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A Comparative Study on Human Embryonic Stem Cell Patent Law in the United States, the European Patent Organization, and China

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A Comparative Study on Human Embryonic Stem Cell Patent Law in the United States, the European Patent Organization, and China A Comparative Study on Human Embryonic Stem Cell Patent Law in the United States, the European Patent Organization, and China BY © 2011 Huan Zhu Submitted to the School of Law, University of Kansas in partial fulfillment of the requirements for the degree of Doctor of Judical Science (S.J.D.) ________________________________ Prof. Andrew W. Torrance (Chairperson) ________________________________ Prof. John W. Head (Member) ________________________________ Prof. Mark L. Weiss (Member) ________________________________ Prof. Elizabeth W. Leonard (Member) Date Defended: Apr 6, 2011 The Dissertation Committee for Huan Zhu certifies that this is the approved version of the following dissertation: A Comparative Study on Human Embryonic Stem Cell Patent Law in the United States, the European Patent Organization, and China ________________________________ Chairperson Dr. Andrew W. Torrance Date approved: ________________ ii iii Brief Table of Contents CHAPTER 1: INTRODUCTION ..................................................................................... 1 CHAPTER 2: SCIENTIFIC REVIEW .............................................................................. 9 A. STEM CELLS ................................................................................................................................. 9 B. EMBRYONIC STEM CELLS [ESCS] ......................................................................................... 19 CHAPTER 3: ETHICAL, RELIGIOUS AND PHILOSOPHICAL VIEWPOINTS ON HUMAN EMBRYONIC STEM CELL [HESC] RESEARCH ................................................. 28 A. ETHICAL DEBATES OVER HESC RESEARCH ...................................................................... 28 B. THE START‐LINE OF PERSONHOOD AND ETHICS OF HESC RESEARCH FROM THE PERSPECTIVES OF RELIGION AND PHILOSOPHY ............................................................................... 32 C. LAWS AND POLICIES ON THE STATUS OF HUMAN EMBRYOS .......................................... 41 CHAPTER 4: PATENT LAWS REGARDING HESCS IN THE UNITED STATES 51 A. FEDERAL POLICY ON HESC RESEARCH .............................................................................. 51 B. FEDERAL PATENT LAW REGARDING HESCS ..................................................................... 57 C. STATES LAWS REGARDING HESC RESEARCH .................................................................... 82 D. ACADEMIC DISCUSSION CONCERNING HESC INVENTIONS ............................................. 85 CHAPTER 5: LAWS REGARDING HESCS IN THE EUROPEAN PATENT CONVENTION 92 A. EUROPEAN PATENT SYSTEMS .............................................................................................. 95 B. EUROPEAN UNION PATENT LAWS .................................................................................... 111 C. LAWS OF EUROPEAN COUNTRIES ON PATENTABILITY OF HESCS ............................... 124 D. ACADEMIC DISCUSSION ON HESCS’ PATENTABILITY .................................................... 128 CHAPTER 6: LAWS GOVERNING HESCS IN CHINA ........................................... 132 A. INTRODUCTION TO CHINESE LEGAL SYSTEM .................................................................. 132 B. LAWS ON HUMAN EMBRYONIC STEM CELL RESEARCH, PATENT AND EMBRYONIC STEM CELL INVENTIONS ..................................................................................................................... 154 C. PATENT APPLICATIONS AND CASES CONCERNING HESCS ............................................ 176 D. ACADEMIA IN HESC PATENT ISSUES IN CHINA .............................................................. 179 CHAPTER 7: COMPARISON AND SUGGESTIONS .............................................. 182 iv A. DIFFERENCES OF LAWS AND JUDICIAL PRACTICES AMONG THE UNITED STATES, EUROPE AND CHINA INCLUDING REASONS FOR DIFFERENCES .................................................... 182 B. RATIONALES FOR DIFFERENT LAWS TO HESC INVENTION APPLICATIONS .............. 200 C. THE IMPORTANCE OF HESC LAWS .................................................................................... 215 D. MODEL LAW—SUGGESTIONS REGARDING PATENT REGULATIONS ON HESCS ........ 218 CHAPTER 8: CONCLUSION ...................................................................................... 241 GLOSSARY ........................................................................................................................ 247 BIBLIOGRAPHY .............................................................................................................. 251 v Table of Contents CHAPTER 1: INTRODUCTION ..................................................................................... 1 CHAPTER 2: SCIENTIFIC REVIEW .............................................................................. 9 A. STEM CELLS ................................................................................................................................. 9 1. Definition and Characteristics of Stem Cells ............................................................ 9 2. Scientific and Therapeutic Values of Stem Cells ................................................... 14 3. Global Investments on Stem Cell Research ............................................................ 17 B. EMBRYONIC STEM CELLS [ESCS] ......................................................................................... 19 1. Definition and Formation of Embryonic Stem Cell .............................................. 19 2. Scientific and Therapeutic Values of Embryonic Stem Cells ........................... 24 3. Scientific Uncertainty in hESC Research .................................................................. 26 CHAPTER 3: ETHICAL, RELIGIOUS AND PHILOSOPHICAL VIEWPOINTS ON HUMAN EMBRYONIC STEM CELL [HESC] RESEARCH ................................................. 28 A. ETHICAL DEBATES OVER HESC RESEARCH ...................................................................... 28 B. THE START‐LINE OF PERSONHOOD AND ETHICS OF HESC RESEARCH FROM THE PERSPECTIVES OF RELIGION AND PHILOSOPHY ............................................................................... 32 1. Religious Viewpoints on Human Embryo’s Status and hESC Research ...... 32 2. Philosophical Perspectives on Human Embryo’s Status and hESC Research 39 C. LAWS AND POLICIES ON THE STATUS OF HUMAN EMBRYOS .......................................... 41 1. National Laws regarding the Status of Embryos ................................................. 41 2. Laws and Policies towards hESC Research ............................................................. 46 CHAPTER 4: PATENT LAWS REGARDING HESCS IN THE UNITED STATES 51 A. FEDERAL POLICY ON HESC RESEARCH .............................................................................. 51 B. FEDERAL PATENT LAW REGARDING HESCS ..................................................................... 57 1. History of U.S. Patent System ........................................................................................ 57 2. Current U.S. Patent Law .................................................................................................. 59 a. U.S. PateNt System .................................................................................................................................... 59 b. The CurreNt PateNt Law ......................................................................................................................... 62 i. Subject matter ....................................................................................................................................... 62 ii. Utility ....................................................................................................................................................... 65 iii. Novelty .................................................................................................................................................. 66 vi iv. NoNobviousNess ................................................................................................................................ 68 v. Morality CoNsideratioN .................................................................................................................... 69 3. hESC Related Patents Issued by the USPTO ............................................................ 70 4. Biotechnological Patent Case Law ............................................................................. 77 a. WARF PateNts ............................................................................................................................................. 78 b. GeNe pateNts ............................................................................................................................................... 81 C. STATES LAWS REGARDING HESC RESEARCH .................................................................... 82 1. hESC Research in Constitutions ................................................................................... 82 2. hESC Research in Statutes .............................................................................................. 83 D. ACADEMIC DISCUSSION CONCERNING HESC INVENTIONS ............................................. 85 1. The Status of Human Embryos ..................................................................................... 85 2. Morality Consideration in Patent Law ..................................................................... 87 3. Research Tool Doctrine ..................................................................................................
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