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)
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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).
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53.In re Buspirone Patent Litigation, 185 F.Supp.2d 363 (S.D.N.Y.2002).”
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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)
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72.Mova Pharmaceutical Corp. v. Shalala, 955 F. Supp. 128 (D.D.C. 1997)
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100.Takeda Chem. Indus., Ltd. v. Mylan Laboratories, Inc., 549 F.3d 1381 (Fed. Cir. 2008),
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