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Regulating Human Embryonic Stem Cell in China pp 77–109Cite as

Stem Cells, Patents and Policy in the US: Inefficiency

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Abstract

The question of the morality of HESC related invention and the inadequate HESC regulation in China has been widely addressed in previous chapter. This chapter will address how effective the US deals with the patentability and morality disputes on HESC.

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Notes

  1. 1.

    David B Resnik, ‘Embryonic Stem Cell Patents and Human Dignity’ (2007) 15 Health Care Anal 211–222 (observing that patent examiners focus on technical questions concerning novelty, non-obviousness, utility, and disclosure, while the courts focus on policy questions related to economic development, competition, and scientific and technical innovation.).

  2. 2.

    Jean Jacques Rousseau, The Social Contract (1st ed., Create Space Independent Publishing Platform2010) 1–138.

  3. 3.

    ibid.

  4. 4.

    See Sheryl Gay Stolberg, ‘Obama is leaving some stem cell issues to Congress’ (2009) New York Times, March 8 2009 http://www.nytimes.com/2009/03/09/us/politics/09stem.html accessed October 28 2015.

  5. 5.

    Diamond v Chakrabarty [1980] 447 US 303, http://supreme.justia.com/us/447/303/ accessed October 28 2015.

  6. 6.

    Section 101–103 United State Code Title 35-Patents.

  7. 7.

    US Patent and Trademark off Notice: Animals-Patentability, reprinted in 1077 Official Gazette Patent and Trademark off. 24 (April, 7, 1987), http://www.jstor.org/pss/797469 accessed October 28 2015.

  8. 8.

    Lowell v Lewis [1817] 15 F Cas 1019.

  9. 9.

    U.S. Patent No.5, 843,780, U.S. Patent No.6, 200,806 and U.S. Patent No.7, 029,913.

  10. 10.

    Primate Embryonic Stem Cell, U.S. Patent No.5, 843,780 (filed Jan.18,1996)(issued Dec.1,1998).

  11. 11.

    Primate Embryonic Stem Cell, U.S. Patent No.6, 200,806 (filed Jan.26,1998)(issued Mar 13,2001).

  12. 12.

    Primate Embryonic Stem Cell, U.S. Patent No.7, 029,913 (filed Oct 18,2001)(issued Apr 18, 2006).

  13. 13.

    McDermott E, ‘USPTO backs WARF stem cell patents’ (2008) 178 Managing Intellectual Property 62.

  14. 14.

    Lowell v Lewis, 15 F.Cas.1019 (1817).

  15. 15.

    United State Patent Law.

  16. 16.

    Dec. Com. Pat.123, 126 (1889).

  17. 17.

    Diamond v. Chakrabarty, 447 US 303 (1980).

  18. 18.

    US Patent and Trademark office Notice: Animals Patentability, reprinted in 1077 Official Gazette Patent and Trademark Office, 7 April 1987 http://www.uspto.gov/web/offices/pac/mpep/s2105.html accessed July 24 2015.

  19. 19.

    ibid.

  20. 20.

    David B Resnik, ‘Embryonic Stem Cell Patents and Human Dignity’(2007) 15 Health Care Anal 211.

  21. 21.

    Media Advisory, ‘Facts on Patenting Life Forms Having a relationship to Human’ US Patent and Trademark Office, April 1 1998 http://www.uspto.gov/news/pr/1998/98-06.jsp accessed July 14 2015.

  22. 22.

    Juicy Whip, Inc. v. Orange Bang, 185 F.3d 1364 (Fed. Cir.1999).

  23. 23.

    ibid. (involving with a dispute on a patent. This patent owner is a beverage dispenser called post-mix beverage dispenser with an associated simulated display of beverage, Juicy Whip sued Orange Bang for patent infringement. The court held that patent lacked utility and was therefore unpatentable.)

  24. 24.

    Wendy H. Schacht, ‘The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology’ (2005) CRS Report for Congress Order Code RL32076 https://www.autm.net/Bayh_Dole_Act_Report.htm accessed July 24 2015.

  25. 25.

    The Bayh-Dole Act, P.L.96–517, Section 200.

  26. 26.

    35 U.S.C. §203(a) states that “[w]ith respect to any subject invention in which a small business firm or nonprofit organization has acquired title under this chapter, the Federal agency under whose funding agreement the subject invention was made shall have the right, in accordance with such procedures as are provided in regulations promulgated hereunder to require the contractor, an assignee or exclusive licensee of a subject invention to grant a nonexclusive, partially exclusive, or exclusive license in any field of use to a responsible applicant or applicants, upon terms that are reasonable under the circumstances, and if the contractor, assignee, or exclusive licensee refuses such request, to grant such a license itself, if the Federal agency determines that such—(1) action is necessary because the contractor or assignee has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in such field of use; (2) action is necessary to alleviate health or safety needs which are not reasonably satisfied by the contractor, assignee, or their licensees; (3) action is necessary to meet requirements for public use specified by Federal regulations and such requirements arenot reasonably satisfied by the contractor, assignee, or licensees; or (4) action is necessary because the agreement required by section has not been obtained or waived or because a licensee of the exclusive right to use or sell any subject invention in the United States is in breach of its agreement obtained pursuant to section.”

  27. 27.

    Michael S Mireles, ‘States as innovation system laboratories: California, patents and stem cell technology’ (2006) 28 Cardozo L. REV. 1133–1159.

  28. 28.

    Ann L. Gisolfi and Anthony M. Insogna, “States fund stem cell research’ (2005) the national law journal.

  29. 29.

    Hughes et al. (2008).

  30. 30.

    ibid.

  31. 31.

    See NIH Response to the Conference Report Request for a plan to ensure Taxpayers’ Interests are Protected, the study of National Institutes of health conducted in July 2001, http://www.ott.nih.gov/sites/default/files/documents/policy/wydenrpt.pdf accessed July 24 2015.

  32. 32.

    Arti K.Rai and Rebecca S. Eisenberg, ‘and Bayh-Dole reform the Progress of Biomedicine’ (2003) 66 Law and contemporary problems 289.

  33. 33.

    Using cloning technology, scientists could create billions of unfertilized human embryos for research or therapeutic use, called “human embryo farms”.

  34. 34.

    President Bush on cloning, April 10, 2002 http://www.pbs.org/newshour/updates/april02/bush-cloning_4-10.html accessed December 12 2015.

  35. 35.

    Section 101, 102, 103 of Title 35 of the United State Code.

  36. 36.

    Diamond v. Chakrabarty, 447 US 303 (1980). (The application asserted 36 claims related to Chakrabarty’s invention of a bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids. The patent examiner allowed the claims falling into the first two categories, but rejected claims for the bacteria. His decision rested on two grounds: (1) that mircro-organisms are products of nature and (2) that as living things they are not patentable subject matter under 35 U.S.C.) § 101.

  37. 37.

    Congress bans patents on human embryos NRLC-backed Weldon Amendment survive BIO attacks, NRLC Federal legislation 2004 http://www.nrlc.org/killing_embryos/Human_Patenting/WeldonAmendmentEnacted.pdf accessed December 11 2015.

  38. 38.

    ibid.

  39. 39.

    ibid.

  40. 40.

    ibid.

  41. 41.

    Alan Fram, ‘Panel Oks Anti-Abortion Provision’ (the Washington post, July 14 2004) http://www.washingtonpost.com/wp-dyn/articles/A49778-2004Jul14.html accessed December 10 2015.

  42. 42.

    Jeremy Kryn, ‘Amendment banning human embryo patents becomes permanent US law’ (LifeSiteNews.com, September 20 2011) http://www.lifesitenews.com/news/congress-makes-amendment-banning-human-embryo-patents-permanent/ accessed December 13 2015.

  43. 43.

    America Invents Act of 2011, http://judiciary.house.gov/issues/issues_patentreformact2011.html accessed December 15 2015.

  44. 44.

    Supra note 37.

  45. 45.

    United States Patent, 5,843,780, United States Patent, 6,200,806 and United States Patent, 7,029,913.

  46. 46.

    Bergman K and Graff GD, ‘the global stem cell patent landscape: implications for efficient technology transfer and commercial development’ (2007) 5 Nature Biotechnology 419.

  47. 47.

    United States Patent, 5,843,780, December 1 1998.

  48. 48.

    United States Patent, 6,200,806, March 13 2001.

  49. 49.

    United States Patent, 7,029,913, April 18 2006.

  50. 50.

    Aurora Plomer, Kenneth S Taymor and Christopher Thomas Scott, ‘Challenges to HESC Patents’ (2008) 2 Cell Stem Cell 13–17.

  51. 51.

    Constance Holden, ‘US patent office casts doubt on Wisconsin Stem Cell Patents’ (2007) 316 Science 182. (Rovert Lanza, from Advanced Cell Technology in Worcester, Massachusetts, claimed that we would be sued if we even tried to develop insulin-producing cells to treat diabetes.).

  52. 52.

    ibid.

  53. 53.

    Request for Ex Parte Reexamination of US Patent No. 5,843,780, Request for Ex Parte Reexamination of US Patent No 6,200,806 and Request for Inter Parties Reexamination of US Patent No 7,029,913.

  54. 54.

    Supra note 51.

  55. 55.

    Joseph Itskovitz, Wisconsin Scientists Culture Elusive Embryonic Stem Cells, November 6, 1998 http://www.sciencedaily.com/releases/1998/11/981109085437.htm accessed November 2 2015.

  56. 56.

    John M Golden, ‘WARF’s stem cell patents and tensions between public and private sector approaches to research’ (2010) 38 Journal Law Medicine and Ethics 314–315. (pointing out that WARF’s patents cover all use of long-lasting hESC lines in the United States has been criticized as overly aggressive. WARF has been accused of improperly asserting control over hESCs and methods of maintaining them that extends far beyond the particular kinds of hESCs and methods developed by Thomson.)

  57. 57.

    ibid. (analyzing that United States patent law provides comparatively little basis for such a morality-oriented barrier to WARF’s patents. Instead, challenges to WARF’s patents in the United States have attacked the value of Thomson’s scientific contribution.)

  58. 58.

    Tim Friend; see also Dillon Beardsley ‘Free Stem-Cell Lines Will Be Offered to Researcher’ USA TODAY (Mclean 22 August 2001) D10; see also Beardsley D, ‘A Two-Front Assault On The Stem Cell Patents’ (2007) The John Marshall Review Of Intellectual Property Law 501.

  59. 59.

    ibid.

  60. 60.

    ibid.

  61. 61.

    Foundation for Taxpayer and Consumer Rights.

  62. 62.

    Jennifer Washburn, ‘The legal Lock on Stem Cells’ L.A.TIMES (Los Angeles 12 April 2006) 13.

  63. 63.

    Madison Wis, Wisconsin Alumni Research Fundation Changes Stem Cell Policies to Encourage Greater Collaboration, (Willcell research institution, 22 Jan 2007) http://www.wicell.org/index.php?option=com_content&task=view&id=166&Itemid=170 accessed October 10 2015.

  64. 64.

    Elleen McDermott, ‘USPTO backs WARF stem cell patents’ (2008) 178 Managing Intellectual Property 62.

  65. 65.

    ibid.

  66. 66.

    Abraham Lincoln, ‘who was the only US president to hold a patent’, http://inventors.about.com/od/lstartinventors/a/Abraham_Lincoln.htm accessed 28 October 2015.

  67. 67.

    Loring F Jeanne and Campbell Cathryn, ‘Intellectual Property and HESC Research’ (2006) 311 Science 1716–1717.

  68. 68.

    Wisconsin Alumni Research Foundation http://www.warf.org/index.jsp accessed October 28 2015.

  69. 69.

    See Knowles P Lori, ‘Stem Cell Patent’ [2008] Stem Cell Network http://www.stemcellnetwork.ca/uploads/File/whitepapers/Stem-Cell-Patents.pdf accessed July 23 2015.

  70. 70.

    Supra note 67.

  71. 71.

    ibid.

  72. 72.

    See Wadman Meredith ‘Licensing fees slow advance of stem cells’ (2005) Nature 18 May 2005 http://www.nature.com/nature/journal/v435/n7040/pdf/435272a.pdf accessed 23 July 2011.

  73. 73.

    Merrill Goozner, ‘innovation in biomedicine: can stem cell research lead the way to affordability’ (2006) 3 PloS Medicine http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0030126 accessed August 2 2015.

  74. 74.

    ibid.

  75. 75.

    ibid.

  76. 76.

    ibid.

  77. 77.

    Frazier B H, New Perspectives on Human Embryonic Stemcell Research: what you need to know about the legal, moral &ethical issues (Vandeplas Publishing, Lake Mary 2009) 342–344.

  78. 78.

    Eisenberg Rebecca, ‘Public Research and Private Development: Patents and Technology Transfer in Government-Sponsored Research’ (1996) 82 Virginia Law Review 1663–1691.

  79. 79.

    Bayh-Dole Act, 35 United States Code, 2000, http://uscode.house.gov/download/pls/35C18.txt (last visited 09/07/2011).

  80. 80.

    Supra note 78.

  81. 81.

    Korobkin Russell and Stephen R Munzer, Stem Cell Century-law and policy for a breakthrough technology (Yale University Press, New haven and London 2007) 135.

  82. 82.

    If the licensee is unable to either satisfy Food and Drug Administration requirements or create a technology able to reliably mass-produce the necessary raw material, the investment will earn no return at all, see David W Louisell, ‘National commission for the protection of Human Subjects of Biomedical and Behavioral research: research on the Fetus’ (1977) 22 Villanova Law Review 300.

  83. 83.

    Christine Vestal and Staff Writer, ‘Stem cell research at the crossroads of religion and politics’, Pew Forum paper, July 17, 2008 available at http://pewforum.org/Science-and-Bioethics/Stem-Cell-Research-at-the-Crossroads-of-Religion-and-Politics.aspx accessed July 24 2015.

  84. 84.

    See Paul Murray McNeill, The ethics and politics of human experimentation (Cambridge university press, 1993) 119; also see Kyla Dunn, ‘The politics of Stem cells’ (NOVA science NOW, January 4th 2005) http://www.pbs.org/wgbh/nova/body/stem-cells-politics.html accessed September 8 2015.

  85. 85.

    See e.g. case Jackson v Burnham (1895); Sawdey v Spokane Falls (1902); Allen v Voje (1902); Owens v McCleary (1926).

  86. 86.

    Jesse A Goldner, ‘An overview of legal controls on human experimentation and the regulatory implications of taking professor katz seriously’ (1993) 38 SAINT LOUIS UNIVERSITY LAW JOURNAL 63–67.

  87. 87.

    See e.g. Nuremberg Code, Thalidomide, Tuskegee Syphilis Study, Declaration of Helsinki and National Research Act.

  88. 88.

    Supra note 82.

  89. 89.

    ibid.

  90. 90.

    ibid.

  91. 91.

    Executive Order 12975, October 3 1995.

  92. 92.

    Eiseman Elisa, The National Bioethics Advisory Commission: contributing to public policy (RAND, 2003) 130.

  93. 93.

    Mary Leinhos, ‘The US National Bioethics Advisory Commission as a boundary organism’ (2005)32 Science and Public Policy 423–426. (The Commission was granted the authority to deliberate on additional issues raised by the general public, other federal bodies and organizations, or NBAC itself.)

  94. 94.

    ibid. at 427 (Consistent with the NBAC’s recommendation, the President's legislative proposal prohibits for five years the use of somatic cell nuclear transfer to create a human being and directs the NBAC to report to the President in four and a half years on whether to continue the ban.).

  95. 95.

    The National Institutes of Health, Human Fetal Tissue Transplantation Research, report of the Advisory Committee to the Director, December 14, 1988.

  96. 96.

    Helen M Maroney, ‘Bioethical catch-22: the moratorium on federal funding of fetal tissue transplantation research and the NIH revitalization amendments’ (1993) 9 Journal Contemporary Health Law and Policy 485–487.

  97. 97.

    Research on Human Fetal Tissue Amendments Act of 1993, March 2, 1993.

  98. 98.

    Case Mary Doe v Donna Shalala, September 26, 1994.

  99. 99.

    Heather J Meeker, ‘Issues of property, ethics and Consent in the transplantation of fetal reproductive tissue’ (1994) 9 Berkeley Technology Law Journal 185–187 (citing profound ethical and moral questions associated with the subject, refused to follow the contrary recommendation of a National Institutes of Health panel.).

  100. 100.

    The Dickey Wicker Amendment 1996.

  101. 101.

    Supra note 96.

  102. 102.

    The Dickey Amendment 1996 Section 509.

  103. 103.

    James A Thomson, ‘Embryonic stem cell lines derived from human blastocysts’ (1998) 282 Science 1145.

  104. 104.

    See Letter from HHS Gen. Counsel Harriet Rabb to Harold Varmus, Director, NIH, January 15, 1999. (General Counsel Rabb determined that the statutory ban on human embryonic research defined an embryo as an “organism” that, when implanted in the uterus, is capable of becoming a human being); see also Judith A Johnson and Erin D Williams, Stem cell research: Federal research funding and oversight, CRS report to Congress 2007 http://www.fas.org/sgp/crs/misc/RL33540.pdf accessed October 10 2015.

  105. 105.

    Wadman (1999)

  106. 106.

    ibid.

  107. 107.

    ibid.

  108. 108.

    Marshall (1999).

  109. 109.

    Meredith Wadman, ‘Congress may block stem cell research’ (1999) 397 Nature 639.

  110. 110.

    ibid.

  111. 111.

    The Clinton administration NIH Guideline for embryonic stem cell funding, 65 Fed Reg. 51,975, Aug. 25, 2000 https://bioethicsarchive.georgetown.edu/pcbe/reports/stemcell/appendix_d.html accessed July 24 2015.

  112. 112.

    ibid.

  113. 113.

    Wade (2000).

  114. 114.

    Kyla Dunn, The politics of stem cells, NOVA Science Now, April 1 2005 http://www.pbs.org/wgbh/nova/body/stem-cells-politics.html accessed July 23 2015.

  115. 115.

    The President’s Council on Bioethics, the administration’s HESC research funding policy: moral and political foundations, the President’s Council on Bioethics, September 2003 https://bioethicsarchive.georgetown.edu/pcbe/background/es_moralfoundations.html accessed July 25 2015.

  116. 116.

    Weiss (2001).

  117. 117.

    ibid.

  118. 118.

    See http://www.presidency.ucsb.edu/ws/?pid=79025 accessed October 7 2015.

  119. 119.

    White house fact sheet embryonic stem cell research, August 9 2001, http://usgovinfo.about.com/blwhrelease17.htm accessed October 7 2015.

  120. 120.

    President George W.Bush’s address on stem cell research, August 9 2001, CNN TV http://edition.cnn.com/2001/ALLPOLITICS/08/09/bush.transcript/index.html accessed July 24 2015.

  121. 121.

    ibid.

  122. 122.

    Supra note 122.

  123. 123.

    Supra note 120.

  124. 124.

    Carter O. Snead, ‘The pedagogical significance of the Bush Stem cell policy: A window into Bioethical regulation in the United States’ (2005) 5 Yale Journal of Health policy, Law and Ethics 491–497 (demonstrating both an acknowledgement of congress’s sole authority to appropriate federal funds and a robust exercise of the President’s authority as head of the executive branch to allocate the appropriated funding according to the administration’s priorities.).

  125. 125.

    Tom Abate, ‘Scientist fears that political uncertainty threatens his research’ (SFGate, 17 July 2001) http://www.sfgate.com/cgi-bin/article.cgi?f=/Chronicle/a/2001/07/17/MN153775.DTL#ixzz1ZfVOVkOj accessed October 2 2015.

  126. 126.

    Monitoring Stem Cell Research, http://bioethics.georgetown.edu/pcbe/index.html accessed November 1 2015.

  127. 127.

    ibid.

  128. 128.

    ibid.

  129. 129.

    Letter of Transmittal to the President of the United State, http://bioethics.georgetown.edu/pcbe/reports/reproductionandresponsibility/transmittal.html accessed November 2 2015.

  130. 130.

    Supra note 122.

  131. 131.

    ibid.

  132. 132.

    Leigh Turner, ‘Science, politics and the President’s Council on Bioethics’(2004) 22 Nature Biotech. 509–510. (analyzing that though the reports produced by the US President’s Council on Bioethics have not yet had a dramatic effect on public debates in the United States, the Council itself is back in the limelight following the departures of Elizabeth Blackbrun and William E. May and the additions of Benjamin Carson, Peter Lawler and Diana Schaub.)

  133. 133.

    Leigh Turner, ‘Has the President’s Council on Bioethics missed the boat?’ (2003) 327 bmj 629.

  134. 134.

    Supra note 129.

  135. 135.

    Obama overturns Bush policy on stem cells, CNN Politics (Washington, March 9 2009) http://articles.cnn.com/2009-03-09/politics/obama.stem.cells_1_cancer-and-spinal-cord-embryonic-cell-research?_s=PM:POLITICS accessed 4 November 2015; see also The White House, Executive Order: Removing barriers to responsible scientific research involving human stem cells, March 9, 2009, http://www.whitehouse.gov/the_press_office/Removing-Barriers-to-Responsible-Scientific-Research-Involving-Human-Stem-Cells/ accessed October 12 2015.

  136. 136.

    Executive Order: Removing barriers to responsible scientific research involving human stem cells, March 9, 2009. http://www.whitehouse.gov/the_press_office/Removing-Barriers-to-Responsible-Scientific-Research-Involving-Human-Stem-Cells/ accessed November 7 2015.

  137. 137.

    Rob Stein, ‘Obama’s Order on Stem Cells Leaves Key Questions to NIH’ The Washington Post (Washington, March 10 2009) http://www.washingtonpost.com/wp-dyn/content/article/2009/03/09/AR2009030903156.html accessed November 8 2015.

  138. 138.

    Sheryl Gay Stolberg, ‘Obama is leaving some stem cell issues to Congress’ The New York Times (NEW York, March 8 2009) http://www.nytimes.com/2009/03/09/us/politics/09stem.html accessed November 8 2015.

  139. 139.

    A debt of gratitude to so many tireless advocates, the White House Blog, March 9 2009 http://www.whitehouse.gov/blog/09/03/09/A-debt-of-gratitude-to-so-many-tireless-advocates/ accessed November 8 2015.

  140. 140.

    See generally Devin Dwyer, ‘NIH Issues new stem cell research Guideline as Obama Administration prepares to Appeal court ruling’, ABC News, Aug. 31, 2010, http://abcnews.go.com/blogs/politics/2010/08/nih-issues-new-stem-cell-research-Guideline-as-obama-administration-prepares-to-appeal-court-ruling/ accessed October 23 2015.

  141. 141.

    ibid.

  142. 142.

    Sherley v. Sebelius, 2010 U.S. Dist. LEXIS 86441 (D.D.C. August 23, 2010).

  143. 143.

    ibid.

  144. 144.

    ibid.

  145. 145.

    Ariane de Vogue, ‘NIH Issues new stem cell research Guideline as Obama Administration prepares to Appeal court ruling’ ABC NEWS, August 31, 2010 http://abcnews.go.com/blogs/politics/2010/08/nih-issues-new-stem-cell-research-Guideline-as-obama-administration-prepares-to-appeal-court-ruling/ accessed 9 November 2015. (criticizing that the ruling as one that could ‘cause irreparable damage and delay potential breakthroughs to improve care for people living with serious diseases and conditions… the injunction threatens to stop progress in one of the most encouraging areas of biomedical research)

  146. 146.

    Janice Hopkins Tanne, ‘US court temporarily lifts ban imposed in August on HESC research’ (2010) 341 BMJ 579 http://www.bmj.com/content/341/bmj.c4981 accessed October 4 2015.

  147. 147.

    ibid. (Stating that the ruling threw the field into disarray, immediately halting some projects and causing the US National Institutes of Health (NIH) to put a hold on many research grants.)

  148. 148.

    Ubaka Ogbogu, ‘US Appeal Court reinstates Obama’s funding policy on stem cell research’ Stem Cell Network, 2 May 2011 http://scnblog.typepad.com/scnblog/2011/05/us-appeal-court-obama-funding-policy-stem-cell-research.html accessed November 9 2015.

  149. 149.

    Bill Mears, ‘Appeal court lifts ban on federal funding for stem cell research’ CNN April 29, 2011 http://articles.cnn.com/2011-04-29/us/stem.cells_1_stem-cell-research-cell-types-ban-research?_s=PM:US accessed November 9 2015.

  150. 150.

    Maggie Fox, ‘Appeals court hands Obama a stem cell victory’ National Journal, April 29, 2011 http://www.nationaljournal.com/healthcare/appeals-court-hands-obama-a-stem-cell-victory-20110429 accessed November 9 2015.

  151. 151.

    Supra note 149.

  152. 152.

    Arif Jamil, ‘Human stem cell research in Europe and the USA: post Brustle and Sherley, ethics issues and patent quagmire’ (2013) NTUT J. of Intell. Prop. L. & Mgmt 145.

  153. 153.

    Geoffrey P Lomax, Erik J Forsberg, Dan Gincel, Debra S Grega, Melissa J Lopes, Caroline J Marshall, Stefan Winkler and Warren Wollschlager, ‘policy harmonization through collaboration: The Interstate Alliance on Stem Cell Research’ (2010) World Stem Cell Report 100.

  154. 154.

    Owen C B Hughes, Alan L Jakimo and Michael J Malinowski, ‘United States regulation of stem cell research: recasting government’s role and questions to be resolved’ (2008) 37 Hofstra Law Review 383.

  155. 155.

    E.g., New Jersey, California, Illinois.

  156. 156.

    E.g., Arkansas, Virginia.

  157. 157.

    E.g., Oklahoma.

  158. 158.

    Proposition 71, California Stem Cell Research and Cures Initiative, http://www.assembly.ca.gov/acs/committee/c15/Publications/Stem%20Cell%20background.doc accessed September 11 2015.

  159. 159.

    Eileen Burgin, ‘embryonic stem cell research and Proposition 71’ (2010) 29 Politics and Life Science 73–78.

  160. 160.

    Klein used his huge wealth to underwrite Proposition 71’s campaign. Klein made tremendous effort on drafting and financing Proposition 71. See Elle Dolgin, ‘Stem cells: The impatient advocate’ (2010) 468 Nature 620.

  161. 161.

    Donna Gerardi Riordan, ‘Research funding via direct democracy: is it good for science?’ (2008) Issues in science and technology http://www.issues.org/24.4/p_riordan.html accessed November 1 2015.

  162. 162.

    ibid.

  163. 163.

    Proposition 71, California Stem Cell Research and Cures Initiative, Section 3, available from Senate Informational Hearing Background Paper, “Implementation of Proposition 71: Options for Handling Intellectual Property Associated with Stem Cell Research Grants,” http://www.assembly.ca.gov/acs/committee/c15/Publications/Stem%20Cell%20background.doc accessed November 7 2015.

  164. 164.

    ibid.

  165. 165.

    Supra note 160.

  166. 166.

    The California Institute for Regenerative Medicine, http://www.cirm.ca.gov/ accessed November 6 2015.

  167. 167.

    Supra note 161.

  168. 168.

    ibid.

  169. 169.

    ibid.

  170. 170.

    ibid.

  171. 171.

    ibid.

  172. 172.

    Jocelyn Kaiser, ‘CIRM Awards Seek to move cell therapies to the Clinic’ (2009) 326 Science 780.

  173. 173.

    ibid.

  174. 174.

    California stem cell project prevails: appellate court affirms constitutionality of proposition 71, February 27, 2007 http://www.cirm.ca.gov/PressRelease_022707b accessed November 9 2015.

  175. 175.

    Joyce E Cutler, ‘State supreme court rejects challenge clearing way for stem cell bond initiative’ Center for Genetics and Society, May 17 2007, http://www.geneticsandsociety.org/article.php?id=3834 accessed November 9 2015.

  176. 176.

    On November 2, 2004, California voters passed the California Stem Cell Research and Cures Bond Act of 2004.

  177. 177.

    Eileen Burgin, ‘Embryonic stem cell research and Proposition 71,’ (2010) 29 Politics and Life Science 73. (noting that Proposition 71 is the outcome of direct democracy that was supported by 59 % of voters.)

  178. 178.

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Jiang, L. (2016). Stem Cells, Patents and Policy in the US: Inefficiency. In: Regulating Human Embryonic Stem Cell in China. Springer, Singapore. https://doi.org/10.1007/978-981-10-2101-5_5

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