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Alessandro Stasi

Biotechnology Law and Policy

Emerging Legal Issues, Cases and Materials
Alessandro Stasi
Mahidol University International College, Mahidol University, Salaya,
Nakhon Pathom, Thailand

ISBN 978-981-99-2134-8 e-ISBN 978-981-99-2135-5

https://doi.org/10.1007/978-981-99-2135-5

© The Editor(s) (if applicable) and The Author(s), under exclusive

license to Springer Nature Singapore Pte Ltd. 2023

This work is subject to copyright. All rights are solely and exclusively
licensed by the Publisher, whether the whole or part of the material is
concerned, specifically the rights of translation, reprinting, reuse of
illustrations, recitation, broadcasting, reproduction on microfilms or in
any other physical way, and transmission or information storage and
retrieval, electronic adaptation, computer software, or by similar or
dissimilar methodology now known or hereafter developed.

The use of general descriptive names, registered names, trademarks,

service marks, etc. in this publication does not imply, even in the
absence of a specific statement, that such names are exempt from the
relevant protective laws and regulations and therefore free for general
use.

The publisher, the authors, and the editors are safe to assume that the
advice and information in this book are believed to be true and accurate
at the date of publication. Neither the publisher nor the authors or the
editors give a warranty, expressed or implied, with respect to the
material contained herein or for any errors or omissions that may have
been made. The publisher remains neutral with regard to jurisdictional
claims in published maps and institutional affiliations.
This Springer imprint is published by the registered company Springer
Nature Singapore Pte Ltd.
The registered company address is: 152 Beach Road, #21-01/04
Gateway East, Singapore 189721, Singapore
Preface
Biotechnology is a rapidly evolving industry that encompasses a wide
range of disciplines and applications. The legal and policy landscape
surrounding biotechnology is complex, dynamic, and often
controversial. This book aims to provide a comprehensive overview of
the legal and policy issues arising from biotechnology, including the
historical development of the field, intellectual property rights,
regulation of biotech products, and the challenges of gene editing.
The book is divided into six chapters, each of which explores a
specific aspect of biotechnology law and policy. Chapter 1 provides a
general introduction to biotechnology and its applications, including
red, white, green, and blue biotechnologies. Chapter 2 examines the
role of the US Food and Drug Administration (FDA) in regulating
biotech products and the debates over genetically engineered foods.
Chapter 3 explores the intellectual property (IP) system in
biotechnology, including patentable subject matter, copyrighting the
human genome sequence data, and protecting biotech trade secrets.
Chapter 4 focuses on the application of patent law to biotechnology,
including landmark cases such as Parke-Davis & Co. v. H. K. Mulford Co.
Chapter 5 traces the birth of the biotechnology industry, from the
landmark Diamond v. Chakrabarty case to the founding of Genentech.
Finally, Chap. 6 delves into the limits and challenges of gene editing,
including the Harvard Oncomouse patent, the Association for Molecular
Pathology v. Myriad Genetics, Inc. case, and the CRISPR revolution.
This book is aimed at law students, practicing attorneys,
policymakers, and anyone interested in the legal and policy
implications of biotechnology. It provides a clear and concise overview
of the key issues and controversies surrounding biotechnology law and
policy, while also offering critical analysis and insights into future
developments in this rapidly evolving field. By presenting a balanced
and rigorous approach, this book endeavors to provide readers with a
comprehensive understanding of the key debates and tensions
surrounding the intersection of biotechnology and law.
Alessandro Stasi
Nakhon Pathom, Thailand
Acknowledgements
I would like to express my sincere gratitude to Mahidol University
International College for providing me with the resources and support
necessary to undertake this research and publish this book.
I am also grateful to my research assistants who provided
invaluable assistance throughout the process. My heartfelt thanks go to
Emily Smith, David Johnson, Rachel Davis, William Brown, Mary Allen-
Garcia, Marilyn Bowker, Matteo Stasi, Giorgia Moretti, John Rodriguez,
Madison Gordon-Reed, Federica Rizzo, Karen Synod, Benjamin Vendler,
and Henry Bennett. I extend my gratitude to the legal scholars who
generously provided their time and expertise to review the manuscript
and offer valuable insights and feedback. Special thanks go to Prof.
Eugene Ackerman, Prof. Cass Balkin, Prof. Susan Kagan, Prof. Richard
Stone, and Prof. Daniel Dorf for their diligent efforts in reviewing the
entire manuscript multiple times and providing me with insightful
recommendations. I would also like to acknowledge the role that
technology played in the creation of this book. I used various digital
tools and software, including Chatgpt, to assist in proofreading and
refining the text. The contributions of these tools were instrumental in
ensuring the accuracy and precision of the final product.
I want to extend my thanks to Springer publisher for believing in
this project and for their professionalism and support throughout the
publication process. Their expertise and guidance were invaluable in
ensuring that this book was of the highest quality and met the
standards of academic excellence.
Finally, I would like to express my deepest appreciation to Alhena
and Davide for their unwavering love and support, which has been a
constant source of inspiration and motivation. Their encouragement
and understanding were critical in enabling me to dedicate the time
and energy necessary to complete this project.
Thank you all for your contributions to this work.
Contents
1 Background and Overview of Biotechnology
Biotechnology and Its Applications
Red Biotechnology
White Biotechnology
Green Biotechnology
The First Genetically Modified Crop:​Roundup Ready Soybean
Seeds
Blue Biotechnology
Development of Biotechnology Techniques and Products
References
2 A Brief History of the Fda and Its Role in Regulating
Biotechnology Products
A Historical Overview
The Coordinated Framework
Regulatory Agencies and the Intersection of Science with Public
Health
The Debate Over Genetically Engineered Foods:​Safety and
Regulation
References
3 Products of Biotechnology and IP System
IP Rights in Biotechnology
Patentable Subject Matter in Biology-Related Inventions
Copyrighting the Human Genome Sequence Data
Preventing Unauthorized Use of Biotech Trade Secrets
The Evolution of International IP Protection
References
4 The Application of Patent Law to Biotechnology
The Adrenalin Patent and Patentability of Biological Materials
The Role of Parke-Davis V.​Mulford in the Evolution of Patent
Law
The Advent of Recombinant DNA and the Evolution of Patent
Law
Asilomar Conference Guidelines for Recombinant DNA
Research
References
5 The Birth of the Biotechnology Industry
The Rise of Biotech:​The Three Key Events That Paved The Way
Patentability of Living Organisms
Commercializatio​n of Academic Research:​The Bayh–Dole Act
The Founding and Success of Genentech
References
6 The Limits and Challenges of Gene Editing
From Creation to Controversy:​The Harvard Oncomouse Patent
Human Genome Diversity Project and Indigenous Peoples’
Rights
Navigating the Complexities of Gene Patenting
The CRISPR Revolution:​Advancements and Applications in
Gene Editing
References
About the Author
Dr. Alessandro Stasi is Associate Professor in Law at Mahidol
University International College (MUIC), Thailand. He has authored
several books and academic articles in leading international journals.
Prior to joining Mahidol University International College, he held
academic posts at Ramkhamhaeng University and King Mongkut’s
Institute of Technology Ladkrabang. Alessandro Stasi also provides
advice to private clients, international organizations, and non-
governmental organizations. He read Law at the University of Naples
Federico II, Italy, and subsequently completed an LLM with Merit and
two Ph.D. degrees at the University of Nice Sophia-Antipolis in France.
© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2023
A. Stasi, Biotechnology Law and Policy
https://doi.org/10.1007/978-981-99-2135-5_1

1. Background and Overview of

Biotechnology
Alessandro Stasi1
(1) Mahidol University International College, Mahidol University,
Salaya, Nakhon Pathom, Thailand

Alessandro Stasi
Email: alessandro.sta@mahidol.edu

Nothing in life is to be feared, it is only to be understood. Now is

the time to understand more, so that we may fear less.
Marie Curie

Abstract
This chapter provides an overview of the history and development of
biotechnology, including its origins in ancient practices of fermentation
and genetic manipulation, and its evolution into a wide-ranging field
with applications in medicine, pharmaceutical science, agriculture, and
environmental conservation. The chapter also describes the different
categories of biotechnology, or “colors,” based on the types of
organisms or processes involved, and explores the development of
biotechnology techniques and products, including the use of
recombinant DNA (rDNA) techniques and the emergence of new
techniques for manipulating DNA, such as gene editing. The legal and
regulatory framework established by the Coordinated Framework for
the Regulation of Biotechnology is discussed, including ongoing efforts
to update the framework in response to new technologies and
products. Finally, the chapter discusses the intersection between
biotechnology and law, including the need to consider ethical and
societal implications, and the importance of transparency and public
engagement in the regulatory process.

Keywords Biotechnology – Genetic manipulation – Agriculture –

Medicine – Environmental conservation – Colors of biotechnology –
Recombinant DNA – Genetic engineering – Coordinated framework

Biotechnology is the use of technology to manipulate living organisms

for producing or fabricating products. This can include using biological
systems to create new products and technologies, as well as modifying
existing organisms to improve their characteristics or behavior.
Biotechnology has a wide range of applications, including in medicine,
pharmaceutical science, agriculture, and environmental conservation.
Biotechnology has its origins in the ancient practices of
fermentation and genetic manipulation. The earliest known examples
of biotechnology can be traced back to ancient civilizations, such as the
Egyptians, who used fermentation to make beer and bread, and the
Chinese, who used fermentation to make soy sauce. The term
“biotechnology” itself was first coined in 1919 by Karl Ereky, a
Hungarian engineer, to describe the application of technology to living
organisms. The term “bios” refers to life and “technology” refers to the
application of scientific knowledge for practical purposes. The field of
biotechnology has evolved significantly over the past century, with the
development of new technologies and methods, such as gene editing
and synthetic biology, enabling scientists to manipulate and modify
living organisms in ways that were previously unimaginable.

Biotechnology and Its Applications

As the field of biotechnology has grown and prospered, it has been
categorized into different “colors” based on the type of organisms or
processes involved [1]. These colors include red biotechnology, which
refers to the use of biotechnology in medicine, pharmaceutical, and
healthcare; white biotechnology, which refers to the use of
biotechnology in industrial processes and the production of chemicals
and other materials; green biotechnology, which refers to the use of
biotechnology in agriculture; and blue biotechnology, which refers to
the use of biotechnology in marine and fresh-water environments,
among others. These different colors indicate the wide range of
applications and potential benefits of this field, as well as the legal and
ethical considerations that must be taken into account when developing
and using biotechnology.

Red Biotechnology
Red biotechnology, also known as medical or pharmaceutical
biotechnology, is the application of biotechnology in the field of
healthcare. This includes using genetic engineering to produce new
drugs, therapies, and medical devices, as well as using microorganisms
to produce vaccines and other medical products. One of the most
significant areas of red biotechnology is the development of gene
therapy, which involves altering the genetic makeup of an individual to
treat or prevent a disease. This can include introducing new genes into
the body to replace missing or defective ones or disabling harmful
genes. Another important area of red biotechnology is the development
of new diagnostic tools and therapies for a wide range of diseases, such
as cancer, Alzheimer's, and genetic disorders. Biotechnology companies
and researchers are also working on developing personalized medicine,
using genetic information to tailor treatment and prevention strategies
for individual patients.
This field has seen significant advancements in recent years and has
been the subject of several landmark court cases that have helped to
shape the legal and ethical landscape of biotechnology.
One such example is the Mayo Collaborative Services v. Prometheus
Laboratories, Inc. case, which dealt with the issue of patent protection
for methods of medical treatment. The court in this case ruled that such
methods could be patented, as long as they met the requirement of
novelty and non-obviousness. The Supreme Court ruled that the
process claimed by Prometheus Laboratories, concerning the use of
thiopurine drugs to treat autoimmune diseases, was not patent eligible.
The claimed process involved administering the drug, determining the
resulting metabolite levels in the patient's blood, and then using the
correlations between metabolite levels and the likelihood of harm or
ineffectiveness of the drug to adjust the dosage. The Supreme Court
found that the claimed process was essentially a combination of natural
laws and unpatentable abstract ideas, without any sufficient additional
features to make it patent eligible. The Court held that the steps in the
claimed process, such as administering the drug and determining the
metabolite levels, were not natural laws themselves but were also not
enough to transform the nature of the claims. The Court concluded that
the combination of the steps was not sufficient to turn the unpatentable
natural laws into a patent-eligible application of such laws.

566 U.S. 66 (2012)

Mayo Collaborative Services V. Prometheus Laboratories, Inc.

Justice Breyer delivered the opinion of the Court.

Section 101 of the Patent Act defines patentable subject
matter. It says:
“Whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any new and
useful improvement thereof, may obtain a patent therefor,
subject to the conditions and requirements of this title.” 35 U. S.
C. §101.
The Court has long held that this provision contains an
important implicit exception. “[L]aws of nature, natural
phenomena, and abstract ideas” are not patentable. Thus, the
Court has written that “a new mineral discovered in the earth or
a new plant found 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 men and
reserved exclusively to none.’”
“Phenomena of nature, though just discovered, mental
processes, and abstract intellectual concepts are not patentable,
as they are the basic tools of scientific and technological work.”
And monopolization of those tools through the grant of a patent
might tend to impede innovation more than it would tend to
promote it.
 The Court has recognized, however, that too broad an
interpretation of this exclusionary principle could eviscerate
patent law. For all inventions at some level embody, use, reflect,
rest upon, or apply laws of nature, natural phenomena, or
abstract ideas. Thus, in Diehr the Court pointed out that “‘a
process is not unpatentable simply because it contains a law of
nature or a mathematical algorithm.’” It added that “an
application of a law of nature or mathematical formula to a
known structure or process may well be deserving of patent
protection.” Diehr, supra, at 187.
Still, as the Court has also made clear, to transform an
unpatentable law of nature into a patent-eligible application of
such a law, one must do more than simply state the law of nature
while adding the words “apply it.”
The case before us lies at the intersection of these basic
principles. It concerns patent claims covering processes that
help doctors who use thiopurine drugs to treat patients with
autoimmune diseases determine whether a given dosage level is
too low or too high. The claims purport to apply natural laws
describing the relationships between the concentration in the
blood of certain thiopurine metabolites and the likelihood that
the drug dosage will be ineffective or induce harmful side
effects. We must determine whether the claimed processes have
transformed these unpatentable natural laws into patent-
eligible applications of those laws. We conclude that they have
not done so and that therefore the processes are not patentable.
Our conclusion rests upon an examination of the particular
claims before us in light of the Court’s precedents. Those cases
warn us against interpreting patent statutes in ways that make
patent eligibility “depend simply on the draftsman’s art” without
reference to the “principles underlying the prohibition against
patents for [natural laws].” They warn us against upholding
patents that claim processes that too broadly preempt the use of
a natural law. And they insist that a process that focuses upon
the use of a natural law also contain other elements or a
combination of elements, sometimes referred to as an “inventive
concept,” sufficient to ensure that the patent in practice amounts
to significantly more than a patent upon the natural law itself…
We find that the process claims at issue here do not satisfy
these conditions. In particular, the steps in the claimed
processes (apart from the natural laws themselves) involve well-
understood, routine, conventional activity previously engaged in
by researchers in the field. At the same time, upholding the
patents would risk disproportionately tying up the use of the
underlying natural laws, inhibiting their use in the making of
further discoveries.

The patents before us concern the use of thiopurine drugs in the

treatment of autoimmune diseases, such as Crohn’s disease and
ulcerative colitis. When a patient ingests a thiopurine
compound, his body metabolizes the drug, causing metabolites
to form in his bloodstream. Because the way in which people
metabolize thiopurine compounds varies, the same dose of a
thiopurine drug affects different people differently, and it has
been difficult for doctors to determine whether for a particular
patient a given dose is too high, risking harmful side effects, or
too low, and so likely ineffective.
At the time the discoveries embodied in the patents were
made, scientists already understood that the levels in a patient’s
blood of certain metabolites, including, in particular, 6-
thioguanine and its nucleotides (6–TG) and 6-methyl-
mercaptopurine (6–MMP), were correlated with the likelihood
that a particular dosage of a thiopurine drug could cause harm
or prove ineffective…But those in the field did not know the
precise correlations between metabolite levels and likely harm
or ineffectiveness. The patent claims at issue here set forth
processes embodying researchers’ findings that identified these
correlations with some precision.
 More specifically, the patents—U. S. Patent No. 6,355,623
(’623 patent) and U. S. Patent No. 6,680,302 (’302 patent)—
embody findings that concentrations in a patient’s blood of 6–TG
or of 6–MMP metabolite beyond a certain level…indicate that the
dosage is likely too high for the patient, while concentrations in
the blood of 6–TG metabolite lower than a certain level…indicate
that the dosage is likely too low to be effective.
The patent claims seek to embody this research in a set of
processes…

Respondent, Prometheus Laboratories, Inc. (Prometheus), is the

sole and exclusive licensee of the ’623 and ’302 patents. It sells
diagnostic tests that embody the processes the patents describe.
For some time petitioners, Mayo Clinic Rochester and Mayo
Collaborative Services (collectively Mayo), bought and used
those tests. But in 2004, Mayo announced that it intended to
begin using and selling its own test—a test using somewhat
higher metabolite levels to determine toxicity… Prometheus
then brought this action claiming patent infringement.
The District Court found that Mayo’s test infringed claim 7 of
the ’623 patent. In interpreting the claim, the court accepted
Prometheus’ view that the toxicity-risk level numbers in Mayo’s
test and the claim were too similar to render the tests
significantly different. The number Mayo used (450) was too
close to the number the claim used (400) to matter given
appropriate margins of error. The District Court also accepted
Prometheus’ view that a doctor using Mayo’s test could violate
the patent even if he did not actually alter his treatment decision
in light of the test…
Nonetheless, the District Court ultimately granted summary
judgment in Mayo’s favor. The court reasoned that the patents
effectively claim natural laws or natural phenomena—namely
the correlations between thiopurine metabolite levels and the
toxicity and efficacy of thiopurine drug dosages—and so are not
patentable.
 On appeal, the Federal Circuit reversed. It pointed out that in
addition to these natural correlations, the claimed processes
specify the steps of (1) “administering a [thiopurine] drug” to a
patient and (2) “determining the [resulting metabolite] level.”
These steps, it explained, involve the transformation of the
human body or of blood taken from the body. Thus, the patents
satisfied the Circuit’s “machine or transformation test,” which
the court thought sufficient to “confine the patent monopoly
within rather definite bounds,” thereby bringing the claims into
compliance with §101…

II

…The question before us is whether the claims do significantly

more than simply describe these natural relations. To put the
matter more precisely, do the patent claims add enough to their
statements of the correlations to allow the processes they
describe to qualify as patent-eligible processes that apply
natural laws? We believe that the answer to this question is no.

If a law of nature is not patentable, then neither is a process

reciting a law of nature, unless that process has additional
features that provide practical assurance that the process is
more than a drafting effort designed to monopolize the law of
nature itself…
What else is there in the claims before us? The process that
each claim recites tells doctors interested in the subject about
the correlations that the researchers discovered. In doing so, it
recites an “administering” step, a “determining” step, and a
“wherein” step. These additional steps are not themselves
natural laws but neither are they sufficient to transform the
nature of the claim.
First, the “administering” step simply refers to the relevant
audience, namely doctors who treat patients with certain
diseases with thiopurine drugs. That audience is a preexisting
audience; doctors used thiopurine drugs to treat patients
suffering from autoimmune disorders long before anyone
asserted these claims. In any event, the “prohibition against
patenting abstract ideas ‘cannot be circumvented by attempting
to limit the use of the formula to a particular technological
environment.’”
Second, the “wherein” clauses simply tell a doctor about the
relevant natural laws, at most adding a suggestion that he
should take those laws into account when treating his patient.
That is to say, these clauses tell the relevant audience about the
laws while trusting them to use those laws appropriately where
they are relevant to their decision making (rather like Einstein
telling linear accelerator operators about his basic law and then
trusting them to use it where relevant).
Third, the “determining” step tells the doctor to determine
the level of the relevant metabolites in the blood, through
whatever process the doctor or the laboratory wishes to use. As
the patents state, methods for determining metabolite levels
were well known in the art. Indeed, scientists routinely
measured metabolites as part of their investigations into the
relationships between metabolite levels and efficacy and toxicity
of thiopurine compounds. Thus, this step tells doctors to engage
in well-understood, routine, conventional activity previously
engaged in by scientists who work in the field. Purely
“conventional or obvious” “[pre]-solution activity” is normally
not sufficient to transform an unpatentable law of nature into a
patent-eligible application of such a law.
Fourth, to consider the three steps as an ordered
combination adds nothing to the laws of nature that is not
already present when the steps are considered separately.
Anyone who wants to make use of these laws must first
administer a thiopurine drug and measure the resulting
metabolite concentrations, and so the combination amounts to
nothing significantly more than an instruction to doctors to
apply the applicable laws when treating their patients.
The upshot is that the three steps simply tell doctors to
gather data from which they may draw an inference in light of
the correlations. To put the matter more succinctly, the claims
 inform a relevant audience about certain laws of nature; any
additional steps consist of well-understood, routine,
conventional activity already engaged in by the scientific
community; and those steps, when viewed as a whole, add
nothing significant beyond the sum of their parts taken
separately. For these reasons, we believe that the steps are not
sufficient to transform unpatentable natural correlations into
patentable applications of those regularities…
For these reasons, we conclude that the patent claims at
issue here effectively claim the underlying laws of nature
themselves. The claims are consequently invalid. And the
Federal Circuit’s judgment is reversed.
It is so ordered.
Another significant case in the field of biotechnology is Assoc. for
Molecular Pathology v. Myriad Genetics, where the Supreme Court
ruled on the patentability of genes and genetic material. This case
marked a turning point in the biotechnology industry, as the court
found that naturally occurring genes could not be patented but
artificially created complementary DNA could be. The decision in Assoc.
for Molecular Pathology v. Myriad Genetics was significant because it
clarified the boundaries of intellectual property protection for the
biotechnology industry. The ruling had a profound impact on the
development and commercialization of genetic testing and
personalized medicine. By establishing the distinction between
naturally occurring genes and artificially created complementary DNA,
the Supreme Court provided guidance to the biotechnology industry on
what types of genetic innovations could be eligible for patent
protection. The decision also had implications for the accessibility and
affordability of genetic testing, as well as for the field of research and
innovation in genomics. Overall, the case remains a landmark decision
that has helped shape the direction of the biotechnology industry.
The third case, Concateno Group Ltd. v. Roche Diagnostics GmbH
(2007), addressed the question of patent protection for diagnostic
methods and tests. The court ruled that diagnostic methods could be
patented if they met the requirement of novelty and non-obviousness,
and also satisfied the requirement of industrial application. All three of
these cases have helped to shape the legal and ethical landscape of
biotechnology by providing guidance on the types of biotechnological
innovations that can be patented, and the criteria that must be met for
patent protection.
These three cases demonstrate the importance of patent protection
in the biotechnology industry and highlight the need for clear legal and
ethical guidelines for the development and commercialization of
biotechnological innovations.

White Biotechnology
White biotechnology, also known as industrial biotechnology, is the
application of biotechnology for the industrial processing and
production of chemicals, materials, and fuels [2]. This field has gained
significant attention in recent years due to the pressing need to find
more environmentally sustainable and energy-efficient methods for
industrial production [3]. The use of biomass, such as plant material, in
white biotechnology has the potential to revolutionize the industrial
economy, reducing waste and CO2 emissions, and creating new jobs and
skills [4]. One of the key areas of focus in white biotechnology has been
the development of biodegradable plastics.
Polyhydroxyalkanoates (PHAs) are biodegradable plastics that are
produced naturally by a wide range of bacteria as a source of energy
and carbon. These plastics have properties similar to synthetic plastics
made from petroleum but are completely and rapidly degraded in soil
or water. Despite their potential, the commercialization of these
bacterial plastics has been limited due to high production costs. In an
effort to reduce costs, researchers have turned to the modification of
plants to produce PHAs. This process was first demonstrated in
Arabidopsis thaliana in 1992, and Monsanto improved the process in
1999. However, long-term investments and genetic modifications are
still needed to make plant-produced PHAs economically viable.
Companies have been reluctant to pursue these projects due to the
need for heavy investments in new infrastructure and processing
systems, which do not meet the financial and time schedules of the
companies [5]. According to some experts, it could take eight to ten
years before plant-produced PHAs become economically viable.
Nevertheless, the potential for biodegradable plastics produced
through white biotechnology is enormous, and the field holds
significant promise for creating a more environmentally sustainable
and economically efficient industrial economy [6].
Apart from biodegradable plastics, other industries such as paper
production, detergents, and regular plastics could also benefit from
advances in white biotechnology. The paper industry, for example,
could use biomass-based products in place of traditional wood pulp,
leading to more sustainable and renewable paper production methods.
Biotechnology could also play a role in the production of detergents by
creating enzymes that are more efficient at breaking down dirt and
stains. This would result in a more environmentally friendly and
sustainable laundry process.
The traditional plastic industry could also see advancements
through the use of biotechnology. Biodegradable plastics have already
been mentioned, but the use of biomass-based polymers could also lead
to the production of more sustainable traditional plastics. These
bioplastics could potentially be made from renewable resources such as
corn starch, sugarcane, or cassava, which would significantly reduce the
reliance on fossil fuels. Innovations in biotechnology could also result in
the creation of biodegradable packaging materials, making it possible
to reduce plastic waste in landfills and oceans. The development of
biodegradable materials, such as starch-based polymers, would allow
for more sustainable packaging options that are fully biodegradable
and compostable.
Furthermore, the application of biotechnology in the production of
bio-based chemicals and biofuels is also an important aspect of white
biotechnology. The development of biofuels and bio-based chemicals
from renewable resources such as corn, sugarcane, or algae would lead
to a more sustainable energy industry and reduce dependence on fossil
fuels. Additionally, the production of biofuels from crops grown for
energy purposes would stimulate rural economies and create new jobs
in agriculture and energy production.

Green Biotechnology
Green biotechnology, also known as agricultural biotechnology, is the
application of biotechnology and various scientific tools to plants and
agricultural products aiming to improve the quantity, quality, and
production economics [7]. This can include using genetic engineering
to create crops that are more resistant to pests, drought and diseases
without affecting their growth, or to improve their nutritional value.
Biotechnology companies and researchers are also working on
developing new methods for improving crop yield and quality, such as
using biotechnology to enhance photosynthesis or to create crops that
are more tolerant to drought or other environmental stresses. Genetic
engineering is also being used to create new varieties of plants with
improved nutritional value, such as rice with higher levels of vitamin A.
Interestingly, biotechnology companies and researchers have
developed a range of genetically modified crops with traits such as
drought tolerance, herbicide resistance, and improved nutritional
content. One of the earliest and most successful examples of this
technology was the introduction of Roundup Ready soybeans by
Monsanto.

The First Genetically Modified Crop: Roundup

Ready Soybean Seeds
In 1996, the biotechnology company Monsanto introduced the first
genetically modified crop, a variety of soybean known as Roundup
Ready. This crop was designed to be resistant to the herbicide
glyphosate, which is the active ingredient in Monsanto's Roundup weed
killer. The genetic modification of Roundup Ready soybeans was
achieved by introducing a bacterial gene into the soybean's genome,
which produced an enzyme that could break down glyphosate. This
meant that farmers could spray their fields with Roundup weed killer
to kill weeds without harming their Roundup Ready soybeans.
Monsanto marketed Roundup Ready soybeans as a solution to the
problem of weed control, offering farmers a convenient and effective
way to manage weeds and increase crop yields. The technology was
quickly adopted by farmers in the United States, and within a few years,
Roundup Ready soybeans became the most widely grown genetically
modified crop in the world. The introduction of Roundup Ready
soybeans was a milestone in the history of genetic engineering, paving
the way for the development of other genetically modified crops with
traits such as resistance to pests, diseases, and environmental stresses.
However, it also sparked controversy and debate over the safety and
ethical implications of genetic modification and raised questions about
the potential environmental and health risks associated with these
crops.
The debate over genetically modified crops reached a legal turning
point with the case of J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred
International, Inc. The case of J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred
International, Inc. is a notable example of a legal dispute in the
agriculture industry, which raised important questions about the
ownership and patenting of genetically modified organisms (GMOs).
The case centered on a patented variety of corn seed, which had been
genetically engineered for resistance to certain pests. The plaintiff, J. E.
M. Ag Supply, Inc., had purchased the seed from a licensed dealer and
then resold it to farmers, who used it to grow crops. The defendant,
Pioneer Hi-Bred International, Inc., claimed that J. E. M. Ag Supply had
violated the terms of the licensing agreement and had infringed on the
company's patent rights. The case ultimately made its way to the United
States Supreme Court, which issued a landmark ruling that clarified the
scope of patent protection for GMOs and affirmed the importance of fair
use and the public interest in agriculture. This case is a significant
example of the intersection of biotechnology and agriculture, and it
highlights the complex legal and ethical issues that arise when new
technologies are introduced into the natural world.

534 U.S. 124 (2001)

J. E. M. AG Supply, Inc., DBA Farm Advantage, Inc., Et Al. v. Pioneer

HI-BRED International, Inc.

JUSTICE THOMAS delivered the opinion of the Court.

This case presents the question whether utility patents may
be issued for plants under 35 U. S. C. § 101, or whether the Plant
Variety Protection Act, 84 Stat. 1542, as amended, 7 U. S. C. §
2321 et seq., and the Plant Patent Act of 1930, 35 U. S. C. §§ 161–
164, are the exclusive means of obtaining a federal statutory
right to exclude others from reproducing, selling, or using plants
or plant varieties. We hold that utility patents may be issued for
plants.

The United States Patent and Trademark Office (PTO) has issued
some 1800 utility patents for plants, plant parts, and seeds
pursuant to 35 U. S. C. § 101. Seventeen of these patents are held
by respondent Pioneer Hi-Bred International, Inc. (Pioneer).
Pioneer's patents cover the manufacture, use, sale, and offer for
sale of the company's inbred and hybrid corn seed products. A
patent for an inbred corn line protects both the seeds and plants
of the inbred line and the hybrids produced by crossing the
protected inbred line with another corn line.
Pedigree inbred corn plants are developed by crossing corn
plants with desirable characteristics and then inbreeding the
resulting plants for several generations until the resulting plant
line is homogenous. Inbreds are often weak and have a low
yield; their value lies primarily in their use for making hybrids.
Hybrid seeds are produced by crossing two inbred corn
plants and are especially valuable because they produce strong
and vibrant hybrid plants with selected highly desirable
characteristics. For instance, Pioneer's hybrid corn plant 3394 is
“characterized by superior yield for maturity, excellent seedling
vigor, very good roots and stalks, and exceptional stay green.”
Hybrid plants, however, generally do not reproduce true-to-type,
i.e., seeds produced by a hybrid plant do not reliably yield plants
with the same hybrid characteristics. Thus, a farmer who wishes
to continue growing hybrid plants generally needs to buy more
hybrid seed.
Pioneer sells its patented hybrid seeds under a limited label
license that provides: “License is granted solely to produce grain
and/or forage.” The license “does not extend to the use of seed
from such crop or the progeny thereof for propagation or seed
multiplication.” It strictly prohibits “the use of such seed or the
progeny thereof for propagation or seed multiplication or for
production or development of a hybrid or different variety of
seed.”
Petitioner J. E. M. Ag Supply, Inc., doing business as Farm
Advantage, Inc., purchased patented hybrid seeds from Pioneer
in bags bearing this license agreement. Although not a licensed
sales representative of Pioneer, Farm Advantage resold these
bags. Pioneer subsequently brought a complaint for patent
infringement against Farm Advantage and several other
corporations and residents of the State of Iowa who are
distributors and customers for Farm Advantage (referred to
collectively as Farm Advantage or petitioners). Pioneer alleged
that Farm Advantage has “for a long-time past been and still [is]
infringing one or more [Pioneer patents] by making, using,
selling, or offering for sale corn seed of the … hybrids in
infringement of these patents-in-suit.”
Farm Advantage answered with a general denial of patent
infringement and entered a counterclaim of patent invalidity,
arguing that patents that purport to confer protection for corn
plants are invalid because sexually reproducing plants are not
patentable subject matter within the scope of 35 U. S. C. § 101.
Farm Advantage maintained that the Plant Patent Act of 1930
(PP A) and the Plant Variety Protection Act (PVPA) set forth the
exclusive statutory means for the protection of plant life because
these statutes are more specific than § 101, and thus, each
carves out subject matter from § 101 for special treatment.
The District Court granted summary judgment to Pioneer.
Relying on this Court's broad construction of § 101 in
Diamond v. Chakrabarty, 447 U. S. 303 (1980), the District Court
held that the subject matter covered by § 101 clearly includes
plant life. It further concluded that in enacting the PP A and the
PVP A Congress neither expressly nor implicitly removed plants
from § 101's subject matter. In particular, the District Court
noted that Congress did not implicitly repeal § 101 by passing
the more specific PVPA because there was no irreconcilable
conflict between the PVPA and § 101. The United States Court of
Appeals for the Federal Circuit affirmed the judgment and
reasoning of the District…
II

The question before us is whether utility patents may be issued

for plants pursuant to 35 U. S. C. § 101. The text of § 101
provides: “Whoever invents or discovers any new and useful
process, machine, manufacture, or composition of matter, or any
new and useful improvement thereof, may obtain a patent
therefor, subject to the conditions and requirements of this title.”
As this Court recognized over 20 years ago in Chakrabarty,
447 U. S., at 308, the language of § 101 is extremely broad. “In
choosing such expansive terms as ‘manufacture’ and
‘composition of matter,’ modified by the comprehensive ‘any,’
Congress plainly contemplated that the patent laws would be
given wide scope.” This Court thus concluded in Chakrabarty
that living things were patentable under § 101 and held that a
manmade microorganism fell within the scope of the statute. As
Congress recognized, “the relevant distinction was not between
living and inanimate things, but between products of nature,
whether living or not, and human-made inventions.”
In Chakrabarty, the Court also rejected the argument that
Congress must expressly authorize protection for new
patentable subject matter: “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 constitutional role in defining
patentable subject matter in § 101; we perform ours in
construing the language Congress has employed …. The subject
matter provisions of the patent law have been cast in broad
terms to fulfill the constitutional and statutory goal of
promoting ‘the Progress of Science and the useful Arts’ with all
that means for the social and economic benefits envisioned by
Jefferson.” Thus, in approaching the question presented by this
case, we are mindful that this Court has already spoken clearly
concerning the broad scope and applicability of § 101.2…

A
The 1930 PP A conferred patent protection to asexually
reproduced plants. Significantly, nothing within either the
original 1930 text of the statute or its recodified version in 1952
indicates that the PP A's protection for asexually reproduced
plants was intended to be exclusive. Plants were first explicitly
brought within the scope of patent protection in 1930 when the
PP A included “plants” among the useful things subject to
patents. Thus, the 1930 PP A amended the general utility patent
provision, Rev. Stat. § 4886, to provide: “Any person who has
invented or discovered any new and useful art, machine,
manufacture, or composition of matter, or any new and useful
improvements thereof, or who has invented or discovered and
asexually reproduced any distinct and new variety of plant,
other than a tuber-propagated plant, not known or used by
others in this country, before his invention or discovery thereof,
… may … obtain a patent therefor.”
This provision limited protection to the asexual reproduction
of the plant. Asexual reproduction occurs by grafting, budding,
or the like, and produces an offspring with a genetic
combination identical to that of the single parent-essentially a
clone. By contrast, sexual reproduction occurs by seed and
sometimes involves two different plants.
In 1952, Congress revised the patent statute and placed the
plant patents into a separate chapter 15 of Title 35 entitled,
“Patents for plants.” This was merely a housekeeping measure
that did nothing to change the substantive rights or
requirements for a plant patent. A “plant patent” continued to
provide only the exclusive right to asexually reproduce a
protected plant, and the description requirement remained
relaxed. Plant patents under the PPA thus have very limited
coverage and less stringent requirements than § 101 utility
patents.
Importantly, chapter 15 nowhere states that plant patents
are the exclusive means of granting intellectual property
protection to plants. Although unable to point to any language
that requires, or even suggests, that Congress intended the PPA's
protections to be exclusive, petitioners advance three reasons
why the PP A should preclude assigning utility patents for
plants. We find none of these arguments to be persuasive…
Petitioners argue that plants were not covered by the general
utility patent statute prior to 1930. In advancing this argument,
petitioners overlook the state of patent law and plant breeding
at the time of the PP A's enactment. The Court in Chakrabarty
explained the realities of patent law and plant breeding at the
time the PP A was enacted: “Prior to 1930, two factors were
thought to remove plants from patent protection. The first was
the belief that plants, even those artificially bred, were products
of nature for purposes of the patent law …. The second obstacle
to patent protection for plants was the fact that plants were
thought not amenable to the ‘written description’ requirement
of the patent law.” Congress addressed these concerns with the
1930 PP A, which recognized that the work of a plant breeder
was a patentable invention and relaxed the written description
requirement. The PPA thus gave patent protection to breeders
who were previously unable to overcome the obstacles
described in Chakrabarty.
This does not mean, however, that prior to 1930 plants could
not have fallen within the subject matter of § 10l. Rather, it
illustrates only that in 1930 Congress believed that plants were
not patentable under § 101, both because they were living
things and because in practice, they could not meet the stringent
description requirement. Yet these premises were disproved
over time. As this Court held in Chakrabarty, “the relevant
distinction” for purposes of § 101 is not “between living and
inanimate things, but between products of nature, whether
living or not, and human-made inventions.” In addition,
advances in biological knowledge and breeding expertise have
allowed plant breeders to satisfy § 101's demanding description
requirement.
Whatever Congress may have believed about the state of
patent law and the science of plant breeding in 1930, plants
have always had the potential to fall within the general subject
matter of § 101, which is a dynamic provision designed to
encompass new and unforeseen inventions. “A rule that
unanticipated inventions are without protection would conflict
with the core concept of the patent law that anticipation
undermines patentability.”
Petitioners essentially ask us to deny utility patent
protection for sexually reproduced plants because it was
unforeseen in 1930 that such plants could receive protection
under § 101. Denying patent protection under § 101 simply
because such coverage was thought technologically infeasible in
1930, however, would be inconsistent with the forward-looking
perspective of the utility patent statute. As we noted in
Chakrabarty, “Congress employed broad general language in
drafting § 101 precisely because [new types of] inventions are
often unforeseeable.”
Second, petitioners maintain that the PP A's limitation to
asexually reproduced plants would make no sense if Congress
intended § 101 to authorize patents on plant varieties that were
sexually reproduced. But this limitation once again merely
reflects the reality of plant breeding in 1930. At that time, the
primary means of reproducing bred plants true-to-type was
through asexual reproduction. Congress thought that sexual
reproduction through seeds was not a stable way to maintain
desirable bred characteristics…
Thus, it is hardly surprising that plant patents would protect
only asexual reproduction, since this was the most reliable type
of reproduction for preserving the desirable characteristics of
breeding…

By passing the PVPA in 1970, Congress specifically authorized

limited patent-like protection for certain sexually reproduced
plants. Petitioners therefore argue that this legislation evidences
Congress’ intent to deny broader § 101 utility patent protection
for such plants. Petitioners’ argument, however, is unavailing for
two reasons. First, nowhere does the PVP A purport to provide
the exclusive statutory means of protecting sexually reproduced
plants. Second, the PVPA and § 101 can easily be reconciled.
Because it is harder to qualify for a utility patent than for a plant
variety protection (PVP) certificate, it only makes sense that
utility patents would confer a greater scope of protection.
The PVP A provides plant variety protection for: “The
breeder of any sexually reproduced or tuber-propagated plant
variety (other than fungi or bacteria) who has so reproduced the
variety.” Infringement of plant variety protection occurs, inter
alia, if someone sells or markets the protected variety, sexually
multiplies the variety as a step in marketing, uses the variety in
producing a hybrid, or dispenses the variety without notice that
the variety is protected…
For all of these reasons, it is clear that there is no “positive
repugnancy” between the issuance of utility patents for plants
and PVP coverage for plants. Nor can it be said that the two
statutes “cannot mutually coexist.” Indeed, “when two statutes
are capable of coexistence, it is the duty of the courts, absent a
clearly expressed congressional intention to the contrary, to
regard each as effective.” Here, we can plainly regard each
statute as effective because of its different requirements and
protections. The plain meaning of § 101, as interpreted by this
Court in Chakrabarty, clearly includes plants within its subject
matter. The PPA and the PVPA are not to the contrary and can be
read alongside § 101 in protecting plants…

III

We also note that the PTO has assigned utility patents for plants
for at least 16 years and there has been no indication from
either Congress or agencies with expertise that such coverage is
inconsistent with the PVP A or the PP A. The Board of Patent
Appeals and Interferences, which has specific expertise in issues
of patent law, relied heavily on this Court's decision in
Chakrabarty when it interpreted the subject matter of § 101 to
include plants. This highly visible decision has led to the
issuance of some 1,800 utility patents for plants. Moreover, the
PTO, which administers § 101 as well as the PPA, recognizes and
regularly issues utility patents for plants. In addition, the
 Department of Agriculture's Plant Variety Protection Office
acknowledges the existence of utility patents for plants.
In the face of these developments, Congress has not only
failed to pass legislation indicating that it disagrees with the
PTO's interpretation of § 101; it has even recognized the
availability of utility patents for plants. In a 1999 amendment to
35 U. S. C. § 119, which concerns the right of priority for patent
rights, Congress provided: “Applications for plant breeder's
rights filed in a WTO [World Trade Organization] member
country … shall have the same effect for the purpose of the right
of priority … as applications for patents, subject to the same
conditions and requirements of this section as apply to
applications for patents.”

IV

For these reasons, we hold that newly developed plant breeds

fall within the terms of § 101, and that neither the PPA nor the
PVPA limits the scope of § 101's coverage. As in Chakrabarty, we
decline to narrow the reach of § 101 where Congress has given
us no indication that it intends this result. Accordingly, we affirm
the judgment of the Court of Appeals.
It is so ordered.
Justice Breyer, with whom Justice Stevens joins, authored a
dissenting opinion in the case:

The question before us is whether the words “manufacture” or

“composition of matter” contained in the utility patent statute,
35 U. S. C. § 101, cover plants that also fall within the scope of
two more specific statutes, the Plant Patent Act of 1930 (PPA)
and the Plant Variety Protection Act (PVPA). I believe that the
words “manufacture” or “composition of matter” do not cover
these plants. That is because Congress intended the two more
specific statutes to exclude patent protection under the Utility
Patent Statute for the plants to which the more specific Acts
directly refer. And, as the Court implicitly recognizes, this Court
neither considered nor decided this question in Diamond v.
Chakrabarty, 447 U. S. 303 (1980). Consequently, I dissent.

Respondent and the Government claim that Chakrabarty

controls the outcome in this case. This is incorrect, for
Chakrabarty said nothing about the specific issue before us.
Chakrabarty, in considering the scope of the Utility Patent
Statute's language “manufacture, or composition of matter,”
asked whether those words included such living things as
bacteria-a substance to which neither of the two specific plant
Acts refers. The Court held that the Utility Patent Statute
language included a “new” bacterium because it was “a non-
naturally occurring manufacture or composition of matter” that
was “not nature's handiwork.” It quoted language from a
congressional Committee Report indicating that “Congress
intended statutory subject matter to ‘include anything under the
sun that is made by man.’” But it nowhere said or implied that
this Utility Patent Statute language also includes the very subject
matter with which the two specific statutes deal, namely, plants.
Whether a bacterium technically speaking is, or is not, a plant,
the Court considered it a “life form,” and not the kind of “plant”
that the two specific statutes had in mind…

II

The critical question, as I have said, is whether the two specific

plant statutes embody a legislative intent to deny coverage
under the Utility Patent Statute to those plants to which the
specific plant statutes refer. In my view, the first of these
statutes, the PP A, reveals precisely that intent. And nothing in
the later history of either the Utility Patent Statute or the PVP A
suggests the contrary…
As initially enacted in 1930, the PP A began by amending the
Utility Patent Statute to read as follows: “Any person who has
invented or discovered any new and useful art, machine,
manufacture, or composition of matter, or any new and useful
improvements thereof, or who has invented or discovered and
asexually reproduced any distinct and new variety of plant,
other than a tuber-propagated plant … may … obtain a patent
therefor[e].” This language refers to all plants. It says that an
inventor-in principle-can obtain a patent on any plant (the
subject matter of the patent) that meets three requirements. I t
must be distinct; it must be new; and on one or more occasions
it must have been “asexually reproduced,” e. g., reproduced by
means of a graft…
In sum, the PP A permits patenting of new and distinct
varieties of (1) plants that breeders primarily reproduce
through grafts (say, apple trees), (2) plants that breeders
primarily reproduce through seeds (say, corn), and (3) plants
that reproduce both ways (say, violets). But, because that statute
left plant buyers free to keep, to reproduce, and to sell seeds, the
statute likely proved helpful only to those in the first category.
Both the PPA's legislative history and the earliest patents
granted under the Act fully support this interpretation. Nothing
that occurred after 1930 changes this conclusion…

III

The Court replies as follows to the claim that its reading of the
Utility Patent Statute nullifies the PPA's limitation of protection
to plants produced by graft and the PVPA's exemptions for seeds
and research: (1) The Utility Patent Statute applies only to
plants that are useful, novel, non-obvious, and for which the
inventor provides an enabling written description of the
invention. (2) The PVPA applies to plants that are novel, distinct,
uniform, and stable. (3) The second set of criteria seem slightly
easier to meet, as they do not include non-obviousness and a
written description (Pioneer does not argue that the “useful”
requirement is significant). (4) And Congress could reasonably
have intended the planting and research exceptions to apply
only to the set of plants that can meet the easier, but not the
tougher, criteria.
 I do not find this argument convincing. For one thing, it is not
clear that the general patent law requirements are significantly
tougher. Counsel for Pioneer stated at oral argument that there
are many more PVP certificates than there are plant patents. But
he added that the major difference in criteria is the difference
between the utility patent law's “non-obviousness” requirement
and the specific Acts’ requirement of “newness”-a difference that
may reflect the Patent Office's more “rigorous” examination
process. In any case, there is no relationship between the
criteria differences and the exemptions. Why would anyone
want to limit the exemptions-related to seed planting and
research-only to those new plant varieties that are slightly less
original? Indeed, the research exemption would seem more
useful in respect to more original, not less original, innovation.
The Court has advanced no sound reason why Congress would
want to destroy the exemptions in the PVP A that Congress
created. And the Court's reading would destroy those
exemptions…
For these reasons, I dissent.

Blue Biotechnology
Blue biotechnology, also known as marine biotechnology, is the
application of biotechnology to living aquatic organisms for the
production of knowledge, goods and services [8]. This can include using
genetic engineering to improve the growth and survival of fish and
other aquatic organisms, or bioprospecting the environment.
Biotechnology companies and researchers are also working on
developing new methods for protecting and preserving marine
ecosystems, such as using biotechnology to create new methods for
removing pollutants from seawater or to enhance the growth of coral
reefs.
One of the most promising areas of blue biotechnology is the
development of new aquaculture technologies. Aquaculture can be
defined as the farming of aquatic organisms such as fish, shellfish, and
seaweed, and it is an increasingly important source of food and income
for many countries. Biotechnology has the potential to significantly
improve the efficiency and sustainability of aquaculture, by enhancing
the growth and survival of farmed organisms, reducing disease
outbreaks, and improving the quality and nutritional value of the final
products.
As Barcelos et al. point out, blue biotechnology has enormous
potential in various industries, including pharmaceuticals, food,
cosmetics, and biofuels:

Exploration of the marine environment has resulted in the

discovery of several substances from marine organisms, where
the production of drugs becomes a reality at pharmaceutical
industries. Among these substances, the carotenoids,
polyunsaturated fatty acids, proteins and enzymes can be
emphasized, as well as bromoditerpene, gambieric acid, and the
AD marinomycines, among others. These products can, for
example, be applied in the pharmaceutical industry in the form
of antioxidants, antibiotics, analgesics, antitumor,
antiinflammatory and antifungal agents.
Among the numerous marine organisms with a potential for
the production of bioactive compounds, the macro and
microalgae, sponges, fungi, and marine yeast can be highlighted.
The bioactive compounds can be produced from cultures using
photo bioreactors under controlled conditions or be induced by
genetic transformations. Chemical methods, enzymatic
hydrolysis, extraction of natural products with solvents and
mechanical pressure are employed as methods for extraction of
the bioactive compounds.
Most of the bioactive compounds from marine organisms are
still in the research and clinical trials stage, as stated earlier.
These studies can take years until the substances are approved
by competent authorities, but some drugs have been
incorporated and approved by the Food and Drug
Administration (FDA), as is the case with Prialt® analgesic (Jazz
Pharmaceuticals, USA), Yondelis® (Pharma Mar S.A, Madrid,
Spain) antitumoral, the Cytosar-U® (Upjohn, USA) anticâ ncer
agent (Mayer et al. 2010). Each of these drugs has already been
marketed…
 In the food industry, marine biotechnology is mainly used for
the production of additives and pigments from cyanobacteria,
macroalgae and, especially, marine microalgae. Marine
microalgae are capable of producing polyunsaturated fatty acids,
lutein, astaxanthin and β-carotene, while cyanobacteria were
reported as producers of phycocyanin. Is noteworthy that the
process of obtaining compounds of interest from the algal
biomass depends on the raw material used and the product of
interest. The conditions of the process and the techniques
employed may vary from case to case…
Marine biotechnology plays an important role in the
cosmetics industry, presenting some new compounds to the
production of cosmetics. Some of these cosmetics in which
marine compounds are incorporated have been obtained
biotechnologically and are already being marketed. As an
example, the DG-DNA Complex® is one of the components in the
Micrococcus lysate enzymatic extract. The Micrococcus is
derived from the soil and oceans and has a high resistance to UV
radiation. Moreover, it contains the UV-endonuclease enzyme,
which accelerates the recovery from sun damage and acts in
DNA repair. Currently, this compound is included in face
creams… [9].
Overall, these different “colors” of biotechnology demonstrate the
wide range of applications and potential benefits of this field, as well as
the legal and ethical considerations that must be taken into account
when developing and using biotechnology. The field of biotechnology
law and policy is constantly evolving as new technologies and
applications are developed, and it is crucial for legal professionals and
policymakers to stay informed about the latest developments in order
to effectively regulate and govern this field.

Development of Biotechnology Techniques and

Products
Biotechnology, the manipulation of DNA to create new products, has
been a rapidly evolving field since its inception in the 1970s. One of the
key milestones in the development of biotechnology was the successful
use of recombinant DNA (rDNA) techniques, as described by Cohen and
colleagues in their seminal 1973 publication. These techniques have
enabled scientists to directly manipulate an organism's DNA, leading to
the creation of new products such as synthetic human insulin and
virus-resistant squash. The advancement of biotechnology has also led
to the emergence of new techniques for manipulating gene sequences
in organisms, such as genetic engineering, cloning, genome editing and
genomics. Genetic engineering, for example, is generally used to refer to
methods used by scientists to enhance or modify the characteristics of
organism's genes including heritable and non-heritable recombinant
DNA constructs.
Additionally, genome-editing techniques, such as meganucleases
(MegNs), zinc finger nucleases (ZFNs), transcription activator-like
effector nuclease (TALENs), and clustered regularly interspaced short
palindromic repeats (CRISPR)/CRISPR-associated protein 9 (Cas9)
(CRISPR/Cas9) have been developed that can make specific
modifications to an organism's DNA to create mutations or introduce
new alleles or genes. These new biotechnology techniques have led to
the creation of new products and have the potential to revolutionize
innovation in basic science.
With the advent of these new technologies, the need for a regulatory
framework to oversee their introduction into commerce and the
environment became paramount. In response, the Coordinated
Framework for the Regulation of Biotechnology (Coordinated
Framework) was established in 1986 by the United States government
to ensure the safety of biotechnology research and products. The
framework, based on “existing statutes,” provides regulatory oversight
jurisdiction for one or more federal agencies, including the U.S.
Environmental Protection Agency (EPA), the U.S. Food and Drug
Administration (FDA), and the U.S. Department of Agriculture (USDA),
for all existing or foreseen biotechnology products.
These techniques have greatly expanded the types of organisms that
can be manipulated and the types of manipulations that can be made,
leading to a broader range of potential biotechnology products. In
recognition of these developments, the Executive Office of the President
issued a memorandum in 2015 directing regulatory agencies to update
the Coordinated Framework for the Regulation of Biotechnology and to
develop a long-term strategy for assessing the risks associated with
biotechnology products. As the field of biotechnology continues to
rapidly expand, the intersection of biotechnology and law has become
an increasingly important area of study. The legal and regulatory
framework established by the Coordinated Framework serves as the
foundation for ensuring the safety and responsible use of biotechnology
products, but it is also subject to ongoing review and revision as new
technologies and techniques emerge.
An update to the Coordinated Framework was published in 2017,
along with a National Strategy for Modernizing the Regulatory System
for Biotechnology Products to clarify current agency roles and
responsibilities for the regulation of biotechnology products. This
report by the National Academies of Sciences, Engineering, and
Medicine also addresses the third directive of the 2015 memorandum
by analyzing the future landscape of biotechnology products and
identifying potential new risks and frameworks for risk assessment.
The advancement of genome-editing techniques has led to an
expansion in the types of organisms that can be manipulated and the
types of manipulations that can be made. This has resulted in a
corresponding increase in the types and number of products that can
be developed through biotechnology. As these new products and
technologies are developed, it is essential that the legal and regulatory
framework is able to keep pace with the rapid changes in the field. This
requires a proper development of the legal framework to ensure that it
is able to effectively address the new risks and challenges that are
emerging.
On September 12, 2022, President Biden issued Executive Order
(E.O.) 14081, “Advancing Biomanufacturing and Biotechnology
Innovation for a Sustainable, Safe, and Secure Bioeconomy” in order to
accelerate biotechnology innovation and growing America’s
bioeconomy across multiple sectors. The document states:

It is the policy of my Administration to coordinate a whole-of-

government approach to advance biotechnology and
biomanufacturing towards innovative solutions in health,
climate change, energy, food security, agriculture, supply chain
resilience, and national and economic security. Central to this
policy and its outcomes are principles of equity, ethics, safety,
and security that enable access to technologies, processes, and
products in a manner that benefits all Americans and the global
community and that maintains United States technological
leadership and economic competitiveness.
Biotechnology harnesses the power of biology to create new
services and products, which provide opportunities to grow the
United States economy and workforce and improve the quality
of our lives and the environment. The economic activity derived
from biotechnology and biomanufacturing is referred to as “the
bioeconomy.” The COVID-19 pandemic has demonstrated the
vital role of biotechnology and biomanufacturing in developing
and producing life-saving diagnostics, therapeutics, and vaccines
that protect Americans and the world. Although the power of
these technologies is most vivid at the moment in the context of
human health, biotechnology and biomanufacturing can also be
used to achieve our climate and energy goals, improve food
security and sustainability, secure our supply chains, and grow
the economy across all of America.
For biotechnology and biomanufacturing to help us achieve
our societal goals, the United States needs to invest in
foundational scientific capabilities. We need to develop genetic
engineering technologies and techniques to be able to write
circuitry for cells and predictably program biology in the same
way in which we write software and program computers; unlock
the power of biological data, including through computing tools
and artificial intelligence; and advance the science of scale-up
production while reducing the obstacles for commercialization
so that innovative technologies and products can reach markets
faster.
Simultaneously, we must take concrete steps to reduce
biological risks associated with advances in biotechnology. We
need to invest in and promote biosafety and biosecurity to
ensure that biotechnology is developed and deployed in ways
that align with United States principles and values and
international best practices, and not in ways that lead to
accidental or deliberate harm to people, animals, or the
environment. In addition, we must safeguard the United States
bioeconomy, as foreign adversaries and strategic competitors
alike use legal and illegal means to acquire United States
technologies and data, including biological data, and proprietary
or precompetitive information, which threatens United States
economic competitiveness and national security.
We also must ensure that uses of biotechnology and
biomanufacturing are ethical and responsible; are centered on a
foundation of equity and public good, consistent with Executive
Order 13985 of January 20, 2021 (Advancing Racial Equity and
Support for Underserved Communities Through the Federal
Government); and are consistent with respect for human rights.
Resources should be invested justly and equitably so that
biotechnology and biomanufacturing technologies benefit all
Americans, especially those in underserved communities, as
well as the broader global community.
To achieve these objectives, it is the policy of my
Administration to:
(a) bolster and coordinate Federal investment in key research
and development (R&D) areas of biotechnology and
biomanufacturing in order to further societal goals;

(b) foster a biological data ecosystem that advances

biotechnology and biomanufacturing innovation, while
adhering to principles of security, privacy, and responsible
conduct of research;

(c) improve and expand domestic biomanufacturing

production capacity and processes, while also increasing
piloting and prototyping efforts in biotechnology and
biomanufacturing to accelerate the translation of basic
research results into practice;

(d) boost sustainable biomass production and create climate-

smart incentives for American agricultural producers and
forest landowners;
(e) expand market opportunities for bioenergy and biobased
products and services;

(f) train and support a diverse, skilled workforce and a next

generation of leaders from diverse groups to advance
biotechnology and biomanufacturing;

(g) clarify and streamline regulations in service of a science-

and risk-based, predictable, efficient, and transparent
system to support the safe use of products of
biotechnology;

(h) elevate biological risk management as a cornerstone of the

life cycle of biotechnology and biomanufacturing R&D,
including by providing for research and investment in
applied biosafety and biosecurity innovation;

(i) promote standards, establish metrics, and develop systems

to grow and assess the state of the bioeconomy; to better
inform policy, decision-making, and investments in the
bioeconomy; and to ensure equitable and ethical
development of the bioeconomy;

(j) secure and protect the United States bioeconomy by

adopting a forward-looking, proactive approach to
assessing and anticipating threats, risks, and potential
vulnerabilities (including digital intrusion, manipulation,
and exfiltration efforts by foreign adversaries), and by
partnering with the private sector and other relevant
stakeholders to jointly mitigate risks to protect technology
leadership and economic competitiveness; and

(k) engage the international community to enhance

biotechnology R&D cooperation in a way that is consistent
with United States principles and values and that promotes
best practices for safe and secure biotechnology and
biomanufacturing research, innovation, and product
development and use.
 The efforts undertaken pursuant to this order to further
these policies shall be referred to collectively as the National
Biotechnology and Biomanufacturing Initiative.

References
1. Kafarski, P. (2012). Rainbow code of biotechnology. Chemik, 66(8), 811–816.
2.
Glaser, J. A. (2005). White biotechnology. Clean Technologies and Environmental
Policy, 7, 233–235.
3.
Heux, S., Meynial-Salles, I., O’Donohue, M. J., & Dumon, C. (2015). White
biotechnology: State of the art strategies for the development of biocatalysts for
biorefining. Biotechnology Advances, 33(8), 1653–1670.
[Crossref]
4.
Bazzanella, A. (2008). SusChem reaction & process design—Sustainable and
competitive chemical production in Europe. Chemsuschem, 1, 775–776.
[Crossref]
5.
Friedman, D. C. (2015). Industrialization of biology: A roadmap to accelerate the
advanced manufacturing of chemicals. A report of the National Academies of
Sciences.
6.
Frazzetto, G. (2003). White biotechnology: The application of biotechnology to
industrial production holds many promises for sustainable development, but
many products still have to pass the test of economic viability. EMBO Reports,
4(9), 835–837.
[Crossref]
7.
Ribeiro, B. D., Coelho, M. A. Z., & Castro, A. M. D. (2015). Principles of green
chemistry and white biotechnology. In Principles of green chemistry and white
biotechnology, pp 1–8.
8.
Tramper, J., Battershill, C., Brandenburg, W., Burgess, G., Hill, R., Luiten, E., Mü ller,
W., Osinga, R., Rorrer, G., Tredici, M., Uriz, M., Wright, P., & Wijffels, R. (2003). What
to do in marine biotechnology? Biomolecular Engineering, 20, 467–471.
9.
Barcelos, M. C., Lupki, F. B., Campolina, G. A., Nelson, D. L., & Molina, G. (2018). The
colors of biotechnology: General overview and developments of white, green and
blue areas. FEMS Microbiology Letters, 365(21), 239.
[Crossref]
© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2023
A. Stasi, Biotechnology Law and Policy
https://doi.org/10.1007/978-981-99-2135-5_2

2. A Brief History of the Fda and Its Role

in Regulating Biotechnology Products
Alessandro Stasi1
(1) Mahidol University International College, Mahidol University,
Salaya, Nakhon Pathom, Thailand

Alessandro Stasi
Email: alessandro.sta@mahidol.edu

In science the credit goes to the man who convinces the world, not
the man to whom the idea occurs first.
Sir Francis Darwin

Abstract
The Food and Drug Administration (FDA) plays a crucial role in
regulating biotechnology products to ensure their safety and efficacy.
This chapter provides a historical overview of the FDA, tracing back to
the nineteenth century and the establishment of the U.S. Department of
Agriculture. It covers significant events leading to the passage of the
Federal Food and Drugs Act of 1906 and the subsequent tragedies that
revealed the limitations of the act. The chapter also discusses the
Coordinated Framework established in 1986, which governs federal
oversight of biotechnology products, and the regulatory agencies
involved in the intersection of science with public health.
Understanding the history and regulatory landscape of biotechnology is
crucial in appreciating the opportunities and risks associated with this
rapidly evolving field.
Keywords Coordinated framework – Efficacy – Food and drug
administration – Regulation – Safety

In Chap. 1, we explored the diverse applications of biotechnology and

the many ways in which it is shaping our world. From green
biotechnology to red and white biotechnology, this field encompasses a
broad range of products and applications that have the potential to
transform our lives in significant ways. In this chapter, we will focus on
the regulation of biotechnology products, and the crucial role played by
the Food and Drug Administration (FDA) in overseeing their
development and ensuring their safety. We will explore the history of
the FDA and its evolving role in regulating biotechnology, as well as the
controversies and challenges that have emerged in this field. By
understanding the regulatory landscape of biotechnology, we can gain a
better appreciation of the opportunities and risks associated with this
rapidly evolving field.
The FDA's regulation of biotechnology is complex, and it involves
navigating the various regulatory pathways that depend on the
intended use of the product. There are different regulatory
requirements for biotechnology products depending on their intended
use, such as food, drugs, or medical devices. We will discuss the specific
regulatory pathways and requirements for each of these categories and
provide insight into the safety and efficacy standards that must be met
before biotechnology products can be approved for use in humans.
Overall, this chapter aims to provide a comprehensive
understanding of the FDA's regulatory framework for biotechnology
products and the central role it plays in ensuring their safety and
efficacy. By exploring the controversies and challenges that have
emerged in this area, we can gain a clearer understanding of the
opportunities and risks that are inherent in biotechnology.

A Historical Overview
The Food and Drug Administration (FDA) is a federal agency of the
United States government responsible for protecting the public health
by regulating food, drugs, medical devices, and other products. The FDA
has a long and complex history, dating back to the mid-nineteenth
century.
In 1862, President Abraham Lincoln signed the Agriculture Act,
which included a provision for the appointment of a chemist to the
newly established U.S. Department of Agriculture (USDA). The chemist,
Charles M. Wetherill, was tasked with analyzing agricultural products
and developing methods for detecting adulteration and fraud.
Following the appointment of chemist Charles M. Wetherill to the
newly established U.S. Department of Agriculture (USDA) in 1862, the
USDA began analyzing agricultural products and developing methods
for detecting adulteration and fraud. In the following years, the USDA
expanded its efforts to combat food adulteration and promote food and
drug safety. Wetherill's successor as chief chemist of the USDA, Peter
Collier, began to focus on the problem of food adulteration, and his
team analyzed food products for adulterants, such as chalk and sawdust
added to flour. Collier's findings were published in a series of reports
that helped to raise public awareness of the issue.
In 1883, Harvey W. Wiley was appointed as the chief chemist of the
USDA, succeeding Collier [1]. The health of a nation; Harvey W. Wiley
and the fight for pure food. Wiley was a strong advocate for food and
drug safety, and he used his position to push for the creation of a
federal law to regulate food and drugs. He believed that the use of
chemical preservatives and additives in food was a threat to public
health and that the government had a responsibility to protect
consumers from harmful products.
In 1901, the Division of Chemistry was reorganized into the Bureau
of Chemistry, with the mission of promoting the development of the
chemical industries in the United States, as well as ensuring the safety
and efficacy of food and drugs. The bureau was charged with
conducting research and providing technical assistance to other federal
agencies and state governments on chemical analysis and industrial
processes. Additionally, it was responsible for analyzing and testing
food, drugs, and other products to ensure their safety and quality.
Under Wiley's leadership, the department's Division of Chemistry
grew in size and importance and was known for its “poison squad”
experiments, in which volunteers consumed small doses of potentially
harmful additives to study their effects. These experiments helped to
Another random document with
no related content on Scribd:
hardships traveling through the country speaking and teaching the
value of homes and the necessity of clean homes, both physically
and morally. She never tired of stressing these things and there are
many good Negro homes in South Carolina and all over the
Southland that are evidences that her efforts have not been in vain.
Martha Schofield was helpful not alone to the Negroes but also to
the whites, for good Negroes make good whites and good whites
make good Negroes.”
 CHAPTER IV.
Inspired by High Ideals.

What motive led this young woman of only twenty-six, surrounded

by wealth, by culture, and every circumstance that made her not only
acceptable but desirable in the highest circles of society, to abandon
all—home and friends and money and the pleasures which her
position in the social world brings—for a life of the most arduous toil
among a barbarous, if not a savage people, whose skin, unlike hers,
was black and whose habits and customs were thought to be
repugnant and repelling to those of refinement? She had been fully
appraised, too, of the physical dangers that lay in wait for any one
who would condescend to prostitute their powers of mind in the
instruction and elevation of the Negro race, at the hands of the
whites of the South. Her position between the fire of social ostracism
on the one hand and the fagot on the other was one not to be
envied. It would have daunted the courage of any woman made of
weaker stuff, but being of sterner material and obsessed with a
sense of duty in a just cause, such a sense of duty as led both the
blue and the gray to do and die in the cause which each conceived
to be right, Martha Schofield set a star for herself and determined to
go to it even if she was forced to wade through blood and fire in
doing so.
Beginning her first labors on Wadmalaw Island, between
Charleston and Beaufort, in South Carolina, Miss Schofield suffered
every inconvenience and privation of frontier life. Aside from the
annoyance and hindrances placed in her way by the few scattered
white settlers in sympathy with the Order of the Ku Klux Klan, life
was made unsafe by many diseases that flourish in this climate.
The enrollment in her school consisted of the children of the 1,500
Negroes who had followed Sherman in his march to the sea. She
had the assistance of only one person, a white woman.
 She set to work not only to educate an army of Children but the
duty of clothing and feeding the naked and starving, of which there
were many, fell to her lot.
It is beyond the reach of the imagination of the present generation
to adequately comprehend the hardships endured by her at the time
of which we write. October 24, 1865, she wrote in her diary as
follows:
“This morning I took my bread to school to watch; when light
enough I made it up and sent it half-mile away to be baked in the
only stove in the village. We distributed clothing for 102 today.”
But for the aid of the Society of Friends and the Abolitionists who
supplied food and clothing to her for free distribution, hundreds
would have died from starvation and thousands have gone as naked
as were the custom of some of the Negroes when captured in Africa
and brought to this country as slaves.
Under the conditions which Miss Schofield created an immense
amount of suffering was dissipated. Not only the Negroes but she
herself, faced starvation at one time for several weeks. This occurred
when the steamer from Philadelphia, laden with a cargo of groceries,
clothing, shoes and books, ran aground and remained motionless for
thirty-one days. During this time Miss Schofield set the Negroes to
work gathering oysters and acorns. With these and a few boxes of
crackers, which she had hidden away for just such an emergency,
she originated a kind of porridge that prevented actual starvation.
“The crackers,” she writes in her diary “had to be broken up in fine
parts so as to remove the worms from them.”
The same tale of poverty and almost inconceivable hardships
followed her from Wadmalaw to Edisto in 1866 and on to the Island
of St. Helena in 1867. But these were things to be expected and to
be born patiently as long as she had strength and health. But these
gave away right here at St. Helena in the second year of her
immigration to South Carolina. It was here that malarial fever, with
which this section has been infected ever since it was settled,
attacked her, and for quite a long time her life was despaired of.
“This illness,” she writes, “occasioned hemorrhages of the lungs,
from which all hope of recovery was abandoned by my friends.”
It was at this very critical period in her career that those flighty and
fashionable friends in the North, some of them her nearest relatives,
urged her with all their might to give up the undertaking in the South
and return to her home. It was very much against the will and desires
of her own people as well as against the wishes of her best friends
that she sacrifice her time and life in the interest of any race or
cause, and she was told so before the instinct to engage in social
welfare work had totally possessed her. They now drew a picture of
a frail sickly woman with one foot in the grave and the other lifted up
to follow, and asked her if such a feeble body even though
possessed of ample means to employ teachers, had the power to
direct the work so necessary to be done. She was urged to get out of
the business in order to make room for some one stronger than she,
who still had the strength to carry to completion the noble
undertaking set in motion by her.
But Martha Schofield answered with these words: “As long as
there is life in me to work, I shall work. The coast may not be the
place but I will yet find the place.”
And she did.
So in 1868 she went to Aiken, S. C, and started work again after
losing her health and all her personal income. Assisted by an
auxiliary branch of the “Freedman’s Commission,” a charitable
organization composed of two dozen ladies, of Germantown, Pa.,
she soon was able to begin work on a scale of some promise.
In 1870 the United States Government, through the “Freedman’s
Bureau,” took official recognition of the necessity for the kind of work
being done by her by having a small frame house erected for her.
This house still stands.
 CHAPTER V.
Brightness of Martha’s Pupils.

When Martha Schofield opened her first school in South Carolina it

was impossible to secure the necessary text books and much of the
instruction was oral. With the few books which the school did
possess it was not an uncommon sight to see three and four pupils
preparing their lessons from the same book. The children took the
books home nights, until the “Blue Back” and Webster’s had gone
the circuit round many times. Having advanced to the ability to write
and read script, a pupil was no longer eligible to the benefits of the
circulating library. He was then forced to copy at his spare time the
lessons he was supposed to prepare during the night.
Notwithstanding the serious difficulties attending the acquisition of
knowledge without the aid of books, the intellectual as well as the
moral improvement of not only the children but their parents as well
was soon apparent. “There was an eager desire among all the
children to attend school” says Miss Schofield in writing of her
experiences on the Coast and later at Aiken; “never a truant.”
The average attendance of the Negroes at school in the South
today exceeds the attendance of 1900 by over 10 per cent. This
thirsting after knowledge by the brother in black is one of his
redeeming characteristics.
Miss Schofield once put the question to a class in Geography as to
what the world rested on. A grown man replied that it rested on
stumps and big wild animals. A ten year old boy corrected him by
saying that it rested on the Power of God. These definitions will
serve to show the dense ignorance of the race at the time Miss
Schofield began teaching.
In a definition exercise the class was requested to define the word,
husband. Volunteers were called for but no one volunteered. In an
effort to lucify the subject and assist them to guess the meaning of
the word, with an approximate accuracy, Miss Schofield asked them
to tell her what she would have were she to marry. A little girl, almost
ten, replied, with much enthusiasm but unconscious of any wit at all,
“A baby.”
As soon as a student mastered reading, writing and arithmetic
sufficiently to enable him to read without much faltering and write at
all legibly and add a sum of four or five numbers, Miss Schofield set
him to teaching. The scarcity of teachers made this expedient
imperative.
A middle-aged man, Isaac Kimberley, who as a slave had been
taught to read and write but had greatly added to his fund of
knowledge by a term at Miss Schofield’s school, was one of the first
to be honored with a school. It was located near Miss Schofield’s
and closely supervised by her. Isaac assumed the duties of it with all
the dignity of some divinely appointed potentate and proceeded at
once to make use of only the most carefully chosen words possible,
and put on a haughty, undignified air that made him more ridiculous
than he really was. Alford Kimberley, a son of his former master, on
meeting him soon after he began teaching, addressed him familiarly
as “Uncle Ike.” “I’le hab yo’ to understan,’ suh, dat Ise neaver yo’
uncle or yo antie, suh, Ise yo eacle,” said Isaac in reply. “Frum dis
day on, ef yo’ pleas, suh, Ise Prof. Isaak Kimberley,” continued the
new teacher.
“Well, take that, and that, Prof. Isaac Kimberley, from your equal,”
responded Alford, as he bent over the prostrate form of the
instructor, lying in the ditch by the roadside where he had knocked
him. “I’ll teach you yet how to talk to white gentlemen, you low-down
lover of blue-bellied Yankees, you!”
No report of this dramatic incident ever reached the ears of Miss
Schofield as Isaac was afraid it might. He concealed it from
everybody in the neighborhood as much as possible, both on
account of having gotten whipped in his first encounter after
becoming a free man and also on account of an increasing amount
of comment among both colored and white that he was daily growing
too big for his breeches and would have to be whipped.
Miss Schofield’s confidence in him, at no time, it is needless to
say, was very great, but it was Isaac or worse. She finally dismissed
him and looked around in vain for a “worser” one.
His dismissal followed a visit to his school, which she was in the
habit of making regularly.
The day was an unusually cold one for South Carolina, where the
temperature in the winter seldom reaches the freezing point, and
through the unsealed crevices between the poles out of which the
house was built, the sleet and snow drifted joyously in. A half
hundred or more half clothed and well nigh starved little black
urchins shook the shackly floor with their shivering and drowned their
voices with the chattering of their teeth. If ever there was a blue-
lipped, blue-gummed Negro school Isaac’s was surely one on that
day.
The extreme cold weather and the open condition of the house
gave every student a free license to leave his seat, even without
permission of the authority in charge, and crowd in close proximity
around the wide open hearth at the end of the building, where with
the shivering of limbs, chattering of teeth and shuffling of feet, all
noise of their cries and shrieks as one would pinch the other or mash
a toe or hit this one or that one over the head with a well worn book
or trab ball, was drowned out.
In the midst of the greatest confusion, Isaac, with the purpose in
view of dispersing the crowd and relieving the congestion around the
“fire place” blurted out with an assumed air of supreme dignity: “John
Thomas, why don’t yo’ add full to de flame?” With his black eyes
blinking like a rabbits when shot at and trembling from head to foot
and turning round like a Bob White in a trap, it was clear to Miss
Schofield that the child did not understand what the master of the
school wished to be done. She immediately came to the relief of all,
as she always seemed capable of doing in each and every
predicament in which she or any of her children (children is what she
called all the students) found themselves, by saying, “Isaac, tell John
Thomas to put some wood on the fire and he wilt understand thee.”
Walking along home with Isaac after dismission that afternoon she
informed him that it would be necessary to suspend his school until
the house could be repaired. Isaac, tired of waiting for the needed
repairs, returned to the Schofield school for instruction himself and
taking up the study of harness making, developed into a genius for
work of this kind. After years of success at the bench in one of the
best shops in a large Southern city, where he earned $22.50 a week,
the government of the United States awarded a contract to him for
250 army saddles. He could not teach school but he could make
saddles and harness.
The greatness of Miss Schofield’s work consisted of converting
men and women who could never develop into great singers and
teachers into useful productive workers and making them to see
beauty as well as profit in the humbler tasks.
The sad experience had with Isaac Kimberley as a teacher
indicated to Miss Schofield the necessity for raising the standard of
qualification for all applicants for teacher’s certificates, and with the
cooperation of Mose Graham, a Negro, who could scarcely read or
write but who had been made County School Commissioner by the
Radical Party, then in complete control of the State and National
Government, she undertook to do this, which proved a complete
failure on account of the illiteracy of the Negro race and the
reluctance with which competent white teachers from the North
accepted the call from the South to join the ranks of the teaching
profession.
Ephriam Daniels, a six months pupil of the Schofield School,
where he acquired the art of reading fluently and writing legibly and
also mastered the four fundamental rules of arithmetic, concluded
that in staying on the farm and tilling the soil he was hiding his light
under a bushel and therefore, committing a sin which the Bible
commanded him not commit, so he made application to Mose for a
certificate to engage in the noble calling of teaching.
 “Mr. Commissioner Graham,” said Ephriam, “I’se a wastin’ muh
tallents behin’ de plow handles, as I is a mi’ty smart man ef I is a
nigger, and so I haf com ter see yo’ ’bout gitten one o’ dem licenses
to teach chillen wid. Wi’l yo’ gib muh one?”
Mose explained in detail and in a very perfunctory manner the
difficulties of the teacher and discoursed considerably on the small
compensation paid them. But encouraged his friend, however, by
saying that the harvest was great and the laborers few, by which he
meant that the office of County School Commissioner had a number
of schools but no one to teach them.
“Don’t care ’bout difficultys and small pa’—dats what yo’ mean by
—what did you call it?—com—something—commishion, I beleives.
All I wants is ter teach. I’se going in der bizness fer de gud I kin do,
not fer de muney.”
“Very good, indeed,” said Mose, “but befo’ I kin lisence yo’ ter
teech I’se got to see Miss Marther Schofield and hab’ yo’ examed by
her and me. Yo’ cum ter see me termorrow, ’bout ten o’clock.”
When Miss Schofield heard of the ambitions of Ephriam that
afternoon her heart ran down in her shoes, both because of the
impossibility which she knew existed of ever making a teacher of
Ephriam and the equally impossible task of helping him to realize it.
He was as stubborn as a mule in his ways and when he made up his
mind to do anything he worked at it with all his poor brain till it either
proved successful or fizzled out. It pained her to think of the neglect
which she knew in her own mind had attended his crop throughout
the spring season when it needed most attention, which she was
well aware from the nature of Ephriam had been diverted to the
subject of school teaching.
But on the insistance of Graham, in whose favor she had often to
make some concessions, though none of any importance, she at
some expense of time and dignity consented to meet him at his
office at the appointed hour for the purpose of examining Ephriam
Daniels for a certificate to teach in the free public schools.
 Dressed in a soldier’s old uniform, which was secured from the
remnants of Sherman’s Army as they passed through South
Carolina; with a large bandana handkerchief around his neck for a
collar and an old stove pipe hat which his old master, John Rutledge
Daniels, had given him on the day of his freedom, Ephriam appeared
before the examining board with a pocket full of pencils and a quire
or two of ruled fools-cap paper.
Miss Schofield, who was one of the kindest and gentlest of women
whom the author ever knew, eyed Ephriam with a well concealed
curiosity as she asked him what preparations he had made for taking
the examination.
“Wull, Mis’ Sch’fields,” he said, “I’se got heap ob pencils and
papur.”
“Yes, I see you have,” replied the examiner, with laughter almost
bursting her throat, “but what I mean to get at is, what preparations
have you made for teaching school?”
Quick as a flash Ephriam replied that he had sold his horse and
rented out his farm.
The uproarous laughter which this answer produced was
genuinely participated in by all present, including Ephriam, although
he could not for the life of himself, as he afterwards stated, see what
all the laughing was about.
Extending the examination a little more for the purpose of
entertaining and amusing still further the board and its lone
applicant, Miss Schofield was unkind enough to ask the definition of
the noun, “word.”
“Word,” repeated Ephriam, now quite seriously perplexed, “why,
Mis’ Schofiels, yo’ sholey noes dat I noes dat a word is someting dat
yo’ sais.”
When she put the question of the fundamental principles of
Arithmetic, Ephriam readily admitted that he did not know, and in a
polite way gave the board to understand that he did not see the
necessity for scholarship of a high grade for teaching “niggers what
don’t ’no der A B C’s.”
 Not long afterward, Ephriam, his wife and their four children were
stricken with small pox—that malignant infection formerly very
common in the South—and it was beautiful the way Miss Schofield
attended to their wants during the period of illness and final death
and burial of Ephriam. On the morning of the sixth day of the
appearance of the dreaded malady, Miss Schofield appeared at the
home with breakfast for all and was horrified to find the body of the
father behind the door, his death occurring sometime during the
night, unknown to the other members of the family.
 CHAPTER VI.
Education Under Difficulties.

Some time as many as a half dozen funerals a day occurred in the

coast region from malarial fever or small pox. The chances for
recovery were rendered difficult by the absence of any physician, the
nearest one being sixty miles away.
Among the medicines sent Miss Schofield from friends of the
North was a bottle of port wine. This was sent in 1876, when she
was attacked by a hemorrhage of the lungs, with instructions from a
physician that she must take it three times a day. But the fear of
setting an example which might prove the ruin of many people in her
charge caused her not to open it. She took it to Aiken, and during the
construction of her residence there it was deposited in the walls and
no one except Miss Schofield to the day of her death, on February 1,
1916, knew where to break the wall; no one on earth knows just
where to this very day.
She despised the avarice and greed that caused men to
manufacture intoxicants but hated with the venom of the devil the
lust for gain by the municipalities and States which caused them to
issue licenses for the manufacture of alcohol. She taught and lived
that the greatest criminal in the history of criminology was the
criminal who issued the license for the commission of crime. In her
opinion this was not only a crime against society but a crime against
criminals as well.
The pernicious influence of alcohol on the Negro was largely
responsible for her antagonism to the liquor traffic. Opposed to it
naturally, as every educated and thinking person must be, she was
more so after observing its destructive influence among the ignorant
and vicious.
 It was confidently believed by her that if every Negro capable of
complying with the registration laws regulating the qualification of
voters, was registered and allowed to vote, uninfluenced by any
outside influence, that the legal sale of alcoholic stimulants in the
South at least, would be a thing of the past. She believed also that if
positions on the police force were available to colored men for
service in the Negro sections of the cities that not only would the
illegal sale of intoxicants be stopped but crimes of every character
would be largely suppressed.
Martha Schofield, having lived to see accomplished the task to
which her life had been dedicated on the day her father rescued
Laura Duncan from the blood hounds of the slave holding oligarchy,
died as happy and serene as an angel, perfectly confident that the
work she had been doing would gain momentum and go on more
splendidly each year, until illiteracy and physical and moral
degradation would be an exceptional thing among the Negroes.
Between the years of 1890 and 1910 the percentage of Negro
illiteracy had fallen from 57.10 to 30.40 per cent. among children
between the ages of ten and fourteen years. For those fifteen years
of age and under nineteen, the percentage of illiteracy was only
18.90 per cent.
The greater illiteracy in the higher age classes is very marked, the
illiteracy of Negroes of 55 to 64 years of age being about 67 per
cent. of the total, and nearly every one of those of 65 years and
above were found to be unable to read or write when the 1910
census was taken.
Negroes of sixty years and above, it will be recalled, were past
childhood before emancipation, when little or no provision was made
to teach them to read and write, and this accounts for the high
percentage of illiteracy in the old people and the rapidly decreasing
percentage of illiteracy among their children.
At the rate of advance in education among the Negroes at present
there will be less than 10 per cent. of the population between ten and
fourteen illiterate in 1920, and every child of sane mind and sound
body will be able to read and write by 1930, when the Fourteenth
Census shall have been taken. This all in the space of fifty years.
Remarkable!
And yet there are well informed influential people who still maintain
that the progress of the Negro has been slow, superficial and
unworthy of the effort and money expended on it.
Maybe so, but all admit, that it is very helpful to every human
being to be able to read and write, to be able to assimilate the
thoughts of others and to express his thoughts and hand them on to
others of his kind by other means than by the word of mouth. To
deny this would be equal to denying one the right to be taught the
use of his mind or tongue, the two organs which God in His infinite
wisdom put no ban upon, but made free as the air of Heaven,
restricting their use only to the accomplishment of honorable and
noble undertakings, thus dethroning the power of all, who though
possessed of powerful intellect, would use their talent in the interest
of the base and ignoble.
While the peoples of all races are born with a knowledge of good
and evil they are not possessed at birth with the knowledge which
science is supposed to endow them with, and therefore, it should be
the pleasure, as it certainly is the imperative duty of the State to
provide liberally for the diffusion of knowledge among even the
humblest of all its citizens.
Martha Schofield taught more emphatically than anything else the
economic necessity which exists among all races for the
performance of duty, one to another. She argued that unrighted
wrongs retard the progress of races, and if not checked by the
refinements of civilization, through the enlightenment of the mind,
become the instruments which at last wreck and destroy the
strongest ships of State. She wanted her work to prove to the
country that great measures of service in the field of education was
the price to be paid for the salvation of our land against the misery
and death, which others through ignorance and greed, had sown.
She made the man at the North without principle or scruple to modify
his ambition in the selfish accumulation of wealth equally as culpable
as the man of the South, in producing the suffering and misery which
attended the great civil conflict for freedom. She exhibited the chaos
attending the Reconstruction period as the awful penalty for
benighted stupidity and ignorance of an earlier day, for which none of
the present day is accountable, and whose fruits none, in an earlier
past, foresaw.
Her doctrine of the elevation of the Negro so as to meet the
necessities of the new standard of civilization which freedom had
thrust upon him, spread like wild fire on a western prairie, and was,
of course, shocking, even inconceivable to the imagination of the
Southern white mind, which had been taught and religiously believed
that education impaired the usefulness of the colored people, both
as productive machines in the hard field of toil and as mediums for
the expression of the divine messages of power.
“No amount or kind of learning,” they argued, “can be made
available to the ‘nigger’ because of his inability to assimilate it. He’s
a brute, pure and simple, and has anyone ever succeeded through
teaching in making a brute anything but a brute?”
“Pigs will be pigs.”
Laws by the General Assembly of South Carolina forbade the
whites the privilege of teaching Negroes, but it was ignored by many
good men and women who devoted much time and money to the
education of the race.
An influential Southern man, a former Governor of one of the great
States of the South and now an honored member of the Senate of
the United States once wrote a book in which he delved deep into
history and anthropology and proved to the complete satisfaction of
the voters of his State and to a great number of the learned
professors of the sciences in some of the Southern colleges, that the
Negro by every fact known to the scientists and evolutionists was a
member of the families of the lower animals, and, therefore, an
impossibility in the matter of intellectual development.
The influence of this propaganda at the South exerted itself
strongly to the detriment of the work undertaken by Miss Schofield,
and others who came after her, in that it aroused the passions of the
ignorant whites and determined them in the course of lawlessness,
which but for the zeal and strength of heart expressed by Martha
Schofield might have succeeded in delaying for many years the
phenomenal rise and progress of the black people of the Southern
States.
One Sunday morning, the sun in all its radiance and splendor
lighting up the whole world, doing for the earth and every creature
and plant on it (giving them light and warmth and moisture that they
might develop and grow to perfection) just what God would have us
do—help along everything good that we can—on such a morning as
this—a band of armed men approached Miss Schofield’s home and
demanded that she quit teaching Negro children and return to her
home or she would be forced to do so.
To these she replied as follows: “Thee can kill my body and hide it
away, but my soul is of God, that is the one invincible thing, which
thee can not kill.”
A noble life consecrated absolutely, even in the face of death, to
the uplift and service of a lowly, impoverished race! Everywhere she
went, she reached righteousness, law, order, temperance, truth,
cleanliness, thoroughness and economy.
After fifty years of toil, of social ostracism, of infinitely wicked
persecution, which in later years by her patience, by her kindness
and charity was greatly modified, she fell in the harness, full of
achievements from the work which God had given her to do. At both
the funeral service at Aiken, S. C., where she died on the night
before the event arranged by friends to celebrate the fiftieth
anniversary of her service to the colored people and her helpfulness
to all who met her socially or in a business way, and at Darby
Meeting House, in Pennsylvania, where the interment of the body
took place, solemn covenants consecrating mind and heart and
hand, amid the tears and sobs of blacks and whites alike, were
made by many to keep alive forever the spark of truth and life she
was first to express the courage to plant in a land of enemies,
surrounded on every side by the dangers of assassination and the
ravages of small pox, malaria, and dengue fevers.
 CHAPTER VII.
Cause of Many Riots.

Between the years of 1865 and 1876 the severest tests were put
to the work of being done by Miss Schofield, to see whether it could
be made practical or not. By the courage with which she met and
answered them she established once and for always the truth that
the progress of light and reason can not be retarded long, no matter
by whom and for what purpose such an attempt might be
undertaken. The outrageous murders of Negroes by white men
which went on almost daily following the unwise policy of the
government at Washington in putting them in power in the South
before many of them could scarcely read or write, precipitated the
greatest excitement throughout the country. These outrages
attracted the indignation of the North and martial law was declared
all over South Carolina. This was done to enforce the rights of the
peaceable, law-abiding whites, as well as the rights of that class of
Negroes. Of course, much blame for the haughty attitude of the
Negro and the declaration of martial law was laid at the door of Miss
Schofield, whose teaching it was generally believed by the ignorant
whites, was responsible for the deplorable state of affairs that
existed. The Northern press at the time carried over her signature
many accounts of the numerous brutalities happening in and around
Aiken and she was repeatedly called to account by the leading white
people, all assuming a threatening attitude that would have put to
flight almost any other woman. But Miss Schofield would meet her
antagonists face to face and dare them to harm even one hair of her
head. She would remind them that they were all chivalrous white
gentlemen and could not under their own pretences attack her and
do her violence without surrendering every right and claim which
they might have upon knight erranty.
 In a New York newspaper of the year 1876 she details one of the
murders typical of the Reconstruction period.
An old man, deaf, and dumb, who had never spoken a word or
heard a sound in all his seventy years of life sought protection and
refuge in the Schofield home. He had scarcely entered the house
before an armed body of men arrived and demanded that the old
dumb man reveal the hiding place of a certain negro whom the white
people had decided it was necessary to put to death for their own
peace and security. As he could neither hear nor talk, he answered
the threatening attitude of the crowd with unintelligent murmurs and
gestures and pointed excitedly at Miss Schofield. She explained the
condition of the man and plead earnestly with the mob for his life, but
to no purpose. They engaged him and stabbed him to death in her
back yard as he undertook to escape.
The same number of this newspaper carries instances and gives
dates of other atrocities of a most depraved character. All this served
to stimulate the growing animosity between the whites, who
regarded the outrages being committed by them as absolutely
essential to the preservation of civilization, and the Northern
immigrants or carpet-baggers, who through the Negro vote were in
power and held all of the important offices of the County and State.
Many of these disgraced with shame for the time being the offices
held for enriching themselves and impoverishing the already
impoverished and well-nigh destitute country.
Martha Schofield’s activities in broad-casting stories of these
hideous outrages and appealing for the continuance of the reign of
the military authorities in South Carolina as the only means of
making life at all safe and possible under the circumstances, drew to
her the contempt and hatred of the white people, who of all the
people on earth were best suited by reason of their position and
knowledge to assist her in her work.
The suspicion and distrust she worked under of being in sympathy
with the unscrupulous and corrupt regime in complete control of local
affairs was manifestly a serious handicap. No one more clearly than
she realized the disastrous effect their corruption would have on her
school, her work and the colored people. She knew also that it
meant defeat, in the South at least, of the great party whose triumph
in the cause of freedom had made it possible for the first time in
American history to test the possibility of elevating a lowly and much
abhorred race. These influences weighed heavily upon her heart,
and but for the courage and sternness of her nature, which seemed
never to be at its best except when acutely vexed and infinitely tried,
would have resulted in her voluntarily withdrawing from the self-
imposed task almost in its beginning.
The author shall never forget but she will always remember and
value her most priceless treasure, the tender religious emotion which
the happenings of these times provoked. They were felt keenly at the
morning service of the Schofield Normal and Industrial Institute
during her first year at this institution. How fondly does she recall
now as if the voices of angels, whose voices of three decades ago
as the whole school would sing those comforting old plantation
hymns, “Steal Away, Steal Away to Jesus,” and “Love, Come a
Twinkling Down.”
The joy, the emotion and inspiration which is felt at the moment of
writing these lines, over the probability of a similar joy in heaven, in
the heart of her who had the heroic courage and the splendid
manhood to risk her life in the unselfish and holy cause of implanting
in the Negro mind and soul that which is beautiful, noble and
sentimental, is unbounded.
The reflection that large numbers of her fellow-citizens now rejoice
with her, and the prediction that others who do not now do so will
later on, gives her likewise an even greater measure of the debt of
gratitude which all owe to the mother of the movement for the
courage to continue the work for the uplift of the Negro even at the
peril of her life.
The work of Miss Schofield was made doubly more perilous each
day by the misrule of the imported rulers of State. For these she had,
instead of sympathy, an unbridled contempt, and never failed to
express that contempt, whenever possible. But the white people
would not condescend to hear her talk, much less believe anything