مقدمه‌ای بر مسائل حقوقی، مقرراتی و حقوق مالکیت معنوی در بیوتکنولوژی

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. 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