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研究生:丘耀華
研究生(外文):Hew, Yaohua
論文名稱:增進台灣國家衛生研究院授權活動成效之研究 -以美國國家衛生研究院授權活動為例
論文名稱(外文):Research to Increase Taiwan National Health Research Institutes Licensing Performance by Comparing The Licensing Practice of United States National Institutes of Health
指導教授:陳桂恒
指導教授(外文):Chan, Keith
學位類別:碩士
校院名稱:國立政治大學
系所名稱:科技管理與智慧財產研究所
學門:商業及管理學門
學類:其他商業及管理學類
論文種類:學術論文
畢業學年度:102
語文別:英文
論文頁數:126
中文關鍵詞:授權績效資訊公開法FOIANIHNHRI國家衛生研究院
外文關鍵詞:Licensing performanceFreedom of InformationNIHNHRIFOIA
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1980年,在美國拜杜法案(Bayh-Dole Act)通過以後,政府補助研發成果從原屬於國家財產,下放歸屬權於研發單位。因此研發單位可自行管理並將研發成果授權至產業界,將研發成果商品化,此過程稱之為「技術移轉」。技術移轉是一個非常細膩且複雜的過程,有許多因素會左右技術移轉的成敗,其中包括:技術之品質、法律限制、政策因素、產業需求和資訊流通等因素。技術移轉將可以使研發成果商品化, 有助於提升政府稅收和權利金收入,並且推動科學發展和增加就業機會,為國家創造經濟收入。

本研究旨探如何提升政府補助國立生醫研究單位-台灣國家衛生研究院(NHRI)之授權績效。本研究將採用美國國家衛生研究院(NIH)之授權績效和授權執行方式當參考指標。為了得到精準和可信的數據,本研究僅截取官方之年報和網站的資料。與此同時,本研究末將會提供如何提升授權績效之建議。

此研究發現就2010年而言,NIH和NHRI之授權績效可謂旗鼓相當。儘管台灣立法規定「政府資訊公開法」,此研究發現台灣國家衛生研究院有選擇性的發表其授權績效的跡象。由於政府所有開銷均從其預算而來,而政府預算部分自人民納稅所得,因此監督政府績效是普羅大眾的基本權利。人民有權監督,並且要求政府就其管理、執行成效做出解釋。然而,台灣國家衛生研究院之資訊不透明舉動,限制了人民監督的權利,此舉將會因缺乏監督而惡性循環的造成授權績效更為疲弱。此外,此研究亦發現較少的授權契約種類、授權策略在地化、研發成果披露之不明確性、智慧財產委員會專利申請和授權策略失衡是造成NHRI授權成果疲弱的因素。

Since the passage of U.S. Bayh-Dole Act in 1980, government-funded research inventions were no longer considered as government property. Invention could be patented and be licensed to industry through the process of commercialization for revenue return. Commercialization will create revenue in the form of royalty and taxes to the government, further driving scientific improvement and increase job opportunities.

Technology commercialization is a very delicate process and there are a lot of factors that might alter the success, including but not limited to i) the quality of invention, ii) legislation restriction, iii) policy incentives, iv) industry interest, v) availability of information and etc. If managed properly, technology commercialization could bring high value to the academic institutes that developed an invention, to government that financially support academic research and to general public that could benefit from the invention itself.

This study intends to identify the factors of the weak licensing performance in Taiwan government-funded national biomedical research organization, National Health Research Institute (NHRI). To evaluate the licensing performance of NHRI, this study will compare the licensing performance of NHRI with National Institute of Health (NIH) in the United States. To get accurate and formal data, this study will mainly retrieve data from official annual report and website. By comparing the practice of technology commercialization process of both institutes, this study could suggest possible flaws in NHRI’s licensing process in comparison to NIH. At the same time, this study will give suggestions to achieve a better licensing performance.

This study concluded that both institute performed equally in FY 2010, but it has been noticed that NHRI were selectively in disclosing its licensing performance statistics and it is difficult to retrieve general information from NHRI, despite the availability of Freedom of Government Information Law (Taiwan). It’s the basic right for the general public to be able to supervise and surveillance a government agency’s performance as it utilizes the taxes contributed by a citizen in a country. The limitation of information disclosure by NHRI has made it difficult for general public supervise its licensing performance, of which might further contribute to even weaker licensing performance due to lack of supervision. This research also concluded that few options of licensing contracts, localization in licensing strategy, confusion in technology disclosure, possible misalignment of patenting &; licensing strategy of the IP Management Committee contributes to weak licensing performance in the NHRI.

Acknowledgement i
English Abstract i
中文摘要 iii
Figure Index vi
Table Index vii
Chapter 1: Introduction 1
1.1 Background 1
1.2 Statement of Problem 3
1.3 Research Objective 5
1.4 Research Methods 6
1.5 Research Structure 7
1.6 Research Restriction 8
1.7 Abbreviated Terminologies 9
Chapter 2: Introduction to Intellectual Property Rights 10
2.1 Types of Intellectual Property Rights 10
2.1.1 Patents 11
2.2 Objective of Providing Patent Protection 13
2.2.2 PCT- Patent Cooperation Treaty 15
Chapter 3: Introduction to Technology Licensing 18
3.1 Background 18
3.2 Due Diligence 19
3.3 Technology Transfer: Licensing 22
3.4 The Process of Technology Licensing 23
3.5 US Legislation: Bayh-Dole Act 26
3.6 Taiwan Legislation: Fundamental Science and Technology Act 29
3.7 Locally Manufacture Clause 30
Chapter 4: Freedom to Information Law 36
4.1 Background 36
4.2 United States Freedom of Information Act (FOIA) 37
4.3 Taiwan Freedom of Government Information Law, 40
4.4 The Importance of Information Transparency to Technology Transfer 42
4.4.1 Information Transparency: From the Point of View of TTO 42
4.4.2 Information Transparency: From the Point of View of Technology Acquirer 43
Chapter 5: Government Funded Biotechnology Research 45
5.1 Background 45
5.2 United States Government Funded Public Research Institute: National Institutes of Health (NIH) 45
5.2.1 Executive Orders and Source of Funding 47
5.2.2 Organization and Structure 51
5.2.3 Intramural Research Program (IRP) 51
5.2.4 Overview of Licensing Process at NIH 53
5.2.4.1 Technology Protection (Patent Application) 54
5.2.4.2 Types of Licenses Available at NIH 55
5.2.4.3 Licensing Process 56
5.2.4.4 Post Licensing Performance Evaluation 58
5.2.5 Reputation and Licensing Performance 59
5.2.5.1 Reputation 59
5.2.5.2 Licensing Reputation 60
5.2.6 NIH OTT Effort to Increase Licensing Activity to Serve Global Public Health 64
5.3 Taiwan Government Funded Public Research Institute: National Health Research Institute (NHRI) 67
5.3.1 Background 67
5.3.2 Executive Orders and Source of Funding 68
5.3.3 Organization and Structure 69
5.3.4 Overview of Licensing Process at NHRI 72
5.3.4.1 Reputation and Licensing Performance 74
Chapter 6: Comparison of Licensing Performance 78
Chapter 7: Conclusion 84
Chapter 8: Discussions 86
8.1 Background 86
8.2 The Announcement of Licensing Opportunities and Licensee Selection 86
8.3 Scope and Types of Licenses 92
8.4 Notice for Available Technology and Time to License 92
8.5 Effort to Market of New Invention 93
8.6 Patenting &; Licensing Manager (NIH) vs. IP Management Committee (NHRI) 95
8.6.1 Decision Making of IP Management Committee 96
8.6.2 Evaluation Standard for Exclusive or Non-Exclusive Licensing 97
8.7 Accessibility of Information 98
8.7.1 Communication Language 98
8.7.2 Freedom to Access Information 99
8.8 Future Suggestions 105
Reference 107
參考資料 112
Appendix 115
Books:
Alasdair Roberts (2006), Blacked Out: Government Secrecy in the Information Age, Cambridge.

Sherman, B.; Bently, L. (1999). The making of modern intellectual property law: the British experience, 1760–1911. Cambridge University Press. p. 207. ISBN 9780521563635

Athan G. Theoharis (1998). A Culture of Secrecy: The Government Versus the People’s Right to Know. Kansas: University Press of Kansas.

Loise, V., Stevens A.J., (December 2010), The Bayh-Dole Act Turns 30, Les Nouvelles December 2010: 185-94.

Papers/Publications:
A Healthy Intramural Program (1988), Institute of Medicine.

Congressional Budget Office (October 2006), p.3, Research and Development in the Pharmaceutical Industry.

Dorsey, E.R., Roulet, J., Thompson J.P., et al., Funding of US Biomedical Research, 2003-2008 (January 13, 2010), Journal of the American Medical Association, vol. 303, no. 2, pp. 137-143.

Lemley, M.A., Rational Ignorance at the Patent Office (February 2001). Northwestern University Law Review, Vol. 95, No. 4, 2001.

Office of Technology Assessment (February 1993), p.201, Pharmaceutical R&;D: Costs, Risks and Rewards.

Henderson, R., Jaffe, A., Trajtenberg, M., (March, 1999), Universities as a source of commercial technology: A detailed analysis of university patenting, 1965-1988, NBER Working Paper, No. 5068.

United State General Account Office (1986), Patent Policy: Universities’ Research Efforts Under Public Law.

Internet Publications:
2013 Biopharmaceutical Research Industry Profile, p40, (July, 2013), Pharmaceutical Research and Manufacturers of America (PhRMA), Retrieved from http://phrma.org/sites/default/files/pdf/PhRMA%20Profile%202013.pdf

A Short History of the National Institute of Health (n.d.), National Institute of Health, Retrieved from http://history.nih.gov/exhibits/history/index.html

About the FOIA (n.d.), The United States Department of Justice, Retrieved from http://www.justice.gov/oip/about-foia.html

Annual Report FY 2008 (2008), NIH Office of Technology Transfer, Retrieved from http://www.ott.nih.gov/sites/default/files/documents/pdfs/AR2008.pdf

Annual Report FY 2009 (2009), NIH Office of Technology Transfer, Retrieved from http://www.ott.nih.gov/sites/default/files/documents/pdfs/AR2009.pdf

Annual Report FY 2010 (2010), NIH Office of Technology Transfer, Retrieved from http://www.ott.nih.gov/sites/default/files/documents/pdfs/AR2010.pdf

Annual Report FY 2011 (2011), NIH Office of Technology Transfer, Retrieved from http://www.ott.nih.gov/sites/default/files/documents/pdfs/AR2011.pdf

Annual Report FY 2012 (2012), NIH Office of Technology Transfer, Retrieved from http://www.ott.nih.gov/sites/default/files/documents/pdfs/AR2012.pdf

Association of University Technology Manager (2012). AUTM U.S. Licensing Activity Survey FY2012 Highlights. Retrieved from http://www.autm.net/AM/Template.cfm?Section=FY2012_Licensing_Activity_Survey&;Template=/CM/ContentDisplay.cfm&;ContentID=11435

Biomedical Research and Development Price Index (BRDPI): Fiscal Year 2012 Update and Projections for FY 2013-FY 2018 (January 2013), Department of Health and Human Services, Retrieved from

Budget Process Calendar (n.d.), National Institute of Health, Retrieved from http://officeofbudget.od.nih.gov/pdfs/FY14/Budget%20Process%20(Timeline%20Chart)-NEW1a.pdf

Countries Not Members of the Patent Cooperation Treaty (PCT) (October 9, 2012), Neustel Law Offices, Retrieved from http://www.patent-ideas.com/international-patents/countries-not-members-of-pct.aspx

Electronic Code of Federal Regulations (November, 2013), U.S. Government Printing Office, Retrieved from http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&;SID=b1b3f0363cc8f316c1f41b2628e8e005&;rgn=div8&;view=text&;node=37:1.0.4.13.1.0.218.14&;idno=37

Forms and Model Agreements (n.d.), NIH Office of Intramural Research &; Office of Technology Transfer, Retrieved from http://www.ott.nih.gov/forms-model-agreements#INTER

Freedom of Information Act – Memorandum for The Heads of Executive Departments and Agencies (n.d.), the WHITEHOUSE, Retrieved from http://www.whitehouse.gov/the_press_office/FreedomofInformationAct/

Government Transparency (n.d.), The United States Department of Justice, Retrieved from http://www.justice.gov/oip/government-transparency.html

Gross Domestic Product (GDP) Price Index (n.d.), NIH Office of Budget, Retrieved from http://officeofbudget.od.nih.gov/gbiPriceIndexes.html

HHS Lights Up The World (n.d.), National Institutes of Health Office of Technology Transfer, Retrieved from http://www.ott.nih.gov/service/hhs-lights-world
http://officeofbudget.od.nih.gov/pdfs/FY13/BRDPI/BRDPI_Proj_Jan_2013_Final.pdf

Indicators of Science and Technology (FY 2012) (n.d.), Taiwan National Science Council, Retrieved from https://nscnt12.nsc.gov.tw/WAS2/technology/AsTechnologyDataIndex.aspx

iPhone/iPad App (n.d.), National Institutes of Health Office of Technology Transfer, Retrieved from http://www.ott.nih.gov/service/iphoneipad-app

Justice Brandies, L.D., (n.d.), Brandies University, Retrieved from http://www.brandeis.edu/legacyfund/bio.html

Kelly Burke (12 Feb, 2013), Report Finds Average US Patent Cost US$ 374,000 In 2012, Intellectual Property Watch, Retrieved from http://www.ip-watch.org/2013/02/12/first-patent-value-quotient-report-shows-average-price-paid-for-issued-us-patents/?utm_source=post&;utm_medium=email&;utm_campaign=alerts

Licensing (n.d.), NIH Office for Technology Transfer, Retrieved from http://www.ott.nih.gov/licensing

Licensing and Patenting Managers, NIH Office of Technology Transfer, Retrieved from http://www.ott.nih.gov/staff-directory/lpms

Licensing FAQs (n.d.), NIH Office for Technology Transfer, Retrieved from http://www.ott.nih.gov/licensing-faqs

Licensing Process (n.d.), NIH Office for Technology Transfer, Retrieved from http://www.ott.nih.gov/licensing-process

Main Science and Technology Indicators (MSTI) 2012/1 (n.d.), Organization for Economic Co-operation and Development (OECD), Retrieved from http://www.oecd.org/sti/msti.htm

Measuring the Economic Impact of IP Systems (2007), World Intellectual Property Organization, Retrieved from http://www.wipo.int/portal/en/news/2007/article_0032.html

Mission (n.d.), National Institutes of Health, Retrieved from http://www.nih.gov/about/mission.htm

Mission (n.d.), NIH Technology Transfer and Incubation Center, Retrieved from http://english.nhri.org.tw/NHRI_WEB/nhriw001Action.do?status=Show_Data&;uid=20110617851073820000

NIH FY 2013 Budget (2013), Department of Health and Human Services National Institutes of Health, Retrieved from http://officeofbudget.od.nih.gov/pdfs/FY13/FY2013_Overview.pdf

NIH Intramural Research at the Threshold of a New Era (September 2009), NIH Office of Intramural Research. Retrieved from http://sourcebook.od.nih.gov/oir/IRP_transition.pdf

NIH Start-Up Exclusive License Agreements (n.d.), NIH Office of Intramural Research and Office of Technology Transfer, http://www.ott.nih.gov/nih-start-exclusive-license-agreements

Non-Profit License Agreement – Summary (n.d.), National Institutes of Health Office of Technology Transfer, Retrieved from http://www.ott.nih.gov/node/non-profit-license-agreement-summary

Oppedahl, C., (June 1999), Filing A PCT Application May Lead To A Faster, Cheaper US Patent, Oppedahl &; Olson LLP, Retrieved from http://www.oppedahl.com/pubs/pctfaster.htm

OTT Statistics (n.d.), NIH Office of Intramural Research and Office of Technology Transfer, Retrieved from http://www.ott.nih.gov/ott-statistics

Overview (n.d.), National Health Research Institute, Retrieved from http://english.nhri.org.tw/NHRI_WEB/nhriw001Action.do?status=Show_Data&;uid=20110617146947300000

Patents: Frequently Asked Questions (n.d.), World Intellectual Property Organization, Retrieved from http://www.wipo.int/patentscope/en/patents_faq.html#protection

PCT – The International Patent System (n.d.), WIPO, Retrieved from http://www.wipo.int/pct/en/

Peptide Inhibitor of p38 Mapk Signaling for the Treatment of Inflammatory Autoimmune Diseases and Inflammatory Cancers(October 2013), NIH Office of Technology Transfer, Retrieved from http://www.ott.nih.gov/technology/e-281-20120

Price Index for Gross Domestic Product (January, 2013), NIH Office of Budget, Retrieved from http://officeofbudget.od.nih.gov/pdfs/FY14/GDPINDEX_Values_for_2012_2023.pdf

Protecting Innovations by Utility Models (n.d.), WIPO, Retrieved from http://www.wipo.int/sme/en/ip_business/utility_models/utility_models.htm

Royalty (n.d.), National Institutes of Health Office of Technology Transfer, Retrieved from http://www.ott.nih.gov/royalty

Smith, P.W., The National Institutes of Health (NIH): Organization, Funding, and Congressional Issues (March 16, 2011), Congressional Research Service, Retrieved from www.crs.gov

The Federal Advisory Committee Act (n.d.), U.S. General Services Administration, Retrieved from http://www.gsa.gov/portal/content/100916

The Freedom of Information Act (1996), USDOJ, Retrieved from http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

The Knowledge Based Economy (1996), Organization of Economic Co-operation and Development, Retrieved from http://www.oecd.org/sti/sci-tech/1913021.pdf

What is the IRP? (n.d.), National Institute of Health Intramural Research Program, Retrieved from http://irp.nih.gov/about-us/what-is-the-irp

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WIPO Intellectual Property Handbook (n.d.), p.3, World Intellectual Property Organization, Retrieved from http://www.wipo.int/export/sites/www/about-ip/en/iprm/pdf/ch1.pdf

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Personal Communication:
Richard Rodriguez (Director, Division of Technology Development &; Transfer), rodrigr@mail.nih.gov, personal communication, Jan 2, 2014.

Richard Rodriguez (Director, Division of Technology Development &; Transfer), rodrigr@mail.nih.gov, personal communication, Jan 3, 2014.

Officer S, sxxx9@nhri.org.tw, personal communication, December 11, 2013

Cases:
Eli Lilly &; Co. v. Barr Laboratories Inc., 251 F.3d 955, 963, 58 USPQ2d 1865, 1874 (Fed. Cir. 2001)

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