing to grant a patent on genetically modified microorganisms. It may seem quite
another to permit ownership of a strain of celery or a breed of mice or cows. But patent protection now
clearly extends to such higher forms of life. In 1985, the PTO Board of Patent Appeals and Interferences
(the board) held that seeds, plants, and plant tissue cultures are patentable subject matter under Section
101.15 In early 1987, the board went further, holding that Section 101 covers nonnaturally occurring
oysters in which polyploidy was induced by hydrostatic pressure.16 Soon thereafter, on April 21, 1987, the
PTO issued a policy statement indicating that it considers all nonnaturally occurring, nonhuman,
multicellular living organisms, including higher animals, to be patentable subject matter under Section 101.
In 1988, the PTO granted the first patent for a genetically modified (“transgenic”) nonhuman mammal: a
mouse—called the Harvard Oncomouse—into which a gene was inserted so that the mouse would be more
susceptible to developing cancerous tumors.17 Since that time, the pace of animal patent applications
steadily increased so that by 2004, the PTO had issued around 436 animal patents, and had a substantial
number of pending applications waiting in the wings.
So far, the majority of the transgenic animals have been developed to aid in drug research. Human
genes responsible for specific diseases or maladies are introduced into the animal, causing it to carry the
genetic disorder. For example, researchers have created transgenic animals that are especially susceptible
to afflictions such as AIDS, enlarged prostate, sickle-cell anemia, and cystic fibrosis. These animals have
great medical potential because they may serve as laboratories for experiments aimed at curing or
preventing afflictions. But they also raise hostile objections, particularly from animal rights activists and
opponents of genetic engineering. For example, the Foundation on Economic Trends aggressively
13
For more information, see Justin Gillis, “Making Way for Designer Insects,” The Washington Post (January 22, 2004), at A1
See David Shenk, “Imitation of Life,” Gourmet (April 2005), at 70.
15
Ex parte Hibbard, 227 U.S.P.Q. 443 (Bd. Pat. App. 1985).
16
Ex parte Allen, 2 U.S.P.Q. 2d 1425 (Bd. Pat. App. 1987).
17
The Oncomouse subsequently was patented in much of Europe and Japan. However in December 2002, the Supreme Court of Canada determined
that the mouse could not be patented under existing Canadian law.
14
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
11
challenged attempts by scientists at the NIH to perform AIDS research on mice that were genetically
altered to improve the study, arguing that the experiment posed an undue danger if the animals were to
escape. Research on transgenic animals also poses serious ethical questions about creating animals that are
purposefully deformed, often with painful and debilitating maladies. Not all research creates diseased
animals, however. For example, researchers at Princeton University created mice with better memory by
inserting the so-called NR2B gene into the nuclei of fertilized eggs. This research could ultimately yield
new drugs and treatments for preventing memory loss in the elderly.
As already mentioned, genetic engineering is having a revolutionary effect on agriculture. Whereas
classical crossbreeding of, say, a tangerine and a pomelo to yield a tangelo is an imprecise science,
manipulation of specific genes could allow the creation of an unlimited number of tangelos having a
precise selection of desired characteristics. Genetically modified crops are now grown in more than 40
countries spanning six continents. By 2003, well over 160 million acres of farmland had been planted with
transgenic crops, especially in the United States, where 68% of the crop was grown, and Argentina, with
23%. Most of these are food staples—such as corn, soybeans, and cotton—that have been genetically
tailored to resist insects and herbicides. And based on Chakrabarty, most of these genetically engineered
crops have been patented by agribusiness concerns. For instance, Monsanto owns a substantial portfolio of
bioengineering-related patents involving corn and other food products. One covers the so-called Bt corn
seed, which has a gene inserted into it so that the corn produces a protein that is toxic to the European corn
borer. Another deals with a method to make crops produce more lysine, an amino acid used in feed that
enhances the development of chickens and hogs. Monsanto also has developed and patented many other
genetically engineered crops, such as soybeans and wheat that are resistant to its Roundup brand herbicide,
cottonseed that is resistant to the bollworm, and a potato that resists the Colorado potato beetle.18
Other patented food products are designed to provide increased nutrition. The most well-known
is Golden Rice, which is genetically modified to be rich in beta carotene, an essential source of vitamin A.
More than 400 million people in poor countries suffer from vitamin A deficiencies, which can impair
immune systems and cause blindness. In 2000, Monsanto, which owns important patent rights needed to
make Golden Rice, offered to license some of these technologies for free, as part of a worldwide campaign
to educate the public about the benefits of biotechnology. Many other research initiatives promise similar
kinds of developments in the near future. For instance, one soon may see bananas that produce human
vaccines against infectious diseases and soybeans that produce cancer-fighting chemicals.
PATENTS ON HUMAN BEINGS AND HUMAN CLONING TECHNIQUES
Advances in cloning technologies now require the public to think about what once was unthinkable. Should
patents be available for novel and nonobvious technologies that produce human beings; indeed, should one be
able to get a patent on a genetically modified human? On the one hand, such outcomes may seem repugnant,
and thus the legal system should not provide incentives for those who achieve them. On the other hand, the
PTO has approved patents for increasingly higher life forms since Chakrabarty, and there seems to be little
justification for stopping the progression at any particular point on the spectrum of living things.
In 1997, the news media reported that a patent application had been filed covering research creatures
that could potentially be as much as half human and half animal. One of the resulting chimera creatures, for
instance, would combine a mouse with a human, and was nicknamed a humouse.19 The application was
filed by Stuart Newman and supported by Jeremy Rifkin (president of the Foundation on Economic Trends
and a biologist) to highlight the general immorality of allowing patents on life, including transgenic
animals, human genes, and other bioengineering inventions. Bruce Lehman, who was then head of the
PTO, assured the public that the patent office would deny patents for monsters and other immoral
inventions, stating that the patent laws give the PTO the power to deny patents for inventions that do not
meet certain public policy and morality criteria. Patent scholars question whether the PTO actually has this
discretion under the law. Notwithstanding the legal debate, there also is the very obvious problem of trying
18
In 2004, Monsanto announced that it was not yet planning to market its Roundup-resistant wheat because of public opposition, especially in
Europe and Japan, to genetic engineering with such a critical food staple. The company also shelved its beetle-resistant potato because fast-food
companies, such as McDonald’s Corp., refused to make their french fries from bioengineered potatoes.
19
The patent application was titled “Chimeric Embryos and Animals Containing Human Cells,” and it described, among other creatures, humanmouse chimeras, human-pig chimeras, and human-chimpanzee chimeras. The Foundation on Economic Trends provides information on the
“humouse” patent at http://www.foet.org. Look under Campaigns.
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
12
to determine just where the line of immorality may be crossed. Already, the PTO is granting patents for
transgenic animals that are tailored to have human diseases or to develop organs that won’t be rejected by
human transplant patients. And, of course, once morality enters the picture, one has to ask about other
technologies, such as effective inexpensive handguns.
The PTO ultimately rejected the patent application, stating that the human–animal hybrid “embraces a
human being” and so does not qualify for patent protection. Although the patent laws do not specifically
direct the PTO to deny human-related patents, some of the communications from the patent examiner
provide the legal and policy rationales supporting the agency’s position. For one, the PTO worried that
such patents would conflict with the Thirteenth Amendment, which prohibits slavery. This is because the
patent owner, by being able to control the use of an invention, could prevent anyone else from employing
it. The PTO also believed that patents on humans would be inconsistent with the constitutional right to
privacy, which gives individuals the right to make personal decisions about procreation.
For the moment, we do not know if the PTO’s determination is correct, since Newman failed to appeal
the agency’s decision to the courts by a 2005 deadline. However, as just mentioned, the PTO now must
come to grips with deciding when an animal becomes too human to permit patent ownership. Newman’s
application perhaps was easy because it covered techniques to make animals that had substantial human
characteristics. Applications for certain specialized research animals are similarly easy because the human
components are so small. Tough decisions lie ahead, though, as genetic research moves to the inevitable
middle ground. In 2004, Congress entered the fray through appropriations, by restricting the PTO from
using any of its funds “to issue patents on claims directed to or encompassing a human organism.” This led
to worry from the research communities, especially those working with stem cells, but Congress clarified
that the limitation was only meant to support current PTO practices. Thus, the difficult questions remain
unanswered.
A related issue is whether the PTO should grant patents on processes that might be used to create
human beings, such as human cloning techniques. The PTO has, for quite some time, granted patents on
cloning techniques, but the claims typically have excluded application to human beings. However, in 2001,
the PTO granted a patent to the University of Missouri that covers a technique to produce cloned
mammals.20 For now, the patent has been licensed to a biotechnology company that is working on creating
pigs for use as human organ donors. But some experts who have reviewed the patent believe that it may
extend to human cloning. In 2004, the PTO issued to Tufts College another cloning patent, which this time
appears to more directly include claims that relate to human beings.21 Thus, the PTO now seems
comfortable with the concept of allowing patents for methods to clone humans. Likewise, the United
Kingdom Patent Office granted a patent in 2000 that not only covers the process used to clone Dolly, but
also certain products, including human cells, that result from the process. For those who oppose patents on
human cloning techniques, these certainly are disturbing trends.
PATENT RIGHTS AND THE OWNERSHIP OF PROGENY
An extremely contentious issue is whether plant and animal patents should cover progeny. In the context of
traditional machine patents, one who purchases a machine is entitled to use it without restriction. Thus, the
buyer is allowed to tear the machine apart or transform it into something else. What the buyer may not do
is duplicate the machine. Plant and animal patents strain the traditional constructs because the subject
matter of the invention—the plant or animal—can reproduce naturally. Can purchasers of a patented plant
or animal breed it without permission or must they contract to pay royalties for the harvested seeds or
offspring? Clearly, this is a critical issue for those engaged in agribusiness ventures.
Unless the patent laws are amended to specifically address this issue, it is likely that plant and animal
patents will extend to progeny. Otherwise, many inventors of transgenic animals and plants will conclude
that their most profitable course of action is to maintain the invention in secrecy and to distribute only the
final products. That outcome is contrary to the disclosure principles of patent policy. Therefore, it is logical
to assume that breeding that duplicates the protected features will be covered by a patent. But what if a
purchaser of a patented animal breeds the animal with one from another species, resulting in some different
20
Patent No. 6,211,429. To review the patent, go to http://www.uspto.gov and search for the patent by its patent number.
Patent No. 6,781,030. The detailed description of the invention states, “The present invention encompasses the cloning of a variety of animals.
These animals include mammals (e.g., human, canines, felines)….”
21
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
13
variation of life? What if the animal runs loose and mates wildly in nature? Is the purchaser liable to pay
royalties for all the resultant offspring? These issues are of such concern to farmers that they once
aggressively lobbied Congress to either place a moratorium on animal patents or amend the patent laws so
as to allow farmers to breed, use, and sell patented farm animals and their offspring.
Plant Patents and the Issue of Sterilized Seeds
So far, most of the litigation regarding progeny has involved Monsanto’s patented “Roundup Ready”
technology that protects crops against the Roundup herbicide. Normally, seeds grow into plants that
produce more seed that then can be used to grow more crops in a continuous cycle. When the original seed
is patented, as it is when it includes Roundup Ready genes, then harvesting seeds from its plants may
indeed be unlawful. A major problem for Monsanto is enforcement, and it takes substantial steps to ensure
that farmers do not replant seeds.22 In fact, at one time, Monsanto considered the possibility of employing a
patented seed sterilizing process that would have prevented its patented crops from creating new seed.
Critics of the process quickly emerged, and farmers around the world denounced the concept. They argued
that the technology, in general, could be misused by multinational seed companies, allowing them to
exercise control over minimally improved seed products. They even began to use the title “Terminator” to
refer to the technology, alluding to the robotic killer played in three movies by Arnold Schwarzenegger.
Opposition to the seed became so widespread that Monsanto pledged to not used the so-called Terminator
sterilizing seed process.
For these reasons, when Monsanto’s more traditional enforcement efforts have failed, the company has
taken farmers to court. In fact, from 2000 to 2004, Monsanto brought around 90 lawsuits in the United
States, charging farmers with unlawfully planting patented seeds saved from previous crop cycles without
paying royalties. Although most of these cases were settled, Monsanto largely prevailed in those disputes
that reached court judgments.23
Perhaps most intriguing is a case that Monsanto brought against a farmer in Canada who claimed that
he never initially planted Roundup Ready seeds, but that his natural crops were pollinated from pollen
blown from neighboring fields. The farmer saved and reused a sufficient amount of seed such that
eventually one-half of his acreage contained the patented gene. In 2004, the Supreme Court of Canada
determined that the farmer had infringed Monsanto’s patent, even under these circumstances. Nonetheless,
the farmer did not have to pay any damages because he never used Roundup on his fields, and thus did not
profit from using the patented technology.
In a fascinating twist, organic farmers in Canada have sued Monsanto for allegedly contaminating their
fields with unwanted Roundup Ready genes. The farmers argue that if Monsanto is claiming ownership of
the patented gene no matter where it lands, then it should take responsibility for it when it causes damage.
Clearly, the outcome of this case will have important repercussions in an international environment that
still harbors substantial distrust of bioengineered crops.
PATENTS ON GENES
Chakrabarty provides that a person may get a patent on a “non-naturally occurring manufacture.” One
extremely contentious issue is whether this entitles someone who creates a gene segment or fragment, such
as cDNA, to receive a patent for the invention. In a sense, all one is doing is observing something that
exists in nature—DNA—and then duplicating a portion of it. However, strictly speaking, the gene
sequence that is manufactured does not exist in nature in its isolated form, separate from the entire strand
of DNA. Also, investments in biotechnology research are far from trivial, and so may necessitate patent
protection to provide suitable rewards for successful endeavors. The question is not altogether new, for
courts have previously considered whether purified versions of natural substances are patentable, and have
concluded that the answer is yes. Because isolating a gene or gene fragment is like purifying an identified
element from DNA, the creation should be patentable under the same logic.
22
Monsanto, for instance, licenses its patented seeds rather than sell them to farmers. Under the licenses, the farmers agree not to save seed, and they
give Monsanto permission to come onto the farm and take samples for three years after seeds are last purchased. Monsanto uses various enforcement
measures, such as providing toll-free tip lines, hiring private investigators, and conducting random DNA tests on plants growing in the fields of
farmers who have bought seed in previous years. R. Weiss, “Seeds of Discord,” The Washington Post (February 3, 1999), p. A1.
23
Monsanto recovered a total of $15.2 million from these lawsuits, with the mean recovery being $412,000. For more information, see Tresa Baldas,
“Clash over Seeds Brings Private Eyes, Angst—And Lawsuits,” National Law Journal (June 20, 2005), p 4.
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
14
In 1991 and 1992, the NIH raised an enormous controversy when it filed patent applications for 2,700
cDNA expressed sequence tags, or ESTs. Recall that by manipulating mRNA, scientists can create these
cDNA snippets, which can then help identify and map actual genes. NIH argued that the ESTs were
“manufactured” into cDNA by its scientists and that they were useful, in that they served as research
probes. On the other hand, the scientists did not yet know the function of the gene that the EST served to
identify. Many experts questioned whether a utility patent is appropriate for a tool whose only value is to
help find something that may be useful for some as yet unknown purpose. At a minimum, one should at
least know the function of the item—here, the gene—that the probe helps to locate.
Patents on ESTs are also troublesome from a practical standpoint. Because ESTs are only small
portions of entire genes, then it is very possible that several different individuals could receive patents on
different fragments of the same gene. After more research, scientists ultimately will map the full gene and
determine its function. At that point, if someone wants to use the gene in a biotechnology application, that
person may have to gain permission from all the different patent holders who own rights to their particular
segments of the full gene sequence. NIH, on the other hand, worried that if it published its findings without
filing for a patent, then scientists who later determined the full genes and their functions would be
precluded from enjoying patent rights, based on a lack of novelty. Thus, the government agency argued
that it wanted to preserve these rights, so that they could be licensed to U.S. biotechnology developers.
The applications caused an international stir, igniting a frantic response by the British government to
withhold information on its gene research discoveries and to begin efforts to patent genes located by its
scientists. Also, the applications raised substantial speculation that other governments and private
companies would join in a global race to file patents for as many genes and gene fragments of the human
body as they could locate. In September 1992, the PTO rejected the EST applications, citing the utility
concerns as well as other problems. NIH subsequently amended the applications. However, in 1994, the
agency announced that it was withdrawing its patent applications on all ESTs, stating that such patents
would not be in the best interests of the public or science. The British government then quickly reached the
same conclusion.
You should not conclude from this episode involving ESTs that the PTO or foreign governments were
not willing to issue patents for the sequences of full genes, for they surely did do so as long as the
functions of the genes were identified. By some accounts, the PTO has issued patents for more than 5,000
human and animal genes since the Chakrabarty decision in 1980. Some important examples include genes
that control or help detect diabetes,24 tuberculosis,25 colon cancer,26 and leukemia.27
In March 2000, just before the Human Genome Project and Celera announced that they had mapped the
human genome, U.S. President Bill Clinton and British Prime Minister Tony Blair stated publicly that the
sequence of the human genome should be within the public domain for ethical reasons. Predictably,
investors in the biotechnology industry reacted with alarm, and the stocks of some companies fell by as
much as 20% that same day. The panic was short lived, however, since President Clinton clarified soon
thereafter that gene sequences should be patentable, although the entire genome should not.
Obviously, the 1990s were marked by substantial confusion over the patentability of genes and ESTs,
especially regarding the utility that must be disclosed. As covered in Chapter 3, the PTO revised its Utility
Examination Guidelines in 2001, mostly as a response to substantial concerns with biotechnology
inventions, particularly gene patents. Indeed, almost all of the examples in the training materials
accompanying the guidelines focus on biotechnology patent claims.
The guidelines make it clear that it is not enough for a patent application to claim that a particular
genetic sequence or EST might have some general utility, such as to serve as a probe to locate a complete
gene. Rather, the application must disclose how the sequence might be used to locate a specific DNA target
with some identified utility. Similarly, it is not enough to claim that a genetic sequence is useful in
diagnosing some unspecified disease. Rather, the patent must specifically disclose the conditions that can
be diagnosed. In other words, the patent must demonstrate the real-world use of the gene sequence.28
Overall, the guidelines seem to make it clear that one cannot get a patent simply by decoding DNA or
mapping its location in the human genome. Similarly, one cannot get a patent for a genetic sequence or
24
U.S. Patent No. 5,324,641.
U.S. Patent No. 5,370,998.
26
U.S. Patent No. 5,362,623.
27
U.S. Patent No. 5,397,696.
28
A recent Federal Circuit decision supports the approach used in the PTO’s guidelines. See In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005).
25
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
15
EST without relating the specific real-world function that it serves. The guidelines perhaps help sort out the
confusion elicited by President Clinton and Prime Minister Blair over patents for the human genome. The
genome itself is not patentable because it has no specific utility. Rather, it serves generally as a means for
discovering potentially useful gene sequences within the genome. Nonetheless, researchers still may
receive patents on particular gene sequences, as long as they can demonstrate that the sequences have
specific and substantial utility.
Clearly, the biotechnology industry has been somewhat successful in steering the public policy process
to meet its objectives regarding patents for genes and gene fragments. Most of its arguments have been
framed in terms of economic incentives, and these have proven compelling in the United States and other
developed nations. Nonetheless, many groups and individuals still harbor strong objections to gene patents.
Some of the protests rest on moral grounds, questioning the right of humans to effectively own the building
blocks of life. However, other arguments point to practical considerations, which include the following:
•
•
•
•
•
To preserve patent interests, private companies may keep valuable genome information secret until
patent applications are filed. This may cause government researchers to duplicate efforts already
completed in the private sector, leading to a waste of public resources. Those involved in publicly
funded research believe that the public sector should be responsible for determining the structure and
function of genomes, while private sources seek ways to make useful products. In their view, patents
should not be available for the sequence of the gene, but only for applications derived from it.
With new technologies, determining the sequence and location of genes is becoming routine. Thus,
gene patents are given to those who simply discover the natural function of genes. Patents, though, are
for inventions, not discoveries.
Patents on genes increase the costs of producing useful applications of those genes.
Patents on ESTs and gene fragments may cause a single gene to be covered by several patents. Such
patent stacking will increase the licensing burdens on those who wish to use the gene.
Patents on genes will allow companies to control many downstream markets, such as those for genetic
testing products.
The biotechnology revolution is in its relatively early stages. It will be interesting to watch whether
warnings, such as these, start translating into reality and, if so, whether political forces will adjust patent
policies to further public interests.
INTERNATIONAL PATENT ISSUES
The heated debates over biotechnology and the propriety of patent protection are not confined to the
United States; they span the entire globe. Many would point to Europe as the epicenter of conflicting
emotions on these issues. Environmental organizations, such as Greenpeace, have moved aggressively to
arouse public passions to oppose biotechnology patents on moral and safety grounds. Europe’s
biotechnology industries, on the other hand, adamantly warn that insufficient patent protection will lead to
their demise, resulting in widespread economic harms throughout the continent.
One merely has to look at the language of the European Patent Convention (EPC) Treaty, and the ways
in which the European Patent Office (EPO) has tried to interpret it, to recognize how European nations
struggle to find consensus on biotechnology issues.29 The EPC Treaty prohibits patents on inventions
where commercial use would be contrary to public policy or moral order. It also explicitly denies patents
for plant and animal varieties. In the early 1990s, the EPO’s Examination Division at first used this
language to deny a patent for the Harvard Oncomouse. However, after receiving instructions from the EPO
Board of Appeal that there is a difference between an “animal” and an “animal variety,” the division
granted the patent. In arriving at its decision, the division also determined that the patent did not violate
public policy because the potential benefits to mankind outweighed the environmental risks and the
potential for cruelty to animals. Many observers assumed that this determination opened the door for
transgenic plant and animal patents in Europe. However, in a subsequent action, the EPO denied patent
claims to a genetically modified plant that had a gene inserted specifically to make the plant resistant to an
herbicide. Although the disparate treatments may have been defensible based on other less prominent
29
The text of the European Patent Convention can be viewed at http://www.european-patent-office.org. Look under Toolbox for applicants.
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16
statutory provisions, the public became confused and discontented over the legality of biotechnology
patents in Europe. Compounding the controversies were the patent laws and decisions within the individual
countries of Europe, which often treated biotechnology inventions in very different ways.
In the midst of this hotly contested environment, the EU has struggled to find consensus through a
directive that would harmonize intellectual property rights for biotechnology inventions among its
members. In the early 1990s, the council began work on a directive providing for patents on living
organisms, including plants and animals, and extending protection to progeny. However, the directive
became bogged down in the parliament in 1993 due to proposed amendments allowing farmers to harvest
plant seed from patented plants and requiring compulsory licensing in certain situations. After many more
years of difficult negotiations, the parliament gave its blessing in 1998 to a revised biotechnology
directive.30 The directive states that patents may be granted on plants and animals, unless the claims extend
to an entire genome that is distinct from other varieties. Also, the directive is very much in line with U.S.
policy regarding the patentability of gene sequences. For instance, it provides that “an element isolated
from the human body or otherwise produced by means of a technical process, including the sequence or
partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is
identical to that of a natural element.” The directive also mirrors the U.S. PTO utility guidelines, since it
demands that the industrial application of the gene sequence be clearly disclosed.
The directive does, however, with various limitations, acknowledge some of the fears raised by those
who oppose biotechnology patents. For instance, patents are not allowed for procedures to clone human
beings, for commercial uses of embryos, and for germline therapies that would transmit genetic changes to
a person’s descendants. In addition, the directive prohibits patents on genetic engineering inventions that
cause animal suffering without substantial medical benefits. Finally, the directive reiterates the right of
individual European nations to prevent the patenting of technologies contrary to public order or morality.
Many other countries, such as Japan, provide biotechnology patent protection, but some nations still do
not. As in the EU, many countries prohibit patent protection for certain forms of biotechnology inventions
on moral or economic grounds. For instance, objections to patents related to human cloning and heredity
are somewhat common. In addition, many nations are reluctant to issue patents for bioengineering products
and processes when they have medical or pharmaceutical applications.31 The successful conclusion of the
Uruguay Round of GATT should improve the situation but will not necessarily end the disparities. The
participants of the Uruguay Round agreed that patents must be available without discrimination as to the
field of technology. However, member countries are allowed to exclude animals, other than
microorganisms, from patentability. Based on this exemption, Canada, for instance, refused to grant patent
protection to the Harvard Oncomouse. Also, nations may prohibit patents for inventions contrary to public
order or morality, such as was done in the EU.
OTHER BIOTECHNOLOGY CONTROVERSIES
BIOLOGICAL SAFETY AND DIVERSITY
In 1992, the United Nations sponsored the Earth Summit in Rio de Janeiro, at which the participants
developed the Convention on Biological Diversity.32 The convention addresses issues regarding the
effects of humans on the vitality of natural species, and as you might expect, many of these closely relate to
the introduction and use of biotechnological innovations.33 For instance, if agriculture comes to depend on
a smaller set of bioengineered food products bred for specific superior traits, then the diversity of living
plants may diminish. This could render the world food supply extremely vulnerable to disease, pests, or
changing weather conditions. The convention also focuses attention on the ways in which bioengineered
plants and animals might harm natural species, thereby affecting biological diversity. Another important
30
The text of the biotechnology directive (EC 98/44) and other related information, including a list of frequently asked questions, is available at
http://europa.eu.int. Look under Institutions and click on European Commission. Under Economy and Society, click on Internal Market. Click on
Industrial Property and then Biotechnological Inventions.
31
The TRIPs agreement allows WTO members to exclude from patentable subject matter “diagnostic, therapeutic and surgical methods for the
treatment of humans or animals.” The United States permits patents of medical and surgical procedures, but a law passed in 1996 limits available
remedies for infringement.
32
Information on the biodiversity convention can be found at http://www.biodiv.org.
33
Article 1 of the convention provides that its objectives are to support “the conservation of biological diversity, the sustainable use of its
components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources.”
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007
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topic addressed by the Convention on Biological Diversity regards the extent of control that nations should
have on the genetic raw materials that are derived from natural species found within their borders. The
United States at first failed to sign the Convention on Biological Diversity based, in large part, on
objections from the biotechnology industry. However, President Clinton signed the international agreement
in 1993. Nonetheless, due to continued objections from the biotechnology industry, the Senate, as of 2006,
still had not ratified the treaty, as is required for the United States to be bound by its provisions. Thus, the
United States still is not counted among the convention’s growing number of parties, which numbered 188
in early 2006.
Those opposing the use of bioengineering in agribusiness are not convinced that bioengineering
techniques are as safe as the industry claims. In support of their doubts, they point to some surprising
issues resulting from the injection of recombinant bovine growth hormone (rBGH) into cows to increase
milk production. The rBGH is made through a genetic engineering technique based on a cow gene
responsible for growth. Some studies indicate that cows treated with rBGH have a higher incidence of
mastitis, requiring treatment with antibiotics. If the additional levels of antibiotics pass into the milk
supply, they possibly could result in harmful consequences. As noted in Chapter 2, the United States and
the EU were involved in heated disputes in the late 1990s regarding European import bans on hormonetreated beef. The controversy ultimately landed in the WTO, where a dispute resolution panel determined
that there was insufficient evidence of harmful health effects to justify trade barriers. Notwithstanding this
decision, fears about the use of growth hormones have not abated.
A large set of other concerns centers on the long-term effects of tinkering with nature. Since life can
mutate, reproduce, and migrate, numerous containment issues arise.34 For instance, we have seen that an
herbicide-resistant plant might pollinate in other areas where that plant is not wanted. Removing it then
could necessitate the increased use of more lethal weed killers.35 Indeed, some studies now show that
bioengineered Roundup-resistant bentgrass can pollinate conventional grass 13 miles away.36 Also, organic
farmers who pledge to sell crops that are free of bioengineered substances may suffer greatly from crosspollinization.
Ecological fears are also compelling. As already mentioned, there are constant worries about the
delicate balance of nature. A fish that is engineered to achieve greater size may be beneficial for food
production, but its introduction into the environment might substantially alter the ecosystem. The 1999
laboratory study indicating that bioengineered Bt corn may have unexpected toxic effects on monarch
butterflies serves as a case in point.37 As of 1998, over 250 field tests or introductions of genetically
engineered plants and animals had taken place, including the release in Florida of a predatory mite
specifically designed to eat insects that plague strawberries. Although such organisms often are expected to
be naturally weak and thus have short-term lives in the wild, there is rising concern that this may not
always be the case.
One provision in the Convention on Biological Diversity required the participants to consider
formulating a separate protocol to address how cross-border trade in genetically modified organisms might
affect the safety of the ecosystem. In 1999, some 130 nations participated in a summit at Cartagena,
Colombia, to draft a Biosafety Protocol under the ambit of the biological diversity convention.38 Many
issues were addressed at the summit, and many proved to be extremely controversial. For instance, there
were discussions regarding the kinds of products that would be covered by the protocol, ranging from
living organisms that are intended to be released into the environment to commodities, such as corn, that
have been modified through biotechnology. Another set of issues was related to disclosures, such as when
disclosures have to be made, what kinds of information must be provided, the types of review a country
might use, and whether approval or permits might be required. The participants also debated whether
countries might impose significant liabilities for economic or biological losses caused by the introduction
of modified organisms. The Biosafety Protocol at first became bogged down by disagreements at the 1999
34
Some experts believe that the problems associated with StarLink corn, which are discussed in the next section on food, may have been exacerbated
by containment issues.
35
One study indicates that herbicide-resistant canola in Canada is cross-pollinating with wild plants, creating weeds that now are more difficult to
eliminate with traditional herbicides. See R. Weiss, “Biotech Food Raises a Crop of Questions,” The Washington Post (August 15, 1999), at A1;
J. Carroll, “Gene-Altered Canola Can Spread to Nearby Fields, Risking Lawsuits,” The Wall Street Journal (June 28, 2002)., at B6.
36
See Andrew Pollack, “Can Biotech Crops Be Good Neighbors?” The New York Times (September 26, 2004), section 4, page 12.
37
Other studies indicate that Bt corn also may be inadvertently killing insects that naturally control pests, such as ladybugs and lacewings. See
R. Weiss, “Biotech Food Raises a Crop of Questions,” The Washington Post (August 15, 1999), p. A1.
38
Information about the Biosafety Protocol can be found at http://www.biodiv.org.
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Cartagena meeting, but it was ultimately adopted at a subsequent meeting in 2000. By early 2006, 132
nations had become parties to the accord, although the United States was not one of them.
The Biosafety Protocol creates a Biosafety Clearing-House where nations can share information about
genetically modified organisms, and their experiences with them. Countries also can indicate at the
Clearing-House whether they are willing to accept imports of genetically modified agricultural products.
Companies that wish to export seeds, live fish, and other genetically modified organisms must provide
detailed information to each importing nation in advance of the first shipment, and the importing nations
must authorize the shipments. In addition, the protocol establishes labeling requirements for genetically
modified products.
The Convention on Biological Diversity establishes that individual nations have sovereign rights to
determine who may have access to their genetic resources. It also provides that nations are entitled to
receive a fair and equitable share of the benefits arising out of the utilization of genetic resources.
Biotechnology depends on locating genes that have potential benefits for human applications and then
devising ways to effectively utilize them. For instance, some genes cause cells to manufacture curative
proteins. Drug companies that locate these genes can use biotechnology to mass produce the proteins for
drug products. For example, Merck’s cholesterol drug, Mevacor, is derived from a fungus found in Japan,
and Novartis’s transplant-rejection drug, Cyclosporine, depends on genetic material from a Norwegian
mountain fungus. In fact, according to one source, 7 of the world’s 25 top-selling drugs in 1997 were
derived from natural products.39 Likewise, agribusiness firms search the globe for genetic material that can
be spliced into the genetic makeup of natural agricultural products, resulting in plants that are hardier or
more pest resistant and in foods that are tastier or sweeter.
Many of these useful genetic materials are found in developing regions that are rich with unique varieties
of natural species, such as the Amazon and Africa. Members of these communities have become increasingly
frustrated. They see multinationals from developed countries reap enormous profits from bioengineered
products that depend on original materials found on their lands. Yet, often, the developing countries share little
of the return. Indeed, when the drugs and agricultural products are patented, individuals in these regions may
not even be able to export the very products that were derived from resources found within their homelands.40
Thus, developing countries sometimes accuse foreign multinationals of engaging in “bio-colonialism” or “biopiracy,” since the companies allegedly take their resources without paying any compensation.41
The Convention on Biological Diversity authorizes countries to pass laws that might limit access to
genetic materials and require equitable compensation for their use. The first country to enact such a law
was the Philippines, which passed legislation requiring collaboration with local scientists, informed
consent from the indigenous tribes located where samples might be taken, and compensation. Other
countries, such as Costa Rica, Bolivia, Colombia, Ecuador, Peru, and Venezuela, soon followed suit.
Scientists and biotechnology companies fear that some countries will overestimate the value of their
resources and will prevent access to potentially useful genetic materials. Others lament that these actions
merely continue the disheartening trend toward private ownership of genetic resources. To address these
issues, the members of the convention have established panels of experts to explore options for devising an
international regime of common practices.42 Clearly, issues regarding safety, biological diversity, and the
ownership of genetic resources will be contentious for years to come.
FOOD: LABELING AND OTHER REGULATORY MATTERS
As previously noted, bioengineering has already made a tremendous impact in agriculture, particularly in
the United States. Food products increasingly derive from genetically modified crops that have been
specially designed to resist insects and herbicides or to enhance nutrition or flavor. Manufacturers who sell
bioengineered products and the farmers who use them are subject to regulation by numerous government
39
A. Pollack, “Biological Products Raise Genetic Ownership Issues,” The New York Times (November 26, 1999), at A1.
Examples include patents for (1) ayahuasca, derived from the Amazon, where it is used by indigenous tribes for healing and religious purposes;
(2) basmati rice, based on the prized grain found in the Himalayan foothills of northern India and Pakistan; and (3) a yellow bean, derived from the
Mexican Mayacoba bean. For more information, see David Shenk, “Imitation of Life,” Gourmet (April 2005), at 70.
41
In the latest round of WTO negotiations, India and other countries have negotiated for new measures that would require patent applicants seeking
patents based on foreign biological materials to gain permission from the country of origin, and to share monetary benefits from the patent. See Eric
Bellman, “India to WTO: Help Us Protect Herbs, Tea, Yoga,” The Wall Street Journal (December 15, 2005), at B1.
42
Substantial information is provided at http://www.biodiv.org. Look under Programmes and Issues and then Access to Genetic Resources and
Benefit-sharing.
40
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19
agencies in the United States, including the Environmental Protection Agency and the Department of
Agriculture. The agency getting the most attention in terms of regulating food products, though, is the
FDA.43
In 1992, the FDA issued a policy statement laying out how it would regulate foods derived from new
plant varieties, including those designed through bioengineering.44 Essentially, the policy did not require
genetically modified foods to be reviewed by the FDA prior to marketing. Rather, companies were allowed to
sell these foods once they were satisfied that the food was safe. Genetically modified foods, therefore, were
treated in the same fashion as all other foods, in that they were subject to “postmarket” scrutiny by FDA
officials. This means that the foods could be seized by the government if dangers materialized after they were
sold. Companies, though, were encouraged to consult with the agency prior to marketing so that they could
discuss the nutritional makeup of the products and any safety issues that might exist. The first consultation
occurred in 1994 with Calgene regarding the Flavr Savr tomato, which was genetically engineered to soften
less rapidly. During the next seven years, over 50 firms consulted with the FDA through this voluntary
process.
The 1992 policy also addressed labeling issues, which are listed in Exhibit 3. To the dismay of many
consumers and environmentalists, the policy did not impose a general labeling mandate on all genetically
modified food products, warning consumers that it had been subjected to bioengineering. Instead,
genetically modified food sold in the United States required a special label only in a few circumstances.
One instance was when the food’s composition had been significantly changed from the conventionally
grown counterpart. For example, a manufacturer that modified canola to produce increased levels of lauric
acid in the seed oil had to label it as “laureate canola oil.” Labeling also was required under the 1992
policy when the genetically modified food had fewer nutrients than the traditional food product. In
addition, a label was necessary when genes were transferred from foods that were known to cause allergic
reactions, such as from peanuts or Brazil nuts.45 Under the policy, the food had to be labeled so that buyers
could learn that it contained a gene from an allergen, unless the developer could demonstrate with scientific
proof that the allergenic properties of the food were not transferred by the gene to the modified product.
EXHIBIT 3
FDA Bioengineered Food Labeling Guidelines
•
If a bioengineered food is significantly different from its traditional counterpart such that the common
name no longer adequately describes the food, the name must changed to describe the difference.
•
If a bioengineered food has a significantly different nutritional property, its label must reflect the
difference.
•
If a bioengineered food includes an allergen that consumers would not expect to be present based
on the name of the good, the presence of that allergen must be disclosed on the label.
During the late 1990s, a global groundswell emerged calling for public controls over genetically modified
food products, particularly through labeling.46 The epicenter of the international anti-bioengineering
movement was Europe, with England and France leading the way. There are many explanations why
European sentiment toward bioengineered food products became so antagonistic. Farming interests in Europe,
for instance, may have seen bioengineering more as a threat than an opportunity, and so raised fears to lessen
competition from U.S. corn and soybean imports. In 1996, Great Britain had to deal with a scare about madcow disease, leading to fears about the food supplies and the abilities of public officials to regulate safety. This
was reinforced by reports of contaminated chicken in Belgium and tainted cans of Coca-Cola in Belgium and
France. Then came U.S. trade duties in 1999 on luxury products, such as foie gras, in retaliation for European
43
The FDA’s home page for matters related to food is http://www.cfsan.fda.gov. For information regarding the regulation of biotechnology
products, look under Program Areas and click on Biotechnology.
The 1992 policy statement can be viewed at http://www.cfsan.fda.gov. Look under Program Areas and click on Biotechnology. Go to Regulations
and Guidance on Safety Assessments.
45
A study found that soybeans that had been genetically modified with genes from Brazil nuts caused positive allergic reactions on skin-prick tests.
M. Chase, “Should You Worry About Health Risks from Biotech Food?” The Wall Street Journal (November 5, 1999), p. B1.
46
For substantial information on the biotechnology food industry, including safety, ethical, and international concerns, see the website for the
Biotechnology Industry Organization at http://www.bio.org.
44
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20
restrictions on hormone-fed beef. On top of all this, farmers and others in Europe often portrayed genetically
modified food as a symbol of American imperialism. By 1999, bioengineered products were termed
“Frankenstein foods” in publications throughout Europe.
In the midst of these frenzied negative sentiments, the EU adopted a regulation in 1997 requiring
member countries to begin labeling all foods that contain genetically modified ingredients. The laws of
some individual countries went even further. For instance, in England, restaurants, caterers, and bakers had
to label genetically modified ingredients. In 2000, the EU adopted a new directive requiring even more
extensive and detailed labeling requirements for the entire region.47 In addition, the EU effectively imposed
a moratorium on the approval of new genetically modified crops, leading to such bitter disputes with the
United States that it (along with Canada and Argentina) filed a complaint with the WTO in 2003. The trade
war was seemingly averted in 2004 when the EU technically ended the moratorium by approving the
importation of two genetically modified corn products. However, the U.S. continued to press its complaint
at the WTO, claiming that several EU member nations still banned imports of genetically modified crops.
In early 2006, the WTO panel reviewing the case released a preliminary report indicating some support for
the U.S. position. The panel’s final report was expected later in that year.
Countries in other regions rapidly followed Europe’s lead in placing restrictions on bioengineered food
products. In 1999, Japan was in the midst of bioengineering schizophrenia. On the one hand, the
government was taking steps to stimulate greater development of Japan’s bioengineering industry.
However, consumers shared similar sentiments to those found in Europe. Kirin Brewery Co., for instance,
acquired the Japanese marketing rights to the Flavr Savr tomato and quickly won approval from Japanese
authorities to sell the tomato. A Japanese consumer group, though, threatened to boycott Kirin’s products if
it began selling the tomato, and so Kirin abandoned the project. As in Europe, some of the objection may
have been based on protectionism. Nonetheless, a 1997 government survey in Japan found that 80% of
Japanese consumers had reservations about genetically modified foods, and 92% favored labeling.48 For
this reason, despite the government’s efforts to build confidence in bioengineering, it simultaneously
proposed that mandatory labeling begin in 2001. Experiences in New Zealand and Australia, among other
nations, were similar, leading their governments to impose mandatory labeling.
Labeling laws are philosophically easy to support because in theory they require sellers to supply
consumers with information they might find important to make informed choices. However, when labeling
is required, marketing professionals have found that the safest and most successful course is to promote
their products as free from genetic modification. On the one hand, this has led to disputes about the honesty
of claims. On a more important level, though, labeling has substantially raised demand for grains and
ingredients that are not genetically modified. The effects were felt in the United States as early as 1999.
For example, Archer-Daniels-Midland, one of the largest crop purchasers in the United States, told its
suppliers to begin separating genetically modified crops from those free of bioengineering. Also, Heinz and
Gerber began to remove genetically modified foods from their product lines. Similarly, fast-food
restaurants, such as McDonald’s and Burger King, asked suppliers in 2000 to stop providing genetically
modified potatoes for French fries. Frito-Lay, too, began to refuse bioengineered crops for its corn and
potato chips.
In 1999, the FDA began a series of hearings to address whether the 1992 food policy needed to be
revised. Among the questions posed was whether the FDA should be more involved in safety regulation,
and whether labeling regulations should be modified and strengthened. Biotechnology interests fear that
labeling requirements will lead to the same kind of consumer backlash in the United States that was
experienced in Europe. They worry that labels noting genetic modification will be stigmatized with
implications that safety or nutrition is being compromised. At the same time, food products heralding that
they are free from genetic modification may be perceived as superior. The FDA received more than 50,000
comments about its safety and labeling policy for food products. In the end, the agency considered the
possibility of making its premarket consultation process mandatory, but failed to adopt the proposal.49
Regarding labeling, the agency decided to reaffirm the requirements of the 1992 policy, as listed earlier in
47
This directive was amended in 2001 and 2003, most notably to require labels indicating all the ingredients in food, including bioengineered
substances. The amendments were designed to ensure that consumers have all essential information about the source and composition of food
products. For information on recent regulatory initiatives in the EU, go to the website for Europa at http://europa.eu.int. Click on Food Safety.
48
S. Effron, “Japanese Choke on American Biofood,” Los Angeles Times (March 14, 1999), p. A1.
49
The proposed regulation can be found at http://www.cfsan.fda.gov. Look under Program Areas, click on Biotechnology and then Regulations and
Guidance.
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Exhibit 3. However, the agency did provide new guidance in 2001 for those firms that voluntarily decide to
indicate on their labels that their foods do or do not contain genetically engineered substances.50 This
guidance is helpful since the improper use of terms, such as GMO free, might subject companies to FDA
allegations that they are engaging in false or misleading advertising.51
The StarLink Corn Incident
Companies involved with growing and distributing genetically engineered food products received a stark
reminder in October 2000 that they must tread carefully indeed, since they operate within a public policy
environment steeped in fear and opposition. StarLink is a form of genetically engineered Bt corn that
contains a gene (from the Bacillus thuringiensis bacteria) that causes corn to produce a toxin deadly to
insects. Most Bt corn products create toxins that are commonly used in the field as pesticide sprays. This
has resulted in substantial data demonstrating that the toxins are generally safe for human consumption.
StarLink, however, incorporates a gene from a different strain of Bt bacteria, and creates a toxin that has
not been used in sprays. The bacterium has never been a part of the human diet, so not much data exists
about potential allergic reactions. However, it does have certain chemical characteristics that sometimes
serve as predictors of human allergens. For this reason, the EPA and the FDA approved StarLink for use as
an animal feed, but not for human consumption.
Tests conducted by environmental organizations determined that certain food products, such as taco
shells, contained trace amounts of StarLink corn. StarLink’s developer, Aventis CropScience, had entered
agreements requiring seed companies, farmers, and grain elevators to take steps to keep StarLink corn
separate from other corn products destined for human food consumption. However, these procedures
apparently broke down on at least a few occasions, leading to the commingling of the corn products in
grain elevators. Many farmers plant their fields both with StarLink corn and other varieties of corn.
Mistakes could have been made due to human error during the harvest. However, it also is possible that the
fields were planted too close together, leading to cross-pollination, an overriding fear of those opposed to
genetically engineered food products.
In November 2000, the FDA ordered a Class II recall of nearly 300 products potentially incorporating
StarLink corn, including tortillas, taco chips, taco shells, and items sold at fast-food restaurants, such as
Wendy’s and Applebee’s. A Class II recall means that temporary, reversible health consequences may occur
from eating the food products. At the time, the FDA had received a few reports from people who believed
they may have suffered allergic reactions after eating products that may have contained StarLink, but the
agency could not confirm any cases where health problems arose. To prevent more recalls based on further
contamination, Aventis agreed to buy back StarLink corn from growers. This was a daunting task that cost the
company more than $80 million. For instance, over 135,000 acres in Iowa were planted with StarLink corn,
and by one account, nearly 50% of the grain stored in Iowa contained trace amounts of it. Consumer groups
also found traces of StarLink in snacks sold in Japan, leading Japanese authorities to negotiate with the U.S.
Department of Agriculture for assurances that U.S. corn exports would be tested for StarLink residues.
By 2002, Aventis faced a wave of lawsuits. Some farmers alleged that Aventis failed to provide
sufficient warning that StarLink should be planted more than 660 feet away from grains destined for
human consumption, and that cross-pollination resulted. Other farmers argued that the corn market was
negatively affected by the incident, leading to price decreases for their entire corn crop. Some individuals
sued, claiming that they had suffered allergic reactions. Also, around two dozen Taco Bell franchisees
claimed that they were stigmatized by reports that the food they sold could make people sick.
The biotechnology industry as a whole continues to suffer from the incident as well, since it so well
demonstrated the economic costs associated with even seemingly trivial mistakes.52 As a consequence,
many growers and food product companies became more reluctant to use genetically engineered
ingredients. In addition, the event bolstered arguments by environmental and consumer groups that
genetically engineered food products need substantially more regulatory supervision.
50
The 2001 FDA guidelines for voluntary labeling can be found at http://www.cfsan.fda.gov. Look under Program Areas and click on
Biotechnology. Go to Food Labeling.
51
In 2002, a measure was put on the Oregon ballot that would have required food companies to label their products that contain genetically modified
ingredients. Agriculture and food industry interests opposed the measure, and it ultimately failed.
52
The industry was struck by a similar incident in 2005 when a Swiss biotechnology company, Syngenta AG, disclosed that it had mistakenly sold
hundreds of tons of an unapproved genetically modified corn seed to growers in the United States
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22
GENE THERAPIES
Locating human genes and determining their functions will have tremendous medical benefits but may lead
to numerous social and ethical problems as well. One exciting application of this new technology is called
gene therapy. Many diseases are caused when defects or mutations in genes occur or when genes are
expressed (i.e., used to make proteins) in cells in ways that are not typical. Gene therapies go right to the
source and attempt to change the genetic structures that create the problems. For instance, if methods can
be found to replace unusual genes with healthy ones, then it may be possible to slow or halt the progression
of particular diseases.
As scientists learn more about the human genome and proteome, they increasingly are able to pinpoint
irregular genes and cellular responses that produce various diseases. The challenge then is to devise
methods for the cells to assimilate normal genes or other genetic materials, so that the body produces
needed proteins in an appropriate fashion. For instance, one might splice the healthy gene into a type of
virus, which then can multiply and penetrate cells with its beneficial cargo. A potential problem, though, is
that the body may have a negative response to the virus, which might create serious side effects such as
leukemia.
By 2002, gene therapy experiments had been conducted on around 300 patients over a 12-year period.
Experts believe that their first real success occurred when gene therapy was used to treat a rare immunity
disorder, called bubble boy disease, in France. However, fears were raised in 2002 when one toddler
developed leukemia, prompting a temporary suspension in the studies while scientists reviewed the
situation. In the United States, a gene therapy experiment at the University of Pennsylvania caused similar
kinds of alarm in 1999 when a teenager died from a massive immune reaction to the virus used with the
treatment. Nonetheless, experts believe that in many cases, the benefits from trying gene therapies
outweigh the risks. For instance, in 2002, scientists proposed a gene therapy experiment for relatively
young patients with advanced cases of Parkinson’s disease, for which few beneficial options exist. In
addition, scientists are optimistic that they can reduce the risks from gene therapies as they discover new
methods to deliver genetic materials to cells.
Many other technical problems are associated with conducting gene therapies—besides finding the
right delivery mechanisms—that still need to be worked out if the treatments are going to be consistently
successful. For example, most genetic disorders involve issues with more than one gene. In addition, the
environment is often a crucial variable. Gene therapies, though, also raise several ethical concerns. For
instance, what kinds of genetic differences need to be treated? Some believe that variations in life should
be celebrated, not pegged as defects. So who gets to decide when a condition is a disability and what
criteria should be used to draw the line? Should gene therapy only be used to correct life-threatening
conditions? What if a person wants to be taller, stronger, or have blue eyes? In this regard, we have so far
been talking about what are called somatic cell therapies. Somatic cells affect a person’s tissues and
organs, but their structures are not passed along to other generations through reproduction. Thus, gene
therapies directed at somatic cells may heal the individuals who are being treated, but have no affect on the
conditions of their offspring. On the other hand, gene therapies also may be directed at what are called
germline cells, which are involved in reproduction. Through germline techniques, one may find permanent
treatments to inheritable diseases. However, they also raise the possibility that people may predetermine
the characteristics of their children, which many people find morally offensive. For this reason, germline
therapies face more difficult regulatory hurdles than those involving somatic cells. This is why the EU
biotechnology directive, for instance, prohibits patents on germline therapies while allowing them for
somatic cell processes.
EMBRYONIC STEM CELLS AND THERAPEUTIC CLONING
The medical community is enormously excited about the potential curative powers of embryonic stem
cells. However, the methods for harvesting these cells offend members of religious communities and
antiabortion forces, among others, because they involve the destruction of human embryos. The
debate over stem cells is both fascinating and emotional because it requires judgments about issues
such as when human life begins and the relative values of human existence.
After a sperm fertilizes a human egg, the resulting embryo begins dividing into genetically identical
cells. At first, the egg grows into a ball of uniform cells, but in about four days, the embryo starts to form a
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hollow ball of cells called a blastocyst. Cells on the outer layer of the blastocyst will become the placenta,
while those in the inner layer still have an undetermined future. These cells are called pluripotent because
they still have the capacity to differentiate into any of the 220 cell types within the human body that
ultimately become organs, skin, and tissues. These are the embryonic stem cells that scientists believe hold
the key to relieving much human suffering. Embryonic stem cells are not blank slates for long—by the time
the embryo is 14 days old, their fate has been determined. But for a few short days, they await instructions
to become almost anything the body needs. This is what so excites medical scientists. Perhaps stem cells
can be coaxed to restore lost organ functions, replace brain or nerve cells, repair damaged skin cells,
strengthen hardened arteries, or take care of deteriorating joints. In 1998, the research community got a
boost when medical research teams discovered a way to preserve a line of stem cells once they had been
drawn from a human embryo and cultured. Through this technique, the stem cells do not quickly
differentiate, but rather continue to divide into new pluripotent cells. This means that far fewer embryos
have to be destroyed, since each may be used to create a stream of stem cells that then can be used for
research or therapies.
Any time medical research involves the destruction of human life, a variety of powerful interest groups
will be morally offended. For this reason, since 1996, Congress annually has passed legislation banning the
use of federal funds for research that destroys human embryos. This restriction does not affect experiments
conducted solely with private or state money, but most stem cell research is very expensive and
realistically requires federal subsidies to be carried out. Also, it does not stop research on existing cell lines
that have already been cultured, but their numbers and viability may not be sufficient for all contemplated
research needs. Thus researchers claim they need federal funds to support research using new lines of
embryonic stem cells, which unfortunately requires the destruction of human embryos.
A related issue regards the integration of cloning techniques with embryonic stem cell research to
enhance the probability of success. One potential problem with stem cell therapies is that the patient may
reject tissues generated by the stem cells because the cells originated from a foreign body. One possible
way to overcome this difficulty is to clone the patient using somatic cell nuclear transfer, and then draw the
stem cells from the embryo in its first 14 days. As noted before, this practice, which is called therapeutic
cloning, is more palatable to some than reproductive cloning because of the medical benefits. However,
others find it equally reprehensible—perhaps more so—because with therapeutic cloning one is creating
life for the purpose of destroying it. Under current U.S. policy, federal funds cannot be used for therapeutic
cloning experiments because they involve the destruction of human embryos. However, researchers
depending on private or state funds may engage in therapeutic cloning as long as the practice is not
prohibited by their governing state laws.53 Also, the laws of some other countries specifically sanction the
practice. For instance, the British government passed a law in 2001 allowing human cloning for the
purpose of embryonic stem cell research as long as the embryos are destroyed within the first 14 days. The
law permits the use of government funds as well as private money, leading many researchers to argue that
Britain has the most suitable climate to encourage their work.
In August 2000, while Bill Clinton was still president, the NIH adopted controversial new guidelines
that allowed scientists following certain procedures to receive federally funded grants from NIH to conduct
stem cell research with human embryos.54 The guidelines technically avoided the legislative ban because
the federal grants could only be distributed to researchers who used stem cells that were derived from
embryos created in private fertility clinics and exceeded the clinical needs of the individuals seeking
fertility treatment. The underlying concept supporting this policy was that the embryos were going to be
destroyed anyway, so why not allow them to be used in some potentially beneficial way. Opponents
worried, though, that people would start working with fertility clinics to create embryos for monetary
remuneration. The guidelines therefore contained numerous conditions that attempted to alleviate these
concerns. For instance, the fertility clinic had to have written policies ensuring that no monetary
inducements were offered to those donating human embryos. Also, the physician at the fertility clinic could
not be the same person undertaking the stem cell research.
53
From 2001 through 2005, several bills dealing with human cloning were introduced in Congress. Some of these prohibited only reproductive
cloning, while others outlawed all human cloning, both for reproductive and therapeutic purposes. A complete ban would affect therapeutic
embryonic stem cell research currently being conducted at privately financed and state-funded clinics.
54
The 2000 guidelines for federally funded stem cell research are posted at http://www.nih.gov. Look under News and click on Stem Cell
Information. Under Federal Policy, click on Policy & Guidelines.
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In February 2001, newly elected President Bush halted NIH funding for stem cell research under this
policy before any grants had yet been made. During the next six months, President Bush grappled with the
issue, which required him to balance campaign statements indicating his opposition to stem cell research on
personal, moral, and religious grounds with the enormous potential benefits articulated by scientific and
medical communities. Making the decision more difficult were policies adopted in foreign countries, such
as in England, allowing human cloning to develop stem cells for therapeutic purposes. The availability of
funding in foreign nations might lead to an exodus of U.S. medical researchers if federal funding were not
available for similar research in the United States.
On August 9, 2001, President Bush announced a compromise that allowed federal funding for some
stem cell research, but under much more limited conditions than with the Clinton policy.55 In particular,
federal funding would be permitted for research on stem cell lines that were created by private sources
before August 9, 2001. However, no money would be available to create new stem cell lines either from
currently existing or future embryos, even those that exceed clinical needs at private fertility clinics.
According to NIH, 64 stem cell lines had been developed by 10 companies and academic institutions
before the August 9 deadline, and thus became available for experimental research with federal funding.
As expected, the compromise was criticized from both sides of the issue. Opponents argued that even a
limited option granting a green light to some research opens the door to further exceptions in the future.
Research advocates believed that the quantity and diversity of available stem cell lines would be
insufficient for experimental needs. For instance, there were substantial questions about whether the
64 lines were all viable and sustainable. In addition, recipients may reject stem cell therapies if there is not
a suitable immunological match. Thus, it may be important to have stem cell lines that are derived from a
wide range of racial and ethnic groups across the globe. Indeed, some argued that the policy rings with
racial discrimination because most of the stem cell lines were harvested from white patients at U.S.,
Swedish, and Israeli fertility clinics.
The stem cell debate is so emotional because it balances the value of a human embryonic life against
the life or health of loved ones. Even some policy makers who oppose abortion rights have turned a
sympathetic ear to embryonic stem cell research. Of course, if there were some way to obtain beneficial
stem cells without destroying embryos, then the controversy might be defused. This may not be impossible.
Adults have other kinds of stem cells—in the blood, liver, and other sources—that may have renewable
properties. These cells are called multipotent, since they can differentiate into many other kinds of cells,
although not to the wide degree that is possible with pluripotent embryonic stem cells. However, at this
time, most researchers have substantial doubts that multipotent adult cells can fulfill the dreams expected
with embryonic stem cells.56 Thus, they criticize those who wish to outlaw embryonic stem cell research
based on the availability of adult stem cells.
With all the doubts about multipotent cells, there has been little to dissuade proponents of stem cell
research from seeking opportunities to conduct research beyond that permitted by President Bush’s 2001
policy declaration. One avenue that quickly developed came out of universities that established research
centers and projects financed with private money. For instance, Stanford University established the
Institute for Cancer/Stem Cell Biology and Medicine in 2002, which has, among its goals, to use private
funds for developing a series of embryonic stem cell lines for cancer research. Other universities, such as
the University of California at San Francisco, the Massachusetts Institute of Technology, and Harvard soon
followed with plans to conduct stem cell experiments.
Another financing route that became established was that of tapping state government funds, which are
not subject to the restriction on federal dollars. California was the leader here when its citizens in 2004
approved Proposition 71, which is intended to provide $3 billion in research grants and loans from state
coffers over a 10-year period. By early 2006, several other states, including Connecticut, Maryland, and
New Jersey had passed multi-million dollar legislative initiatives designed to dole out state funds for
therapeutic stem cell research.57
55
Information on the 2001 stem cell policy is available on the NIH website under Policy & Guidelines, as in the previous footnote.
Some recent studies do show some progress with multipotent cells. For instance, a study at the University of Pittsburgh School of Medicine
indicated in 2004 that heart patients improved after doctors injected their damaged hearts with stem cells taken from their own bone marrow. In
addition, in 2005 scientists were working on other techniques to create stem cells without destroying an embryo. For instance, one method would
create a new line of stem cells by extracting a single cell from an embryo, without damaging the embryo.
57
Other states that by early 2006 were either allocating or seriously considering public funding to support stem cell research included New York,
Wisconsin, Massachusetts, and Minnesota.
56
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In 2005 the federal government began debating legislation that would allow federal dollars to be used
for therapeutic stem cell research under restrictions similar to those established in the Clinton policy.
Support for this proposal accelerated when Nancy Reagan took center stage and touted the possible
benefits from stem cell research to help treat Alzheimer’s disease, which so publicly devastated President
Reagan in the final years of his life. Likewise, Senator Orrin Hatch, who typically advocates right-to-life
issues, backed the legislation, claiming that the opportunity to combat disease and save the living
outweighs the ethical and religious issues involved. Actors, such as Christopher Reeve and Michael J. Fox,
also focused public attention on the need for federal funds. Then, in July 2005, Republican Senate Majority
Leader Bill Frist shocked stem cell opponents when he announced that he would support federal funding
for therapeutic stem cell research because it promises so many potential medical benefits. As a result of all
these events, most political observers predicted that Congress might soon pass federal funding legislation,
notwithstanding a likely presidential veto.
Finally, stem cell research has significantly advanced in foreign countries, where the research is clearly
allowed and often supported with substantial government funds. In fact, international competitive pressures
to achieve recognized milestones became so intense in 2005 that improprieties resulted, which at least
temporarily tarnished the perception of progress in the field. In May 2005, Hwang Woo Suk announced
that his team of research scientists in South Korea had successfully taken skin cells from 11 sick or injured
people and created stem cells through therapeutic cloning techniques. On the same day, Newcastle
University in Great Britain announced that two of its research scientists, Miodrag Stojkovic and Alison
Murdoch, had used therapeutic cloning to create four human embryos that lived for three to five days. In
September 2005, though, Stojkovic left Great Britain for a post in Spain, claiming, among other things, that
the University prematurely released the results of the research before it had been thoroughly reviewed by
independent experts. Then, in December 2005, Hwang Woo Suk’s work was discredited with evidence that
he had falsified data, and he soon resigned from Seoul National University in shame. Despite these
incidents, no one doubts that foreign interests are on the threshold of significant breakthroughs in
therapeutic cloning and stem cell research. Thus, it appears that in the international environment, the genie
is nearly, if not already, out of the bottle, and this likely will put added pressure on U.S. policy makers to
more fully support stem cell research with appropriate limitations.
GENETIC TESTING, DISCRIMINATION, AND BEHAVIORAL ISSUES
Understanding the structure and function of the human genome allows scientists to determine with genetic
testing when particular individuals have irregularities in their DNA that might result in diseases or other
conditions.58 Genetic tests have enormous applications as diagnostic tools. For instance, the following are
just some of the reasons to undertake genetic tests:
•
•
•
•
•
•
•
Presymptomatic testing for predicting the potential onset of medical disorders, such as Huntington’s
disease;
Presymptomatic testing for estimating the risk of developing certain cancers or Alzheimer’s
disease;
Carrier screening, to see if an individual has one copy of a gene when two are needed for the
disease to materialize;
Confirmation of a diagnosis made for a person having symptoms;
Pharmacological testing to determine an individual’s likely response to particular medicines;
Prenatal testing; and
Forensic testing.
All of these applications clearly yield information that might provide enormous personal benefits. For
instance, genetic tests may help individuals who have family histories of particular diseases to select the
most appropriate treatment regimens. If a test is positive, then one might take appropriate intervention
measures, such as more frequent screenings or adopting healthier lifestyles. In addition, early warnings
provide opportunities to seek psychological counseling. A negative test, on the other hand, not only brings
58
Information on genetic testing can be found at http://www/doegenomes.org. Look for Gene Testing under Medicine.
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tremendous relief, but also may prevent one from incurring unnecessary expenses, such as the costs associated
with frequent checkups.
In some circumstances, though, genetic testing raises significant social and personal concerns. For
example, it may be very useful to learn about one’s susceptibility to a disease when reasonable corrective
actions are available, but what about when the treatments are invasive, debilitating, and often ineffectual?
The emotional impact in terms of worry, confusion, anger, and depression can overwhelm a person who
otherwise may have been able to enjoy many perfectly healthy years of life. There also are problems with
false-positives and false-negatives, which may lead one to take the wrong actions under the circumstances.59
Genetic tests also raise concerns if others can discover the results and take actions based on them. For
example, employers and insurance companies may rely on information from genetic tests to discriminate
against those who have a higher statistical probability of requiring medical care in the future. Employers
also might want to use genetic testing to appraise job skills or the potential for harmful medical reactions
from environmental conditions in the workplace. Obviously, in these contexts, genetic testing raises
substantial privacy issues, a topic that is addressed more fully in Chapter 13. But you should recognize that
current laws and policies may restrict some uses of genetic testing, and that many more comprehensive
initiatives have been proposed. For instance, a federal executive order prohibits federal agencies from
using genetic information in employment actions. Also, the Americans with Disabilities Act may condemn
genetic testing in certain circumstances. In addition, more than one-half of the states have passed laws that
target workplace discrimination based on genetic testing. Finally, Congress is in the midst of debating
proposed legislation that would ban businesses and insurance companies from denying jobs or health
coverage based on inherited traits.
The more that scientists study genetics, the more they realize that certain genes may affect the
likelihood of specific behaviors. For instance, certain genes may help determine if one will be homosexual
or prone to anger. If human behavior is greatly predetermined by the sequence of one’s genes, then
philosophers and legal scholars may have to rethink traditional principles that often are based on notions of
human free will. Consider what this will mean in the context of criminal proceedings. Could accused
individuals be able to prove with genetic testing that they were not culpable for what happened because
their genes made them act the way they did? Also, discrimination laws often protect those with immutable
traits or conditions. Thus, as we learn that genes define specific conditions or behavior, society may have
to reassess when discrimination may be tolerable. Obviously, genetic testing opens a Pandora’s box of
fascinating behavioral issues that may challenge important notions regarding human responsibility and
social consequences.
CONCLUSION
The biotechnology revolution is merely beginning, and we have only seen a glimpse of what the future
portends. The legal, economic, and social issues are already perplexing, and they certainly will multiply as
the technology continues to advance. The prospects of understanding and perhaps controlling the basic
units of human life have enormous medical and religious implications. There also seems little doubt that
we will soon see advanced forms of biological machines, which will merge biological processes with
computer innovations. Who will own these innovations and what rights will the creations have, if any?
These are questions that have been asked for generations, but soon they will no longer be hypothetical and
will require real answers. Among all the new technological developments, biotechnology may offer the
greatest potential rewards, but it also presents the most serious social challenges. Clearly, biotechnology no
longer is an obscure topic that only garners interest from specialized scientists. Rather, it is rapidly
becoming the most critical and contentious of all emerging business fields.
59
Doctors also now must worry about facing liability for failure to use genetic tests when information from the test may have affected the treatment
decisions of patients or prospective parents. For more information, see Lindsay Fortado, “Genetic Testing Maps New Legal Turf,” National Law
Journal (September 6, 2004) at 1.
Burgunder, Lee. Legal Aspects of Managing Technology, 4th ed. Mason, OH: Thomson West, 2007