逆向給付協議為專利藥廠與學名藥廠間基於彼此之專利訴訟爭端所達成的和解協議類型，就其內容常引發不法延長無效、未受侵權專利排他效力、拖延學名藥上市期程的爭議，對於藥價、健保公衛體系所產生的負面效應更常受到關注，過去亦已陸續有諸多學術研究、司法判決指明此等協議須受競爭法限制之必要性。於美國法制，此議題因Hatch-Waxman法案更受到凸顯，在該藥證取得與藥品專利狀態連結之制度下，一方面有180天專屬銷售期誘使學名藥廠起而挑戰專利藥廠專利，另一方面則有30個月自動停止核准期規範使專利藥廠可藉專利訴訟的發動延後學名藥上市的時間，在此背景下雙方即有較大傾向達成逆向給付協議以將彼此利益最大化，而針對此問題，美國學說及司法實務已有相當詳盡之研究、執法經驗，晚近亦已透過FTC v. Actavis, Inc.案確立依合理原則審查此類型協議的方向，為本文研究較為側重之探究核心；至於歐盟法制，雖先天上與我國相同並未如美國存在專利連結制度，惟因歐體內部藥品專利有效性、侵權爭端主要仍係透過各會員國法院審理，使專利藥廠於訴訟成本提高的狀況下，仍有與較具潛在競爭力之學名藥廠達成逆向給付協議的動機，亦已出現相關案例，因此在其與我國法制現況相近之情況下，亦為本文之次要研究對象。
我國法制目前雖未有逆向給付協議之案例形成，然如何透過現有公平交易法機制處理此議題仍相當重要，特別是未來因應台美FTA談判等國際情勢，或將透過藥事法修正草案引進專利連結制度的情況下更為如此，故本研究即希冀將前述外國法經驗透過比較法研究途徑，供我國未來實務發展做為參考。依本研究結果，美國及歐盟法制皆肯認此類協議並不得以專利權行使為由而排除競爭法之制約，而前者除延續合理原則之實務審查外，現於審查標的已確立包含非現金給付內容之專利和解協議，至於審查要素方面，就專利有效性疑義之釐清與否則尚未形成定見；就後者而言，目前雖以目的性限制原則形式的審查方向為多，但經Servier案後已可見兼採合理原則的趨
勢，未來仍尚待歐盟法院之判決觀察之。經參照前述外國法制經驗後，本研究認我國法在公
平交易法第7、9、14、15及第20條第4-5款的適用上或有其限制，未來或仍可以同法第45條作為主管機關、法院介入此等議題之敲門磚，並可依同法第25條比照美國法制合理原則的處理模式，在廣納各給付類型作為審查標的內涵的前提下，對給付額度、學名藥進入市場是否有所遲延及法規範目的等要素為限制競爭判定，至於專利有效性要素，依我國法制環境多尚無充分資源、條件於審查階段考量，故當前對此部分或應佐以其他有關要素為形式上審查較為適當。

SUMMARY
Reverse Payment Settlement has become a major issue in U.S. and E.U. pharmaceutical environment, owing to its negative effects on competition and the public’s health interest. In U.S., this issue is more difficult to handle with Patent Linkage system, which inducing all types of patent settlement by its mechanism.
After FTC v. Actavis Inc., the U.S. law has determined to apply Rule of Reason to these practices, and decided not to rule out non-monetary payment, however, whether to review patent validity factor deliberately still remains unclear. In E.U., the situation is quite different, both law enforcement and courts still use “by object” approach mainly, but after the case of Servier, it’s possible that the “by effect’’ approach which is similar to U.S. law’s Rule of Reason would be used more frequently in the future.
By learning both foreign laws’ experience, this thesis believes in T.W. law, there is also room for Fair Trading Act to involve in the reverse payment settlement cases, and by the application of Article 45, the Rule of Reason approach would be introduced to the law enforcement process.

Key Words: Reverse Payment Settlement, Competition Law, Rule of Reason, Patent Linkage System, Patent Settlement.

INTRODUCTION
Reverse payment settlement is a type of settlement between Originators and Generics. It’s terms normally raise doubts about the extension of invalid drug patents' exclusive rights and stalling generics' marketing process. Furthermore, It’s negative impact on drug price or public health insurance system also draws the public’s attention, many studies and judgments have long indicated this type of agreements should be restrained by competition laws.
In U.S. law, this issue becomes more significant with Hatch-Waxman Act. By tying drugs' patent status to Drug permit license application process, on one hand, there is 180-day Exclusivity to induce Generics to challenge Originators’ drug patents; on the other hand, Brands' are also able to use Automatic 30-Month Stay to postpone generic drugs’ entry date. Behind these industrial and judicial backgrounds, both parties tend to reach reverse payment settlement in order to maximize each other’s commercial interests. Aiming at this issue, U.S. scholars and courts already has delicate studies and law enforcement experiences, for example, one of the major case this paper focus on - FTC v. Actavis Inc., has already set the path for applying Rule of Reason to these typical agreements.
In E.U. law, though it's unlike U.S. with Patent Linkage system in the pharmaceutical area, owing to patent lawsuit cost and patent territorial principle issue, the market still provides fuel to the occurrence of reverse payment settlements. In fact, several judicial cases have already been brought out in the past few years. Besides this, while the legal environment of EU is close to TW law, it's evolving process is also this paper's secondary research target.
In Taiwan, reverse payment settlement hasn't appeared in judicial cases yet, however, how to deal with this kind of agreements in Fair Trading Act is still crucial, especially in the circumstances that Patent Linkage system might be introduced after FTA trade negotiations or legislative process.

RESULTS AND DISCUSSION
According to this thesis's achievement, both U.S. and E.U. law system affirm the Implementation of patent rights can't be the reason for ruling out the possibility for competition law to apply. The former now also includes non-cash payments into the Rule of Reason scale, but when it comes to patent validity issue, there still hasn't formed conclusion about whether to use it as a factor to weigh the anti-competitive effect.
The latter now not only continue to apply by object rule but also starts to embrace the by effect rule which is familiar to US 's Rule of Reason, however, with a couple cases pending in the European court, it still has a long way to go for the definite conclusion to come.
After reviewing the foregoing foreign laws’ practical experience, as a result, this study advocates that Article 7、9、14、15、20(4)-(5) of Fair Trading Act has its limits on reverse payment settlement cases, therefore, the authority might be able to use Article 45 of Fair Trading Act as a stepping stone to this type of issue, and introducing the Rule of Reason model in the U.S. law into the following trial procedure. At last, while taking both monetary and non-monetary payment into account, by reviewing the amount of payment, generics’ entry delay and the legislative purpose would also be a good way to determine the anti-competitive effect. As to the patent validity factor, considering the lacking of the administrative or judiciary source and the current condition, a formality examination with other related factors might be more suitable at this time.

CONCLUSION
The first and second parts of this thesis will describe the research structure, the pharmaceutical industry and law background in U.S. The third and forth parts will discuss how the U.S. legal system changing from the Per Se Rule to Rule of Reason perspectives on reverse payment settlement cases. After that, this article will introduce the current issues of monetary, non-monetary payment and patent validity in U.S. judiciary process. The fifth part will discover the difference between U.S. law and E.U. law approaches, and to see how Europe Commission and courts apply their competition law in current cases. The sixth part will be centered on T.W. law, in order to see how to apply Fair Trading Act, and reasoning whether the U.S. and E.U. law experience would be suitable to introduce into our legal system. Finally, the seventh part will sum up the above discussion and suggest some routes to further discuss this issue.

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18.智慧財產法院網站，智慧財產案件管轄─民事、行政訴訟事件管轄，http://ipc.judicial.gov.tw/ipr_internet/index.php?option=com_content&view=article&id=121&catid=50&Itemid=100031，最後瀏覽日期：106年6月5日。
19.經濟部工業局2016年生技產業白皮書，http://www.biopharm.org.tw/download/Biotechnology_Industry_in_Taiwan_2016.pdf，經濟部工業局，2016年7月，頁68。最後瀏覽日：2017年3月29日。
20.經濟部談判代表辦公室網站資料， https://www.moea.gov.tw/MNS/otn/content/Content.aspx?menu_id=14117，最後瀏覽日：2017年1月5日。
21.經濟部談判代表辦公室網站資料， https://www.moea.gov.tw/MNS/otn/content/Content.aspx?menu_id=20357，最後瀏覽日:2017年1月4日。
22.鄒玫君，新藥審查，衛生福利部食品藥物管理署藥品組，http://www.fda.gov.tw/upload/133/Content/2014033109011129474.pdf，最後瀏覽日期：2017年2月24日。
23.衛生福利部中央健康保險署，106 年度 C 型肝炎全口服新藥健保給付執行計畫，http://www.nhi.gov.tw/Resource/webdata/32064_3_1060034779-3.pdf，最後瀏覽日期：2017年3月24日。
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二 英文文獻
（一）專書
1.AREEDA & HERBERT HOVENKAMP, ANTITRUST LAW 805b2 (2d ed. 2002).
2.BODER, A GUIDE TO US ANTITRUST LAW, SWEET & MAXWELL (May 23, 2005).
3.HOVENKAMP, FEDERAL ANTITRUST POLICY (2D ED. 1999).
4.HOVENKAMP, FEDERAL ANTITRUST POLICY: THE LAW OF COMPETITION AND ITS PRACTICE (4th ed. 2011).
5.H.L.A. HART, THE CONCEPT OF LAW (3d ed. 2012).
6.LEON SHARGEL, ISADORE KANFER, GENERIC DRUG PRODUCT DEVELOPMENT: SOLID ORAL DOSAGE FORMS, SECOND EDITION (2005).
7.NARD, THE LAW OF PATENTS, ASPEN PUBLISHERS (2008).

（二）期刊
1.Apel, An Administrative Meter Maid: Using Inter Partes Review and Post-Grant Review to Curb Exclusivity Parking via the "Failure to Market" Provision of the Hatch-Waxman Act, 114 MICH. L. REV. 107 (2015).
2.Aoki, The Problem of Reverse Payment in the Pharmaceutical Industry Following Actavis, 67 HASTINGS L.J. 259 (2015-2016).
3.Balto, Pharmaceutical Patent Settlements: The Antitrust Risks, 55 FOOD & DRUG L.J. 321 (2000).
4.Bourke & M. Edward Danberg, Current Trends in Hatch-Waxman Patent Litigation: A System Still in Flux, in PHARMACEUTICAL LAW 2006: ACROSS THE PRODUCT LIFE CYCLE 939 (Practicing Law Inst. ed., 2006).
5.Brown , Reverse Payment Settlements in the European Commission's Pharmaceutical Sector Inquiry Report: A Missed Opportunity to Benefit from U.S. Experience, 33 COLUM. J.L. & ARTS 377 (2010).
6.Butler & Jeffrey Paul Jarosch, Policy Reversal on Reverse Payments: Why Courts Should Not Follow the New DOJ Position on Reverse-Payment Settlements of
Pharmaceutical Patent Litigation, 96 IOWAL. REV. 57 (2010).
7.Brown, 2012 Clinical Legal Education Symposium: Comment: Modest Proposals for a Complex Problem: Patent Misuse and Incremental Changes to the Hatch-Waxman Act As Solutions to the Problem of Reverse Payment Settlements, 41 U. BALT. L. REV. 583 (2012).
8.Balajthy, A Pharmaceutical Park Place: Why The Supreme Court Should Modify The Scope of the Patent Test for Reverse Payment Deals, 20 J.INTELL.PROP.L. 315 (2013).
9.Blume & Rebecca K. Helm, The Unexonerated: Factually Innocent Defendants Who Plead Guilty, 100 CORNELL L. REV. 157 (2014).
10.Bieri, Implications of FTC v. Actavis: A Reasonable Approach to Evaluating Reverse Payment Settlements, 15 MINN. J.L. SCI. & TECH. 135 (2014).
11.Crane, Exit Payments in Settlement of Patent Infringement Lawsuits: Antitrust Rules and Economic Implications, 54 FLA. L. REV. 747 (2002).
12.Crane, Ease Over Accuracy in Assessing Patent Settlements: A Response to Herbert Hovenkamp, Mark Janis, and Mark A. Lemley, Anticompetitive Settlement of Intellectual Property Disputes, 88 MINN. L. REV. 698 (2003).
13.Chen, Authorized Generics: A Prescription For Hatch-Waxman Reform, 93 VA. L. REV. 459 (2007).
14.Carrier, Solving the Drug Settlement Problem: The Legislative Approach, 41 RUTGERS L.J. 83 (2009).
15.Chatterji & Xiang Yu, Why Brand Pharmaceutical Companies Choose to Pay Generics in Settling Patent Disputes: A Systematic Evaluation of Asymmetric Risks in Litigation, 10 NW. J. TECH. & INTELL. PROP. 19 (2011).
16.Carrier, Payment After Actavis, 100 IOWA L. REV. 7 (2014).
17.Cotter, FTC v. Actavis, Inc.: When Is the Rule of Reason Not the Rule of Reason?, 15 Minn. J.L. Sci. & Tech. 41 (2014).
18.Carrier, How Not to Apply Actavis, 109 NW. U. L. REV. ONLINE 113 (2015).
19.Carrier, Eight Reasons Why ‘’No-Authorized-Generic’’ Promises Constitute Payment, 67 RUTGERS U. L. REV. 697 (2015).
20.Dickey, Jonathan Orszag & Laura Tyson, An Economic Assessment of Patent Settlements in the Pharmaceutical Industry, 19 ANNALS HEALTH L. 367 (2010).
21.Dolin, M.D., Reverse Settlements as Patent Invalidity signals, 24 HARV. J. LAW & TEC 281 (2011).
22.Davis and Ryan J. McEwan, Deactivating Actavis: The Clash Between the Supreme Court and (some) Lower Courts, 67 RUTGERS U. L. REV. 557 (2015).
23.Edlin, Scott Hemphill, Herbert Hovencamp & Carl Shaprio, Activating Actavis, 28 ANTITRUST ABA 16 (Fall 2013).
24.Edlin, Scott Hemphill, Herbert Hovenkamp and Carl Shapiro, The Actavis Inference: Theory and Practice, 67 RUTGERS U. L. REV. 585 (2015).
25.Frank & David S. Salkever, Generic Entry and the Pricing of Pharmaceuticals, 6 J. ECON. & MGMT. STRATEGY 75 (1997).
26.Fischman, The Circular Logic of Actavis, 66 AM. U.L. REV. 91 (2016).
27.Grabowski & John Vernon, Longer Patents for Increased Generic Competition: The Waxman-Hatch Act After One Decade, 10 PHARMACOECON. SUPP. 2 (1996).
28.Geradin, Douglas Ginsburg, and Graham Safty, Reverse Payment Patent Settlements In the E.U. and U.S.A., GEORGE MASON LAW & ECONOMICS RESEARCH PAPER 15 (2015).
29.Hovenkamp, Mark Janis & Mark A. Lemley,Anticompetitive Settlement of Intellectual Property Disputes, 87 MINN. L. REV. 1719 (2003).
30.Holmes, The Path of the Law, 110 HARV. L. REV. 991 (1997).
31.Hovenkamp, Sensible Antitrust Rules for Pharmaceutical Competition, 39 U.S. F. L. REV.11 (2004).
32.Hemphill, Paying for Delay: Pharmaceutical Patent Settlement as a Regulatory Design Problem, 81 N.Y.U. L. REV. 1553 (2006).
33.Hemphill, Collusive and Exclusive Settlements of Intellectual Property Litigation, 2010 COLUM. BUS. L. REV. 685 (2010).
34.Hogges-Thomas, Special Issue on Circuit Split: Winning the War on Drug Price: Analyzing Reverse Payment Settlements Through the Lens of Trinko, 64 HASTINGS L.J. 1421 (2013).
35.Ingle, Reverse Payment Settlements: A Patent Approach to Defending the Argument for Illegality, 7 I/S: J.L. & POL’Y FOR INFO. SOC’Y 503 (2012).
36.Juckniess, Don’t Settle for Less? : Antitrust Risks of Settling Your Intellectual Property Lawsuit After Actavis, 93 ML BAR JNL. 34 (2014).
37.Kelly, The Balance Between Innovation and Competition: The Hatch-Waxman Act, the 2003 Amendments, and Beyond, 66 FOOD DRUG L.J. 417 (2011).
38.Khatibifar, The Need for a Patent-Centric Standard of Antitrust Review to Evaluate Reverse Payment Settlements, 23 FORDHAM INTELL. PROP. MEDIA & ENT. L.J. 1351 (2013).
39.Knuckles, Reverse Payment Settlements: The Ongoing Dilemma After FTC v. Actavis, 8 BROOK. J. CORP. FIN. & COM. L. 516 (2014).
40.Krickl & Matthew Avery, Roberts Was Wrong: Increased Antitrust Scrutiny after FTC v. Actavis Has Accelerated Generic Competition, 19 VA. J.L. & TECH. 509 (2015).
41.Luban, The Bad Man and the Good Lawyer: A Centennial Essay on Holmes's The Path of the Law, 72 N.Y.U. L. REV. 1547 (1997).
42.Morse, Product Market Definition in the Pharmaceutical Industry, 71 ANTITRUST L.J. 633 (2003).
43.Miller, Antitrust Analysis After Actavis: Applying the Rule of Reason to Reverse Payments, 15 WAKE FOREST J. BUS. & INTELL. PROP. L. 382 (2015).
44.Pitofsky, New Definitions of Relevant Market and the Assault on Antitrust, 90 COLUM. L. REV. 1805 (1990).
45.Shapiro, Antitrust Limits to Patent Settlements, 34 RAND J. ECON. 391 (2003).
46.Sobel, Consideration of Patent Validity in Antitrust Cases Challenging Hatch-Waxman Act Settlements, 20 FED. CIR. B.J. 47 (2010).
47.Taavola, The 30th Anniversary of the Hatch-Waxman Act: Jumping into the Actavis Briar Patch – Insight Into How Courts May Structure Reverse Payment Antitrust Proceedings and the Questions That Actavis Left Unanswered, 40 Wm. Mitchell L. Rev. 1370 (2014).
48.Vaishnav, Survey: Product Market Definition in Pharmaceutical Antitrust Case: Evaluating Cross-Price Elasticity of Demand, 2011 COLUM. BUS. L. REV. 586 (2011).
49.Virtue, FTC v. Actavis: Analysis of the Court's Decision and How it Affects Drug Prices for Those Who Need Them the Most, 21 WASH. & LEE J. CIVIL RTS. & SOC. JUST. 121 (2014).
50.Wang, Reanalyzing Reverse-Payment Settlements: A Solution to the Patentee’s Dilemma, 99 CORNELL L. REV. 1227 (2014).

（三）學位論文
1.Karus, Definition of Relevant Product Market in Reference to R&D Poles in Pharmaceutical Sector Mergers, FACULTY OF LAW LUND UNIVERSITY JAEM03 MASTER THESIS (2015).
2.Şahin, Reviving an Old Debate: The Rule of Reason under Article 101, THESIS/RESEARCH REPORT OF LL.M. IN COMPETITION LAW KING’S COLLEGE LONDON (2013).

（四）其他網路資料
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