簡易檢索 / 詳目顯示

回結果列表
研究生： 林傑森
Lin, Jason
論文名稱： Disease Gene Patents in the United States: Is the Allaying of Concerns Premature?
Disease Gene Patents in the United States: Is the Allaying of Concerns Premature?
指導教授： 陳俊仁
Chen, Jun-Ren
學位類別： 碩士
Master
系所名稱： 管理學院 - 國際經營管理研究所碩士班
Institute of International Management (IIMBA--Master)
論文出版年： 2009
畢業學年度： 97
語文別： 英文
論文頁數： 94
外文關鍵詞： Diagnostic Testing, Patent Coding, USPTO, Cook-Deegan Algorithm, Myriad Genetics, Gene Patents, BRCA, Disease Gene Patents
相關次數： 點閱：171  下載：2 
分享至:
查詢本校圖書館目錄 查詢臺灣博碩士論文知識加值系統 勘誤回報

    • Gene patents have long been controversial but whereas the discussion over gene patents is no longer as fervent as it was during the high-profile Myriad Genetics controversy, authors generally concur that serious problems still exist with disease gene patents. This study looks at disease gene patents granted in the previous two years and compares them to Myriad Genetics’ breast cancer gene patents. The study addresses the discussion over the concerns associated with Myriad Genetics’ patents, the shift in the general perception from one with generally apocalyptic undertones to one less dire, and the content of newly issued disease gene patents as they relate to the concerns and the current perception. The study employs a combination of quantitative and qualitative methodologies. Patents were identified using a modified Cook-Deegan search algorithm to identify patents on genes that have been implicated in hereditary disorders and were analyzed using a gene patent classification scheme developed by Verbeure, Matthijs, and Van Overwalle (2006). The study concludes that changes to patenting practices since the grant of Myriad’s BRCA patents have been minimal and that the old concerns are still relevant to newly granted patents. Managerial implications and future routes of study are also addressed.

    ACKNOWLEDGEMENTS I ABSTRACT II TABLE OF CONTENTS III LIST OF TABLES VI LIST OF FIGURES VII CHAPTER ONE INTRODUCTION 1 CHAPTER TWO LITERATURE REVIEW 5 2.1 Introduction to the Patent System in the United States. 5 2.1.1 General Patent Law. 5 2.1.2 Grants, Expirations, and Reexaminations of Patents. 7 2.1.3 Unpatentable Subject Matter. 8 2.2 Patenting in the Biosciences. 10 2.2.1 Opening of the Patent System to Genetics. 10 2.2.2 35 U.S.C.A. § 103(b). 11 2.2.3 Pharmaceutical and Biotechnology Industry Reliance on Patent Protection. 12 2.2.4 Concerns. 16 2.2.5 Extent of Human Gene Patenting. 18 2.2.6 Scope of Protection Granted by the USPTO. 20 2.2.7 Genes as Information. 22 2.3 Disease Gene Patents and the Healthcare Industry. 23 2.3.1 Impediment of Further Research and Development. 23 2.3.2 Negative Effects on the Cost of Care and the Standard of Care. 26 2.4 Sources of Funding for Research and Development. 28 2.5 Myriad and the Breast Cancer Genes. 30 2.5.1 Myriad’s Role in the Debate. 30 2.5.2 Myriad’s Patents. 30 2.5.3 Myriad and the Provincial Clinics in Canada. 32 2.5.4 Myriad and the National Health Service in Britain. 33 2.5.5 Myriad and the Opposition in the European Union 34 2.5.6 The True Severity of Myriad’s Actions. 34 CHAPTER THREE RESEARCH DESIGN AND METHODOLOGY 36 3.1 Decision to Use the DNA Patent Database. 37 3.2 Patent Search Strategy. 37 3.2.1 Development of the Algorithm. 38 3.2.2 The Algorithm Used for the Search on the DPD. 40 3.2.3 Differences in the Algorithms. 42 3.2.4 Identification of Genes to be Searched. 42 3.2.5 Identification of Disease Gene Patents. 45 3.3 Analysis of the Patents for Indications of Government Support. 45 3.4 Analysis of the Patents. 46 3.4.1 The Patent Sets. 47 3.4.2 The Classification Template. 48 CHAPTER FOUR RESEARCH RESULTS 50 4.1 Testing of the Search Algorithm. 50 4.2 The Set of Disease Gene Patents Identified. 51 4.3 Patents with Indications of Government Support. 58 4.4 Identification of Disease Gene Patents. 59 4.4.1 Search Term-related Notes. 59 4.4.2 Claims-related Notes. 61 4.5 Results of Coding. 64 4.5.1 Public Welfare. 70 4.5.2 Prior Art and Utility. 74 4.5.3 Scope of Protection. 78 CHAPTER FIVE CONCLUSION AND SUGGESTIONS 80 5.1 Summary. 80 5.2 Conclusions. 81 5.3 Contributions. 82 5.4 Managerial Implications. 82 5.5 Limitations. 84 5.6 Future Research. 85 REFERENCES 87

    35 United States Code Annotated §§ 1-42, 161, 101, 103, 311.
    ACLU. (2009). American Civil Liberties Union : ACLU Challenges Patents On Breast Cancer Genes. Retrieved June 2, 2009, from http://www.aclu.org/freespeech/gen/brca.html?72db4ed8
    Adler, J. E., Li, X., Staszewski, L., O'Connell, S., & Zozulya, S. (2007). United States of America Patent No. 7,241,880. www.uspto.gov: USPTO.
    Adler, J. E., Zozulya, S., Li, X., O'Connell, S., & Staszewski, L. (2007). United States of America Patent No. 7,244,835. www.uspto.gov: USPTO.
    Aggarwal, S., Gupta, V., & Bagchi-Sen, S. (2006). Insights into US public biotech sector using patenting trends. Nature Biotechnology, 24(6), 643-651.
    Aizenstein, B. D., Rasmussen, E. B., Hall, J. G., Agarwal, P., Arco, D., Atiles, M. W., et al. (2005). United States of America Patent No. 6,913,881. www.uspto.gov: USPTO.
    Andrews, L. (2002). Genes and patent policy: Rethinking intellectual property rights. Nature Reviews Genetics, 3(10), 803-808.
    Andrews, L., Paradise, J., Holbrook, T., & Bochneak, D. (2006). Science and law: When patents threaten science. Science, 314(5804), 1395-1396.
    AUTM. (2008). AUTM U.S. Licensing Activity Survey, FY2007 Survey Summary. from http://www.autm.net/AM/Template.cfm?Section=FY_2007_Licensing_Activity_Survey&Template=/CM/ContentDisplay.cfm&ContentID=2805
    Barany, F., Cao, W., Huang, J., & Lu, J. (2007). United States of America Patent No. 7,198,894. www.uspto.gov: USPTO.
    Barton, J. H., & Emanuel, E. J. (2005). The patents-based pharmaceutical development process rationale, problems, and potential reforms. JAMA, 294(16), 2075-2082.
    Bayh-Dole Act, 37 CFR 401.14(a)(f)(4) (1980).
    Bertina, R. M., & Reitsma, P. H. (2003). United States of America Patent No. 5,874,256. www.uspto.gov: USPTO.
    Campbell, E. G., Clarridge, B. R., Gokhale, M., & Birenbaum, L. (2002). Data withholding in academic genetics: Evidence from a national survey. JAMA, 287(4), 473-480.
    Carrino, J. J., Gerrue, L. O., & Diver, J. M. (2001). United States of America Patent No. 6,238,868. www.uspto.gov: USPTO.
    Caulfield, T. (2005). Policy conflicts: Gene patents and health care in Canada. Community Genetics, 8(4), 223-227.
    Caulfield, T., Bubela, T., & Murdoch, C. J. (2007). Myriad and the mass media: The covering of a gene patent controversy. Genetics in Medicine, 9(12), 850-855.
    Caulfield, T., Cook-Deegan, R. M., Kieff, F. S., & Walsh, J. P. (2006). Evidence and anecdotes: an analysis of human gene patenting controversies. Nat Biotechnol, 24(9), 1091-1094.
    Caulfield, T., Ogbogu, U., Murdoch, C., & Einsiedel, E. (2008). Patents, commercialization and the Canadian stem cell research community. Regenerative Medicine, 3(4), 483-496.
    Caulfield, T., & von Tigerstrom, B. (2006). Gene patents, health care policy and licensing schemes. Trends in Biotechnology, 24(6), 251-254.
    Center for Excellence in ELSI Research. (2007). DPD: Delphion Search Algorithm. Retrieved June 16, 2009, from http://dnapatents.georgetown.edu/SearchAlgorithm-Delphion-20030512.htm
    Center for Excellence in ELSI Research. (2009). DPD: About the DNA Patent Database. Retrieved June 17, 2009, from http://dnapatents.georgetown.edu/aboutdpd.htm
    Chee, M., Cronin, M. T., Fodor, S. P. A., Gingeras, T. R., Huang, X. C., Hubbell, E. A., et al. (2006). United States of America Patent No. 7,115,364. www.uspto.gov: USPTO.
    Cho, M. K., Illangasekare, S., Weaver, M. A., Leonard, D. G., & Merz, J. F. (2003). Effects of patents and licenses on the provision of clinical genetic testing services. The Journal of Molecular Diagnostics, 5(1), 3-8.
    Commission on Intellectual Property Rights. (2002). Integrating intellectual property rights and development policy: Report of the commission on intellectual property rights. London: Commission on Intellectual Property Rights.
    Cook-Deegan, R. (2007). The science commons in health research: Structure, function, and value. The Journal of Technology Transfer, 32(3), 133-156.
    Cook-Deegan, R., Chandrasekharan, S., & Angrist, M. (2009). The dangers of diagnostic monopolies. Nature, 458, 405-406.
    Crespi, R. S. (2005). Erythropoietin in the UK: A setback for gene patents? Nature Biotechnology, 23(3), 367-368.
    Deftos, L. J. (2001). Harvard v. Canada: The MYC mouse that still squeaks in the maze of biopatent law. Academic Medicine : Journal of the Association of American Medical Colleges, 76(7), 684-692.
    Demaine, L. J., & Fellmeth, A. X. (2002). Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent. Stanford Law Review, 55(2), 303-462.
    Diamond v. Chakrabarty, 447 US 303, 309 (1980)
    Dickinson, Q. T. (2001). Federal Register. Retrieved. from http://www.uspto.gov/web/offices/com/sol/notices/utilexmguide.pdf.
    Drayna, D., Kim, U.-K., & Leppert, M. (2008). United States of America Patent No. 7,314,725. www.uspto.gov: USPTO.
    Eisenberg, R. S. (2002). How can you patent genes? The American Journal of Bioethics, 2(3), 3-11.
    Eriksson, B. M. H., Collins, F. S., Gordon, L. B., & Brown, W. T. (2007). United States of America Patent No. 7,297,492. www.uspto.gov: USPTO.
    European Patent Convention, Art. 100
    Futreal, P. A., Coin, L., Marshall, M., Down, T., & Hubbard, T. (2004). A census of human cancer genes. Nature Reviews Cancer, 4(3), 177-183.
    Gelb, B. D., & Tartaglia, M. (2008). United States of America Patent No. 7,335,469. www.uspto.gov: USPTO.
    Giaccotto, C., Santerre, R. E., & Vernon, J. (2005). Drug prices and research and development investment behavior in the pharmaceutical industry. The Journal of Law and Economics, 48(1), 195-214.
    Gordon, J., & Rundell, C. A. (2003). United States of America Patent No. 6,607,911. www.uspto.gov: USPTO.
    Grabowski, H. (2002). Patents, innovation and access to new pharmaceuticals. Journal of International Economic Law, 5(4), 849-860.
    Grabowski, H., Vernon, J., & DiMasi, J. A. (2002). Returns on research and development for 1990s new drug introductions. Pharmacoeconomics, 20, 11-29.
    Hansen, S., Brewster, A., Asher, J., & Kisielewski, M. (2006). The Effects of Patenting in the AAAS Scientific Community. Retrieved. from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=2102738694022065425related:EW2nkLNtLh0J.
    Hashimoto, K., & Aida, T. (2008). Antibody patenting without antibodies: A global trend. Nature Biotechnology, 26(12), 1341-1343.
    Hassouna, H. I. (1996). United States of America Patent No. 5,525,477. www.uspto.gov: USPTO.
    Henry, M. R., Cho, M. K., Weaver, M. A., & Merz, J. F. (2002). Genetics: DNA patenting and licensing. Science, 297(5585), 1279.
    Holman, C. (2007a). Patent border wars: Defining the boundary between scientific discoveries and patentable inventions. Trends in Biotechnology, 25(12), 539-543.
    Holman, C. (2007b). The impact of human gene patents on innovation and access: A survey of human gene patent litigation. UMKC Law Review, 76(295-361), 295.
    Holman, C. (2008). Genetics: Trends in human gene patent litigation. Science, 322(5899), 198-199.
    Holtzman, N. A., & Merz, J. F. (2005). Introduction. Community Genetics, 8(4), 201-202.
    Hopkins, M. M., Mahdi, S., Patel, P., & Thomas, S. M. (2007). DNA patenting: The end of an era? Nature Biotechnology, 25(2), 185-187.
    Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11, 25 S.Ct. 358, 359-360 (1905)
    Jensen, K., & Murray, F. (2005). Intellectual Property: Enhanced: Intellectual property landscape of the human genome. Science, 310(5746), 239-240.
    Jones, J. G., Hennigan, A. N., Curran, J. A., Allen, S. K., Robichaud, N. J., Wang, J., et al. (2009). United States of America Patent No. 7,521,190. www.uspto.gov: USPTO.
    Kanwar, S., & Evenson, R. (2001). Does intellectual property protection spur technological change? Oxford Economic Papers, 55(2), 235-264.
    Kaye, J., Hawkins, N., & Taylor, J. (2007). Patents and translational research in genomics. Nature Biotechnology, 25(7), 739-741.
    Kesselheim, A. S. (2007). Intellectual property policy in the pharmaceutical sciences: The effect of inappropriate patents and market exclusivity extensions on the health care system. The AAPS Journal, 9(3), E306-311.
    Kesselheim, A. S., & Avorn, J. (2005). University-based science and biotechnology products defining the boundaries of intellectual property. JAMA, 293(7), 850-854.
    Klein, R. D. (2007). Gene patents and genetic testing in the United States. Nature Biotechnology, 25(9), 989-990.
    Klein, R. D., & Mahoney, M. J. (2008). LabCorp v. Metabolite Laboratories: The Supreme Court listens, but declines to speak. The Journal of Law, 36(1), 141-149.
    Kopchick, J. J., & Tiong, J. (2005). United States of America Patent No. 6,858,389. www.uspto.gov: USPTO.
    Kopchick, J. J., & Tiong, J. (2007). United States of America Patent No. 7,309,572. www.uspto.gov: USPTO.
    Kunkel, L. M., Monaco, A., Hoffman, E. P., & Koenig, M. (1996). United States of America Patent No. 5,541,074. www.uspto.gov: USPTO.
    Lei, Z., Juneja, R., & Wright, B. D. (2009). Patents versus patenting: Implications of intellectual property protection for biological research. Nature Biotechnology, 27(1), 36-40.
    LeMaistre, A., & Lee, M. S. (1992). United States of America Patent No. 5,137,806. www.uspto.gov: USPTO.
    Lipsky, R. H., Mazzanti, C., & Goldman, D. (2007). United States of America Patent No. 7,273,699. www.uspto.gov: USPTO.
    Lubinski, J., Suchy, J., Kurzawski, G., D bniak, T., & Cybulski, C. (2008). United States of America Patent No. 7,407,755. www.uspto.gov: USPTO.
    Madey v. Duke University, 307 F.3d 1351, 1361-62 (2002)
    Manual of Patent Examining Procedure (8th ed.). (2008). USPTO. Retrieved June 21, 2009, from http://www.uspto.gov/web/offices/pac/mpep/index.html
    Matthijs, G. (2006). The European opposition against the BRCA gene patents. Familial Cancer, 5(1), 95-102.
    Mazzoleni, R., & Nelson, R. R. (1998). The benefits and costs of strong patent protection: A contribution to the current debate. Research Policy, 27(3), 273-284.
    Meloso, D., Copic, J., & Bossaerts, P. (2009). Promoting intellectual discovery: Patents versus markets. Science, 323(5919), 1335.
    Merz, J. F. (1999). Disease gene patents: Overcoming unethical constraints on clinical laboratory medicine. Clinical Chemistry, 45(3), 324-330.
    Merz, J. F., & Cho, M. K. (2005). What are gene patents and why are people worried about them? Community Genetics, 8(4), 203-208.
    Merz, J. F., & Henry, M. R. (2004). The prevalence of patent interferences in gene technology. Nature Biotechnology, 22(2), 153-154.
    Merz, J. F., Kriss, A. G., Leonard, D. G., & Cho, M. K. (2002). Diagnostic testing fails the test. Nature, 415(6872), 577-579.
    Miao, X., Ireland, J., Hardenbol, P., Daly, T. M., Fu, D.-J., & Hockett, R. D. (2008). United States of America Patent No. 7,368,242. www.uspto.gov: USPTO.
    Mills, A. E., & Tereskerz, P. (2008). DNA-based patents: An empirical analysis. Nature Biotechnology, 26(9), 993-995.
    Morin, G. B. (2002). United States of America Patent No. 6,337,200. www.uspto.gov: USPTO.
    National Human Genome Research Institute. (2009a). genome.gov | About the Institute: A History and Timeline. Retrieved June 17, 2009, from http://www.genome.gov/10001763
    National Human Genome Research Institute. (2009b). genome.gov | Specific Genetic Disorders. Retrieved June 17, 2009, from http://www.genome.gov/10001204
    National Institutes of Health. (2003). Patents under the Bayh-Dole Act of 1980. Retrieved. from http://www.niddk.nih.gov/patient/patent.pdf.
    Nuffield Council on Bioethics. (2002). The Ethics of Patenting DNA: Nuffield Council on Bioethics.
    Nunnally, A., Webster, C., Brown, S., & Cohen, G. (2005). Genetic patent protection in the pharmaceutical and biotechnology industries. Community genetics, 8(4), 209-216.
    Online Mendelian Inheritance in Man. (n.d.). OMIM Home. Retrieved June 17, 2009, from http://www.ncbi.nlm.nih.gov/omim/
    Paradise, J. (2004). European opposition to exclusive control over predictive breast cancer testing and the Inherent Implications for United States patent law and public policy: A case study of the Myriad Genetics' BRCA patent controversy. Food & Drug Law Journal, 59(1), 133-154.
    Paradise, J., & Andrews, L. (2005). Gene patents: The need for bioethics scrutiny and legal change. Yale Journal of Health, 5, 1-9.
    Paradise, J., Andrews, L., & Holbrook, T. (2005). Intellectual property: Patents on human genes: An analysis of scope and claims. Science, 307(5715), 1566-1567.
    Paradise, J., & Janson, C. (2006). Decoding the research exemption. Nature Reviews Genetics, 7(2), 148-154.
    Parthasarathy, S. (2005). The patent is political: The consequences of patenting the BRCA genes in Britain. Community Genetics, 8(4), 235-242.
    Patent Reform Act of 2009 (2009). S. 515/S. 610/H.R. 1260, 111 Cong.
    Pressman, L., Burgess, R., Cook-Deegan, R. M., McCormack, S. J., Nami-Wolk, I., Soucy, M., et al. (2006). The licensing of DNA patents by US academic institutions: An empirical survey. Nature Biotechnology, 24(1), 31-39.
    Prockop, D., Colige, A., Baserga, R., & Nugent, P. (1999). United States of America Patent No. 5,861,502. www.uspto.gov: USPTO.
    Ranade, K., Vishnupad, P. S., & Delmonte, T. A. (2008). United States of America Patent No. 7,329,490. www.uspto.gov: USPTO.
    Reed, R. R., Yau, K.-W., & Krautwurst, D. (2008). United States of America Patent No. 7,351,814. www.uspto.gov: U. S. P. a. T. Office.
    Resnik, D. B. (2003). Are DNA patents bad for medicine? Health Policy (Amsterdam, Netherlands), 65(2), 181-197.
    Rolla, J. J., Paradise, J., Andrews, L., & Holbrook, T. (2005). Problems in patenting human genes. Science, 308(5730), 1868-1870.
    Shattuck-Eidens, D. M., Simard, J., Durocher, F., Emi, M., & Nakamura, Y. (1997). United States of America Patent No. 5,693,473. www.uspto.gov: USPTO.
    Shattuck-Eidens, D. M., Simard, J., Durocher, F., Emi, M., & Nakamura, Y. (1998). United States of America Patent No. 5,709,999. www.uspto.gov: USPTO.
    Shuber, A. P., & Lapidus, S. N. (2003). United States of America Patent No. 6,566,101. www.uspto.org: USPTO.
    Skolnick, M. H., Goldgar, D. E., Miki, Y., Swenson, J., Kamb, A., Harshman, K. D., et al. (1998). United States of America Patent No. 5,710,001. www.uspto.gov: USPTO.
    Smith, J. B. (1998). United States of America Patent No. 5,750,339. www.uspto.org: USPTO.
    Soini, S., Ayme, S., & Matthijs, G. (2008). Patenting and licensing in genetic testing: Ethical, legal and social issues. European Journal of Human Genetics, 16(S1), S10-S50.
    Somlo, S., & Mochizuki, T. (2007). United States of America Patent No. 7,294,465. www.uspto.gov: USPTO.
    Sommer, S. S., Feng, J., Buzin, C., Yan, J., & Towbin, J. (2008). United States of America Patent No. 7,449,561. www.uspto.gov: USPTO.
    Tavtigian, S. V., Kamb, A., Simard, J., Couch, F., Rommens, J. M., & Weber, B. L. (1998). United States of America Patent No. 5,837,492. www.uspto.gov: USPTO.
    Teem, J. L. (2002). United States of America Patent No. 6,468,793. www.uspto.gov: USPTO.
    Toole, A. A. (2007). Does public scientific research complement private investment in research and development in the pharmaceutical industry? The Journal of Law and Economics, 50(1), 81-104.
    U.S. Constitution, Preamble, Art. I, § 8, cl. 8
    USPTO. (2009). Patent Classification Home Page - Internet. Retrieved June 17, 2009, from http://www.uspto.gov/go/classification/index.htm
    Van Ness, J., Tabone, J. C., Howbert, J. J., & Mulligan, J. T. (2001). United States of America Patent No. 6,312,893. www.uspto.gov: USPTO.
    Verbeure, B., Matthijs, G., & Van Overwalle, G. (2006). Analysing DNA patents in relation with diagnostic genetic testing. European Journal of Human Genetics, 14(1), 26-33.
    Wallace, R. B. (1988). United States of America Patent No. 4,767,700. www.uspto.gov: USPTO.
    Walsh, J. P., Cho, C., & Cohen, W. M. (2005). Science and law: View from the bench: Patents and material transfers. Science, 309(5743), 2002-2003.
    Williams-Jones, B. (2002). History of a gene patent: Tracing the development and application of commercial BRCA testing. Health Law Journal, 10, 123-146.
    Williams-Jones, B., & Burgess, M. M. (2006). Democratising access to genetic services. Familial Cancer, 5(1), 117-121.
    Wong, A. K. C., Bartel, P. L., Teng, D. H.-F., & Tavtigian, S. V. (2000). United States of America Patent No. 6,030,832. www.uspto.gov: USPTO.
    Wright, D. J., Milla, M. A., Nadeau, J. G., & Walker, G. T. (2007). United States of America Patent No. 7,223,536. www.uspto.gov: USPTO.

    下載圖示 校內：立即公開
    校外：2009-07-27公開
    QR CODE