Exclusion payments in patent settlements: a legal and economic perspective

Legal context. The application of antitrust law to assess settlementsof patent litigation raises difficult issues concerning theappropriate balance of patent law and competition policy. Recentprivate and public invocations of US antitrust law to challengesettlement agreements covering pharmaceutical patents have broughtthese issues to the forefront. The agreements share the commonfeature of an ‘exclusion payment’ from a brand-namedrug manufacturer (the patentee) to a generic drug manufacturer(the accused infringer) in exchange for a promise by the genericcompany to refrain from marketing its product for some time.US federal courts that have examined these agreements have variedin their approach and conclusions regarding the appropriateantitrust analysis to be applied to these settlements. Key points. This article argues that informed antitrust analysisof such agreements must take due note of the ‘probabilistic’nature of patent property rights. Practical significance. The article concludes that exclusionpayments fall outside the scope of a patent's exclusionary scopeand thus are subject to antitrust scrutiny. It demonstratesthat barring anticompetitive exclusion payments in settlementnegotiation prevents collusive bargains that harm consumer welfarewithout discouraging efficient settlements.     

Antitrust issues in the settlement of pharmaceutical patent disputes, Part II

The settlement of patent disputes in the pharmaceutical industry, and the possible antitrust issues arising therefrom, are of notable concern to the Federal Trade Commission. In this Comment, based on his second speech on the subject, Commissioner Leary re-examines some of this earlier positions under the light of the Commission's further experience with these matters, and provides the industry with some additional objective standards under which it may legally operate. With the Hatch-Waxman Act as a backdrop for patent settlements between manufacturers of patented drugs and potential generic entrants to the market, the Commissioner reviews a variety of scenarios that may or may not be permissible. After initially noting the circumstances of presumptively valid settlements, Commissioner Leary reviews the often complex settlement structures that will be deemed unlawful when and if the finding of reverse payments is evidenced. Finally, the Commissioner concludes with a brief examination of other settlement structures and offers his general views as to their likely legality.     

PATENT HOLDUP AND OLIGOPSONISTIC COLLUSION IN STANDARD-SETTING ORGANIZATIONS

Current controversies over patent policy place standard-settingorganizations (SSOs) on a collision course with antitrust law.Recent theoretical research conjectures that, in an SSO, patentowners can "hold up" patent users in the sense of demandinghigh royalties for a patented input after the SSO has adoptedthe patented technology as an industry standard and manufacturerswithin the SSO have incurred sunk costs to design end productsthat incorporate that standard. Consistent with this conjecture,actual SSOs have recently sought no-action letters from theAntitrust Division for a variety of amendments to SSO rulesthat would require or request, at the time a standard is underconsideration, the ex ante disclosure by the patent owner ofthe maximum royalty that the patent owner would charge underthe regime of fair, reasonable, and nondiscriminatory licensing.This price information—which is characterized as the "cost"of the patented input—would, under at least one recentSSO rule modification, be a permissible topic for potentialusers of the patent to discuss when deciding whether to selectit in lieu of some alternative standard. This exchange of informationamong horizontal competitors would occur ostensibly becausethe cost of the patented technology had been characterized assimply one more technical attribute of the standard to be set,albeit an important technical attribute. The Antitrust Divisionand the Federal Trade Commission have jointly stated that suchdiscussion, by prospective buyers who are competitors in thedownstream market, of the price of a patented invention thatmight become part of an industry standard should be subjectto antitrust scrutiny under the rule of reason rather than therule of per se illegality. The rationale that the antitrustagencies offer for applying the rule of reason to such conductis that such horizontal collaboration might avert patent holdup.The Antitrust Modernization Commission (AMC) similarly endorsedthe view that rule-of-reason analysis is appropriate for exante discussion of royalty terms by competing buyers of patentedtechnology. This rule-of-reason approach, however, is problematicbecause it conflicts with both the body of economic researchon bidder collusion and with the antitrust jurisprudence oninformation exchange and facilitation of collusion. Put differently,because of their concern over the possibility of patent holdup,the U.S. antitrust agencies and the AMC in effect have indicatedthat they may be willing in at least some circumstances to forgoenforcement actions against practices that facilitate oligopsonisticcollusion by encouraging the ex ante exchange of informationamong competitors concerning the price to be paid for a patentedinput as an implicit condition of those competitors' endorsementof that particular patented technology for adoption in the industrystandard. However, neither the proponents of these SSO policiesnor the antitrust agencies and the AMC have offered any theoreticalor empirical foundation for their implicit assumption that theexpected social cost of patent holdup exceeds the expected socialcost of oligopsonistic collusion. This conclusion does not changeeven if one conjectures that such collusion will benefit consumersby enabling licensees to pass through royalty reductions intheir pricing of the downstream product incorporating the patentedtechnology. Proper economic evaluation of the plausibility ofthe pass-through conjecture will require information about thecalculation of royalty payments; the demand and supply elasticitiesfacing the licensees; and the structure of any industries furtherdownstream between the manufacturer and the final consumer.Consequently, the magnitude of this effect will likely be amatter of empirical dispute in every case. Moreover, such ajustification for tolerating horizontal price fixing finds nosupport in antitrust jurisprudence. Given the analytical andfactual uncertainty over whether patent holdup is a seriousproblem, it is foreseeable that antitrust questions of firstimpression will arise and affect a wide range of high-technologyindustries that rely on SSOs. However, there is no indicationthat scholars and policy makers have seriously considered whetheroligopsonistic collusion in SSOs is a larger problem than patentholdup.     

Injunctive and reverse settlements in competition-blocking litigation

We distinguish standard settlements, in which the status quo is preserved, and injunctive settlements, which prohibit the defendant’s activity. The reverse (payment) settlement is a special type of injunctive settlement. We examine the divergence between private and social incentives to settle and policies that would minimize socially undesirable injunctive and reverse settlements (e.g., banning reverse settlements). The results are applied to competition-blocking litigation, such as patent infringement and antidumping.     

Anticompetitive Employment

Scholars, antitrust agencies, and policy makers have historically paid little attention to anticompetitive practices in labor markets. This was largely due a misconception that antitrust law is meant to govern conventional markets in which goods and services trade, rather than govern labor markets. Antitrust law may also offer a poor remedy to redress employers who enter no-poaching agreements or otherwise impair competition. The primary tension involves antitrust's purpose, which is to promote “consumer welfare.” To identify whether conduct eroded consumer welfare, courts tend to scrutinize whether prices increased. But here, lessening wages can enable firms to sell goods at cheaper prices, benefiting consumers. Another issue is that the typical restraint affects only a smattering of workers instead of lessening wages throughout the greater market. This article uses empirical analyses to show that antitrust should promote labor's welfare as it does consumer welfare, and it argues that enforcement must condemn labor cartels as per se illegal. The research demonstrates that labor cartels are more pernicious than restraints in product markets, as employers can lessen wages with less effort than in product markets. Antitrust should even proscribe no-poaching agreements formed for a legitimate purpose (e.g., to protect trade secrets) because employers could have achieved the same goals using less coercive means; the noncompete agreement, at least, provides labor with a semblance of notice and bargaining power without drawing antitrust scrutiny. The prohibition of labor cartels would thus promote competition and consumer welfare, especially in minimum wage labor markets.     

消费者反垄断诉讼的本源与我国应然之探

对于私人反垄断执行,美国《反托拉斯法》所规定的三倍赔偿制度功不可没,为此,许多学者都认为,在确定消费者反垄断诉讼的制度中,也应确定这种民事惩罚性的机制,才能使消费者反垄断诉讼得到很好的运行。但在私人反垄断践行最好的美国,消费者个人是被排除在私人执行之外的,按照美国《反托拉斯法》的规定,消费者个人并不能获得三倍赔偿的诉讼激励。美国《反托拉斯法》所规定的三倍赔偿机制系基于其责任体系仅有民事责任和刑事责任,没有处于刑事和民事责任之间的行政处罚责任,民事责任的三倍赔偿机制实际起到了落实"应刑罚性"和刑罚"最后手段性"的威慑与嚇阻重任。而在反垄断法责任中存在刑事责任、民事责任和行政责任的国家,行政责任中的行政处罚责任完全担当了刑事威慑和遏制的补充责任,为避免过度制裁和重复制裁而普遍都没有设置三倍的民事赔偿责任。消费者反垄断诉讼必须以维持市场秩序为本,对消费者反垄断诉讼的高热情和高厚望必须回归到理性和现实,在具体制度的设置时也应有所体现。     

THE STOCHASTIC RELATIONSHIP BETWEEN PATENTS AND ANTITRUST

This article develops a novel theory by which to construe theinteraction between the patent and antitrust laws. The rulesof these respective disciplines are often portrayed as conflictingin means, yet harmonious in purpose. Although the intellectualproperty and antitrust laws have ostensibly divergent viewson the role of competition, their interaction is typically limitedto one of constraint. More specifically, antitrust rules havebeen (poorly) designed to limit the exclusivity inherent ina patent grant to the claimed invention alone. This article,however, articulates a new vision for the role of antitrust:it posits that competition rules operate as a stochastic regulatorof exclusionary patent rights. The Sherman Act constrains patentees'efforts to positively transform the probabilistic nature oftheir intellectual property rights through contract. Yet, becausethe empirical calculation of optimal innovation rates is anelusive, if not Sisyphean, task, the normative desirabilityof the foregoing fact is abstruse. Nevertheless, policymakers'inability to pinpoint precisely the ex post rewards requiredto trigger ideal levels of ex ante investment need not bindour hands to inaction. If contemporary rates of innovation aredeemed acceptable (even if not necessarily perfect), there maybe ways to trigger equivalent levels of ex ante investment withlower social cost. In this regard, it is clear that currentlyenacted competition rules significantly accentuate the uncertaintysurrounding patents' apotropaic effect. Concluding that contractssecuring otherwise stochastic rights may be highly desirable,the article calls for the incorporation of this concern intocontemporary rules, with modest substantive effect, and furtheradvocates a qualified antitrust immunity for "gold-plated" patentsif and when they are introduced.     

A primer on US antitrust claims against patentees under Walker Process

Legal context: In the wake of two recent cases from the Federal Circuit onthe subject, this article provides an introduction to the WalkerProcess doctrine under US law. Under the doctrine, a patenteewho knowingly enforces a patent procured by intentional fraudon the patent office may lose its immunity to antitrust claims,should it act to enforce its patent. Key points: Walker Process fraud refers to a knowing and deliberate fraudperpetrated on the patent office as opposed to mere acts ofinequitable conduct. Proving that a patent applicant engagedin Walker Process fraud does not by itself prove liability foran antitrust violation. The accused infringer must still provethe individual elements of an antitrust claim. Antitrust claimsbased on Walker Process fraud require significant time and resourcesto litigate. Practical significance: With the allure of mandatory treble damages and attorney's fees,antitrust claims based on Walker Process fraud can serve asa potent counterclaim for an accused infringer's arsenal. Butthe legal requirements and resources needed to successfullylitigate these claims to a conclusion may temper their effectivenessfor the typical patent-infringement suit.     

Private credentialing of health care personnel: an antitrust perspective. Part One

This Article explores the antitrust and other implications of private credentialing and accrediting programs in the health care industry. Although such programs are usually sponsored by powerful competitor groups, they serve the procompetitive purpose of providing useful information and authoritative advice to independent decision makers. Part One examines the risk that credentialing will sometimes be unfair to competitors and deceive consumers. Its survey of common-law, antitrust, and regulatory interventions to correct such unfairness and deception seeks to determine the degree of oversight to which credentialing and similar activities have been and should be subjected. In recommending that judicial or regulatory scrutiny should be limited to discovering whether standards and practices have a rational relation to a procompetitive purpose, the Article argues that greater intrusion into credentialing schemes would be inconsistent with market theory and first amendment values and would discourage line-drawing efforts that stimulate competition and facilitate consumer choice. By emphasizing throughout that personnel certification and institutional accreditation embody ideology and opinion as well as factual information, Part One sets the stage for the argument in Part Two that antitrust law can and should be used to contest the dominance of a single ideology of health care and to facilitate the development of alternative sources of consumer information. The Article's overall thesis is that, whereas the quality of advice given to the public about health care personnel and similar matters should not be closely regulated, neither should the supply of competing information and opinion be artificially curtailed.     

Non-voluntary licensing of antivirals under patent: options the Australian Government should consider in light of a potential bird flu pandemic

In the face of a potential bird flu pandemic, Australian Federal Health Minister, Tony Abbott, has recently dismissed expert advice that the government should begin, or even publicly consider, authorising generic manufacturers to produce antivirals, such as Tamiflu and Relenza, under patent via non-voluntary licensing methods. This is despite the fact that the demand for antivirals in Australia, and throughout the world, cannot be met by manufacturers under the control of limited patent owners alone. This article proposes that Australian patent law, which allows for non-voluntary licensing when it comes to important public health issues that affect Australian citizens, is relevant in meeting the demand for increased antiviral treatments during a possible bird flu pandemic, domestically and abroad. It argues that the Australian Government must go beyond what is currently being done and investigate and pursue such options.     

Barriers to achieving a cost-effective workforce mix: lessons from anesthesiology

As pressures to control health care costs increase, competition among physicians, advanced practice nurses, and other allied health providers has also intensified. Anesthesia care is one of the most highly contested terrains, where the growth in anesthesiologist supply has far outstripped total demand. This article explains why the supply has grown so fast despite evidence that nurse anesthetists provide equally good care at a fraction of the cost. Emphasis is given to payment incentives in the private sector and Medicare. Laudable attempts by the government to make Medicare payments more efficient and equitable by lowering the economic return to physicians specializing in anesthesia have created a hostile work environment. Nurse anesthetists are being dismissed from hospitals in favor of anesthesiologists who do not appear "on the payroll" but cost society more, nonetheless. Claims of antitrust violations by nurse anesthetists against anesthesiologists have not found much support in the courts for several reasons outlined in this essay. HMO penetration and other market forces have begun signaling new domestic physician graduates to eschew anesthesia, but, again, Medicare payment incentives encourage teaching hospitals to recruit international medical graduates to maintain graduate medical education payments. After suggesting desirable but likely ineffective reforms involving licensure laws and hospital organizational restructuring, the article discusses several alternative payment methods that would encourage hospitals and medical staffs to adopt a more cost-effective anesthesia workforce mix. Lessons for other nonphysician personnel conclude the article.     

Managing generic competition and patent strategies in the pharmaceutical industry

Legal context: The income streams of originating pharmaceutical manufacturersare under pressure as never before, from increasing R&Dcosts, regulatory pressures, and competition from generic manufacturers.This article examines the various strategies which originatingpharmaceutical manufacturers have adopted in response to thesethreats. Key points: The authors consider various strategies, including SupplementaryProtection Certificates, life-cycle management (‘evergreening’),second pharmaceutical use claims, trade marks, and the use ofdata exclusivity and interim injunctions, in order to prolongthe protection given to existing products, and to manage competitionfrom generic manufacturers. Practical significance: The authors also include two real-life case studies in orderto illustrate the practical applications of the strategies discussedin the article.     

我国医药发明专利试验例外制度研究

医药发明专利试验例外作为我国专利法上一项新生的侵权抗辩事由,在实施中尚缺乏应有的制度保障。通过追溯医药发明专利试验例外的起源和发展,考察主要国家医药发明专利试验例外制度的具体内容,分析了我国医药发明专利试验例外在实施中将面临的困惑,并从适用范围、专利补偿期限、专利链接制度三方面入手,对我国医药发明专利试验例外制度的完善提出了建议,以期能充分实现专利药物制造商与仿制药物制造商、药物制造商与社会公众之间的利益平衡。     

Doctors and hospitals: an antitrust perspective on traditional relationships

Under new pressures for cost containment, hospitals are increasingly asserting interests that conflict with those of physicians. Professor Havighurst argues that legal rules under which practitioners have challenged denials of hospital admitting privileges should be clarified in order that hospitals can more effectively carry out their new cost-containment and other responsibilities. He invokes antitrust law's "essential-facilities" doctrine to protect those abused by their competitors on a hospital staff, but he contends that, if a hospital participates in decisionmaking as an independent actor--even though it acts in concert with its physicians--, antitrust courts should lower the level of scrutiny to a point at which most challenges can be dismissed summarily. He analogizes restraints imposed by hospitals on competition between health professionals to vertical restraints of other kinds, and draws conclusions critical of doctrine traditionally applicable to the latter.     

UNILATERAL REFUSALS TO LICENSE

Most antitrust claims relating to intellectual property involvechallenges to agreements, licensing practices, or affirmativeconduct involving the use or disposition of the intellectualproperty rights or the products they cover. However, sometimesan antitrust claim centers on an intellectual property owner'srefusal to use or license an intellectual property right, perhapscoupled with efforts to enforce the intellectual property rightagainst infringers. The allegation may be that the intellectualproperty right is so essential to competition that it must belicensed across the board, or that a refusal to license it toone particular party was discriminatory, or that in contexta refusal to license helped a monopolist to acquire or maintainmarket power. Claims based on a unilateral refusal to licensepresent important issues at the center of the tension betweenantitrust and intellectual property. Unilateral refusal to licensecases cut to the heart of the intellectual property owner'sright to exclude others from practising the intellectual property.As such, efforts to invoke antitrust law in this context deservespecial scrutiny. We examine the basic principles relating tounilateral refusals to license intellectual property rights.We then analyze the various sets of circumstances in which antitrustplaintiffs argue for exceptions to those basic rules. Finally,we distinguish unilateral from concerted and conditional refusalsto deal.     

Ready or not? A systematic review of case studies using data-driven approaches to detect real-world antitrust violations

Cartels and other anti-competitive behaviour by companies have a tremendously negative impact on the economy and, ultimately, on consumers. To detect such anti-competitive behaviour, competition authorities need reliable tools. Recently, new data-driven approaches have started to emerge in the area of computational antitrust that can complement already established tools, such as leniency programs. Our systematic review of case studies shows how data-driven approaches can be used to detect real-world antitrust violations. Relying on statistical analysis or machine learning, ever more sophisticated methods have been developed and applied to real-world scenarios to identify whether an antitrust infringement has taken place. Our review suggests that the approaches already applied in case studies have become more complex and more sophisticated over time, and may also be transferrable to further types of cases. While computational tools may not yet be ready to take over antitrust enforcement, they are ready to be employed more fully.     

Hospital mergers: the shift from federal antitrust enforcement to state regulation

The authors examine and analyze the burgeoning merger activity in the hospital arena, as well as the nonfederal attempts made to regulate that activity. They conclude that the present, ad hoc, system of state regulation is sorely wanting and that it would be preferable if stronger antitrust enforcement and judical decisions prevented competition reducing mergers. If a merger results in a true monopoly (and nonetheless passes antitrust scrutiny), its regulation should be the responsibility of the pertinent state public utility board which, unlike the courts and state attorneys general, has sufficient expertise to adequately regulate the merged entities. Otherwise, the faults of the present system, which is easily manipulated by hospitals seeking political and legal cover for their activities, are likely to be perpetuated.     

格式条款标准化的垄断协议认定

传统的逆向选择模型将低质量格式条款的生成归因于需求端的认知缺陷;共谋模型将低质量维持原因解释为供给端的共谋,为反垄断法介入提供依据。格式条款标准化的横向垄断协议认定应满足《反垄断法》第13条规定的形式要件与效果要件,采用一般举证规则作为分析模式,由原告证明其"协议、决定或协同行为"形式及反竞争效果。形式要件以"形式与反竞争效果的尽可能耦合"为逻辑起点,应基于市场力的持久性与显著性标准加以重构。反竞争效果要件以对竞争的实质限制为标准,参照美国法实践,可通过质量或交易自由限制路径证成。     

A note on antitrust damages and leniency programs

The European Commission has in recent years initiated an effort to facilitate private actions for damages in cartel cases. This paper demonstrates in a stylized game-theoretic framework that an increase in antitrust damages can be pro-collusive when a leniency program is already in place. The result holds true even if antitrust authorities are allowed to re-shape their leniency program in reaction to the higher damage level. Larger damage payments imply lower incentives to self-report if damages are not fully encompassed by the leniency program; in effect, the program has to be more generous to enforce self-reporting. But if antitrust authorities are not allowed to offer cash rewards to whistle-blowers, the sufficient level of generosity might be unattainable.