An Introduction to Legal, Regulatory and Intellectual Property Rights Issues in Biotechnology

An Introduction to Legal, Regulatory and Intellectual Property Rights Issues in Biotechnology

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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...

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Bibliographische Detailangaben
1. Verfasser: Stasi, Alessandro (VerfasserIn)
Format: Elektronisch E-Book
Sprache:English
Veröffentlicht: Minneapolis Bentham Science Publishers 2023
Ausgabe:1st ed
Online-Zugang:HWR01
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Inhaltsangabe:
  • 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

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