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.