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題名 論美國之生醫科技研究工具之專利保護與授權
Research tool patent protection and licensing for biomedical innovations in united states作者 蔡鴻文 貢獻者 沈宗倫
蔡鴻文關鍵詞 研究工具
安全港條款
試驗免責
延展性授權契約
延展性保護範圍
書面描述要件
Research tools
Safe harbor
Test exemption
Reach-through royalties
Reach-through claim
Written description日期 2009 上傳時間 3-九月-2013 17:03:47 (UTC+8) 摘要 論文內容著重在以下三個重點: 試驗免責、延展性授權與延展性專利範圍、書面描述要件。首先是35 U.S.C. § 271(e)(1)之Safe Harbor 緣由、案例、Integra v. Merck 一案之過程與後續影響以及271(e)(1)的試驗免責與研究工具的關係, 最後提出建議應限縮試驗免責範圍, 以強制授權或是明定專利法中的試驗免責範圍緩和基礎研究專利範圍過大現象(第二、三章)。 研究工具專利開發者多所採用之延展性授權與延展性專利範圍無非是想多獲得利益, 而研究工具專利對於生物科技發展是相當重要的, 第四章先以四方角色(大藥廠、大學與非營利機構、小藥廠與政府單位)討論研究工具對於本身的利益考量, 並且因試驗免責範圍不明, 延展性授權契約已是普遍存在, 詳細地討論其存在的意義, 並且分析已探討延展性授權金/契約議題文章, 另外對於延展性專利保護範圍, 明確指出哪一些核准專利是延展性保護範圍, 雖然2001年的三方會議已經明確地限制此類專利的核准, 由於Rochester v. G.D. Searle一案, 法院認為Rochester 專利包含延展性保護範圍, 歸因於未揭露出清楚的書面描述要件, 於是進行第五章書面描述要件的討論。 進而較詳細地探討生物機轉的途徑特性、功能性敘述必要性以及書面描述上的困難, 然後進行相關案件探討, 提出自己對於專利文件之書面描述要件的看法, 希望能在生物類研究工具專利保護範圍與書面描述要件中取平衡, 適切地保護研究工具發明。最後並提出總結與建議。
Over the last twenty years, the biotechnology industry has grown very rapidly, and increased our understanding of incurable diseases. Research tools are playing important role to form the core of the pharmaceutical research, development, and testing. Because this industry is so research tool intensive, numerous problems have arisen stemming from the competing interests of the many players in this field. From the legislative history, the Hatch-Waxman Act embodies the legislative compromise balancing the competing interests of the pioneer pharmaceutical and allied research-based products industries with those of the generic drug industry. And the section 35 U.S.C. § 271(e)(1) statute provides a “safe harbor” from patent infringement based on activities that are reasonably related to obtaining FDA regulatory approval of drug products, but the plain language is fairly ambiguous. In Eli Lilly v. Medtronic, Supreme Court held the safe harbor extends to medical devices, despite the fact that § 271(e)(1) does not refer specifically to medical devices. Recently, for the case of Merck v. Integra, Federal Circuit announced that the term “solely” limits the safe harbor exemption from extending beyond uses of patented inventions that are reasonably related to those specified in § 271(e)(1). But Supreme Court rejected and held that § 271(e)(1) applies to uses of patented inventions that are reasonably related to the development and submission of any information to the FDA. The Court was silent on the potential applications and opened the questions of the safe harbor`s application to patented research tools. These problems may be the reason that research tool providers attempt to request royalties such as reach-through royalties for covering the downstream compounds or products. They also try to file the patent application with the reach-through claim for claiming a future invention. However, the use of reach-through royalties is still controversial and causing a decrease in innovation. Patentees attempt to obtain reach-through claims for covering a future invention without actually describing in the written description. The Federal Circuit`s holding in Rochester v. G.D. Searle that the Rochester`s patents failed the written description requirement, and Rochester should curtail the use of reach-through claims. So far the USPTO has not been uniform in its application of written description requirement. We therefore propose a new test to determine whether, and under which circumstances, functional claiming may satisfy the written description requirement. One should not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification. The approach would provide sufficient incentive for pioneering inventions, preserve room for the future, and thus expect to promote progress and to advance the purposes of patent law.參考文獻 Paper:1.Arti K. Rai & Rebecca S. Eisenberg, Bayh-Dole Reform and the Progress of Biomedicine, 66 LAW AND CONTEMPORARY PROBLEMS 289 (2003).2.Arti K. Rai, Regulating Scientific Research: Intellectual Property Rights and the Norms of Science, 94 NORTHWESTERN UNIVERSITY LAW REVIEW 77 (1999).3.Bharat B. Aggarwal, Aladin M. Boriek, Ashok Kumar & Yasunari Takada, Nuclear Factor-: Its Role in Health and Disease, 82 JOURNAL OF MOLECULAR MEDICINE 434 (2003).4.Charles Raubicheck, Integra v. Merck: A Mixed Bag for Research Tool Patents, 21 NATURE 1099 (2003).5.Dan L. Burk & Mark A. Lemley, Biotechnology`s Uncertainty Principle, 54 CASE WESTERN RESERVE LAW REVIEW 691 (2004).6.David C. Hoffman, A Modest Proposal: Toward Improved Access to Biotechnology Research Tools by Implementing a Broad Experimental Use Exception, 89 CORNELL LAW REVIEW 993 (2004).7.David E. Adelman, A Fallacy of the Commons in Biotech Patent Policy, 20 BERKELEY TECHNOLOGY LAW JOURNAL 985 (2005).8.David L. Parker, Patent Infringement Exemptions for Life Science Research, 16 HOUSTON JOURNAL OF INTERNATIONAL LAW 615 (1994).9.Desmond Mascarenhas, Negotiating the Maze of Biotech "Tool Patents", 16 NATURE BIOTECHNOLOGY 1371 (1998).10.Donald R. Ware, Research Tool Patents: Judicial Remedies, 38 AIPLA QUARTERLY JOURNAL 267 (2002).11.Elizabeth Stotland Weiswasser & Scott D. Danzis, The Hatch-Waxman Act: History, Structure, and Legacy, 71 ANTITRUST LAW JOURNAL 585 (2003).12.Eric K. Steffe & Timothy J. Shea, Jr., Drug Discovery Tools and the Clinical Research Exemption from Patent Infringement, 22 BIOTECHNOLOGY LAW REPORT 369 (2003).13.George Fox, Note, Integra v. Merck: Limiting the Scope of the § 271(e)(1) Exception to Patent Infringement, 19 BERKELEY TECHNOLOGY LAW JOURNAL 193 (2004).14.Gerald J. Flattmann & Jonathon M. Kaplan, Licensing Research Tool Patents, 20 NATURE BIOTECHNOLOGY 945 (2002).15.Guang Ming Whitley, A Patent Doctrine without Bounds: The “Extended” Written Description Requirement, 71 UNIVERSITY OF CHICAGO LAW REVIEW 617 (2004).16.Heather Hamme Ramirez, Comment, Defending The Privatization of Research Tools: An Examination of the “Tragedy of the Anticommons” in Biotechnology Research and Development, 53 EMORY LAW JOURNAL 359 (2004).17.Henry Grabowski & John Vernon, Longer Patents for Increased Generic Competition in the US: The Waxman-Hatch Act After One Decade, 10 PHARMACOECONOMICS, 110 (Supp. 2 1996).18.Hideaki Kamata, Michael Karin & Jun-Li Luo, IKK/ NF-kB Signaling: Balancing Life and Death—A New Approach to Cancer Therapy, 115 THE JOURNAL OF CLINICAL INVESTIGATION 2625 (2005).19.Jaclyn L. Miller, Drug Price Competition and Patent Term Restoration Act: The Elimination of Competition Between Drug Manufacturers, 5 DEPAUL JOURNAL OF HEALTH CARE LAW 91 (2002).20.Janice M. Mueller, No "Dilettante Affair": Rethinking the Experimental Use Exception to Patent Infringement for Biomedical Research Tools, 76 WASHINGTON LAW REVIEW 1 (2001).21.Jennifer A. Johnson, The Experimental Use Exception in Japan. A Model for US. Patent Law?, 12 PACIFIC RIM LAW & POLICY JOURNAL 499 (2003).22.Jian Xiao, Carving Out a Biotechnology Research Tool Exception to the Safe Harbor Provision of 35 U.S.C. § 271(e)(1), 12 TEXAS INTELLECTUAL PROPERTY LAW JOURNAL 23 (2003).23.Jill Wechsler, Pharmaceutical Pricing and Innovation Key Issues for 2003, PHARMACEUTICAL TECHNOLOGY (2003).24.John J. Doll, Biotechnology: The Patenting of DNA, 280 SCIENCE 689 (1998).25.John M. Golden, Biotechnology, Technology Policy, and Patentability: Natural Products and Invention in the American System, 50 EMORY LAW JOURNAL 101, 175 (2001).26.Katherine J. Strandburg, What Does the Public Get? Experimental Use and the Patent Bargain, 2004 WISCONSIN LAW REVIEW 81 (2004).27.Kunin et al., Reach-Through Claims in the Age of Biotechnology, 51 AMERICAN UNIVERSITY LAW. REVIEW 609 (2002).28.Kurt M. Saunders, Patent Nonuse and the Role of Public Interest as a Deterrent to Technology Suppression, 15 HARVARD JOURNAL OF LAW & TECHNOLOGY 389 (2002).29.Larissa Burford, In Re Cardizem & Valley Drug Co.: The Hatch-Waxman Act, Anticompetitive Actions, and Regulatory Reform, 19 BERKELEY TECHNOLOGY LAW JOURNAL 365 (2004).30.Laura Giles, Promoting Generic Drug Availability: Reforming the Hatch-Waxman Act to Prevent Unnecessary Delays to Consumers, 75 ST. JOHN`S LAW REVIEW 357 (2001).31.Laurie L. Hill, The Race to Patent the Genome: Free Riders, Hold Ups, and the Future of Medical Breakthroughs, 11 TEXAS INTELLECTUAL PROPERTY LAW JOURNAL 221 (2003).32.Laurie L. Hill, The Race to Patent the Genome: Free Riders, Hold Ups, and the Future of Medical Breakthroughs, 11 TEXAS INTELLECTUAL PROPERTY LAW JOURNAL 221 (2003).33.Mandy Wilson, Pharmaceutical Patent Protection: More Generic Favored Legislation May Cause Pioneer Drug Companies to Pull the Plug on Innovation, 90 KENTUCKY LAW JOURNAL 495 (2001).34.Marzia Bianchi, Rita Crinelli, Lucia Gentilini & Mauro Magnai, Design and Characterization of Decoy Oligonucleotides Containing Locked Nucleic Acids, 20 NUCLEIC ACIDS RESEARCH 2435 (2002).35.Maureen A. O`Rourke, Toward a Doctrine of Fair Use in Patent Law, 100 COLUMBIA LAW REVIEW 1177 (2000).36.Michael E. Burczynski et al., Clinical Pharmacogenomics and Transcriptional Profiling in Early Phase Oncology Clinical Trials, 5 CURRENT MOLECULAR MEDICINE 83 (2005).37.Michael J. Malinowski & Maureen A. O`Rourke, A False Start? The Impact of Federal Policy on the Genotechnology Industry, 13 YALE JOURNAL ON REGULATION 162 (1996).38.Michael Karin, Nuclear factor- in Cancer Development and Progression, 44 NATURE 431 (2006).39.Michelle Cai, Madey v. Duke Univ.: Shattering the Myth of Universities` Experimental Use Defense, 19 BERKELEY TECHNOLOGY LAW JOURNAL 175 (2004).40.Natalie M. Derzko, In Search of a Compromised Solution to the Problem Arising from Patenting Biomedical Research Tools, 20 SANTA CLARA COMPUTER & HIGH TECHNOLOGY LAW JOURNAL 347 (2004).41.Nicholas Groombridge and Sheryl Calabro, Integra Lifesciences v. Merck — Good for Research or Just Good for Research Tool Patent Owners?, 22 BIOTECHNOLOGY LAW REPORT 462 (2003).42.Paul Fehlner, Not Such a Safe Harbor After All, 10 No. 6 ANDREWS INTELLECTUAL PROPERTY LITIGATION REPORTER 18 (2003).43.Paul N. Moynagh, The NF-kB Pathway, 118 J. CELL SCIENCE 4589 (2005).44.Paula K. Davis, Questioning the Requirement for Written Description: Enzo Biochem v. Gen-Probe and Overly Broad Patent Cases, 37 INDIANA LAW REVIEW 467 (2004).45.Qiutang Li & Inder M. Verma, NF-kB Regulation in the Immune System, 2 NATURE REVIEWS IMMUNOLOGY 725 (2002).46.Raymond Wadlow & Syidhar Ramaswamy, DNA Microarrays in Clinical Cancer Research, 5 CURRENT MOLECULAR MEDICINE 111 (2005).47.Rebecca S. Eisenberg, Patents and the Progress of Science: Exclusive Rights and Experimental Use, 56 UNIVERSITY OF CHICAGO LAW REVIEW 1017 (1989).48.Rebecca S. Eisenberg, Reaching Through the Genome, Science and Cents: Exploring the Economics of Biotechnology Proceedings of a 2002 Conference (2004).49.Regina M. Rotting, Timothy Hla, & Daniel L. Simmons, Cyclooxygenase Isozymes: The Biology of Prostaglandin Synthesis and Inhibition, 56 PHARMACOLOGICAL REVIEWS 387 (2004).50.Richard J. Warburg et al., Patentability and Maximum Protection of Intellectual Property in Proteomics and Genomics, 22 BIOTECHNOLOGY LAW REPORT 264 (2003).51.Robin Feldman, The Inventor`s Contribution, 2005 UCLA JOURNAL OF LAW & TECHNOLOGY 6 (2005).52.Rochelle Dreyfuss, Protecting the Public Domain of Science: Has the Time for an Experimental Use Defense Arrived?, 46 ARIZONA LAW REVIEW 457 (2004).53.Sarah E. Eurek, Comment, Hatch-Waxman Reform and Accelerated Market Entry of Generic Drugs: Is faster Necessarily Better?, 2003 DUCK LAW AND TECHNOLOGY REVIEW 18 (2003).54.Stephen J. Burdick, Moba v. Diamond Automation, Inc.: Questioning the Separate Written Description Requirement, 19 BERKELEY TECHNOLOGY LAW JOURNAL 133 (2004).55.Thomas J. Kowalski & Christian M. Smolizza, Reach-through Licensing: A US Perspective, 6 JOURNAL OF COMMERCIAL BIOTECHNOLOGY 349 (2000).56.Wenrong Huang, Enzo`s Written Description Requirement: Can It an Effective Check Against Overly Broad Biotechnology Claims?, 16 ALBANY LAW JOURNAL OF SCIENCE AND TECHNOLOGY 1 (2006).57.Wen-Yin Chen, To Study the Impacts of Basic Science on the Biotechnology from the U.S. Practical Experiences, 67 TAIPEI UNIVERSITY LAW REVIEW 115 (2008).58.Yixue Cao, Michael Karin, Florian R. Greten & Zhi-Wei Li, NF-kB in Cancer: From Innocent Bystander to Major Culprit, 2 NATURE REVIEWS CANCER 301 (2002). 描述 碩士
國立政治大學
法律科際整合研究所
93652004
98資料來源 http://thesis.lib.nccu.edu.tw/record/#G0093652004 資料類型 thesis dc.contributor.advisor 沈宗倫 zh_TW dc.contributor.author (作者) 蔡鴻文 zh_TW dc.creator (作者) 蔡鴻文 zh_TW dc.date (日期) 2009 en_US dc.date.accessioned 3-九月-2013 17:03:47 (UTC+8) - dc.date.available 3-九月-2013 17:03:47 (UTC+8) - dc.date.issued (上傳時間) 3-九月-2013 17:03:47 (UTC+8) - dc.identifier (其他 識別碼) G0093652004 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/59902 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 法律科際整合研究所 zh_TW dc.description (描述) 93652004 zh_TW dc.description (描述) 98 zh_TW dc.description.abstract (摘要) 論文內容著重在以下三個重點: 試驗免責、延展性授權與延展性專利範圍、書面描述要件。首先是35 U.S.C. § 271(e)(1)之Safe Harbor 緣由、案例、Integra v. Merck 一案之過程與後續影響以及271(e)(1)的試驗免責與研究工具的關係, 最後提出建議應限縮試驗免責範圍, 以強制授權或是明定專利法中的試驗免責範圍緩和基礎研究專利範圍過大現象(第二、三章)。 研究工具專利開發者多所採用之延展性授權與延展性專利範圍無非是想多獲得利益, 而研究工具專利對於生物科技發展是相當重要的, 第四章先以四方角色(大藥廠、大學與非營利機構、小藥廠與政府單位)討論研究工具對於本身的利益考量, 並且因試驗免責範圍不明, 延展性授權契約已是普遍存在, 詳細地討論其存在的意義, 並且分析已探討延展性授權金/契約議題文章, 另外對於延展性專利保護範圍, 明確指出哪一些核准專利是延展性保護範圍, 雖然2001年的三方會議已經明確地限制此類專利的核准, 由於Rochester v. G.D. Searle一案, 法院認為Rochester 專利包含延展性保護範圍, 歸因於未揭露出清楚的書面描述要件, 於是進行第五章書面描述要件的討論。 進而較詳細地探討生物機轉的途徑特性、功能性敘述必要性以及書面描述上的困難, 然後進行相關案件探討, 提出自己對於專利文件之書面描述要件的看法, 希望能在生物類研究工具專利保護範圍與書面描述要件中取平衡, 適切地保護研究工具發明。最後並提出總結與建議。 zh_TW dc.description.abstract (摘要) Over the last twenty years, the biotechnology industry has grown very rapidly, and increased our understanding of incurable diseases. Research tools are playing important role to form the core of the pharmaceutical research, development, and testing. Because this industry is so research tool intensive, numerous problems have arisen stemming from the competing interests of the many players in this field. From the legislative history, the Hatch-Waxman Act embodies the legislative compromise balancing the competing interests of the pioneer pharmaceutical and allied research-based products industries with those of the generic drug industry. And the section 35 U.S.C. § 271(e)(1) statute provides a “safe harbor” from patent infringement based on activities that are reasonably related to obtaining FDA regulatory approval of drug products, but the plain language is fairly ambiguous. In Eli Lilly v. Medtronic, Supreme Court held the safe harbor extends to medical devices, despite the fact that § 271(e)(1) does not refer specifically to medical devices. Recently, for the case of Merck v. Integra, Federal Circuit announced that the term “solely” limits the safe harbor exemption from extending beyond uses of patented inventions that are reasonably related to those specified in § 271(e)(1). But Supreme Court rejected and held that § 271(e)(1) applies to uses of patented inventions that are reasonably related to the development and submission of any information to the FDA. The Court was silent on the potential applications and opened the questions of the safe harbor`s application to patented research tools. These problems may be the reason that research tool providers attempt to request royalties such as reach-through royalties for covering the downstream compounds or products. They also try to file the patent application with the reach-through claim for claiming a future invention. However, the use of reach-through royalties is still controversial and causing a decrease in innovation. Patentees attempt to obtain reach-through claims for covering a future invention without actually describing in the written description. The Federal Circuit`s holding in Rochester v. G.D. Searle that the Rochester`s patents failed the written description requirement, and Rochester should curtail the use of reach-through claims. So far the USPTO has not been uniform in its application of written description requirement. We therefore propose a new test to determine whether, and under which circumstances, functional claiming may satisfy the written description requirement. One should not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification. The approach would provide sufficient incentive for pioneering inventions, preserve room for the future, and thus expect to promote progress and to advance the purposes of patent law. en_US dc.description.tableofcontents I. Introduction 4II. Overview of the Research Tools 9A. The Concepts of Research Tools 9B. The Types of Research Tools and the Marketing Strategy 10C. Concerns and Problems on Research Tools 12III. Legislative Problems of § 271(e)(1) for Research Tool Patents 14A. Introduction of Safe Harbor of § 271(e)(1) 151. The Status of Pharmaceutical Industrials before Hatch-Waxman Act. 152. The Competition of Drug Price and Patent Term Restoration Act 17B. Judicial Interpretations 181. Eli Lilly & Co. v. Medtronic, Inc. 192. Intermedics, Inc. v. Ventritex, Inc. 203. AbTox, Inc. v. Exitron Corp. 204. Infigen, Inc. v. Advanced Cell Technology, Inc. 21C. Integra Lifesciences I, Ltd. v. Merck KGaA 211. Progress of Integra Lifesciences I, Ltd. v. Merck KGaA 222. Analysis of Disputed Patent Claims in Integra v. Merck and Rader’s Opinions 27D. Research Exemption versus the Safe Harbor 31E. Scope of § 271(e) (1) with Respect to Research Tool Patent 321. Legislative Considerations Under § 271(e) (1) 332. Reasonably Related and Patented Invention of the Interpre. of § 271(e) (1) 343. The Arguments of Public Policy, de minimis Interference, Legislative Intent and Plain Language 39F. Legislative Proposals for Safe Harbor 461. Limiting the Research Exemption 462. Adopting the Fair Use for Patent Law 473. Applying the Compulsory Licensing 484. Expanding the Research Exemption for Non-commercial Use 49G. Outlook and Compromised Solutions of Research Tools 491. Positive Effects for Research Tools 502. Negative Effects for Research Tools 51IV. Reach-Through Royalties and Claims of Research Tools 53A. The Competing Interests of Various Users 551. For Large Pharmaceutical Companies 552. For Universities and Other Non profits 563. For Small and Start-up Biotechnology Firms 574. For Government Interests 59B. Reach-Through Royalties 601. Trends in the Use of Reach-Through Royalty Provisions 602. Reach-Through Royalties 613. Reach-through Licensing Provisions for Small Biotechnology Firms 63C. Reach-Through Claims 661. The Explanation of Reach-Through Claims 672. Trilateral Project B3b and the Univ. of Rochester v. G.D. Searle Case 68V. Written Description Requirements 71A. The Nature of Biological Pathway 731. Biological Pathways in General and the NF- Pathway 732. The NF- Patent 74B. Case Study for Written Description Requirement 771. Regents of Univ. of Cal. v. Eli Lilly & Co. 772. Enzo Biochem, Inc. v. Gen-Probe Inc. 783. Univ. of Rochester v. G.D. Searle & Co. 80C. Proposal: Appropriate Protecting Biomedical Inventions 811. Referring the Opinions from Scholars 812. Adopting the Common Feature Test 823. Disclosing the Functional Claims 834. Biological Patent Application Practices 845. The Common Feature Test Practices 87V. Conclusions 88Reference 90 zh_TW dc.format.extent 648187 bytes - dc.format.mimetype application/pdf - dc.language.iso en_US - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0093652004 en_US dc.subject (關鍵詞) 研究工具 zh_TW dc.subject (關鍵詞) 安全港條款 zh_TW dc.subject (關鍵詞) 試驗免責 zh_TW dc.subject (關鍵詞) 延展性授權契約 zh_TW dc.subject (關鍵詞) 延展性保護範圍 zh_TW dc.subject (關鍵詞) 書面描述要件 zh_TW dc.subject (關鍵詞) Research tools en_US dc.subject (關鍵詞) Safe harbor en_US dc.subject (關鍵詞) Test exemption en_US dc.subject (關鍵詞) Reach-through royalties en_US dc.subject (關鍵詞) Reach-through claim en_US dc.subject (關鍵詞) Written description en_US dc.title (題名) 論美國之生醫科技研究工具之專利保護與授權 zh_TW dc.title (題名) Research tool patent protection and licensing for biomedical innovations in united states en_US dc.type (資料類型) thesis en dc.relation.reference (參考文獻) Paper:1.Arti K. Rai & Rebecca S. Eisenberg, Bayh-Dole Reform and the Progress of Biomedicine, 66 LAW AND CONTEMPORARY PROBLEMS 289 (2003).2.Arti K. Rai, Regulating Scientific Research: Intellectual Property Rights and the Norms of Science, 94 NORTHWESTERN UNIVERSITY LAW REVIEW 77 (1999).3.Bharat B. Aggarwal, Aladin M. Boriek, Ashok Kumar & Yasunari Takada, Nuclear Factor-: Its Role in Health and Disease, 82 JOURNAL OF MOLECULAR MEDICINE 434 (2003).4.Charles Raubicheck, Integra v. Merck: A Mixed Bag for Research Tool Patents, 21 NATURE 1099 (2003).5.Dan L. Burk & Mark A. Lemley, Biotechnology`s Uncertainty Principle, 54 CASE WESTERN RESERVE LAW REVIEW 691 (2004).6.David C. Hoffman, A Modest Proposal: Toward Improved Access to Biotechnology Research Tools by Implementing a Broad Experimental Use Exception, 89 CORNELL LAW REVIEW 993 (2004).7.David E. Adelman, A Fallacy of the Commons in Biotech Patent Policy, 20 BERKELEY TECHNOLOGY LAW JOURNAL 985 (2005).8.David L. Parker, Patent Infringement Exemptions for Life Science Research, 16 HOUSTON JOURNAL OF INTERNATIONAL LAW 615 (1994).9.Desmond Mascarenhas, Negotiating the Maze of Biotech "Tool Patents", 16 NATURE BIOTECHNOLOGY 1371 (1998).10.Donald R. Ware, Research Tool Patents: Judicial Remedies, 38 AIPLA QUARTERLY JOURNAL 267 (2002).11.Elizabeth Stotland Weiswasser & Scott D. Danzis, The Hatch-Waxman Act: History, Structure, and Legacy, 71 ANTITRUST LAW JOURNAL 585 (2003).12.Eric K. Steffe & Timothy J. Shea, Jr., Drug Discovery Tools and the Clinical Research Exemption from Patent Infringement, 22 BIOTECHNOLOGY LAW REPORT 369 (2003).13.George Fox, Note, Integra v. Merck: Limiting the Scope of the § 271(e)(1) Exception to Patent Infringement, 19 BERKELEY TECHNOLOGY LAW JOURNAL 193 (2004).14.Gerald J. Flattmann & Jonathon M. Kaplan, Licensing Research Tool Patents, 20 NATURE BIOTECHNOLOGY 945 (2002).15.Guang Ming Whitley, A Patent Doctrine without Bounds: The “Extended” Written Description Requirement, 71 UNIVERSITY OF CHICAGO LAW REVIEW 617 (2004).16.Heather Hamme Ramirez, Comment, Defending The Privatization of Research Tools: An Examination of the “Tragedy of the Anticommons” in Biotechnology Research and Development, 53 EMORY LAW JOURNAL 359 (2004).17.Henry Grabowski & John Vernon, Longer Patents for Increased Generic Competition in the US: The Waxman-Hatch Act After One Decade, 10 PHARMACOECONOMICS, 110 (Supp. 2 1996).18.Hideaki Kamata, Michael Karin & Jun-Li Luo, IKK/ NF-kB Signaling: Balancing Life and Death—A New Approach to Cancer Therapy, 115 THE JOURNAL OF CLINICAL INVESTIGATION 2625 (2005).19.Jaclyn L. Miller, Drug Price Competition and Patent Term Restoration Act: The Elimination of Competition Between Drug Manufacturers, 5 DEPAUL JOURNAL OF HEALTH CARE LAW 91 (2002).20.Janice M. 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