Biotechnology, a branch of science and a fast-growing source of developing technologies, has shown immense potential for its utility across all the dimensions of our lives. Its applications range from drugs and therapeutics, industrial, household applications, biofuels, and information technology to almost all resource-based sectors, such as manufacturing, aquaculture, agriculture, and forestry. Biotechnology offers outstanding potential to meet the growing demand for food and energy production in a sustainable way. Recognizing its economic and strategic value, countries have implemented several measures to generate a homegrown biotechnology sector and help science-based companies develop.
This book covers some of the most important legal issues arising in relation to biotechnology. Topics covered in chapters include 1) the historical development of a legal framework sufficient to protect public safety, 2) the current biotechnology regulatory system and the rules directing the primary agencies that regulate the products of biotechnology (namely the FDA, USDA and EPA), 3) the regulation of human genome editing and its impact on health research, 4) law and emerging genome editing technologies from recombinant DNA technology to CRISPR/Cas9 editing, 5) the development of legal principles to protect property rights in the human body and allow the efficient use of human tissue, organs, DNA, and cell-lines in medical research, and 6) legal issues arising from the use of genetic engineered plants and animals. The authors have ensured that the contents are easy to understand, making this an accessible reference for a broad range of readers.
This book, therefore, serves as a quick summary of the prominent legal and regulatory issues in the biotech industry for professionals, as well as scholars in legal study programs.
Author(s): Alessandro Stasi, Tan Weng Chiang David
Publisher: Bentham Science Publihers
Year: 2023
Language: English
Pages: 163
City: Singapore
Cover
Title
Copyright
End User License Agreement
Contents
Preface
CONSENT FOR PUBLICATION
CONFLICT OF INTEREST
ACKOWNOLEDGEMENTS
The History of Biotechnology and the Law
INTRODUCTION
THE RISE OF MODERN MEDICINE
THE GREAT AMERICAN FRAUD
THE POISON SQUAD AND THE LEGISLATIVE HISTORY OF THE PURE FOOD AND DRUGS ACT
THE DISASTER THAT SHAPED THE FDA
CONCLUDING REMARKS
REFERENCES
The Regulatory Framework
INTRODUCTION
AN OVERVIEW OF THE FEDERAL REGULATIONS
FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF AGRICULTURE
ENVIRONMENTAL PROTECTION AGENCY
CONCLUDING REMARKS
REFERENCES
The Regulation of Human Genome Editing
INTRODUCTION
COMPETING FOR THE HUMAN GROWTH HORMONE
THE HUMAN GENOME PROJECT
THE LEGAL ISSUES OF GENE PATENTING
GENE PATENTS IN THE WAKE OF ASSOCIATION FOR MOLECULAR PATHOLOGY V. MYRIAD GENETICS
CONCLUDING REMARKS
REFERENCES
Law and Emerging Genome Editing Technologies
INTRODUCTION
FROM RECOMBINANT DNA TO NEW GENOME EDITING TECHNOLOGIES
THE FIRST CRISPR PATENT
Interestingly, the patent also states:
The patent describes the invention as follows:
Nucleic Acids
DNA-Targeting RNA
DNA-Targeting Segment of a DNA-Targeting RNA
Protein-Binding Segment of a DNA-Targeting RNA
Regarding the Utility Criteria, the Patent States:
PATENT BATTLE, SCIENTIFIC PROGRESS AND THE OBVIOUSNESS TEST
COURT RULING ON CRISPR GENE EDITING TECHNOLOGIES
Reasonable Expectation of Success
Specific Instructions
Treatment of Simultaneous Invention Evidence
CONCLUDING REMARKS
REFERENCES
Biotechnology, Property and The Human Body
INTRODUCTION
DEAD BODY
LIVING BODIES AND SEPARATED BIOLOGICAL MATERIALS
Unique T-Lymphocyte Line and Products Derived Therefrom
Abstract
Unique T-Lymphocyte Line and Products Derived Therefrom
Field of the Invention
Brief Description of the Prior Art
SUMMARY OF THE INVENTION
Case History
EXPERIMENTAL PROCEDURES
PATENTING HUMAN GENETIC MATERIAL: THE UNUSUAL CASE OF JOHN MOORE
Introduction
Facts
Discussion
Breach of Fiduciary Duty and Lack of Informed Consent
Moore's Claim Under Existing Law
Should Conversion Liability Be Extended?
Disposition
PATIENTS TISSUE AND THE IMMORTAL HERITAGE OF HENRIETTA LACKS
CONCLUDING REMARKS
REFERENCES
The Regulation of Genetically Engineered Plants and Animals
INTRODUCTION
POLICY ISSUES IN GENETICALLY ENGINEERED ANIMALS
FDA STATUTORY AND REGULATORY AUTHORITY
ANIMALS WITH INTENTIONALLY ALTERED GENOMIC DNA
GENETICALLY MODIFIED FOOD
FOOD POLICY LAWSUITS
BACKGROUND
DISCUSSION
Subject Matter Jurisdiction
Notice and Comment
NEPA
GRAS Presumption
Labeling
CONCLUDING REMARKS
REFERENCES
Subject Index
Back Cover
