反竞争性专利和解协议与最高法院对阿特维斯案的判决
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摘要
在联邦贸易委员会诉阿特维斯案中,最高法院认为一个涉及品牌药的专利权人向仿制药侵权人支付以使其离开市场的专利侵权诉讼和解协议,根据反垄断法可能是违法的。布雷耶大法官的多数意见令人惊讶地宽泛,这表现在两个关键的意义上。首先,他谈到了一种远远超出仿制药争议范畴的普遍性,这些争议已经引发了大量的延迟支付和解协议。其次是法院选择的侵略性做法。一种显而易见的替代方案是大多数巡回法院普遍采用的规则,即任何和解协议如果它表面上在"专利范围内",则免受反垄断攻击。根据这种方法,法院可能不会通过调查专利的有效性来对和解协议进行二次推测;和解协议本身就可以屏蔽法院的这种质疑。第二种替代选择是,一个巨额的和解付款就表明专利存在问题,从而提请法院更密切地审视基础专利,以确定和解是否真的是一种管理诉讼和商业风险的善意尝试。第三种方法是,根据反垄断合理原则,与诉讼风险不成比例的大额和解排除支付可能是违法的,而无需询问专利是否事实上无效,即使和解协议并未超出专利名义上覆盖的范围。最后,法院可能会应用"快速审查",或者缩短的反垄断分析,其中原告可以享有关于市场力量或反竞争效果的推定。最高法院选择了第三种方法,即合理原则,但它明确指出原告不需要完成一个长形式的合理原则的证明,并提出重要的捷径。同样重要的是,双方无异议地一致认为消费者福利应当是反垄断法的目标。数额大小与风险相关的支付对于企业决策至关重要,但企业风险通常是私有的,因为企业拿自己股东的资源冒风险。然而,在药品延迟支付的环境中,被置于风险中的是原研药企的投资和消费者福利,这是两种相反方向上的利益。消费者代表了一种重要的外部性。他们不是这场纠纷的参与者,但他们将失去原本会发生的竞争的好处。传统的和解协议反映了他们所谓的专利无效的风险。例如,由于各方直观认为专利较弱,和解的许可费率将较低。哈奇—韦克斯曼法案创造了一种独特的激励,让各方去消除专利中的所有风险,因为在和解协议的有效期内,没有第三方会对专利提出质疑。即使是一个非常弱的专利也能获得对第三方的排他性以及与专利产品全部卡特尔价值相当的利润。虽然法院没有讨论私人消费者的挑战,但它对法律的实质性修改同样适用于私人诉讼,并且可以合理地预期会出现一些私人诉讼。尽管那些从反竞争的延迟支付和解协议中寻求反垄断超额赔偿的购买者将受到法院为联邦贸易委员会创建的相同的合理原则限制,但是他们应该能够在不用证明专利无效的情况下继续进行诉讼。最后,阿特维斯案意见的宽泛使其与哈奇—韦克斯曼制度语境外的许多情况发生关联。例如,最高法院的判决严格限制了它在1926年通用电气案中允许专利及其被许可人之间进行价格固定的决定,并含蓄地否决了诸如比门特案的决定,这些决定允许一个专利池内的成员之间进行产品价格固定。一个核心问题是,专利法是否明确地或是通过合理的暗示,授权了被质疑的行为。如果答案是否定的,则可以进行一般性的反垄断分析。
In FTC v. Actavis the Supreme Court held that settlement of a patent infringement suit in which the patentee of a branded pharmaceutical drug pays a generic infringer to stay out of the market may be illegal under the antitrust laws. Justice Breyer's majority opinion was surprisingly broad, in two critical senses. First, he spoke with a generality that reached far beyond the pharmaceutical generic drug disputes that have provoked numerous pay-for-delay settlements.Second was the aggressive approach that the Court chose. The obvious alternatives were the rule that prevailed in most Circuits, that any settlement is immune from antitrust attack if it is facially "within the scope of the patent." Under this approach the court may not second guess the settlement by inquiring into the validity of the patent; the settlement itself shields this query from the court. A second alternative concludes that a very large settlement payment is a sign that something is wrong with the patent, inviting the court to look more closely at the underlying patent to determine whether the settlement is really a good faith attempt to manage litigation and business risk. A third approach is that a large settlement exclusion payment disproportionate to litigation risk can be unlawful under antitrust's rule of reason,without inquiry into whether the patent is actually invalid, and even if the settlement agreement does not go "beyond the scope" of the patent's nominal coverage. Finally, the court might apply a "quick look," or truncated, antitrust analysis in which the plaintiff can enjoy presumptions about market power or anticompetitive effect. The Supreme Court chose the third, or rule of reason, option, but it made clear that the plaintiff need not make a long form rule of reason showing and suggested important shortcuts.Also significant is that both sides, without dissent agreed that consumer welfare should be the goal of antitrust law.Payments whose size correlates with risk are essential to entrepreneurial decision making, but entrepreneurial risk is usually private in the sense that the firm risks the resources of its own shareholders. In the pharmaceutical pay-fordelay setting, however, what is being placed at risk is both the investment of the pioneer and the welfare of consumers,interests that pull in opposite directions. Consumers represent an important externality. They are not participants in this dispute, but they stand to lose the benefits of competition that would otherwise have occurred. Traditional settlements reflect the risk of patent invalidity in their terms. For example, as a patent is perceived by the parties to be weaker,settlement royalties rates will be lower. The Hatch Waxman Act uniquely creates an incentive for the parties to take all risk out of the patent because for the life of the settlement no third party may challenge it. Even a very weak patent can obtain both exclusion against third parties and profits equal to the full cartel value of the patented product.While the Court did not discuss private consumer challenges, its substantial revision of the law applies equally to private actions and it is reasonable to expect that several will emerge. Purchasers seeking antitrust overcharge damages from an anticompetitive pay-for-delay settlement should be able to proceed without proving patent invalidity, although they would be subject to the same rule-of-reason constraints that the Court created for the FTC.Finally, the breadth of the Activis opinion makes it relevant for many situations outside of the Hatch-Waxman context. For example, the Court's dicta severely limited its 1926 GE decision permitting price fixing among a patent and its licensees, and implicitly overruled decisions such as Bement, which permitted product price fixing among the members of a patent pool. A central question was whether the Patent Act, either explicitly or by reasonable implication,authorized the challenged conduct. If the answer is no, ordinary antitrust analysis can proceed.
In FTC v. Actavis the Supreme Court held that settlement of a patent infringement suit in which the patentee of a branded pharmaceutical drug pays a generic infringer to stay out of the market may be illegal under the antitrust laws. Justice Breyer's majority opinion was surprisingly broad, in two critical senses. First, he spoke with a generality that reached far beyond the pharmaceutical generic drug disputes that have provoked numerous pay-for-delay settlements.Second was the aggressive approach that the Court chose. The obvious alternatives were the rule that prevailed in most Circuits, that any settlement is immune from antitrust attack if it is facially "within the scope of the patent." Under this approach the court may not second guess the settlement by inquiring into the validity of the patent; the settlement itself shields this query from the court. A second alternative concludes that a very large settlement payment is a sign that something is wrong with the patent, inviting the court to look more closely at the underlying patent to determine whether the settlement is really a good faith attempt to manage litigation and business risk. A third approach is that a large settlement exclusion payment disproportionate to litigation risk can be unlawful under antitrust's rule of reason,without inquiry into whether the patent is actually invalid, and even if the settlement agreement does not go "beyond the scope" of the patent's nominal coverage. Finally, the court might apply a "quick look," or truncated, antitrust analysis in which the plaintiff can enjoy presumptions about market power or anticompetitive effect. The Supreme Court chose the third, or rule of reason, option, but it made clear that the plaintiff need not make a long form rule of reason showing and suggested important shortcuts.Also significant is that both sides, without dissent agreed that consumer welfare should be the goal of antitrust law.Payments whose size correlates with risk are essential to entrepreneurial decision making, but entrepreneurial risk is usually private in the sense that the firm risks the resources of its own shareholders. In the pharmaceutical pay-fordelay setting, however, what is being placed at risk is both the investment of the pioneer and the welfare of consumers,interests that pull in opposite directions. Consumers represent an important externality. They are not participants in this dispute, but they stand to lose the benefits of competition that would otherwise have occurred. Traditional settlements reflect the risk of patent invalidity in their terms. For example, as a patent is perceived by the parties to be weaker,settlement royalties rates will be lower. The Hatch Waxman Act uniquely creates an incentive for the parties to take all risk out of the patent because for the life of the settlement no third party may challenge it. Even a very weak patent can obtain both exclusion against third parties and profits equal to the full cartel value of the patented product.While the Court did not discuss private consumer challenges, its substantial revision of the law applies equally to private actions and it is reasonable to expect that several will emerge. Purchasers seeking antitrust overcharge damages from an anticompetitive pay-for-delay settlement should be able to proceed without proving patent invalidity, although they would be subject to the same rule-of-reason constraints that the Court created for the FTC.Finally, the breadth of the Activis opinion makes it relevant for many situations outside of the Hatch-Waxman context. For example, the Court's dicta severely limited its 1926 GE decision permitting price fixing among a patent and its licensees, and implicitly overruled decisions such as Bement, which permitted product price fixing among the members of a patent pool. A central question was whether the Patent Act, either explicitly or by reasonable implication,authorized the challenged conduct. If the answer is no, ordinary antitrust analysis can proceed.
引文
1.FTC v.Actavis,Inc.,133 S.Ct.2223,2229(2013).
2.同上注,第2230-2231页。
3.同上注,第2237-2238页。
4.同上注,第2227页。
5.同上注(参见FTC v.Watson Pharm.,Inc.,677 F.3d 1298,1312(11th Cir.2012))。
6.Actavis,133 S.Ct.at 2227(引自12 HERBERT HOVENKAMP,ANTITRUST LAW?2046,第338页(3d ed.2012);Herbert Hovenkamp,Sensible Antitrust Rules for Pharmaceutical Competition,39 U.S.F.L.REV.11,24(2004))(附加的内部引文已省略)。
7.参见注42-57对应的后文。
8.参见Actavis,133 S.Ct.at 2239(罗伯茨,C.J.,异议)(“如果[专利持有人的]行为在专利范围内,则它们不受反垄断审查……”)。
9.In re K-Dur Antitrust Litig.,686 F.3d 197,214(3d Cir.2012)(拒绝“专利范围”测试法)。
10.FTC v.Watson Pharm.,Inc.,677 F.3d 1298,1312(11th Cir.2012)(“[一个]反向支付和解协议免受反垄断攻击,只要其反竞争效果落于专利的排他性潜在范围之内。”);也可参见In re Ciprofloxacin Hydrochloride Antitrust Litig.,544 F.3d1323,1332-37(Fed.Cir.2008);In re Tamoxifen Citrate Antitrust Litig.,466 F.3d 187,212-13(2d Cir.2006);Valley Drug Co.v.Geneva Pharm.,Inc.,344 F.3d 1294,1304,1308(11th Cir.2003).关于专利和解协议的司法尊重,一般参见12 Hovenkamp,前注6,?2046。关于较早先例所采取的做法,参见1 HERBERT HOVENKAMP,MARK D.JANIS,MARK A.LEMLEY&CHRISTOPHER R.LESLIE,IP AND ANTITRUST:AN ANALYSIS OF ANTITRUST PRINCIPLES APPLIED TOINTELLECTUAL PROPERTY LAW,§15.3a1(B)(2d ed.Supp.2012).
11.Actavis,133 S.Ct.at 2234(citing several decisions).
12.参见CHRISTINA BOHANNAN&HERBERT HOVENKAMP,CREATION WITHOUT RESTRAINT:PROMOTINGLIBERTY AND RIVALRY IN INNOVATION 93-96(2012);Gregory Dolin,Reverse Settlements as Patent Invalidity Signals,24 HARV.J.L.&TECH.281,324-26(2011).
13.Actavis,133 S.Ct.at 2237-38.
14.药品价格竞争和专利期限恢复(哈奇-韦克斯曼)法案,Pub.L.No.98-417,98 Stat.1585(1984)(在15,21,28和35的分散章节进行了修订)。
15.Actavis,133 S.Ct.at 2228(“哈奇-韦克斯曼程序通过允许仿制药企搭乘原研药企审批努力之便车的方式,‘加速了低成本仿制药向市场的引入’……”(转引自Caraco Pharm.Labs.,Ltd.v.Novo Nordisk A/S,132 S.Ct.1670,1676(2012))。
16.参见上注;Caraco,132 S.Ct.at 1676.
17.21 U.S.C.§355(j)(2012).
18.参见,如C.Scott Hemphill&Mark A.Lemley,Earning Exclusivity:Generic Drug Incentives and the Hatch-Waxman Act,77 ANTITRUST L.J.947,952(2011).
19.首席大法官罗伯茨的异议意见指出,本案中的当事人在达成延迟支付和解协议前,已经陷入了三年的诉讼。Actavis,133 S.Ct.at 2238(罗伯茨,C.J.,异议)。但是,因为该法案不允许在诉讼持续满30个月之前让另一个仿制药企进入市场,对于当事人而言,没有什么激励促使他们在那之前就达成协议。
20.21 U.S.C.§355(j)(5)(B)(iv)(2012).
21.布雷耶大法官的观点简要描述了这一程序。Actavis,133 S.Ct.at 2228.关于更多的细节和分析,参见12HOVENKAMP,前注6,?2046c,第340-341页;Hemphill&Lemley,前注18,第956-958页;C.Scott Hemphill,Paying for Delay:Pharmaceutical Patent Settlement as a Regulatory Design Problem,81 N.Y.U.L.REV.1553,1583-86(2006)(描述了“制度红利”,其将第一仿制药申报人区别于后续挑战者);Herbert Hovenkamp,Mark Janis&Mark A.Lemley,Anticompetitive Settlement of Intellectual Property Disputes,87 MINN.L.REV.1719,1754-56(2003).
22.Actavis,133 S.Ct.at 2234-35(分析了由专利和解协议提供的消费者福利);同上注,at 2238(罗伯茨,C.J.,异议).
23.Actavis,133 S.Ct.at 2238(罗伯茨,C.J.,异议).
24.参见,例如,HERBERT HOVENKAMP,FEDERAL ANTITRUST POLICY:THE LAW OF COMPETITION AND ITSPRACTICE§§4.1-4.2,at 158-78(4th ed.2011).
25.Actavis,133 S.Ct.at 2235(引自Hemphill,Paying for Delay,前注21,第1581页);也可参见Carl Shapiro,Antitrust Limits to Patent Settlements,34 RAND J.ECON.391,408(2003).
26.参见,例如,LUKE M.FROEB ET AL.,MANAGERIAL ECONOMICS 26(3d ed.2014)(“因为[沉没]成本不随着改变产出的决定而变化,所以在关于产出变化的决定中不应当考虑它们。”).
27.参见上注。
28.参见,例如,上注,第62-63页。
29.参见Nabil I.Al-Najjar,Sandeep Baliga&David Besanko,The Sunk Cost Bias and Managerial Pricing Practices(SSRNWorking Paper,Oct.2005),available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=825986(对该文献进行了总结和解释).
30.FTC,GENERIC DRUG ENTRY PRIOR TO PATENT EXPIRATION:AN FTC STUDY 9(2002)[下文简称FTC STUDY],available at www.ftc.gov/os/2002/07/genericdrugstudy.pdf.
31.参见Einer Elhauge&Alex Krueger,Solving the Patent Settlement Puzzle,91 TEX.L.REV.283,316(2012)(得出的结论是,单个仿制药的进入价格是原研药公司进入前价格的70-88%).
32.CONG.BUDGET OFFICE(CBO),EFFECTS OF USING GENERIC DRUGS ON MEDICARE’S PRESCRIPTIONDRUG SPENDING 8-9(Sept.2010),available at http://cbo.gov/sites/default/files/cbofiles/ftpdocs/118xx/doc11838/09-15-prescriptiondrugs.pdf.
33.参见,例如,Rebecca S.Eisenberg,The Role of the FDA in Innovation Policy,13 MICH.TELECOMM.&TECH.L.REV.345,354(2007).
34.参见C.Scott Hemphill&Bhaven Sampat,Drug Patents at the Supreme Court,339 SCIENCE 1386,1387(Mar.22,2013);FTC STUDY,前注30,第16页(发现仿制药申请者73%的时间占优);也可参见Caraco Pharm.Labs.,Ltd.v.Novo Nordisk A/S,132 S.Ct.1670,1673(2012)(允许仿制药企挑战那些限制指定药品之应用的过于宽泛的“使用规范”).相比之下,被诉专利的一般无效性概率在40%-50%范围内。John R.Allison&Mark A.Lemley,Empirical Evidence on the Validity of Litigated Patents,26 AIPLA Q.J.185,194,205-06(1998).
35.参见C.Scott Hemphill&Bhaven N.Sampat,Evergreening,Patent Challenges,and Effective Market Life in Pharmaceuticals,31 J.HEALTH ECON.327,334(2012);C.Scott Hemphill&Bhaven N.Sampat,When Do Generics Challenge Drug Patents?,8 J.EMPIRICAL LEGAL STUD.613,621(2011).
36.参见Second Amended Complaint for Injunctive and Other Equitable Relief?31,FTC v.Watson Pharm.,Inc.,No.1:09-CV-00955-TWT(N.D.Ga.May 28,2009).
37.参见下注38和对应的正文。
38.独占期间从提交仿制药ANDA申请之时起算,直至提起专利侵权诉讼后的30个月,或是仿制药进行生产后的180天。参见21 U.S.C.§§355(j)(B)(iii),355(j)(B)(iv)(2012).不同于欧盟法,美国不允许任何人对专利提出质疑;该权利主要限于被控侵权或面临一个侵权索赔的现实威胁的那些人。在这种情况下,哈奇-韦克斯曼法通过自身条款阻止除了ANDA申请者之外的所有人侵权。关于欧盟的程序,参见Guidelines for Examination,Part D-Guidelines for Opposition and Limitation/Revocation Procedures,EUR.PATENT OFF.,http://www.epo.org/law-practice/legal-texts/html/guidelines/e/d.htm(last updated Sept.16,2013).
39.Cf.Ritz Camera&Image,LLC v.SanDisk Corp.,700 F.3d 503,508(Fed.Cir.2012)(允许消费者根据反垄断法对其宣称的非法专利排他行为提出挑战).
40.In re K-Dur Antitrust Litig.,686 F.3d 197(3d Cir.2012),vacated sub nom.Merck&Co.,Inc.v.La.Wholesale Drug Co.,133 S.Ct.2849(2013);see also In re DDAVP Direct Purchaser Antitrust Litig.,585 F.3d 677,691-92(2d Cir.2009)(允许消费者挑战据称抬高仿制药价格的原研药企和仿制药企之间的协议).
41.参见Merck&Co.,133 S.Ct.at 2849.
42.关于限制较小的替代方法与合理原则分析的相关性,参见7 PHILLIP E.AREEDA&HERBERT HOVENKAMP,ANTITRUST LAW?1505b,at 417-19(3d ed.2010).
43.参见Actavis,133 S.Ct.at 2235(引自1 HOVENKAMP,JANIS,LEMLEY&LESLIE,前注10,§15.3,at p.15-45 n.161(2d ed.Supp.2011)).
44.参见Actavis,133 S.Ct.at 2243(罗伯茨,C.J.,异议)(discussing Marc G.Schildkraut,Patent-Splitting Settlements and the Reverse Payment Fallacy,71 ANTITRUST L.J.1033,1046(2004)).
45.同上注。
46.Metro-Goldwyn Mayer,Inc.v.007 Safety Prods.,Inc.,183 F.3d 10(1st Cir.1999).
47.同上注,第13页。
48.同上注。
49.同上注。
50.In Time Prods.,Ltd.v.Toy Biz,Inc.,38 F.3d 660,662(2d Cir.1994).
51.同上注。
52.参见Douglas F.Gray,Microsoft Sues Lindows.com over Name,TECH HIVE(Dec.21,2001,8:00 AM),http://www.pcworld.com/article/77163/article.html.
53.参见Brief for Respondent Actavis,Inc.at 54 n.20,FTC v.Actavis,Inc.,133 S.Ct.2223(2013)(No.12-416),2013 WL662705,at*54 n.20;Joris Evers,Microsoft,Lindows Make a Deal,TECH HIVE(July 19,2004,2:00 PM),http://www.techhive.com/article/116947/article.html.
54.参见Microsoft Corp.v.Lindows.com,Inc.,No.C01-2115C,2002 WL 32085605 at*3-5(W.D.Wash.May 13,2002).
55.参见Microsoft Corp.v.Lindows.com,Inc.,No.C01-2115C,2004 WL 329250(W.D.Wash.Feb.10,2004).
56.参见上注;Microsoft Corp.v.Lindows.com,Inc.,No.C01-2115C,2002 WL 31499324(W.D.Wash.Mar.15,2002).
57.“延迟支付”这一术语在这里似乎是不合适的,因为在被讨论案件中系争商标的期限是无限的。这些和解协议很可能是“永久的”,让被告永久地退出市场。
58.布雷耶大法官恰当地驳回了一项被他归于异议意见的建议,即专利权人如果以低于其最初要求的筹码达成和解,则实际上是在接受对剩余期限的“反向支付”。参见Actavis,133 S.Ct.at 2233(discussing Schildkraut,前注44,第1046页).布雷耶大法官提及了专利权人,其要求一个从事生产的侵权者为侵权行为赔偿1亿美元,并最终以4000万美元的赔偿金达成和解,布雷耶大法官指出这实际上相当于未支付6000万美元的“反向付款”。同上注。无论如何,在这个故事中所谓的侵权者实际上是在生产而不是退出市场,而且许可费的大小是无关紧要的。事实上,在没有任何侵权诉讼的情况下,专利权人可以合法地接受其希望从生产商处获得的任何价格作为许可费。
59.BOHANNAN&HOVENKAMP,前注12,第83-85页。
60.参见1A PHILLIP E.AREEDA&HERBERT HOVENKAMP,ANTITRUST LAW??240-44(4th ed.2013).
61.即使是最高法院在Walker过程设备案(Walker Process Equip.,Inc.v.Food Mach.&Chem.Corp.,382 U.S.172,177(1965))的规则,也并未涉及为获得一个专利的在先销售而对虚假陈述的最初使用,而是涉及对一个在侵权诉讼中已知无效的专利的授予后声明。参见3 PHILLIP E.AREEDA&HERBERT HOVENKAMP,ANTITRUST LAW?706(3d ed.2008).根据美国法,仅仅通过欺诈或不公平行为获取专利,会受到专利法以及美国专利和商标局程序的约束,而不是诉诸反垄断法。参见上注,?706,第255页(“作为一项一般性的主张,仅仅通过欺诈获得专利而没有后续的执行尝试,则并不是[反托拉斯法]下的排他性做法。”).
62.参见5 PHILLIP E.AREEDA&HERBERT HOVENKAMP,ANTITRUST LAW?1202f,at 273(3d ed.2009)(专利是受反垄断法并购规范调整的“资产”).
63.United States v.Line Material Co.,333 U.S.287,315(1948).
64.15 U.S.C.§14(2012)(禁止搭售或独家交易等反竞争性使用,“无论其是专利产品抑或非专利产品”).
65.关于明示豁免,参见1A AREEDA&HOVENKAMP,前注60,?243b,第336-338页。
66.Cf.Hemphill,Paying for Delay,前注21,第1574页(“由于医药专利案件具有高技术性,很多联邦法官宁愿避免这类案件,因而[一种支持和解的司法反应]可能会异常剧烈。”).
67.作为例外的一些情况是,和解还考虑产品价格固定、市场分割或可能损害消费者的其他限制。参见12HOVENKAMP,前注6,??2046b4-2046b5.
68.参见,例如,Michael J.Chapman,Using Settlement Licenses in Reasonable Royalty Determinations,49 IDEA 313,315-16(2009).
69.35 U.S.C.§261(2006&Supp.V 2011).
70.FTC v.Actavis,Inc.,133 S.Ct.2223,2232-33(discussing Standard Oil Co.(Ind.)v.United States,283 U.S.163,174(1931)).
71.United States v.Gen.Elec.Co.,272 U.S.476,494(1926)(支持专利权人与单一在生产的被许可人之间的固定后者产品价格的许可协议);E.Bement&Sons v.Nat’l Harrow Co.,186 U.S.70(1902)(支持固定产品价格的专利池).
72.United States v.Singer Mfg.Co.,374 U.S.174(1963).
73.E.g.,Hartford-Empire Co.v.United States,323 U.S.386(1945).Cf.Palmer v.BRG of Ga.,Inc.,498 U.S.46(1990)(将本身违法原则适用于带有地域分割性质的水平商标许可协议).
74.35 U.S.C.§261(2006&Supp.V 2011).
75.Actavis,133 S.Ct.at 2231(转引自United States v.Line Material Co.,333 U.S.287,310-11(1948)).
76.Actavis,133 S.Ct.at 2233.
77.同上注,第2234页。
78.参见Robert P.Merges,One Hundred Years of Solicitude:Intellectual Property Law,1900-2000,88 CAL L.REV.2187,2200(2000);Liza Vertinsky,Comparing Alternative Institutional Paths to Patent Reform,61 ALA.L.REV.501,526(2010)(“实际上,产业集团在影响甚至是起草知识产权立法方面的作用已经被注意到了……”)。
79.参见Herbert Hovenkamp,Consumer Welfare in Competition and Intellectual Property Law,9 COMPETITION POL’YINT’L J.(forthcoming 2013),available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2329150;Craig Allen Nard,Legal Forms and the Common Law of Patents,90 B.U.L.REV.51,52 n.2(2010).
80.参见HERBERT HOVENKAMP,THE OPENING OF AMERICAN LAW:NEOCLASSICAL LEGAL THOUGHT,1870-1970 at ch.10(forthcoming 2014);也可参见Nard,前注79,第72页(“1952年法案的核心是对前几年最高法院的专利法学理论的直接回应。”).
81.35 U.S.C.§271(d)(4)-(5)(2006&Supp.V 2011);也可参见Christina Bohannan,IP Misuse as Foreclosure,96 IOWA L.REV.475,487-88(2012).
82.Actavis,,133 S.Ct..at 2237.
83.同上注,第2230页。
84.同上注。
85.同上注,第2236-2237页(引自12 HOVENKAMP,前注6,?2046第350-352页)(emphasis added).
86.Actavis,133 S.Ct.at 2237-38(转引自Cal.Dental Ass’n v.FTC,526 U.S.756,780(1999)(转引自7 PHILLIPAREEDA&HERBERT HOVENKAMP,ANTITRUST LAW?1507,at 402(1st ed.1986))).
87.参见David L.Schwartz,Practice Makes Perfect?An Empirical Study of Claim Construction Reversal Rates in Patent Cases,107 MICH.L.REV.223,246(2008)(根据所使用的定义,发现在索赔结构中地区法院的出错率在25%到50%之间);也可参见J.Jonas Anderson&Peter S.Menell,Informal Deference:An Historical,Empirical,and Normative Analysis of Patent Claim Construction,108 NW.U.L.REV.(forthcoming 2013),available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2150360.
88.Allison&Lemley,前注34;也可参见Ted L.Field,“Juridical Hyperactivity”in the Federal Circuit:An Empirical Study,46U.S.F.L.REV.721,723(2012)(发现联邦巡回法院被推翻的概率要高于其他被研究的巡回法院).关于特定地区法院的推翻概率,参见Teresa Lii,Shopping for Reversals:How Accuracy Differs Across Patent Litigation Forums,12 CHI.-KENT J.INTELL.PROP.31,43(2013)(观察很多地区法院,发现加权平均的推翻率为37.8%).
89.参见前注34-36和对应的正文。
90.Actavis,133 S.Ct.at 2236.
91.同上注,第2231页(内部引文已省略).
92.参见,例如,上注,2231页(“法院必须‘平衡[专利持有人]的及其被许可人根据专利授权获得的特权与谢尔曼法对联合和试图垄断的禁止’”(转引自United States v.U.S.Gypsum Co.,333 U.S.364,390-91(1948))).
93.Actavis,133 S.Ct.at 2232(discussing United States v.Gen.Elec.Co.,272 U.S.476,489(1926)).一些低层法院已经采纳了该公式。参见12 HOVENKAMP,前注6,?2041b.
94.E.Bement&Sons v.Nat’l Harrow Co.,186 U.S.70(1902).
95.参见7 AREEDA&HOVENKAMP,前注42,?1502,第389页.
96.Actavis,133 S.Ct.at 2238.
97.参见7 AREEDA&HOVENKAMP,前注42,??1507,1508c.
98.Actavis,133 S.Ct.at 2237-38(转引自Cal.Dental Ass’n v.FTC 526 U.S.756,780(1999)(转引自7 AREEDA&HOVENKAMP,前注86,?1507,第402页)(内部标点符号已省略)).
99.同上注,第2237页。
100.同上注,第2236页(转引自12 HOVENKAMP,前注6,?2046,第351页).
101.参见2B PHILLIP E.AREEDA,JOHN L.SOLOW&HERBERT HOVENKAMP,ANTITRUST LAW??515,521(3d ed.2007)(在?515部分描述了价格-成本差额和在?521部分描述了基于需求弹性的直接测量方法).
102.勒纳指数也称为勒纳垄断势力指数。它通过对价格与边际成本偏离程度的度量,反映市场中垄断力量的强弱(译者注)。
103.2B PHILLIP E.AREEDA&HERBERT HOVENKAMP,ANTITRUST LAW?520e(forthcoming 4th ed.2014)
104.同上注.??536-539.
105.Actavis,133 S.Ct.at 2236.
106.同上注,第2237页。
107.同上注,第2236页。
108.同上注。
109.同上注。
110.参见,例如,PhRMA Statement on Supreme Court Ruling in Patent Settlement Case,PHRMA(June 17,2013),http://phrma.org/phrma-statement-on-supreme-court-ruling-in-patent-settlement-case.
111.参见Antitrust Guidelines for the Licensing of Intellectual Property§2.3(Antitrust Division,Department of Justice,and Federal Trade Commission April 6,1996),available at http://www.justice.gov/atr/public/guidelines/0558.pdf(提及了许可促进竞争的好处).Cf.Adam Hemlock&Jennifer Wu,U.S.Antitrust Implications of Patent Licensing,52 FED.LAW.,June 2005,at39,40(“专利许可可能具有促进竞争的显著潜在利益。”).
112.Actavis,133 S.Ct.at 2236.关于低层法院未来应当如何管理延迟支付的反垄断挑战,参见Aaron S.Edlin,C.Scott Hemphill,Herbert J.Hovenkamp&Carl Shapiro,Activating Actavis,28 ANTITRUST(forthcoming Dec.2013),available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2317241.
113.同上注,第2247页(罗伯茨,C.J.,异议).
114.同上注,第2243-2244页(引自Michael R.Herman,Note,The Stay Dilemma:Examining Brand and Generic Incentives for Delaying the Resolution of Pharmaceutical Patent Litigation,111 COLUM.L.REV.1788,1795 n.41(2011)).Cf.1HOVENKAMP,JANIS,LEMLEY&LESLIE,前注10,§7.1c,at 5 n.6(指出每方的法律费用为150万美元).
115.Actavis,133 S.Ct.at 2238.
116.同上注,第2239页。
117.这是Twombly案的原则问题,其中不进入的事实是清楚的,反垄断责任取决于这种不进入是否是一项协议单方面决定的结果。Bell Atlantic Corp.v.Twombly,550 U.S.544(2007).
118.Standard Oil Co.(Ind.)v.United States,283 U.S.163,174(1931).
119.Actavis,133 S.Ct.at 2239(罗伯茨,C.J.,异议).
120.参见前注93-94和对应的正文(discussing United States v.Gen.Elec.Co.,272 U.S.476(1926)).
121.35 U.S.C.§261(2006&Supp.V 2011)(允许覆盖“整个美国或其任何特定部分”的转让或许可).
122.Actavis,133 S.Ct.at 2240.
123.参见前注62-64和对应的正文。
124.35 U.S.C.§261.
125.同上注,§271(d).
126.Actavis,133 S.Ct.at 2233(大多数意见).
2.同上注,第2230-2231页。
3.同上注,第2237-2238页。
4.同上注,第2227页。
5.同上注(参见FTC v.Watson Pharm.,Inc.,677 F.3d 1298,1312(11th Cir.2012))。
6.Actavis,133 S.Ct.at 2227(引自12 HERBERT HOVENKAMP,ANTITRUST LAW?2046,第338页(3d ed.2012);Herbert Hovenkamp,Sensible Antitrust Rules for Pharmaceutical Competition,39 U.S.F.L.REV.11,24(2004))(附加的内部引文已省略)。
7.参见注42-57对应的后文。
8.参见Actavis,133 S.Ct.at 2239(罗伯茨,C.J.,异议)(“如果[专利持有人的]行为在专利范围内,则它们不受反垄断审查……”)。
9.In re K-Dur Antitrust Litig.,686 F.3d 197,214(3d Cir.2012)(拒绝“专利范围”测试法)。
10.FTC v.Watson Pharm.,Inc.,677 F.3d 1298,1312(11th Cir.2012)(“[一个]反向支付和解协议免受反垄断攻击,只要其反竞争效果落于专利的排他性潜在范围之内。”);也可参见In re Ciprofloxacin Hydrochloride Antitrust Litig.,544 F.3d1323,1332-37(Fed.Cir.2008);In re Tamoxifen Citrate Antitrust Litig.,466 F.3d 187,212-13(2d Cir.2006);Valley Drug Co.v.Geneva Pharm.,Inc.,344 F.3d 1294,1304,1308(11th Cir.2003).关于专利和解协议的司法尊重,一般参见12 Hovenkamp,前注6,?2046。关于较早先例所采取的做法,参见1 HERBERT HOVENKAMP,MARK D.JANIS,MARK A.LEMLEY&CHRISTOPHER R.LESLIE,IP AND ANTITRUST:AN ANALYSIS OF ANTITRUST PRINCIPLES APPLIED TOINTELLECTUAL PROPERTY LAW,§15.3a1(B)(2d ed.Supp.2012).
11.Actavis,133 S.Ct.at 2234(citing several decisions).
12.参见CHRISTINA BOHANNAN&HERBERT HOVENKAMP,CREATION WITHOUT RESTRAINT:PROMOTINGLIBERTY AND RIVALRY IN INNOVATION 93-96(2012);Gregory Dolin,Reverse Settlements as Patent Invalidity Signals,24 HARV.J.L.&TECH.281,324-26(2011).
13.Actavis,133 S.Ct.at 2237-38.
14.药品价格竞争和专利期限恢复(哈奇-韦克斯曼)法案,Pub.L.No.98-417,98 Stat.1585(1984)(在15,21,28和35的分散章节进行了修订)。
15.Actavis,133 S.Ct.at 2228(“哈奇-韦克斯曼程序通过允许仿制药企搭乘原研药企审批努力之便车的方式,‘加速了低成本仿制药向市场的引入’……”(转引自Caraco Pharm.Labs.,Ltd.v.Novo Nordisk A/S,132 S.Ct.1670,1676(2012))。
16.参见上注;Caraco,132 S.Ct.at 1676.
17.21 U.S.C.§355(j)(2012).
18.参见,如C.Scott Hemphill&Mark A.Lemley,Earning Exclusivity:Generic Drug Incentives and the Hatch-Waxman Act,77 ANTITRUST L.J.947,952(2011).
19.首席大法官罗伯茨的异议意见指出,本案中的当事人在达成延迟支付和解协议前,已经陷入了三年的诉讼。Actavis,133 S.Ct.at 2238(罗伯茨,C.J.,异议)。但是,因为该法案不允许在诉讼持续满30个月之前让另一个仿制药企进入市场,对于当事人而言,没有什么激励促使他们在那之前就达成协议。
20.21 U.S.C.§355(j)(5)(B)(iv)(2012).
21.布雷耶大法官的观点简要描述了这一程序。Actavis,133 S.Ct.at 2228.关于更多的细节和分析,参见12HOVENKAMP,前注6,?2046c,第340-341页;Hemphill&Lemley,前注18,第956-958页;C.Scott Hemphill,Paying for Delay:Pharmaceutical Patent Settlement as a Regulatory Design Problem,81 N.Y.U.L.REV.1553,1583-86(2006)(描述了“制度红利”,其将第一仿制药申报人区别于后续挑战者);Herbert Hovenkamp,Mark Janis&Mark A.Lemley,Anticompetitive Settlement of Intellectual Property Disputes,87 MINN.L.REV.1719,1754-56(2003).
22.Actavis,133 S.Ct.at 2234-35(分析了由专利和解协议提供的消费者福利);同上注,at 2238(罗伯茨,C.J.,异议).
23.Actavis,133 S.Ct.at 2238(罗伯茨,C.J.,异议).
24.参见,例如,HERBERT HOVENKAMP,FEDERAL ANTITRUST POLICY:THE LAW OF COMPETITION AND ITSPRACTICE§§4.1-4.2,at 158-78(4th ed.2011).
25.Actavis,133 S.Ct.at 2235(引自Hemphill,Paying for Delay,前注21,第1581页);也可参见Carl Shapiro,Antitrust Limits to Patent Settlements,34 RAND J.ECON.391,408(2003).
26.参见,例如,LUKE M.FROEB ET AL.,MANAGERIAL ECONOMICS 26(3d ed.2014)(“因为[沉没]成本不随着改变产出的决定而变化,所以在关于产出变化的决定中不应当考虑它们。”).
27.参见上注。
28.参见,例如,上注,第62-63页。
29.参见Nabil I.Al-Najjar,Sandeep Baliga&David Besanko,The Sunk Cost Bias and Managerial Pricing Practices(SSRNWorking Paper,Oct.2005),available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=825986(对该文献进行了总结和解释).
30.FTC,GENERIC DRUG ENTRY PRIOR TO PATENT EXPIRATION:AN FTC STUDY 9(2002)[下文简称FTC STUDY],available at www.ftc.gov/os/2002/07/genericdrugstudy.pdf.
31.参见Einer Elhauge&Alex Krueger,Solving the Patent Settlement Puzzle,91 TEX.L.REV.283,316(2012)(得出的结论是,单个仿制药的进入价格是原研药公司进入前价格的70-88%).
32.CONG.BUDGET OFFICE(CBO),EFFECTS OF USING GENERIC DRUGS ON MEDICARE’S PRESCRIPTIONDRUG SPENDING 8-9(Sept.2010),available at http://cbo.gov/sites/default/files/cbofiles/ftpdocs/118xx/doc11838/09-15-prescriptiondrugs.pdf.
33.参见,例如,Rebecca S.Eisenberg,The Role of the FDA in Innovation Policy,13 MICH.TELECOMM.&TECH.L.REV.345,354(2007).
34.参见C.Scott Hemphill&Bhaven Sampat,Drug Patents at the Supreme Court,339 SCIENCE 1386,1387(Mar.22,2013);FTC STUDY,前注30,第16页(发现仿制药申请者73%的时间占优);也可参见Caraco Pharm.Labs.,Ltd.v.Novo Nordisk A/S,132 S.Ct.1670,1673(2012)(允许仿制药企挑战那些限制指定药品之应用的过于宽泛的“使用规范”).相比之下,被诉专利的一般无效性概率在40%-50%范围内。John R.Allison&Mark A.Lemley,Empirical Evidence on the Validity of Litigated Patents,26 AIPLA Q.J.185,194,205-06(1998).
35.参见C.Scott Hemphill&Bhaven N.Sampat,Evergreening,Patent Challenges,and Effective Market Life in Pharmaceuticals,31 J.HEALTH ECON.327,334(2012);C.Scott Hemphill&Bhaven N.Sampat,When Do Generics Challenge Drug Patents?,8 J.EMPIRICAL LEGAL STUD.613,621(2011).
36.参见Second Amended Complaint for Injunctive and Other Equitable Relief?31,FTC v.Watson Pharm.,Inc.,No.1:09-CV-00955-TWT(N.D.Ga.May 28,2009).
37.参见下注38和对应的正文。
38.独占期间从提交仿制药ANDA申请之时起算,直至提起专利侵权诉讼后的30个月,或是仿制药进行生产后的180天。参见21 U.S.C.§§355(j)(B)(iii),355(j)(B)(iv)(2012).不同于欧盟法,美国不允许任何人对专利提出质疑;该权利主要限于被控侵权或面临一个侵权索赔的现实威胁的那些人。在这种情况下,哈奇-韦克斯曼法通过自身条款阻止除了ANDA申请者之外的所有人侵权。关于欧盟的程序,参见Guidelines for Examination,Part D-Guidelines for Opposition and Limitation/Revocation Procedures,EUR.PATENT OFF.,http://www.epo.org/law-practice/legal-texts/html/guidelines/e/d.htm(last updated Sept.16,2013).
39.Cf.Ritz Camera&Image,LLC v.SanDisk Corp.,700 F.3d 503,508(Fed.Cir.2012)(允许消费者根据反垄断法对其宣称的非法专利排他行为提出挑战).
40.In re K-Dur Antitrust Litig.,686 F.3d 197(3d Cir.2012),vacated sub nom.Merck&Co.,Inc.v.La.Wholesale Drug Co.,133 S.Ct.2849(2013);see also In re DDAVP Direct Purchaser Antitrust Litig.,585 F.3d 677,691-92(2d Cir.2009)(允许消费者挑战据称抬高仿制药价格的原研药企和仿制药企之间的协议).
41.参见Merck&Co.,133 S.Ct.at 2849.
42.关于限制较小的替代方法与合理原则分析的相关性,参见7 PHILLIP E.AREEDA&HERBERT HOVENKAMP,ANTITRUST LAW?1505b,at 417-19(3d ed.2010).
43.参见Actavis,133 S.Ct.at 2235(引自1 HOVENKAMP,JANIS,LEMLEY&LESLIE,前注10,§15.3,at p.15-45 n.161(2d ed.Supp.2011)).
44.参见Actavis,133 S.Ct.at 2243(罗伯茨,C.J.,异议)(discussing Marc G.Schildkraut,Patent-Splitting Settlements and the Reverse Payment Fallacy,71 ANTITRUST L.J.1033,1046(2004)).
45.同上注。
46.Metro-Goldwyn Mayer,Inc.v.007 Safety Prods.,Inc.,183 F.3d 10(1st Cir.1999).
47.同上注,第13页。
48.同上注。
49.同上注。
50.In Time Prods.,Ltd.v.Toy Biz,Inc.,38 F.3d 660,662(2d Cir.1994).
51.同上注。
52.参见Douglas F.Gray,Microsoft Sues Lindows.com over Name,TECH HIVE(Dec.21,2001,8:00 AM),http://www.pcworld.com/article/77163/article.html.
53.参见Brief for Respondent Actavis,Inc.at 54 n.20,FTC v.Actavis,Inc.,133 S.Ct.2223(2013)(No.12-416),2013 WL662705,at*54 n.20;Joris Evers,Microsoft,Lindows Make a Deal,TECH HIVE(July 19,2004,2:00 PM),http://www.techhive.com/article/116947/article.html.
54.参见Microsoft Corp.v.Lindows.com,Inc.,No.C01-2115C,2002 WL 32085605 at*3-5(W.D.Wash.May 13,2002).
55.参见Microsoft Corp.v.Lindows.com,Inc.,No.C01-2115C,2004 WL 329250(W.D.Wash.Feb.10,2004).
56.参见上注;Microsoft Corp.v.Lindows.com,Inc.,No.C01-2115C,2002 WL 31499324(W.D.Wash.Mar.15,2002).
57.“延迟支付”这一术语在这里似乎是不合适的,因为在被讨论案件中系争商标的期限是无限的。这些和解协议很可能是“永久的”,让被告永久地退出市场。
58.布雷耶大法官恰当地驳回了一项被他归于异议意见的建议,即专利权人如果以低于其最初要求的筹码达成和解,则实际上是在接受对剩余期限的“反向支付”。参见Actavis,133 S.Ct.at 2233(discussing Schildkraut,前注44,第1046页).布雷耶大法官提及了专利权人,其要求一个从事生产的侵权者为侵权行为赔偿1亿美元,并最终以4000万美元的赔偿金达成和解,布雷耶大法官指出这实际上相当于未支付6000万美元的“反向付款”。同上注。无论如何,在这个故事中所谓的侵权者实际上是在生产而不是退出市场,而且许可费的大小是无关紧要的。事实上,在没有任何侵权诉讼的情况下,专利权人可以合法地接受其希望从生产商处获得的任何价格作为许可费。
59.BOHANNAN&HOVENKAMP,前注12,第83-85页。
60.参见1A PHILLIP E.AREEDA&HERBERT HOVENKAMP,ANTITRUST LAW??240-44(4th ed.2013).
61.即使是最高法院在Walker过程设备案(Walker Process Equip.,Inc.v.Food Mach.&Chem.Corp.,382 U.S.172,177(1965))的规则,也并未涉及为获得一个专利的在先销售而对虚假陈述的最初使用,而是涉及对一个在侵权诉讼中已知无效的专利的授予后声明。参见3 PHILLIP E.AREEDA&HERBERT HOVENKAMP,ANTITRUST LAW?706(3d ed.2008).根据美国法,仅仅通过欺诈或不公平行为获取专利,会受到专利法以及美国专利和商标局程序的约束,而不是诉诸反垄断法。参见上注,?706,第255页(“作为一项一般性的主张,仅仅通过欺诈获得专利而没有后续的执行尝试,则并不是[反托拉斯法]下的排他性做法。”).
62.参见5 PHILLIP E.AREEDA&HERBERT HOVENKAMP,ANTITRUST LAW?1202f,at 273(3d ed.2009)(专利是受反垄断法并购规范调整的“资产”).
63.United States v.Line Material Co.,333 U.S.287,315(1948).
64.15 U.S.C.§14(2012)(禁止搭售或独家交易等反竞争性使用,“无论其是专利产品抑或非专利产品”).
65.关于明示豁免,参见1A AREEDA&HOVENKAMP,前注60,?243b,第336-338页。
66.Cf.Hemphill,Paying for Delay,前注21,第1574页(“由于医药专利案件具有高技术性,很多联邦法官宁愿避免这类案件,因而[一种支持和解的司法反应]可能会异常剧烈。”).
67.作为例外的一些情况是,和解还考虑产品价格固定、市场分割或可能损害消费者的其他限制。参见12HOVENKAMP,前注6,??2046b4-2046b5.
68.参见,例如,Michael J.Chapman,Using Settlement Licenses in Reasonable Royalty Determinations,49 IDEA 313,315-16(2009).
69.35 U.S.C.§261(2006&Supp.V 2011).
70.FTC v.Actavis,Inc.,133 S.Ct.2223,2232-33(discussing Standard Oil Co.(Ind.)v.United States,283 U.S.163,174(1931)).
71.United States v.Gen.Elec.Co.,272 U.S.476,494(1926)(支持专利权人与单一在生产的被许可人之间的固定后者产品价格的许可协议);E.Bement&Sons v.Nat’l Harrow Co.,186 U.S.70(1902)(支持固定产品价格的专利池).
72.United States v.Singer Mfg.Co.,374 U.S.174(1963).
73.E.g.,Hartford-Empire Co.v.United States,323 U.S.386(1945).Cf.Palmer v.BRG of Ga.,Inc.,498 U.S.46(1990)(将本身违法原则适用于带有地域分割性质的水平商标许可协议).
74.35 U.S.C.§261(2006&Supp.V 2011).
75.Actavis,133 S.Ct.at 2231(转引自United States v.Line Material Co.,333 U.S.287,310-11(1948)).
76.Actavis,133 S.Ct.at 2233.
77.同上注,第2234页。
78.参见Robert P.Merges,One Hundred Years of Solicitude:Intellectual Property Law,1900-2000,88 CAL L.REV.2187,2200(2000);Liza Vertinsky,Comparing Alternative Institutional Paths to Patent Reform,61 ALA.L.REV.501,526(2010)(“实际上,产业集团在影响甚至是起草知识产权立法方面的作用已经被注意到了……”)。
79.参见Herbert Hovenkamp,Consumer Welfare in Competition and Intellectual Property Law,9 COMPETITION POL’YINT’L J.(forthcoming 2013),available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2329150;Craig Allen Nard,Legal Forms and the Common Law of Patents,90 B.U.L.REV.51,52 n.2(2010).
80.参见HERBERT HOVENKAMP,THE OPENING OF AMERICAN LAW:NEOCLASSICAL LEGAL THOUGHT,1870-1970 at ch.10(forthcoming 2014);也可参见Nard,前注79,第72页(“1952年法案的核心是对前几年最高法院的专利法学理论的直接回应。”).
81.35 U.S.C.§271(d)(4)-(5)(2006&Supp.V 2011);也可参见Christina Bohannan,IP Misuse as Foreclosure,96 IOWA L.REV.475,487-88(2012).
82.Actavis,,133 S.Ct..at 2237.
83.同上注,第2230页。
84.同上注。
85.同上注,第2236-2237页(引自12 HOVENKAMP,前注6,?2046第350-352页)(emphasis added).
86.Actavis,133 S.Ct.at 2237-38(转引自Cal.Dental Ass’n v.FTC,526 U.S.756,780(1999)(转引自7 PHILLIPAREEDA&HERBERT HOVENKAMP,ANTITRUST LAW?1507,at 402(1st ed.1986))).
87.参见David L.Schwartz,Practice Makes Perfect?An Empirical Study of Claim Construction Reversal Rates in Patent Cases,107 MICH.L.REV.223,246(2008)(根据所使用的定义,发现在索赔结构中地区法院的出错率在25%到50%之间);也可参见J.Jonas Anderson&Peter S.Menell,Informal Deference:An Historical,Empirical,and Normative Analysis of Patent Claim Construction,108 NW.U.L.REV.(forthcoming 2013),available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2150360.
88.Allison&Lemley,前注34;也可参见Ted L.Field,“Juridical Hyperactivity”in the Federal Circuit:An Empirical Study,46U.S.F.L.REV.721,723(2012)(发现联邦巡回法院被推翻的概率要高于其他被研究的巡回法院).关于特定地区法院的推翻概率,参见Teresa Lii,Shopping for Reversals:How Accuracy Differs Across Patent Litigation Forums,12 CHI.-KENT J.INTELL.PROP.31,43(2013)(观察很多地区法院,发现加权平均的推翻率为37.8%).
89.参见前注34-36和对应的正文。
90.Actavis,133 S.Ct.at 2236.
91.同上注,第2231页(内部引文已省略).
92.参见,例如,上注,2231页(“法院必须‘平衡[专利持有人]的及其被许可人根据专利授权获得的特权与谢尔曼法对联合和试图垄断的禁止’”(转引自United States v.U.S.Gypsum Co.,333 U.S.364,390-91(1948))).
93.Actavis,133 S.Ct.at 2232(discussing United States v.Gen.Elec.Co.,272 U.S.476,489(1926)).一些低层法院已经采纳了该公式。参见12 HOVENKAMP,前注6,?2041b.
94.E.Bement&Sons v.Nat’l Harrow Co.,186 U.S.70(1902).
95.参见7 AREEDA&HOVENKAMP,前注42,?1502,第389页.
96.Actavis,133 S.Ct.at 2238.
97.参见7 AREEDA&HOVENKAMP,前注42,??1507,1508c.
98.Actavis,133 S.Ct.at 2237-38(转引自Cal.Dental Ass’n v.FTC 526 U.S.756,780(1999)(转引自7 AREEDA&HOVENKAMP,前注86,?1507,第402页)(内部标点符号已省略)).
99.同上注,第2237页。
100.同上注,第2236页(转引自12 HOVENKAMP,前注6,?2046,第351页).
101.参见2B PHILLIP E.AREEDA,JOHN L.SOLOW&HERBERT HOVENKAMP,ANTITRUST LAW??515,521(3d ed.2007)(在?515部分描述了价格-成本差额和在?521部分描述了基于需求弹性的直接测量方法).
102.勒纳指数也称为勒纳垄断势力指数。它通过对价格与边际成本偏离程度的度量,反映市场中垄断力量的强弱(译者注)。
103.2B PHILLIP E.AREEDA&HERBERT HOVENKAMP,ANTITRUST LAW?520e(forthcoming 4th ed.2014)
104.同上注.??536-539.
105.Actavis,133 S.Ct.at 2236.
106.同上注,第2237页。
107.同上注,第2236页。
108.同上注。
109.同上注。
110.参见,例如,PhRMA Statement on Supreme Court Ruling in Patent Settlement Case,PHRMA(June 17,2013),http://phrma.org/phrma-statement-on-supreme-court-ruling-in-patent-settlement-case.
111.参见Antitrust Guidelines for the Licensing of Intellectual Property§2.3(Antitrust Division,Department of Justice,and Federal Trade Commission April 6,1996),available at http://www.justice.gov/atr/public/guidelines/0558.pdf(提及了许可促进竞争的好处).Cf.Adam Hemlock&Jennifer Wu,U.S.Antitrust Implications of Patent Licensing,52 FED.LAW.,June 2005,at39,40(“专利许可可能具有促进竞争的显著潜在利益。”).
112.Actavis,133 S.Ct.at 2236.关于低层法院未来应当如何管理延迟支付的反垄断挑战,参见Aaron S.Edlin,C.Scott Hemphill,Herbert J.Hovenkamp&Carl Shapiro,Activating Actavis,28 ANTITRUST(forthcoming Dec.2013),available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2317241.
113.同上注,第2247页(罗伯茨,C.J.,异议).
114.同上注,第2243-2244页(引自Michael R.Herman,Note,The Stay Dilemma:Examining Brand and Generic Incentives for Delaying the Resolution of Pharmaceutical Patent Litigation,111 COLUM.L.REV.1788,1795 n.41(2011)).Cf.1HOVENKAMP,JANIS,LEMLEY&LESLIE,前注10,§7.1c,at 5 n.6(指出每方的法律费用为150万美元).
115.Actavis,133 S.Ct.at 2238.
116.同上注,第2239页。
117.这是Twombly案的原则问题,其中不进入的事实是清楚的,反垄断责任取决于这种不进入是否是一项协议单方面决定的结果。Bell Atlantic Corp.v.Twombly,550 U.S.544(2007).
118.Standard Oil Co.(Ind.)v.United States,283 U.S.163,174(1931).
119.Actavis,133 S.Ct.at 2239(罗伯茨,C.J.,异议).
120.参见前注93-94和对应的正文(discussing United States v.Gen.Elec.Co.,272 U.S.476(1926)).
121.35 U.S.C.§261(2006&Supp.V 2011)(允许覆盖“整个美国或其任何特定部分”的转让或许可).
122.Actavis,133 S.Ct.at 2240.
123.参见前注62-64和对应的正文。
124.35 U.S.C.§261.
125.同上注,§271(d).
126.Actavis,133 S.Ct.at 2233(大多数意见).
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