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研究生:吳東哲
研究生(外文):Wu, Tung-Che
論文名稱:藥品的核准前專利爭端解決程序- 美國專利連結為借鏡
論文名稱(外文):Pre-Approval Patent Resolution Process of Drug Product- Lessons From U.S. Patent Linkage
指導教授:沈宗倫沈宗倫引用關係
指導教授(外文):Shen, Chung-Lun
口試委員:沈宗倫馮震宇熊誦梅
口試日期:2015-11-30
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
論文出版年:2015
畢業學年度:104
語文別:中文
論文頁數:320
中文關鍵詞:核准前專利爭端解決程序專利連結專利扣合專利登錄專利切結擬制侵權自動停止核准期自動停止發證期180天專屬期橘皮書
外文關鍵詞:pre-approval patent resolution processpatent linkagepatent listingpatent certificationartificial infringementautomatic stay30-month-stay180-day exclusivitygeneric exclusivityorange book
相關次數:
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美國作為醫藥技術的領導者,為了確保其利益,並維持其領導地位,不斷在各種貿易談判場合,向世界各國施加壓力,要求提供醫藥品更強力的智慧財產保護。台灣當然也不例外,在加入跨太平洋戰略經濟夥伴關係協議 (Trans-Pacific Partnership Agreement, TPP)、簽訂臺美貿易暨投資架構協定 (Trade and Investment Framework Agreement, TIFA) 的壓力下,我國政府從2014年開始積極推動專利連結,雖然獲得美國商會肯定,但卻在國內業界卻引起十分強力的反彈。

專利連結,本質上只是核准前專利爭端解決程序 (Pre-Approval Patent Resolution Process) 的其中一個類型而已。核准前專利爭端解決程序,就是在特定產品上市核准的准駁中,把專利侵權問題作為准駁的考量。國際上類似的制度主要出現在人用藥品、動物藥品中,通常是在允許引據他人安全性、有效性資料的藥品中 (類新藥、學名藥)。

我國目前對類似制度的了解並不深,尤其缺乏對制度原生國-美國的全面性研究。本研究選擇以發展最早的藥品專利連結作為研究標的,並全面、深入分析其中每個機制的目的、立法/修法歷史 (含行政法規)、法院判決,探求其爭議的發展過程。在這個基礎上,本研究就引進的必要性、各種立法手段的選擇與優劣,提出「修正版柔性專利連結」,主要特徵在排除了自動停止核准期、重定核准日條款,使藥品審查和專利爭端大致維持獨立,並符合TPP的要求。希望本研究能夠幫助台灣建立一套明確、合理,且符合我國國情的核准前專利爭端解決程序。
As the phamaceutical industry’s market leader, the United States continues to call for strengthening patent protection for pharmaceutical products during every trade negotiation, to preserve its national profit and leadership. Taiwan, being highly interested in joining “Trans-Pacific Partnership Agreement” (TPP) and signing “Trade and Investment Framework Agreement” (TIFA) with the United States, Taiwan's government is actively promoting the “patent linkage” since 2014. Althougn the effort done by Taiwan's government is extremely welcomed by American Chamber of Commerce, the domestic industry, which is mainly organized with generic drug manufactors, has expressed their opposition resolutely.

Patent linkage, as a kind of “pre-approval patent resolution process”, considers the possibility of patent infringement as a factor when issuing market approval. Such process are normally found in those countries that are trade partners of the United States, and espetially during the approval prosses of human-use drug products, animal drug products, which permits persons to rely on evidence or information concerning the safety and efficacy of a product that was previously approved.

Our current knowledge of pre-approval patent resolution process is limited, especially on how it was oranginally created in the United States. This research will focus on the purpose, enactment, amendment, court decisions, development, and issues of patent linkage, the first-of-its-kind which is established in 1984. On this basis, the reseach will then look back to what Taiwan has faced now, and provides recommendations on whether there is necessity of introdution, how to adjust the prosses, and how to enforce it, without serious abuse. This research propose “revised soft patent linkage”, which excludes automatic stay and re-date remedy, generally keeps the independence between drug approval and patent infringement, and at the same time meets TPP requirement. The research hopes to help Taiwan establishing its own pre-approval patent resolution, fair, clear and meet the need of domestic and public the industry.
第一章 緒論 1
第一節 研究動機與範圍 1
第二節 研究方法 2
第三節 論文架構 3
第四節 研究範圍與限制 4
第二章 美國藥品上市核准流程 6
第一節 上市核准流程 6
第一項 證明安全性、有效性的科學試驗 8
第二項 應繳交文件的準備、送件 11
第三項 主管機關審查 12
第二節 上市核准流程的彈性 13
第三節 小結 15
第三章 美國專利連結的定義 、起源與修正 20
第一節 何謂專利連結 20
第一項 從時序觀察 20
第二項 從架構觀察 - 辨識、強化、鼓勵/補償三部曲 26
第二節 HWA的起源 (1906~1962) 29
第一項 Food and Drugs Act (1906) 29
第二項 Food, Drug, and Cosmetic Act (1938) 29
第三項 Kefauver-Harris Drug Amendments (1962) 30
第四項 Kefauver-Harris Drug Amendments後的發展 (1962~1983) 31
第五項 小結 34
第三節 HWA的立法 (1984) 35
第一項 引據與非專利專屬期 38
第二項 試驗免責與專利期間回復/延長 50
第三項 專利連結 52
第四項 小結 52
第四節 HWA訂立後的發展 (1984~2003) 53
第五節 MMA修正 (2003) 54
第六節 MMA修正後的發展 (2003~2015) 54
第七節 小結 55
第四章 美國專利連結的規範與爭議 56
第一節 辨識階段 56
第一項 專利登錄 56
第二項 專利切結 75
第二節 強化階段 86
第一項 送件通知 86
第二項 擬制侵權 101
第三項 45天期間 128
第四項 30個月自動停止核准期 132
第五項 確認訴訟 158
第三節 獎勵/補償階段 169
第一項 180天專屬期 169
第五章 藥品核准前專利爭端解決程序之討論與分析 219
第一節 美國專利連結評析 219
第一項 專利連結係對藥品專利「質的強化」 219
第二項 制度缺陷 220
第三項 小結 226
第二節 我國現況 227
第一項 產業面 227
第二項 法制面 233
第三項 國際現實面 243
第四項 小結 264
第三節 立法建議 267
第一項 大方向:謹慎保守、暫緩引進 267
第二項 立法建議 268
第三項 加強辨識功能 274
第四項 提供藥品專利合理保護 283
第五項 適度鼓勵/補償學名藥廠 294
第六項 打擊違反公平交易法的行為 295
第四節 結論 297
參考資料 300
第一節 中文文獻 300
第一項 專書 300
第二項 期刊論文 300
第三項 判決 302
第四項 其他 302
第二節 外文文獻 305
第一項 專書 305
第二項 期刊論文 305
第三項 判決 306
第四項 其他 311

第一節中文文獻

第一項專書
1.楊代華,處方藥產業的法律戰爭-藥品試驗資料保護,元照,初版 (2007.11)

第二項期刊論文
1.王立達、邱靖芳,藥品市場產品跳躍行為之競爭法研究:以美歐實務案例為中心,月旦財經法第37期 (2015)
2.王立達、陳蔚奇,學名藥上市審查之專利連結制度:從美國經驗檢證其存立基礎與制度設計,國立臺灣大學法學論叢,第 39 卷第 4 期,2010年
3.吳東哲、陳桂恒,美國藥品專利連結與橘皮書登錄制度相關規範:對台灣之影響,2015年, available at http://www.lawbank.com.tw/treatise/dt_article.aspx?AID=D000023512 (最後瀏覽日:2015.6.18)
4.吳靜美,全民健保的推動與實施,臺灣民眾滿意度高 臺灣健保 美國發光 (2008), available at http://www.nhi.gov.tw/webdata/webdata.aspx?menu=17&menu_id=1028&webdata_id=2305 (最後瀏覽日 2015.10.21)
5.李芳全,建構我國學名藥法制之研究,交通大學管理學院科技法律學程論文,2010年
6.林于令、侯春岑,新藥與學名藥的戰爭─淺談Hatch-Waxman法案及其最新修正,萬國法律,136期,2004年
7.林宗緯,Hatch-Waxman法案及我國既有法規之比較-對我國引進專利連結制度之建議,萬國法律,頁47-57 第201期 (2015.5)
8.國立陽明大學衛生福利研究所,藥品許可證與專利資訊扣合機制之研究,行政院衛生署九十六年度委託科技計畫,2007年, available at http://grbsearch.stpi.narl.org.tw/GRB_Search/grb/show_doc.jsp?id=1402913&q=(%20(%22%E8%97%A5%E5%93%81%E8%A8%B1%E5%8F%AF%E8%AD%89%22%20PNCH_DESC%3A%2F.*%E8%97%A5%E5%93%81%E8%A8%B1%E5%8F%AF%E8%AD%89.*%2F%20PENG_DESC%3A%2F.*%20%E8%97%A5%E5%93%81%E8%A8%B1%E5%8F%AF%E8%AD%89%20.*%2F)%20%20)%20 (最後瀏覽日:2015.10.18)
9.張哲倫,產業契機與挑戰-國際專利制度調和與藥品審查機制政策建言,2015年推進國際區域經濟論壇 加TPP、RCEP 對生技新藥產業之契機與挑戰,頁70-71 (2015)
10.陳蔚奇,論美國專利連結制度於我國實行之妥適性,交大科法所碩士論文,2010年
11.陳璸如,藥品專利權與上市審查之交錯--專利連結制度之研究,世新大學法研所碩士論文,2015年
12.陳韻珊,製藥業的藥品轉換與競爭,公平交易委員會電子報第33期 (2015.8), available at http://www.ftc.gov.tw/upload/1040819-1.pdf (最後瀏覽日:2015.11.4)
13.黃秋蓉,美國藥品上市審查之專利連結程序,雲科大科法所碩士論文,2013年
14.黃慧嫺,淺析美國藥品上市審查程序之專利連結機制及其實施對我國可能產生之影響 (上),科技法律透析,第18卷第6期,2006年6月
15.黃慧嫺,淺析美國藥品上市審查程序之專利連結機制及其實施對我國可能產生之影響 (下),科技法律透析,第18卷第7期,2006年7月
16.黃慧嫻,專利連結 (Patent Linkage)--藥品研發與競爭之阻力或助力?:談藥品查驗登記程序與專利權利狀態連結之發展 (上),科技法律透析,21卷第2期,2009年2月
17.黃慧嫻,專利連結 (Patent Linkage)--藥品研發與競爭之阻力或助力?:談藥品查驗登記程序與專利權利狀態連結之發展(下),科技法律透析,21卷第3期,2009年3月
18.葉雲卿,淺談美國專利聯結制度系列:學名藥180天市場專屬權之起源,北美智權報,2014年, available at http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Industry_Economy/publish-318.htm (最後瀏覽日:2015.9.14)
19.葉雲卿,淺談美國專利聯結制度系列II:30個月暫停核准期間之立法,北美智權報,2015年, available at http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Industry_Economy/publish-327.htm (最後瀏覽日:2015.9.14)
20.廖柏豪,論專利連結與資料保護對我國醫藥產業之影響,台北大學法研所法專組碩士論文,2013年
21.鄭耀誠,論藥品研發、上市許可之規範與相關智慧財產權之保護-專利連結、資料專屬與專利權之探討,輔仁大學財經法律學系碩士論文,2009年
22.蕭郁溏、陳誌雄,從比較法觀點建構台灣專利連結制度,萬國法律 第200期,頁92-110 (2015.4)
23.謝欣晏、蘇郁珊,試以美國雙邊貿易協定分析其推動藥品專利連結規範對台灣之影響,經貿法訊 第166期 (2014), available at http://www.tradelaw.nccu.edu.tw/epaper/no166/1.pdf (最後瀏覽日:2014.12.30)

第三項判決
1.臺灣高等法院台中分院93年度抗字第857號民事裁定。
2.臺灣高等法院臺中分院96年度智上字第18號民事判決
3.臺灣智慧財產法院97年度民專上字第20號民事判決
4.臺灣智慧財產法院98年度民公訴字第6號民事判決
5.臺灣智慧財產法院99年度民公上字第3號民事判決
6.臺灣最高法院94年度台抗字第229號民事裁定
7.臺灣最高法院98年度台上字第367號民事判決
8.臺灣臺中地方法院93年度裁全字第3340號民事裁定。
9.臺灣臺中地方法院95年度智更字第1號民事判決

第四項其他
1.中華民國製藥發展協會,智慧財產權與學名藥產業發展之研究,行政院衛生署藥政處輔助研究 (2008), available at http://grbsearch.stpi.narl.org.tw/GRB_Search/grb/show_doc.jsp?id=1602121&q=(%20(%22%E6%99%BA%E6%85%A7%E8%B2%A1%E7%94%A2%22%20PNCH_DESC%3A%2F.*%E6%99%BA%E6%85%A7%E8%B2%A1%E7%94%A2.*%2F%20PENG_DESC%3A%2F.*%20%E6%99%BA%E6%85%A7%E8%B2%A1%E7%94%A2%20.*%2F)%20AND%20(%22%E8%97%A5%22%20PNCH_DESC%3A%2F.*%E8%97%A5.*%2F%20PENG_DESC%3A%2F.*%20%E8%97%A5%20.*%2F)%20%20)%20 (最後瀏覽日:2015.11.8)
2.公平交易委員會,出席 2014 年6 月經濟合作發展組織(OECD)「競爭委員會」會議報告 (2014), available at http://www.google.com.tw/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CB0QFjAAahUKEwiLjunas_bIAhVFE6YKHbS5CHc&url=http%3A%2F%2Freport.nat.gov.tw%2FReportFront%2Freport_download.jspx%3FsysId%3DC10302024%26fileNo%3D001&usg=AFQjCNHTvDLu8yRUlM0uVpp3yjKAGLrQ2w&sig2=BQdxcPMibxxnfFw6hN3Tgg (最後瀏覽日:2015.11.4)
3.立法院,立法院公報 第94卷 第7期 院會紀錄,頁342-356 (2005), available at http://lis.ly.gov.tw/ttscgi/lgimg?@940701;0342;0356 (最後瀏覽日:2015.10.18)
4.行政院衛生署藥政處,公告「已揭露專利字號/案號切結書」,衛署藥字第0940330797號 (2005), available at http://www.fda.gov.tw/pda/page01Content.aspx?id=1032&chk=787b7135-d0b9-467f-b572-9054f9a4af0d¶m=pn%3D145 (最後瀏覽日:2015.10.18)
5.呂雪彗,搶TPP第二輪門票 政院下動員令,工商時報 (2015.10.26), available at http://www.chinatimes.com/newspapers/20151026000028-260202 (最後瀏覽日:2015.10.31)
6.社團法人台灣藥物品質協會,103年度「藥品專利及生體相等性試驗相關資料庫建置計畫」(2014), available at http://grbsearch.stpi.narl.org.tw/GRB_Search/grb/show_doc.jsp?id=8434314&q=(%20(%22%E5%B0%88%E5%88%A9%22%20PNCH_DESC%3A%2F.*%E5%B0%88%E5%88%A9.*%2F%20PENG_DESC%3A%2F.*%20%E5%B0%88%E5%88%A9%20.*%2F)%20%20)%20 (最後瀏覽日:2015.10.18)
7.社團法人台灣藥物品質協會,104年度「藥品專利資料建立計畫」,2015年, available at http://web.pcc.gov.tw/tps/main/pms/tps/atm/atmAwardAction.do?newEdit=false&searchMode=common&method=inquiryForPublic&pkAtmMain=51515715&tenderCaseNo=104-TFDA-P-036 (最後瀏覽日:2015.10.18)
8.財團法人工業技術研究院,104年度「專利連結產業經濟衝擊評估」,2015年, available at http://web.pcc.gov.tw/tps/main/pms/tps/atm/atmAwardAction.do?newEdit=false&searchMode=common&method=inquiryForPublic&pkAtmMain=51573716&tenderCaseNo=MOHW104-FDA-D-113-000437 (最後瀏覽日:2015.10.18)
9.財團法人台灣藥物品質學會,臺灣藥事論壇,第49屆、第61屆、第63屆、第64屆藥事論壇
10.國立台北大學,藥品專利連結中部南部座談會 (2015), available at http://www.tpmma.org.tw/epaper/Upload_Files/%E8%97%A5%E5%93%81%E5%B0%88%E5%88%A9%E9%80%A3%E7%B5%90%E5%88%B6%E5%BA%A6_%E4%B8%AD%E9%83%A808.20_%E5%8D%97%E9%83%A808.21%E5%BA%A7%E8%AB%87%E6%9C%83.pdf (最後瀏覽日 2015.8.17)
11.國立政治大學國際經營與貿易學系,跨太平洋合作夥伴協定醫藥衛生部門談判草案與爭議之研究,科技部學術補助計畫 (2014) , available at http://grbsearch.stpi.narl.org.tw/GRB_Search/grb/show_doc.jsp?id=8323026&q=(%20(%22%E8%B7%A8%E5%A4%AA%E5%B9%B3%E6%B4%8B%22%20PNCH_DESC%3A%2F.*%E8%B7%A8%E5%A4%AA%E5%B9%B3%E6%B4%8B.*%2F%20PENG_DESC%3A%2F.*%20%E8%B7%A8%E5%A4%AA%E5%B9%B3%E6%B4%8B%20.*%2F)%20%20)%20 (最後瀏覽日:2015.11.8)
12.國立臺北大學,104年度「自由化法規鬆綁落實藥品智慧財產保護之法規修訂計畫」 (2015), available at http://web.pcc.gov.tw/tps/main/pms/tps/atm/atmAwardAction.do?newEdit=false&searchMode=common&method=inquiryForPublic&pkAtmMain=51499096&tenderCaseNo=MOHW104-FDA-D-114-000436 (最後瀏覽日:2015.10.18)
13.理律法律事務所,美國專利連結與橘皮書登錄制度研究,經濟部智慧財產局研究計畫 (2014), available at http://www.tipo.gov.tw/public/Attachment/511916312153.pdf (最後瀏覽日:2015.10.18)
14.郭建志,TPP談判 經長: 2017加入、2年談完,工商時報 (2015.10.14), available at http://ctee.com.tw/News/Content.aspx?id=658442&yyyymmdd=20151014&f=0ebae44a076d0475c18fd31b25cae744&h=0dd41d89c03443ae95a2b97037512940&t=t5d (最後瀏覽日:2015.10.18)
15.黃巧雯,法律檢視未完成 TPP內容將延後公布,中央社 (2015.10.30), available at http://www.cna.com.tw/news/afe/201510300428-1.aspx (最後瀏覽日:2015.10.31) see also Public Citizen, Petition to Release the TPP Text (2015), available at http://action.citizen.org/p/dia/action3/common/public/?action_KEY=12972 (最後瀏覽日:2015.10.31)
16.經貿談判代表辦公室,第8屆臺美TIFA會議相關資訊 (2015), available at https://www.moea.gov.tw/Mns/otn/content/Content.aspx?menu_id=14117 (最後瀏覽日:2015.10.31)
17.經濟部國際貿易局,TPP簡介 (2015) , available at http://www.tpptrade.tw/intro1.aspx (last visited 2015.12.20)
18.衛生署藥政處,切結書 (甲) (2005), available at http://www.fda.gov.tw/TC/newsContent.aspx?id=897&chk=936a8bd8-cd34-47ac-9b9e-bf09f355d4be¶m=pn&cid=3&cchk=46552e96-810a-42c3-83e1-bd5e42344633&key1=%e5%88%87%e7%b5%90%e6%9b%b8#.Vixvc_3ouos (最後瀏覽日:2015.10.18)
19.衛生福利部食品藥物管理局,通用技術文件(CTD)格式 (2012) http://www.fda.gov.tw/TC/siteContent.aspx?sid=3225#.VaDv47kw_q4 (最後瀏覽日:2015.07.11)
20.衛生福利部食品藥物管理署,GMP藥廠名單 (2015.8.27), available at http://www.fda.gov.tw/TC/siteListContent.aspx?sid=2067&id=3475&chk=5b6f2ebd-8ed2-46ee-a17b-f7c7517bbaf0#.ViccAv3ouos (最後瀏覽日:2015.10.21)

第二節外文文獻

第一項專書
1.John R. Thomas, Pharmaceutical Patent Law, BNA Books, A Division of Bureau of National Affairs (2nd ed. 2010).
2.Mark Mathieu, New Drug Development: A Regulatory Overview, PAREXEL International Corp (8th ed. 2008)
3.Robert A. Matthews Jr., Annotated Patent Digest, Thomson West (2015)
4.Shashank Upadhye, Generic Pharmaceutical Patent and FDA Law, Thomson West (2015)

第二項期刊論文
1.Aidan Hollis, Closing the FDA's Orange Book: Current drug regulations invite abuse of patent laws, Regulation 24, p.14-17 (2007) also available at http://object.cato.org/sites/cato.org/files/serials/files/regulation/2001/12/v24n4-2.pdf (最後瀏覽日:2015.9.12)
2.Alyssa L. Brown, Modest Proposals for A Complex Problem: Patent Misuse and Incremental Change to the Hatch-Waxman ACT as Solutions to The Problem of Reverse Payment Settlement, 40U. Balt. L. Rew. (2012)
3.Eric H. Weisblatt & A. Claire Frezza, Who to Sue and Where in ANDA Litigation: Personal Jurisdiction Post-Daimler, Food & Drug Law Journal, Vol. 69, No. 3 (August 2014)
4.Michelle Meadows, Promoting Safe and Effective Drugs for 100 Years, FDA Consumer magazine, The Centennial Edition (2006) http://www.fda.gov/AboutFDA/WhatWeDo/History/CentennialofFDA/CentennialEditionofFDAConsumer/ucm093787.htm (最後瀏覽日:2015.6.12)
5.Shashank Upadhye, There's a Hole in My Bucket Dear Liza, Dear Liza: The 30-Year Anniversary of the Hatch-Watchman Act: Resolved and Unresolved Gaps and Court- Driven Policy Gap Filling, 40 Wm. Mitchell L. Rev. 1307, 1338 (2014), available at http://open.wmitchell.edu/cgi/viewcontent.cgi?article=1587&context=wmlr (最後瀏覽日:2015.8.25)
6.Shashank Upadhye, Understanding Patent Infringement under 35 U.S.C. 271(e): The Collisions Between Patent, Medical Device and Drug Laws, 17 Santa Clara High Tech. L.J. 1 (2000), available at http://digitalcommons.law.scu.edu/chtlj/vol17/iss1/1 (最後瀏覽日:2015.9.14)
7.Srivastava D, The Food and Drug Administration and Patent Law at a Crossroads: The Listing of Polymorph Patents as a Barrier to Generic Drug Entry, Food Drug Law J. 2004;59(2):339-54.

第三項判決
1.AaiPharma Inc. v. Thompson, 296 F.3d 227 (Fed. Cir. 2002)
2.Abbott Lab. v. Novopharm Ltd., 104 F.3d 1305 (Fed. Cir. 1997)
3.Abbott Laboratories v. Matrix Laboratories, Inc., 2009 WL 3719214, (N.D. Ill. 2009)
4.Abbott Laboratories, Inc. v. Apotex Inc., 725 F. Supp. 2d 724, 727-28 (N.D. Ill. 2010)
5.Abbott Labs. v. Mylan Pharms., Inc., 2006 WL 850916 (N.D. Ill. 2006)
6.Abbott Labs. v. Zenith Labs., Inc., 934 F. Supp. 925, 936 (N.D. Ill. 1995),
7.Aktiebolag v. Kremers Urban Development Co., 2000 WL 257125 (S.D.N.Y. Mar. 28, 2000)
8.Alcon, Inc. v. Teva Pharmaceuticals USA, Inc., 2010 WL 3081327, *1 (D. Del. 2010)
9.Allergan, Inc. v. Alcon Labs., 324 F.3d 1322, 1330 (Fed.Cir.2003).
10.Allergan, Inc. v. Apotex Inc., 2013 WL 1750757 (M.D. N.C. 2013)
11.Andrx Pharmaceuticals, Inc. v. Biovail Corp., 276 F.3d 1368 (Fed. Cir. 2002)
12.Andrx Pharmaceuticals, Inc. v. Elan Corp., 421 F.3d 1227 (11th Cir.2005)
13.Andrx Pharms., Inc. v. Biovail Corp, 256 F.3d 799 (D.C. Cir. 2001)
14.Apotex Inc. v. U.S. Food and Drug Admin., 508 F. Supp. 2d 78 (D.D.C. 2007)
15.Apotex, Inc. v. Shalala, 53 F.Supp.2d 454 (D.D.C. 1999), aff’d, F.3d, 1999 WL 956686 (D.C. Cir. 1999)
16.Arkansas Carpenters Health And Welfare v. Bayer AG, 604 F.3d 98 (2nd Cir. 2010)
17.AstraZeneca AB v. Anchen Pharmaceuticals Inc., 2014 WL 2611488 (D.N.J. 2014)
18.AstraZeneca AB v. Impax Laboratories, Inc., 490 F. Supp. 2d 368 (S.D. N.Y. 2007)
19.AstraZeneca Pharm. v. Apotex Corp., 669 F.3d 1370, 1379-1380 (Fed. Cir. 2012)
20.Avanir Pharmaceuticals Inc. v. Impax Laboratories Inc. Case No. 1:12-cv-01298 (2014)
21.Bayer AG v. Elan Pharmaceutical Research Corp., 212 F.3d 1241 (Fed.Cir.2000)
22.Bayer AG. v. Biovail Corp., 279 F.3d 1340 (Fed. Cir. 2002)
23.Bayer Healthcare LLC v. Norbrook Labs., Ltd., 2011 WL 2262454(E.D. Wis. June 7, 2011)
24.Bayer Schera Pharma AG v. Sandoz, Inc., 2010 WL 3447906 (S.D. N.Y. 2010)
25.Ben Venue Laboratories, Inc. v. Novartis Pharmaceutical Corp., 10 F. Supp.2d 446 (D.N.J. 1998)
26.Ben Venue Laboratories, Inc. v. Novartis Pharmaceutical Corp., 146 F.Supp.2d 572, 578 (D.N.J.. 2001)
27.Boehringer Ingelheim Corp. v. Shalala, 993 F.Supp. 1 (D.D.C. 1997)
28.Bristol-Myers Squibb Co. v. Royce Labs., Inc., 69 F.3d 1130 (1995);
29.Brooks Furniture Mfg., Inc. v. Dutailier Int'l, Inc., 393 F.3d 1378 (Fed. Cir. 2005)
30.Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, 527 F.3d 1278, 1289 (Fed.Cir.2008)
31.Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk, 132 S.Ct. 1670 (2012)
32.Cephalon, Inc. v. Watson Pharmaceuticals, Inc., 2009 WL 1838352 (D. Del. 2009)
33.Daimler A.G v. Bauman,134 S. Ct. 746 (2014)
34.Dey, L.P. v. Eon Labs, Inc, 2005 WL 3578120 (C.D.Cal. 2005)
35.Dey, L.P. v. Ivax Pharmaceuticals, Inc, 233 F.R.D. 567 (C.D. Cal. 2005)
36.Dr. Reddy's Labs., Inc. v. Thompson, 302 F.Supp.2d 340 (D.N.J.2003)
37.eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006)
38.Eisai Co., Ltd. v. Mutual Pharmaceutical Co., Inc., 2007 WL 4556958 (D.N.J. 2007)
39.Eli Lilly & Co. v. Medtronic, Inc., 110 S.Ct. 2683 (1990)
40.Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 678 (1990);
41.Eli Lilly & Co. v. Zenith Goldline Pharmaceuticals, Inc, 2001 WL 238090 (S.D.Ind. 2001)
42.Eli Lilly and Co. v. Teva Pharmaceuticals USA, Inc., 557 F.3d 1346 (Fed. Cir. 2009)
43.Ferring B.V. v. Watson Laboratories, Inc.-Fla, 764 F.3d 1382 (Fed Cir 2014)
44.FTC v. Actavis, Inc., 133 S. Ct. 2233 (June 17, 2013)
45.FTC v. Watson, 677 F.3d 1298 (11th Cir.2013)
46.Glaxo Group Ltd. v. Apotex, Inc., 376 F.3d 1339 (Fed.Cir.2004)
47.Glaxo Inc. v. Novopharm Ltd., 110 F.3d 1562 (Fed.Cir.1997).
48.Glaxo, Inc. v. Novopharm, Ltd., 931 F.Supp. 1280 (E.D.N.C. 1996)
49.Granutec, Inc. v. Shalala, 139 F.3d 889 (4th Cir. 1998)
50.Granutec, Inc. v. Shalala, 1997 WL 1403894 (E.D.N.C. 1997)
51.In re Barr Labs., Inc., 930 F.2d 72, 76 (D.C.Cir.), cert. denied, 502 U.S. 906, 112 S.Ct. 297, 116 L.Ed.2d 241 (1991).
52.In re Brimonidine Patent Litigation, 2008 WL 4809037 (D. Del. 2008)
53.In re Buspirone Patent Litigation, 185 F.Supp.2d 363 (S.D.N.Y.2002).”
54.In re Cardizem CD Antitrust Litigation, 391 F.3d 812 (6th Cir.2003)
55.In re Ciprofloxacin Hydrochloride Antitrust Litigation, 544 F.3d 1323 (Fed. Cir. 2008)
56.In re Omeprazole Patent Litigation, 536 F.3d 1361 (Fed. Cir. 2008);
57.In re Pfizer Inc., 2010 WL 375112(Fed. Cir. 2010)
58.In re Rosuvastatin Calcium Patent Litigation, 703 F.3d 511 (D. Del. 2008)
59.In re: Cyclobenzaprine Hydrochloride Extended Release Capsule Patent Litigation, 693 F.Supp.2d 409 (D. Del. 2010)
60.In Re: K-Dur Antitrust Litigation, No. 10-2077 (3d Cir. July 16, 2012)
61.In Re: Tamoxifen Citrate Antitrust Litigation, 466 F.3d 187 (2nd Cir.2005)
62.Intendis, Inc. v. River's Edge Pharm., LLC, 2011 WL 5513195(D.N.J., 2011)
63.Inwood Laboratories, Inc. v. Young, 43 F.3d 712, 1989 WL 513201 (C.A.D.C. 1989)
64.Inwood Laboratories, Inc. v. Young, 723 F. Supp. 1523 (D.D.C. 1989)
65.Kowa Co. v. Orient Pharma Co., l:14-cv-02759 (S.D.N.Y. Apr. 17, 2014)
66.MedImmune, Inc., v. Genentech, Inc., 549 U.S. 118 (2007)
67.Minnesota Mining & Manufacturing v. Alphapharm Pty. Ltd., 2002 WL 1299996 (D. Minn. 2002)
68.Minnesota Mining And Mfg. Co. v. Barr Laboratories, Inc., 139 F.Supp.2d 1109 (Fed. Cir. 2001)
69.Minnesota Mining And Mfg. Co. v. Barr Laboratories, Inc., 289 F.3d 775 (Fed. Cir. 2002)
70.Momenta Pharmaceuticals v. Amphastar Pharma., 686 F.3d 1348 (Fed. Cir. 2012)
71.Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 1060 (D.C. Cir. 1998)
72.Mova Pharmaceutical Corp. v. Shalala, 955 F. Supp. 128 (D.D.C. 1997)
73.Mylan Pharmaceuticals v. U.S. Food and Drug Administration, 454 F.3d 270 (2006)
74.Mylan Pharmaceuticals, Inc. v. Thompson, 207 F.Supp.2d 476 (N.D.W. Va. 2001)
75.Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 1323 (Fed. Cir. 2001)
76.Mylan v, Shalala, 81 F.Supp.2d 30 (D.D.C. 2000)
77.Mylan v. Henney, 94 F.Supp.2d 36 (D.D.C. 2000)
78.Novartis Corp. v. Dr. Reddy's Labs., Ltd., 2004 WL 2368007 (S.D.N.Y. Oct. 21, 2004)
79.Octane Fitness, LLC v ICON Health & Fitness, Inc, 134 S Ct 1749 (2014)
80.Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc, 520 F.3d 1358 (Fed. Cir. 2008)
81.Pfizer Inc. v. Apotex Inc., 2009 WL 1657572 (N.D. Ill. 2009)
82.Pfizer Inc. v. Apotex Inc., 2010 WL 3087458 (N.D. Ill. 2010)
83.Pfizer Inc. v. Apotex, Inc., 2009 WL 2843288, (D. Del. 2009)
84.Pfizer Inc. v. Sandoz Inc., 2010 WL 256548 (D.Del. 2010)
85.Pfizer Inc. v. Synthon Holding, B.V., 386 F.Supp.2d 666 (M.D.N.C. 2005)
86.Pfizer, Inc. v. Food And Drug Administration, 753 F.Supp. 171 (D.Md. 1990)
87.Photocure ASA v. Kappos, 603 F.3d 1372 (Fed Cir 2010)
88.Purepac Pharmaceutical Co. v. Thompson, 354 F.3d 877 (D.C. Cir. 2004)
89.Ranbaxy Laboratories Ltd. v. Leavitt, 469 F.3d 120 (DC. Cir. 2006)
90.Roche Palo Alto LLC v. Apotex, Inc., 526 F. Supp. 2d 985 (N.D. Cal. 2007)
91.Roche Products v. Bolar Pharmaceutical, 733 F.2d 858 (Fed. Cir. 1984)
92.Sanofi-Aventis v. FDA, 643 F.Supp.2d 82, 86 (D.D.C. 2009)
93.SB Pharmco Puerto Rico, Inc. v. Mutual Pharmaceutical Co., Inc., 552 F.Supp.2d 500, 2008 WL 1869284 (E.D. Pa. 2008)
94.Schering–Plough Corp. v. FTC, 402 F.3d 1056 (11th Cir.2005)
95.Sepracor, Inc. v. Barr Pharmaceuticals, Inc., 2010 WL 6243314 (E.D. N.C. 2010)
96.Shire LLC v. Watson Pharmaceuticals, Inc., 2012 WL 4477605 (S.D. N.Y. 2012)
97.Smithkline Beecham Corp. v. Apotex Corp., 2000 WL 116082(N.D.Ill. Jan. 24, 2000)
98.Sunovion Pharmaceuticals, Inc. v. Sandoz, Inc., 2011 WL 3875397 (E.D.N.C. 2011)
99.Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals, Inc., 731 F.3d 1271 (Fed.Cir.2013)
100.Takeda Chem. Indus., Ltd. v. Mylan Laboratories, Inc., 549 F.3d 1381 (Fed. Cir. 2008),
101.Teva Pharm. USA, Inc. v. Abbott Labs., 301 F. Supp. 2d 819, 829 (N.D. Ill. 2004)
102.Teva Pharm. USA, Inc. v. Pfizer Inc., 405 F.3d 990 (Fed.Cir.2005)
103.Teva Pharmaceuticals USA, Inc. v. FDA, 182 F.3d 1003 (D.C.Cir.1999)
104.Teva Pharmaceuticals USA, Inc. v. Novartis Pharmaceuticals Corp, 482 F.3d 1330 (Fed.Cir.2007)
105.Teva Pharmaceuticals USA, Inc. v. Pfizer, Inc., 395 F.3d 1324, 1336 (Fed. Cir. 2005)
106.Teva Pharmaceuticals USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010)
107.Teva Pharmaceuticals, USA, Inc. v. U.S. Food and Drug Admin., 182 F.3d 1003 (D.C. Cir. 1999)
108.Teva Pharms. Indus. Ltd. v. Crawford, 410 F.3d 51 (D.C.Cir.2005)
109.Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276 (Fed. Cir. 2011)
110.Torpharm v. Shalala, 1997 WL 33472411 (D.D.C. 1997)
111.Valley Drug Co. v. Geneva Pharm., Inc., 344 F.3d 1294 (11th Cir.2003)
112.Walton v. Eaton Corp., 563 F.2d 66 (3d Cir. 1970)
113.Warner–Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed.Cir.2003)
114.Winter v. Natural Resources Defense Council, Inc., 129 S.Ct. 365 (2008)
115.Wyeth v. Lupin Ltd., 505 F. Supp. 2d 303 (D. Md. 2007)
116.Wyeth v. Teva Pharmaceuticals USA Inc., 2010 WL 32111264 (D.N.J. 2010);
117.Yamanouchi Pharmaceutical Co. v. Danbury Pharmacal, Inc., 231 F.3d 1339 (Fed. Cir. 2000)
118.Zeneca Ltd. v. Mylan Pharmaceuticals, Inc., 173 F.3d 829 (Fed. Cir. 1999)
119.Zeneca Ltd. v. Pharmachemie B.V., 16 F. Supp. 2d 112, 116 (D. Mass. 1998)
120.Zenith Laboratories, Inc. v. Abbott Laboratories, Inc., 1996 WL 33344963 (D.N.J. 1996)

第四項其他
1.130 Cong.Rec. 24,427 (1984)
2.149 Cong. Rec. S15746 (2003)
3.Agreement On Trade-Related Aspects Of Intellectual Property Rights (1994), available at https://www.wto.org/english/docs_e/legal_e/27-trips.pdf (最後瀏覽日 2015.10.31)
4.Ambassador Michael B.G. Froman, United States Trade Representative, 2015 Special 301 Report (2015), available at https://ustr.gov/sites/default/files/2015-Special-301-Report-FINAL.pdf (最後瀏覽日:2015.10.31)
5.Australia – United States Free Trade Agreement (2005), available at https://ustr.gov/trade-agreements/free-trade-agreements/australian-fta/final-text (最後瀏覽日:2015.10.31)
6.Benjamin Burck, Preparing for Paragraph IV Patent Challenges (February 2011), available at http://thomsonreuters.com/business-unit/science/pdf/ls/newport_paragraphIV_webinar_slides.pdf (最後瀏覽日:2015.2.2)
7.Burcu Kilic & Peter Maybarduk, What’s New in the TPP Intellectual Property Text? Pharmaceutical Provisions (2015), available at https://wikileaks.org/tpp-ip3/pharmaceutical/Pharmaceutical%20Provisions%20in%20the%20TPP.pdf (最後瀏覽日:2015.10.31)
8.Chile – United States Free Trade Agreement (2004), available at https://ustr.gov/trade-agreements/free-trade-agreements/chile-fta/final-text (最後瀏覽日:2015.10.31)
9.Citizens Trade Campaign, Leaked Trans-Pacific FTA Texts Reveal U.S. Undermining Access to Medicine (2011.10.22), available at http://www.citizenstrade.org/ctc/blog/2011/10/22/leaked-trans-pacific-fta-texts-reveal-u-s-undermining-access-to-medicine/ (last visited 2015.12.21)
10.Dan Merica, Clinton takes on 'profiteering' drug companies, CNN (2015), available at http://edition.cnn.com/2015/09/22/politics/hillary-clinton-drug-companies-obamacare/ (最後瀏覽日 2015.10.21)
11.Declaration On The Trips Agreement And Public Health (2001), available at https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.pdf (最後瀏覽日 2015.10.31)
12.FDA Law Blog, 180-Day Exclusivity Tracker, available at http://www.fdalawblog.net/fda_law_blog_hyman_phelps/files/180-Day%20Exclusivity%20Tracker.xls (最後瀏覽日 2015.10.14)
13.FDA, 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications, 64 Fed. Reg. 42873 (August 06, 1999), available at http://www.gpo.gov/fdsys/pkg/FR-1999-08-06/pdf/99-20353.pdf (最後瀏覽日:2015.6.18)
14.FDA, 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications, 67 Fed. Reg. 66593 (November 01, 2002), available at http://www.gpo.gov/fdsys/pkg/FR-2002-11-01/pdf/02-27797.pdf (最後瀏覽日:2015.6.18)
15.FDA, 2007N-0389: Granisetron Hydrochloride Injection and 180-day Generic Drug Exclusivity (2007), available at http://www.fda.gov/ohrms/dockets/dockets/07n0389/07n0389.html (最後瀏覽日:2015.10.13)
16.FDA, Abbreviated New Drug Application (ANDA): Generics (2014), available at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ (最後瀏覽日:2014.11.10)
17.FDA, Abbreviated New Drug Application Regulations, 57 Fed.Reg. 17950 (April 28, 1992)
18.FDA, Abbreviated New Drug Application Regulations; Patent and Exclusivity Provisions, 54 Fed.Reg. 28872 (July 10, 1989)
19.FDA, Abbreviated New Drug Application Regulations; Patent and Exclusivity Provisions, 59 Fed.Reg. 50338, (October 3, 1994), available at http://www.gpo.gov/fdsys/pkg/FR-1994-11-21/html/X94-21121.htm (最後瀏覽日:2015.6.18)
20.FDA, Abbreviated New Drug Applications and 505(b)(2) Applications, 80 Fed. Reg. 6801 (February 06, 2015), available at http://www.gpo.gov/fdsys/pkg/FR-1998-11-05/pdf/98-29610.pdf (最後瀏覽日:2015.6.18)
21.FDA, Abbreviated New Drug Applications and 505(b)(2) Applications; Extension of Comment Period, 80 Fed. Reg. 22953 (April 24, 2015), available at http://www.gpo.gov/fdsys/pkg/FR-2015-04-24/pdf/2015-09523.pdf (最後瀏覽日:2015.6.18)
22.FDA, Application of 30-Month Stays on Approval of Abbreviated New Drug Applications and Certain New Drug Applications Containing a Certification That a Patent Claiming the Drug Is Invalid or Will Not Be Infringed; Technical Amendment, 69 Fed. Reg. 11309 (March 10, 2004), available at http://www.gpo.gov/fdsys/pkg/FR-2004-03-10/pdf/04-5407.pdf (最後瀏覽日:2015.6.18)
23.FDA, Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed, 67 Fed. Reg. 65448 (October 24, 2002), available at http://www.gpo.gov/fdsys/pkg/FR-2002-10-24/pdf/02-27082.pdf (最後瀏覽日:2015.6.18)
24.FDA, Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed, 68 Fed. Reg. 36676 (June 18, 2003), available at http://www.gpo.gov/fdsys/pkg/FR-2003-06-18/pdf/03-15065.pdf (最後瀏覽日:2015.6.18)
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