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研究生:蔡鴻文
論文名稱:論美國之生醫科技研究工具之專利保護與授權
論文名稱(外文):Research tool patent protection and licensing for biomedical innovations in united states
指導教授:沈宗倫沈宗倫引用關係
學位類別:碩士
校院名稱:國立政治大學
系所名稱:法律科際整合研究所
學門:法律學門
學類:專業法律學類
論文種類:學術論文
畢業學年度:98
語文別:英文
論文頁數:97
中文關鍵詞: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
外文關鍵詞:Research toolsSafe harborTest exemptionReach-through royaltiesReach-through claimWritten description
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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.
I. Introduction 4
II. Overview of the Research Tools 9
A. The Concepts of Research Tools 9
B. The Types of Research Tools and the Marketing Strategy 10
C. Concerns and Problems on Research Tools 12
III. Legislative Problems of § 271(e)(1) for Research Tool Patents 14
A. Introduction of Safe Harbor of § 271(e)(1) 15
1. The Status of Pharmaceutical Industrials before Hatch-Waxman Act. 15
2. The Competition of Drug Price and Patent Term Restoration Act 17
B. Judicial Interpretations 18
1. Eli Lilly & Co. v. Medtronic, Inc. 19
2. Intermedics, Inc. v. Ventritex, Inc. 20
3. AbTox, Inc. v. Exitron Corp. 20
4. Infigen, Inc. v. Advanced Cell Technology, Inc. 21
C. Integra Lifesciences I, Ltd. v. Merck KGaA 21
1. Progress of Integra Lifesciences I, Ltd. v. Merck KGaA 22
2. Analysis of Disputed Patent Claims in Integra v. Merck and Rader’s Opinions 27
D. Research Exemption versus the Safe Harbor 31
E. Scope of § 271(e) (1) with Respect to Research Tool Patent 32
1. Legislative Considerations Under § 271(e) (1) 33
2. Reasonably Related and Patented Invention of the Interpre. of § 271(e) (1) 34
3. The Arguments of Public Policy, de minimis Interference, Legislative Intent and Plain Language 39
F. Legislative Proposals for Safe Harbor 46
1. Limiting the Research Exemption 46
2. Adopting the Fair Use for Patent Law 47
3. Applying the Compulsory Licensing 48
4. Expanding the Research Exemption for Non-commercial Use 49
G. Outlook and Compromised Solutions of Research Tools 49
1. Positive Effects for Research Tools 50
2. Negative Effects for Research Tools 51
IV. Reach-Through Royalties and Claims of Research Tools 53
A. The Competing Interests of Various Users 55
1. For Large Pharmaceutical Companies 55
2. For Universities and Other Non profits 56
3. For Small and Start-up Biotechnology Firms 57
4. For Government Interests 59
B. Reach-Through Royalties 60
1. Trends in the Use of Reach-Through Royalty Provisions 60
2. Reach-Through Royalties 61
3. Reach-through Licensing Provisions for Small Biotechnology Firms 63
C. Reach-Through Claims 66
1. The Explanation of Reach-Through Claims 67
2. Trilateral Project B3b and the Univ. of Rochester v. G.D. Searle Case 68
V. Written Description Requirements 71
A. The Nature of Biological Pathway 73
1. Biological Pathways in General and the NF- Pathway 73
2. The NF- Patent 74
B. Case Study for Written Description Requirement 77
1. Regents of Univ. of Cal. v. Eli Lilly & Co. 77
2. Enzo Biochem, Inc. v. Gen-Probe Inc. 78
3. Univ. of Rochester v. G.D. Searle & Co. 80
C. Proposal: Appropriate Protecting Biomedical Inventions 81
1. Referring the Opinions from Scholars 81
2. Adopting the Common Feature Test 82
3. Disclosing the Functional Claims 83
4. Biological Patent Application Practices 84
5. The Common Feature Test Practices 87
V. Conclusions 88
Reference 90


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