Showing papers in "Harvard Journal of Law and Public Policy in 2016"

Linguistic Relativism And The Decline Of The Rule Of Law

Abstract: INTRODUCTION Nobody today on any side of the political spectrum opposes the rule of law. And for good reason. At a minimum, the rule of law carries with it the idea that legal rules should be certain, so that individuals will not be left at sea as to their legal obligations. The fixity of the law, by constraining the behavior of political actors, also improves the odds that the liberty and property of any individual will not be subject to continuous political pressures and intrigue. The standard set of requirements for the rule of law has been summarized by Lon Fuller. In his 1964 classic, The Morality of Law, he lists a variety of additional constraints, including that rules be simple enough to give clear notice of what they require, be internally consistent, have only prospective application, possess relative constancy over time, and be administered by neutral officials. (1) For these purposes, it is not necessary to resolve the many fine points that arise over the proper interpretation of this doctrine. It is quite sufficient to note that each and every one of these constraints presupposes that the language we use to express our legal rules--and hence our commands to ordinary citizens and public officials alike--is intelligible enough to meet the requirements of fair notice and neutral interpretation, even if public officials frequently violate (and are known to violate) these norms. Unless that requisite level of intellectual clarity is satisfied, then the rule of law emerges stillborn from the mouths of philosophers and legal theorists. Finguistic coherence is a minimum condition for the rule of law. Yet, as will become clear, this minimalist conception of the law does not lack any substantive component. Rightly understood, the rule of law carries more meat on its bones than an appeal to legal certainty. It has to make normative commitments to particular principles--principles, I shall argue, reflected in both Roman and common law, whose fundamental similarities are far more important than their refined differences. (2) Both the narrow and broad conceptions of the rule of law presuppose that the tools of ordinary language are powerful enough to allow judges and scholars to formulate legal rules that make implementing the rule of law possible. Unfortunately, many scholars despair that the tools of textual analysis are not strong enough to meet the persistent challenges of the linguistic skeptic. Today, many people, both on the bench and in the academy, share this all too fashionable view of ordinary language. This undermines the rule of law, fanning the general populist unease that now infects much of our public discourse. At a theoretical level, it is common for linguistic skeptics to scoff at language as the fundamental unit of law. For example, Mark Tushnet, in his caustic review of my book Design for Liberty: Private Property, Public Administration, and the Rule of Law, celebrates the proposition that terms like "property" and "nuisance" "have no determinate content, which means that the judges must actually be relying on something else to resolve the dispute," (3) without ever letting us know what that "something else" is. This type of relativism easily extends to other terms, most notably "liberty" and "coercion," which have similarly been attacked as otiose, most famously by Robert L. Hale. In his highly influential essay, Coercion and Distribution in a Supposedly Non-Coercive State, (4) he finds that any refusal to deal should be regarded as coercive both in competitive and monopoly markets. The danger of that position on the meaning of coercion and harm is starkly illustrated by the aggressive modern application of the idea that there is nothing wrong with limiting ordinary businessmen and women, under the antidiscrimination laws, to the choice between serving same-sex couples and losing their businesses. One notable example is the recent case of Craig v. Masterpiece Cakeshop, (5) decided by the Colorado Court of Appeals, in which the defendant cake artist, Jack Phillips, refused to prepare a wedding cake for a gay couple. …

Public Choice Theory and Occupational Licensing

Abstract: 1. The Rehabilitation of Lochner Some contemporary scholars have urged the Supreme Court to reconsider its New Deal era precedents, including ones upholding occupational licensing restrictions, on the ground that "property" rights are no less important than "liberty" rights. (214) In their opinion, the prevailing view of Lochner grossly overstates the adverse effect of that decision. Progressives won the battle over intrusive judicial review of social and economic legislation, those academics concede, (215) and the victors always write the history. But the story they tell is inaccurate because Lochner was hardly the legislative kryptonite it has been made out to be. The Supreme Court of that era upheld more laws than it struck down, and some of those that the Court held unconstitutional were classic examples of special interest legislation. (216) The Court also did not throw in with the interests of large businesses. For example, the poor were the principal beneficiaries of decisions that held entry restrictions invalid. (217) These scholars maintain that the Supreme Court mistakenly abandoned the field of economic regulation to the political process in the 1930s while strictly scrutinizing any government effort to restrict civil or political liberties. "While few Americans will discount the importance of the so-called civil liberties, the reality is that economic liberties are the lubricant of a market economy." (218) Each category of liberties should receive the same respect as the other. In fact, the current state of the law is not only mistaken, but also undeniably elitist, because the "average person," the people who form the majority of the nation, would enthusiastically trade off some personal freedoms for greater economic opportunity. (219) So far, the Supreme Court has been unwilling to fundamentally re-examine its New Deal era economic regulation precedents and apply the same degree of scrutiny to economic legislation that it has used to assess restrictions on certain personal freedoms. Litigants, of course, could try to resurrect substantive due process principles. If they do, they likely would argue along the following lines. 2. A New Old Fundamental Right to Property A changed economic theory. Critics of New Deal jurisprudence would start out by noting that the economic background to the New Deal era decisions has changed, justifying a reexamination of those rulings. The argument would be that the nation has witnessed a fundamental shift in how economic policy and law should treat competition. The Depression caused a lack of public confidence in the efficacy of free markets and a desire for government intervention. (220) New Deal economics sought to protect rivals against the "brutal ethos" and "anarchical" effects of "excess" or "ruinous competition" through government regulation of price, output, and factors of production. (221) Part of the rationale for government intervention was the fear that price wars would add to the greatest unemployment rate in American history, but another component was the belief that central planning could rationally avoid the faults of a laissez-faire free market economic system. (222) The demise of Marxist economies beginning in 1989 shows that central planning cannot produce economic growth. (223) "Today, claims of ruinous competition usually are met with a snicker and the observation that ruinous competition is nothing more than competition." (224) Contemporary national competition policy has changed direction by one hundred-eighty degrees. American law now strongly demands that competition between rivals be robust and, with limited exceptions, prohibits state actions that would foreclose rivalry or lead to the cartelization of an industry. (225) The difference in how the law treats competition is due to a fundamental shift, universally acknowledged, in the focus of the federal antitrust laws away from protecting the interests of rivals to advancing the interests of consumers. …

Measuring Diversity: Law Faculties in 1997 and 2013

Abstract: B. Overrepresented Groups Compared to the U.S. Full-Time Working Population and the General Population Proportional representation is a zero-sum game. If someone is on the bottom, someone else must be on the top. Which groups are the most overrepresented in law teaching? Table 6 shows the forty significantly overrepresented groups in law teaching in absolute and relative terms. At the top of the list are white Democrats, the excess accounting for two-fifths of a faculty (40%). All of the thirty-four most overrepresented groups are white (or predominately white), most are Democratic, and most are either Jewish or nonreligious. If Table 6 were sorted according to a ratio of percentages, (69) all of the twenty-eight most overrepresented groups would be Jewish or nonreligious. Nearly half of these twenty-eight are also white and Democratic. The most overrepresented groups not defined by religion are white male Democrats, white Democrats, male Democrats, Democrats, and white female Democrats. By ratios, the most overrepresented group is white male Jewish Democrats. They are overrepresented by a ratio of nearly 28 to 1. Yet Jews were a traditionally locked-out group. In the 1930s, many law schools had no Jews or had a quota of one or two. (70) If one were serious about proportional representation, then one would wait to hire more white male Jewish Democratic law professors until 97% of them died out or resigned, perhaps taking as long as thirty years. Just to state this possibility shows that the proportional representation notion of diversity, taken seriously, is profoundly anti-Semitic in effect, if not in intent. Thus, the most overrepresented groups tend to be white or mostly white, just as the most underrepresented groups tend to be white or mostly white. The overrepresented groups tend to be Jewish or nonreligious; the underrepresented groups tend to be Republican, Independent, and Christian. One sees the same patterns of overrepresentation in Table 7, comparing law professors to the U.S. non-institutionalized general population ages 30-75. Ranked by percentage differences, the most overrepresented group is white Democrats, followed by Democrats. Ranked by ratios, all of the twenty-eight most overrepresented groups are Jewish or nonreligious. (71) C. The Underrepresented and Overrepresented Groups Compared to Lawyers Evaluations of employment discrimination usually use the pool of qualified eligible workers, not the general population, as the proper comparison group. (72) Although the best comparison might be the makeup of the pool of those lawyers with top credentials over the last 40 years, information about this elite group is unavailable. All we have is information about those minimally qualified--lawyers, judges, and law professors in private or government service. In Tables 8 and 9 I compare the law professor population to the population of private lawyers, public lawyers, judges, and law professors of age 30-75. Current Population Survey data were used for race and gender, but the sample size of lawyers was only 413. (73) Even worse, the 1972-94 General Social Survey had only 129 lawyers aged 30-75. Thus, the estimates for lawyers, particularly their religion and party identification, are limited by the small samples. For this reason, the conclusions that one may legitimately draw from these data are tentative. Yet even by this excessively broad construction of the "pool," women and most minorities are either at parity or overrepresented in law teaching. Since on average African Americans receive lower grades in law school, (74) one would expect them to be underrepresented in law teaching compared to the lawyer population, even if there were no discrimination in hiring. Yet the data in Tables 8 and 9 show that most minorities and Democratic women are overrepresented in law teaching compared to lawyers more generally. The most obvious explanation--though not the only one--is that affirmative action is strong enough to overcome discrimination in the hiring decision itself. …

The Regulatory Turn in IP

Abstract: History shows technologies flourish where market entry is free. (1) If people are free to come up with a new idea, completely different than anything done before, and launch it into the marketplace, society benefits, people make a lot of money, and we change the world. So we don't want a "Mother, may I?" regulatory regime for innovation. A regulatory regime that requires permission to enter the market or develop a new product is a problem for innovation because it relies on the government, not the innovator, to decide the course of innovation. Nor should we give a private company or individual "Mother, may I?" control over market entry. We are right to worry about government restrictions on entry. But we should also worry about incumbents, who can and will have an incentive to impose similar restrictions. It is important to remember, because it is quite often lost in the rhetoric surrounding these debates, that it is not the case that individual private decisionmaking is necessarily efficient. It is the case, however, that market decisionmaking is generally efficient. (2) But market decisionmaking is efficient largely because when stupid, greedy, or shortsighted people in the private sector make poor decisions, they are overthrown by people who make correct decisions. For private decisionmaking to produce efficient decisions, there must be a competitive market. In a "Mother, may I?" regulatory regime, whether government-imposed or incumbent-imposed, that competitive market will not exist and private decision making will not be efficient. Instead, a single private company (or the government) would make decisions for all participants. Unconstrained by market forces, such a private company is no more likely to perform well than government regulators. Is intellectual property (IP) a "Mother, may I?" regime? The answer is complex. One way to view IP--the way Richard Epstein does--is to say: IP is a property regime; it is something around which parties can freely contract. (3) To libertarians, property regimes are good, so if IP rights are property regimes, more IP is better. But another way to view IP rights is to say, "this is a government restriction on what people can do with their own physical property and their own ideas." To libertarians, government restrictions on what people can do in a marketplace are bad, and so libertarians ought to think IP rights are bad. (4) The problem is that IP is both. It is at once a basis around which we can contract and allow the spread of new ideas and a government regulatory intervention in the marketplace that is designed to restrict what people can do with their own ideas and their own property. If the idea of IP has this dual character, so too does IP law. In both copyright and patent in the last few years, maybe in the last few decades, we have seen a turn increasingly towards the regulatory side of IP and away from freedom of contract. The IP statutes contain some evidence of this change. The Copyright Act is almost ten times longer today than it was before it was amended in 1976.5 Large swathes of the Copyright Act really are regulation: regulating price, setting compulsory licenses, determining what can be done, etc. (6) The Patent Act is also moving in the same direction. Historically, most of the main provisions of the Patent Act were common law oriented. (7) As Richard Epstein has suggested, the new patent statute is definitely a step towards a regulatory rather than a common law regime. (8) This regulatory turn in IP is not only evident in the statutory frameworks but also in the application of the law. In copyright law, after about fifteen years in which the government more or less left the Internet alone, copyright owners are making greater efforts to get the government to regulate what people can do online. Copyright owners are rightly concerned that there is a lot of copyright infringement online, but the new efforts are troubling. …

The Outer Limits of Equity: A Proposal for Cautious Expansion

Abstract: Equity had long been established when the Constitution and the Judiciary Act of 1789 incorporated it into the new American legal system. In concept, it dates back to Aristotle; in implementation, at least back to the English Chancery courts. (1) These developed as "court[s] of conscience," free to provide individualized justice that could not come from the general rules of common law. (2) But despite equity's long pedigree, the scope of equitable power remains difficult to define. (3) The Supreme Court's declaration that American equity jurisdiction follows the principles of judicial remedies that developed in the Chancery courts provides a good starting point. (4) But that said, at the time the Founders imported equity from the Chancery courts, there was no consensus among their contemporaries in England as to what exactly equity was. (5) Some argued that equity judges had the power to render a just judgment any time natural law compelled a result different from the dictates of common law precedent (the "expansive view"). (6) Others saw equity merely as a parallel system that did not in essence differ from the common law: governed by precedent and bound by rules (the "restrictive" view). (7) That debate came to the United States along with equity, and it has continued to the present day. (8) The Supreme Court has always been at the center of this debate. During the first half-century of the nation's existence, the Court fluctuated from an expansive view of equity to a restrictive one and back again. (9) Recent Supreme Court opinions have given voice to both views of equity. (10) This Note will propose a synthesis between the restrictive and the expansive views. Part I will examine a 1999 case to elucidate the principles underlying each view. Part II will review in depth a 2015 case that may indicate a shift in the Court's equity jurisprudence. Part III will use the principles from Part I and the facts from Part II to outline an effective synthesis of the two views, ensuring that courts retain the flexibility afforded by equity while seeing that flexibility cabined to particularly exigent circumstances. I. GRUPO MEXICANO AND THE COMPETING VIEWS OF EQUITY In Grupo Mexicano de Desarollo, S.A v. Alliance Bond Fund, (11) a bare majority of the Court took the restrictive view over a spirited dissent arguing for the expansive view. The facts of that case, briefly, are as follows: In anticipation of a company's impending insolvency, creditors had sought and received a temporary restraining order (TRO) preventing the company from transferring certain assets lest those assets disappear before debts could be satisfied. (12) Justice Scalia, writing for the Court, held that the district court lacked equitable power to grant the TRO. (13) According to Justice Scalia, the only equitable remedies available to federal courts are those "traditionally accorded by courts of equity"--traditionally, that is, as of 1789, when the Constitution and the Judiciary Act of 1789 adopted what then existed in equity. (14) And at that time, equity courts did not issue anything analogous to TROs for creditor protection. (15) Justice Ginsburg dissented in relevant part. Writing for herself and three other Justices, she argued that the Founders had adopted equitable principles rather than equitable practices, leaving room for evolution and expansion of equitable remedies. (16) In following a narrow view of equity jurisdiction, Justice Scalia focused on the dangers of unbounded equity. He wrote that, "[t]o accord a type of relief that has never been available before" would mean that courts were not simply flexible, but effectively omnipotent. (17) He also noted that, to the extent that changed circumstances in business practices necessitated new remedies, Congress was in a much better position to make that assessment than the Court. (18) Justice Scalia then undertook a lengthy examination of the development of debtor-creditor law, noting that a balance had developed over time, which courts should be loath to unsettle. …

How innovation makes us more equal

Abstract: Inequality is said by many of our leading thinkers to be the defining issue of our time. Often, the reason given for the increase in inequality is located in innovation itself. Under this view, technology disproportionately increases the incomes of those who can take advantage of it, helping the one percent more than anyone else. (1) It also threatens the jobs of the less skilled. In my view, however, modern innovation ultimately helps reduce real inequality, certainly globally, and even within the United States. And it does so for fundamental, not contingent, reasons. Information technology changes the world by using information to better deploy material resources. Because of the nature of our accelerating technology, that information rapidly becomes common property, benefiting everyone. Modern information technology dematerializes the world and thus democratizes it. Material resources are ultimately finite, but functionality of technology is not. The move from "its" to "bits" is thus a move to equality, and so is the acceleration of change because that acceleration rapidly pushes down the cost of previous innovations. Economic value is increasingly created not by material things but by the information from our accelerating technology that arranges the material. Information can be shared equally in ways that material goods cannot. This means that our circumstances are more equal than conventional income measures would suggest. (2) To the extent that inequality should be addressed by policy, acknowledging these observations will help us draft more promising solutions, policies designed to increase innovation, and improvements to education rather than simply transfer resources from one group to another. I. OUR DEMATERIALIZING, ACCELERATING TECHNOLOGY Thomas Jefferson once said, "He who receives an idea from me receives instruction himself without lessening mine; as he who lights his taper at mine receives light without darkening me." (3) In the Information Age, we enjoy an ever-greater access to an ever-brighter light that generates more value and consumption for all--substantially tempering the effect of technology's differential boost on incomes. (4) The accelerating pace of technological change drives down the cost of these information-based products, sometimes so far that they decrease to zero. (5) What is the driving force of technology and its acceleration today? It is largely information technology and computation. (6) Moore's Law is part of a long-term growth in computation. (7) Electromechanical methods began the push for enhanced computation more than a century ago. (8) They were replaced by vacuum tubes, which were surpassed by transistors, which gave way to today's integrated circuit. (9) Other methods under research today, from optical computing to nanotubes, are likely to be responsible for continued growth. (10) This dramatic increase in hardware capacity is only part of the story. Software has been improving apace as well. (11) This interconnectivity by the Internet brings machines closer together, and this accelerating power in hardware, software, and connectivity relentlessly transforms economic sectors. (12) In artificial intelligence's most recent trial, Watson, the IBM machine, beat the best Jeopardy! players in the world. (13) This reflects advances in all those areas. The computer disentangled humor, recognized puns, and resolved ambiguity. Unlike its predecessor, Big Blue, which defeated the world chess champion fifteen years earlier, Watson succeeded in a less-precisely rule-driven game--one much more like the chaotic world we inhabit. (14) This fluidity enables computing applications in an increasing number of areas. Watson is going into medical diagnostics, (15) and these diagnostic programs will level the standard of health care, making the rich's access to the best doctors relatively less valuable than it was before. (16) The story of machine intelligence and its ability to level up is always the same: once it gains a foothold, it improves until it dominates. …

Innovation and Inequality: The Separability Thesis

Abstract: The topic of this Essay concerns the interaction between innovation in areas of intellectual property on the one hand and the demand for greater equality of income and wealth in society on the other. Whatever one thinks of the latter objective, I think that it is a social mistake to link these two separate topics together. The correct approach is instead sequential. First, develop a set of rules that promotes the maximum level of innovation. Once that innovation question is settled, address inequality in income and wealth from a broader perspective-one that does not develop special rules to deal with intellectual property issues. I call this the "separability thesis." In making this claim, I do not wish to insist that the problem of inequality, which for many people is the dominant social challenge of our time, does not matter. Instead I want to address the related question of whether inequality is addressed better by private or public means--to which my own answer is that decentralized private activity, buttressed by a charitable contribution deduction, will on balance work better than any modification of intellectual property rights. Hence I would argue that inequality matters but is better addressed separately from the question of innovation. I think that the Essays of Professor John McGinnis (1) and Beth Kregor (2) strengthen the case for the separability thesis. In his presentation, Professor McGinnis speaks about the huge power of intellectual property to speed up the leveling of wealth and opportunities across people in different social strata. His central point is that the rapid reduction in the costs of standard technologies--think smartphones and social media--increases the opportunities for personal advancement of those who are at the bottom of the income distribution. Lower prices give greater access to all, producing higher levels of overall social satisfaction, even if, as Adam Smith's invisible hand reminds us, that consequence was not part of the innovator's intention. (3) The innovator's own self-interest aligns with a desirable social objective. (4) The more controversial portion of McGinnis's thesis is that the pace of innovation will insulate the new technological industries from the heavy hand of government innovation. In general, I think that his prognosis is overly optimistic, because resourceful and determined governments can always initiate anti-competitive regulations no matter what the present level of technology by focusing on its most vulnerable components. To give a simple example, companies like Uber and Airbnb do not just operate in an online environment. They have to deliver their rides and their accommodations in physical space, where they are vulnerable to regulations. Hence, it is possible for a single mid-level administrative official to attack the Uber business model that treats its drivers as independent contractors and not as employees--a status that is right now under serious legal challenge. (5) Airbnb must arrange for its customers to have rooms, which in turn could subject individual owners to various restrictions and hotel taxes, which Airbnb actually wants to collect itself in order to gain legal legitimacy. (6) And, of course, it must worry about serious issues such as zoning laws and landlord restrictions as it runs its business. (7) It is not possible here to comment at length on the soundness of these various taxes and regulations. But that lack of specificity does not in my view undermine the essential argument for the separability thesis. Do not use regulation of specific firms or industries to secure redistributive ends. Indeed, it is critical to note that innovation can be socially valuable even if it does not result in higher levels of income equality. The argument runs as follows: Greater access is a byproduct of greater innovation, as are the benefits to those at the bottom of the income distribution. Yet by the same token, it is not clear that greater equality follows. …

Revitalizing the Clemency Process

Abstract: 4. Justice vs. Mercy Clemency can be used to ameliorate a punishment that, while permissible in some or even most cases, turns out to be wholly unjust when applied to a specific offender. Jean Valjean is a classic example; (129) statutes imposing mandatory minimum sentences are modern examples. Clemency can extend an offender mercy even when his sentence appears entirely just. (130) But there is no consensus with respect to that opinion. Some scholars have argued that justice and mercy are distinct (albeit sometimes confused (131)) concepts. (132) Because of that difference, they can be (or at least appear to be) in irreconcilable conflict. Immanuel Kant certainly thought so. He concluded that pardoning someone guilty of a crime is "the greatest injustice" to society. (133) Others have held that opinion too. (134) For a President who is concerned about how clemency will appear to the public, that prospect can give him pause. Given the reforms that the criminal justice system has undergone since the Pardon Clause became law, a President could reasonably be troubled by two perceived results of granting an individual clemency. He could decide that extending mercy to a justly convicted and sentenced offender creates an injustice for other offenders in similar circumstances who have not sought clemency, or could give rise to a public perception that some offenders receive favorable treatment because they are fortunate enough to have a lawyer or someone in a position to gain the President's attention. A President who makes the categorical judgment that mercy is unnecessary in a system that, to the extent humanly possible, produces justice in individual cases will be reluctant to intervene in the criminal justice system's operation and will devote to other matters the time that he would have spent making clemency decisions. That fear may explain why George W. Bush, when he was Governor of Texas, declined to commute the capital sentence of Karla Fay Tucker, a woman convicted of pick-axing two people to death, but whom impartial observers believed had undergone a wholesale transformation while on death row. Bush may have feared that granting an attractive white woman mercy would have generated considerable criticism as showing illegitimate favoritism. (135) The proper tradeoff between justice and mercy is not an easy one to resolve, philosophically or legally. (136) The issue arises most acutely today in connection with the racial disparity in imprisonment arising from the application of the mandatory minimum sentencing laws to crack cocaine offenders. The lengthier sentences imposed on primarily African-American small-scale crack offenders than on predominantly white small-scale powder cocaine offenders is not due to intentional racial discrimination, but is nonetheless troubling to many people today. (137) The reason is that the disparity could leave the black community with the impression that they are victimized both by the traffic in crack cocaine they witness in their communities and by the federal laws that are designed to address that problem. (138) As Professor Glenn Loury has noted, "Assessing the propriety of creating a racially defined pariah class in the middle of our great cities at the start of the twenty-first century" poses a very troubling problem, asking us to decide not only whether we have just crack cocaine sentencing laws, but also whether we have a just criminal justice system. (139) A President troubled by that disparity could well decide that granting otherwise justified mercy to a large number of white offenders would undermine public confidence in the legitimacy of the criminal justice system by exacerbating the current racial disparity. By declining to extend clemency, the President would, in effect, be choosing the appearance of justice over mercy. 5. The Victims' Rights Movement Another likely explanation is attributable to the rise of the victims' rights movement over the last few decades. …

Biologics in the Practice of Law

Abstract: Biologics have come to occupy an increasingly important role in the medical industry, accounting for well over $200 billion in worldwide sales in 2014. Not surprisingly, biologics also occupy a prominent place in the practice of life-sciences law. Before expanding on how biologics and the law interact, however, it is important to first define "biologics." Most treatments for chemotherapy and autoimmune disorders are biologics. In contrast to a drug, which is a mixture of chemicals according to a set recipe, a biologic comes from a living organism. (1) Rodents, for example, might be a possible source. (2) Because no two biologics will be identical, there can be no "generic" biologic. Rather, a competing biologic may be deemed "biosimilar" or, if heightened requirements are met, "bioequivalent" to a reference biologic. Until recently, the concept of biosimilars was not recognized or approved in the United States. This changed with a little-known provision of the Patient Protection and Affordable Care Act, which is revolutionizing the pharmaceutical industry. This Essay begins by discussing the recently implemented legislative pathway for marketing biosimilars in the United States, and the intersection of this pathway with the Leahy-Smith America Invents Act's mechanism for inter partes challenges to patents. The Essay then explores the competitive strategies at play in, and the initial economic effects arising from, the burgeoning biosimilars market, and ultimately concludes that the societal effect will be beneficial, if less dramatic than proponents of the Patient Protection and Affordable Care Act intended. Strong demand and high prices for biologics have created a robust black market in which smugglers enable physicians to obtain and administer to unknowing patients delicate, temperature-sensitive, non-FDA-approved biologics intended for use on the other side of the world. Drawing in part on the Author's personal experience as a federal prosecutor, the Essay explains why this black market is dangerous for patients who were neither informed of nor consented to treatment with non-FDA-approved biologics. The Essay concludes by exploring how both the legal and illegal markets for biologics are affected by the relationship between doctors and insurance providers, including federal and state governments and formularies, in which patients are merely passive participants. I. THE LEGISLATIVE PROCESS FOR MARKETING BIOSIMILARS Historically, the Hatch-Waxman Act (3) provided a legislative pathway to obtain FDA approval of generic drugs. (4) This legislation was enacted in 1984 and signed into law by President Ronald Reagan. (5) However, until the Patient Protection and Affordable Care Act (6) (PPACA) was passed in 2010, no equivalent pathway existed for biologics. (7) This legislative vacuum effectively insulated biologics manufacturers from competition, no doubt contributing to biologics' high prices and profit margins. The PPACA changed this competitive landscape through the Biologics Price Competition and Innovation Act (BPCIA). (8) The BPCIA allows companies that wish to introduce "biosimilar" or "bioequivalent" (per a heightened standard) pharmaceuticals to obtain FDA approval and enter the market. (9) These "generic" biologics are aptly called "biosimilars," as they are derived from living organisms and are similar, but not identical, to the biologics for which they will be substituted. (10) This stands in stark contrast to a generic drug, which involves mixing chemicals according to a set recipe. (11) The comparative complexity of biologics makes the process of manufacturing and testing biosimilars much more expensive and time-consuming than the equivalent stages for generic drugs. (12) Yet the vast majority of the most profitable medications in recent years have been biologics, not drugs. (13) As such, everyone from generic drug companies to competing biologics manufacturers is eager to capture a slice of the biosimilars market. …

Current Issues in Patent Law and Policy

Abstract: Patent law and policy have received a surprising amount of attention from courts and policymakers in recent years. (1) This attention is warranted because innovation policy is critical in determining the pace of innovation and the rate of economic growth. The reform proposals pending before Congress are motivated by widespread reports of abusive patent assertions and fears that patents sometimes stifle innovation. (2) I favor most of the pending reforms and worry that our patent system, on balance, discourages innovation. But I part company from most reform proponents who focus on harms caused by the frivolous patent litigation mounted by many "non-practicing entities" (NPEs). (3) Instead, I want to focus on deeper flaws in the U.S. patent system that existed before NPEs became very active and that continue today. In our book Patent Failure, (4) James Bessen and I empirically demonstrated that problems in our patent system predated the flood of NPE litigation that began around 2005. (5) We showed that, on average, the patent system actually taxes innovators in most industries (except, notably, in the chemical and pharmaceutical industries). (6) We attribute this innovation tax to problems of "low patent quality." (7) Though, again, these problems are largely absent in the chemical and pharmaceutical industries, as the patents there are relatively high quality. (8) There are three kinds of quality problems that reformers have identified. First, there are mistakes by patent examiners and courts. Second, the inventive step--the so-called non-obviousness requirement (9)--in our patent system is too low. This means that valid patents are granted on uninteresting and low-quality inventions. (10) Third--and this is my main concern--is that patents are not sufficiently "property-like." (11) I will use the term "notice failure" to denote this kind of problem. Initially, most patent-reform activity in the past decade has focused on quality problems caused by patent examination mistakes. (12) These reforms were well intentioned but were not significant enough to have much effect on the innovation tax. More recent reforms focus on mitigating the harm caused when low-quality patents are asserted. (13) Here, there has been a bit more progress. Now, we possibly have a new wave of reform coming that will address notice failure. (14) Patent notice reform, if it comes at all, likely will come from many sources. Some of the reforms being considered in Congress will improve patent notice and make the patent system more property-like. (15) The U.S. Patent and Trademark Office is considering reforms to make patent ownership more transparent and patent scope more precise. (16) I suspect that much of the significant reform will come from the courts. I hope that scholars will influence Federal Circuit judges and clerks so that judicial lawmaking will be more sensitive to the ways in which an over-reaching patent system can impede innovation. I envision a change in thinking about patents comparable to the change in thinking about antitrust law associated with the "Chicago School" approach to antitrust. (17) So, what do I mean by "notice failure"? Suppose I own the parcel of land called Whiteacre and there is a neighboring parcel owned by another called Blackacre. Suppose I want to build an office tower on Whiteacre. I hire a surveyor, look at the deeds, and talk to my lawyers. Finally, I build the office tower on Whiteacre. In a property system with good notice, I will have little trouble building the tower on Whiteacre and keeping it off of Blackacre. Notice failure, however, could lead me to accidentally build part of my tower on Blackacre. Good notice allows me to avoid such an accident. If I have reason to build partly on Blackacre, I would negotiate to purchase some of Blackacre in advance. If I want to stay entirely on Whiteacre, I can rely on surveying technology and property deeds to assure that. …

The Unknown Achievements of Justice Scalia

Abstract: The death of Justice Antonin Scalia marks the end of an era in the history of the Supreme Court. One of President Ronald Reagan's greatest gifts to the country he so loved has passed away. The Reagan Supreme Court, which once had four Reagan-appointed Justices, is now passing into history. A new generation of Americans voting in the 2016 presidential election will have to decide whether to follow the originalism and textualism of Justice Scalia or the left wing policy-maker jurisprudence of Justice Stephen Breyer and the Supreme Court's other liberal Justices. A huge amount is therefore at stake this November. Many have noted that Justice Scalia was a legal giant who single-handedly restored textualism and originalism in Supreme Court constitutional and statutory interpretation. I will write at length on this subject in a forthcoming book and have mentioned it as well in several tributes to the Justice since his death. But, while it is true that the Justice transformed American legal culture, and while knowing this helps to explain why Justice Scalia was the greatest Justice ever to sit on the Supreme Court, not all of Justice Scalia's triumphs as a Justice were as publically visible as his opinions in Heller and in Morrison v. Olson or as the restoration of textualism and of originalism. As Justice Scalia told me when I was his law clerk in 1987-1988, Justice Scalia's greatest triumphs were often not publically visible at all. For example, he played a key role in persuading the Justices to stop hearing and deciding 150 decisions a year and to aim at only 80 decisions a year instead. Justice Scalia believed that the Supreme Court ought to hear fewer cases and do a better job with them than it had been doing prior to 1986. Justice Scalia's views prevailed and for the last ten years the Supreme Court has on average decided about 80 cases a year. Justice Scalia realized that judicial restraint could often be best accomplished by not hearing a case and by getting his colleagues to do a better job on fewer cases. Another thing that Justice Scalia often did that was publically invisible but was of vital importance was keeping what lawyers call dicta out of his colleague's opinions. Justice Scalia scrutinized all of the majority, concurring, and dissenting opinions he joined, and he often held out on joining them unless activist language that could cause trouble in the lower federal courts and in future Supreme Court opinions was taken out. Justice Scalia told me when I clerked for him that the most important thing he did as a Justice was to keep out of his colleague's opinions language that could cause trouble in the future. Justice Scalia's actions in this regard were totally invisible to the public, but they were hugely consequential. Now that role that Justice Scalia played in editing his colleagues' opinions will have to be played by someone else. I first met Justice Scalia in April 1982 at the first-ever national conference of the Federalist Society, an organization of conservative and libertarian law professors with chapters at every law school in the country and in all major cities. Justice Scalia was then Professor Scalia at the University of Chicago School of Law. Professor Scalia not only offered to be our faculty advisor--he also raised the money we needed to fund our first conference. Without Professor Scalia's help, the Federalist Society would never have gotten off the ground! Justice Scalia continued to help the Federalist Society throughout his tenure on the bench. He spoke at countless events and promoted the legal careers of hundreds of former students and law clerks, including my own. Justice Scalia, Judge Robert H. Bork, and former Attorney General Edwin Meese III all made the Federalist Society what it is today. Justice Scalia was a public intellectual, in addition to writing hundreds of textualist-originalist opinions and a book on constitutional interpretation as well as a treatise on statutory interpretation--a feat accomplished only by one other Justice, Joseph Story. …

Innovation and Inequality: Conservative and Libertarian Perspectives

Abstract: Advances in technology have changed the way we work and the jobs that are available. This presents a challenge for us all to consider--a challenge that is not new. It is one that was encountered during the Industrial Revolution and every major economic transformation since then. (1) But the challenge is particularly acute today. Many occupations have become obsolete quite recently. Others will inevitably be left behind. But, notably, entrepreneurship is not obsolete. In fact, the founders and initial financiers of innovative new companies continue soaring to astronomical wealth, while many workers in other industries are out of jobs. (2) Perhaps part of the financial success of innovators is due to the availability of machines to fill the roles previously held by laborers. (3) Entrepreneurs do not have to distribute their revenue among so many people. Perhaps part of their success is a reward for their rarity. There is only a limited supply of such creative entrepreneurs. (4) Entrepreneurs' uncanny ability to identify and fill previously unimagined needs is worth rewarding because of its scarcity. Whatever the explanation for entrepreneurs' wealth, entrepreneurship can be valued and well compensated when it works, even while certain other kinds of work--assembly-line labor, for example--are facing extinction. The comparison between wealthy entrepreneurs and the endangered species of laborers raises real concerns about inequality, especially because these high-flying entrepreneurs come from a narrow slice of society. If society and the economy allow only certain individuals who are deemed "tech geeks" to succeed, then we are cutting many people out. There is some evidence of that kind of discrimination built into the entrepreneurial ecosystem. Inventors in the technology sector are often free to experiment and grow huge because the law has not regulated cyberspace, (5) while innovators in traditional service sectors--who may be more likely to come from less educated or less wealthy sectors--are regularly handicapped by legal restrictions. (6) Venture capital firms are much more likely to fund ventures started by people who fit a certain mold and are missing out on people who may have great ideas but do not look the way that entrepreneurs are expected to look or sound the way that they are expected to sound. (7) As a result, people with equally excellent ideas have wildly unequal chances at achieving economic success. Putting aside concerns about inequality per se, a society does not maximize innovation if it allows only a small slice of its population to execute their ideas and insights. Failing to take full advantage of the entire population's creativity and insight is simply foolish, as every individual is differently situated and has a unique view of the world. Not drawing on these diverse perspectives denies society of an untold number of innovations that could benefit everyone. Each individual, shaped by his own experience and perspective of the world, can see opportunities and solutions in a way that others cannot. No one--constrained as each one is by his own limited worldview--can predict in advance who will be inspired with a winning idea or which idea will in fact win. (8) The more people who are ideating and tinkering with the world, the better the chances are of benefiting from a great idea and a great execution of that idea. For these reasons, Americans should not want a single regulatory agency or single venture capital firm to run the world. Rather, Americans should fight for individual liberty, not only because it is good for individuals but also because it benefits society by, among other things, breeding more innovation. Based on this theoretical groundwork, it is concerning that society is not benefitting from the innovation and creativity of as many people as possible. Too few entrepreneurs are being generated--not because everyone should be an entrepreneur, but because almost everyone should have a job, and it is entrepreneurs, after all, who create jobs. …

The Unscripted Evolution of Presidential Nominations: From Founding-Era Idealism to the Dominance of Party Primaries

Abstract: The field of election law enjoyed something of a renaissance over the first ten years of this young century (1)--perhaps unsurprising given that the decade was bookended by historic rulings in Bush v. Gore (2) and Citizens United v. FEC. (3) In addition to reawakening the legal academy's dormant interest in the subject, (4) these divisive cases permeated public consciousness to an extent that is rare for even the most prominent of legal controversies. (5) What's more, the Supreme Court seems intent on sustaining this reinvigorated focus on election law. Just this Term, for example, the justices expounded on the practical meaning of the "one person, one vote" standard, (6) and this is only one of a number of important election law decisions in the past few years. (7) While applauding this revival of interest in election law and acknowledging the unquestionable significance of the issues at stake in recent cases--which range from campaign finance and political speech to vote-counting procedures and apportionment--it is imperative to illuminate other areas of the field that have been woefully neglected by the public and the legal academy alike. For no subject has the disparity between relative importance and attention received been more acute than for the law applicable to the presidential nomination process, and caucuses in particular. (8) Regrettably, this gap exists despite the literature's clear emphasis on how much the rules of the nomination game matter in shaping ultimate electoral outcomes. (9) In fact, Professor James Davis goes so far as to suggest that candidate selection might have more impact on the country's future than presidential elections themselves. (10) Given its peculiarities, the 2016 election season has engendered a rare focus on America's presidential-nomination process, with numerous calls for change to the mechanics of candidate selection coming from both the right and the left. (11) However, would-be reformers generally have underestimated the complexity of their crusade due to various misapprehensions of the current system. And this is hardly surprising. As American political scientist Austin Ranney once observed, "[I]n America, the presidential nominating game is played under by far the most elaborate, variegated, and complex set of rules in the world. They include national party rules, state statutes (especially those governing presidential primaries), and a wide variety of rulings by national and state courts." (12) To fully appreciate the current nomination process--and before attempting to transform it--reformers would be wise to consider how the system became what it is today. Although there are some wonderful resources on specific aspects of nomination history and several brief overarching chronicles, extensive research has uncovered no comprehensive investigation of the evolution of America's approach to candidate selection. Thus, this Note seeks to address the current dearth of understanding of the nomination process by examining the manner in which the complex web of nomination rules and regulations was woven over the course of American history, from the Founding Era to the modern day. The following sections proceed chronologically, beginning with the Framers' designs for presidential elections and the nomination process. As many readers will know, what little guidance the Constitution provides on presidential elections presumes the absence of political parties. The second section thus discusses how the young Republic grappled with the emergence of factions and the resulting rise of partisan nominations. The Note then explores three eras of nomination reform--the birth of the caucus-convention system, the Progressive push for primaries, and the McGovern-Fraser revolution of the late 1960s--before concluding with "goalposts" for reform based on insights from the past two presidential election cycles. I. EARLY IDEALISM: ANTI-FACTIONAL DOGMA AND THE CONSTITUTION'S SILENCE ON NOMINATIONS The architects of the Constitution devoted considerable time and energy to the issue of presidential selection. …