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The Patent Trial and Appeals Board: A Target for Prescription Drug Patent Reform?
No full textPatents are essential to the pharmaceutical industry, with brand-name manufacturers charging high prices in the US during periods of market exclusivity largely defined by patents on the products. Manufacturers routinely build large portfolios of patents around successful products covering not only the active ingredient but also other features of the drug such as its method of use, formulation, and manufacturing process. With each patent lasting 20 years, portfolios can delay entry of generic or biosimilar competitors that contribute to price reductions, allowing manufacturers to sustain higher prices for longer.
But recently there has been growing recognition that some drug patents in manufacturers’ portfolios should not have been granted. Improper patents and anticompetitive strategies used to obtain and enforce patents have faced heightened attention from the Federal Trade Commission, Patent and Trademark Office, and Congress. One notable patent reform effort that has gained attention is the bipartisan Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act.1 But this bill only threatens to make problematic drug patent portfolios worse by impeding efforts to challenge drug patents as improperly granted, with potential for big impacts on drug availability and prices
Interview with David Webber: Reflections on the Past, Present, and Future of Labor\u27s Capital
Get PDFALVIN VELAZQUEZ: Good afternoon! My name is Alvin Velazquez. I am an Associate General Counsel at the Service Employees International Union (SEIU), where for the last fifteen years I have given advice on bankruptcy, corporate law matters, and tech matters. I’m also an adjunct professor at Georgetown Law School where I have taught employment law and am teaching a seminar called Systemic Racism, Colonialism, and Bankrupt Governments.1 Before arriving at SEIU I worked as a litigation associate at several large law firms. I also admit, rather sheepishly, that I am one of the few graduates of Cornell in the labor movement who did not attend the Industrial and Labor Relations school, but rather am a product of its government department who then attended Harvard Law School. I want to thank Claire Hill for organizing this excellent symposium and inviting me here to conduct this interview.
I am really excited to be joined by David Webber, the author of The Rise of the Working-Class Shareholder: Labor’s Last Best Weapon. David Webber is a familiar name in the corporate governance world, and among labor practitioners of capital stewardship due to his prolific scholarship examining labor and its capital. He is a professor and Paul M. Siskind Scholar at Boston University, and one of the best thinkers out there concerning the interaction of how labor unions have engaged and incorporated corporate governance into their thinking. His book has received reviews or otherwise been covered in the New York Review of Books, the Financial Times, Forbes, Dissent, the National Review, C-SPAN’s BookTV, Bloomberg Radio, Publishers Weekly, the Harvard Law School Forum on Corporate Governance and Financial Regulation, the Harvard OnLabor Blog, and elsewhere. It has also been the subject of op-eds for the New York Times, the Los Angeles Times, and the Washington Post. Finally, his book is assigned as part of the core curriculum for the Harvard Trade Union Program. David did his undergraduate work at Columbia University and obtained his law degree at N.Y.U. Law where he was a member of its law review.
Even though I had nothing to do with it being part of the core curriculum for the Harvard Trade Union Program, I recommend his book because it tells a sweeping story of where labor’s use of capital has been, and provides some important suggestions for where labor’s capital should be going. It is highly accessible to labor practitioners, finance practitioners, and legal audiences. On a personal note, let me just say that reading your book felt like a trip down memory lane for me. You really described what was going on in the labor capital stewardship space over the course of my career in a way that I had not conceived of previously. When you are doing the work on a day-today basis it is difficult to reflect. A lot of the time you are just trying to get things done. However, your book really helped me reflect on how far the conversation concerning labor’s role has changed since I started doing this work in 2008. It also provided me with some new ways of discussing the work that I do with our members.
Let’s get started with some general questions to kick off our interview. Can you tell us what motivated you to write the book
Transplantation and Immortality: A Selective History of Boston University’s Center for Health Law, Ethics & Human Rights
Get PDFThe celebration of the anniversary of the Center for Health Law, Ethics & Human Rights (the “Center”) provides an opportunity to reflect on what defines the field of health law, as well as its conjoined twins of bioethics and human rights. The related fields are vast, and the subjects they encompass are ever-expanding. It is probably impossible to lay out a summary that does justice to their expansive, interdisciplinary scope. Instead, my discussion of the Center examines a subject that barely existed when the Center was formed in 19581 and that continues to make headlines more than sixty–six years later — organ transplantation. Transplantation is useful as an illustration of the joint fields of health law, bioethics, and human rights. It is a field that grew with us from infancy to maturity during the time of the Center’s growth and that illustrates how several related disciplines — most notably law and medical sciences — are essential to the development of organ transplantation. Additionally, organ transplantation and experiments involving organ transplantation have produced some of the most spectacular cases of human experimentation. Because of both the novelty and human drama these experiments involve, I will use some of them as examples of the pivotal health law and bioethics work the Center engages in. These examples, and others that will be touched on, lead me to conclude that there is no field that matches the life and death drama of health law, especially in the human organ transplantation field. This selective history of health law at the Center, including the definition of death and the limits of surrogate consent, suggest that the legal and bioethical issues brought to us by innovative organ transplantation surgery are unlikely to be exhausted any time soon
Just Fix the Damn Payment System!
Get PDFThis piece takes as a given that we are stuck with our fragmented, inefficient, multi-payor health care system for at least the short run. It then analyzes the deficiencies of three payment mechanisms whereby regulators (including Congress) have invited private sector providers to help ameliorate perceived problems. The first concerns an inadequate supply of nursing home beds in the early ‘70s, the next focuses on Medicare Advantage as a supposedly superior cost containment alternative to traditional Medicare, and the final one involves the ‘devil’s bargain’ struck with the pharmaceutical industry to get prescription drug coverage added to Medicare. All three teach the same lesson: the government needs to be more vigilant not to give away the store when it invites the private sector in
DCI Submission to the Brazil Ministry of Economy on the Economic and Competitive Aspects of Digital Platforms
Get PDFIn its comments on the ‘Economic and Competitive Aspects of Digital Platforms’ for the Brazil Ministry of Economy, the Dynamic Competition Initiative (DCI) suggests that law and policy initiatives towards digital platforms should (1) focus on curbing monopoly rents in bottleneck markets, and not undermine diversification efforts towards technological frontiers; (2) leverage the capability and flexibility of existing competition rules to address digital platforms anticompetitive conduct; and (3) properly credit the consumer welfare gains stemming from digital platforms ecosystems given the domestic economic context
The Intangible Divide: Why Do So Few Firms Invest in Innovation?
Get PDFInvestments in software, R&D, and advertising have grown rapidly, now approaching half of U.S. private nonresidential investment. Yet just a few hundred firms account for almost all this growth. Most firms, including many large ones, regularly invest little in capitalized software and R&D, and this intangible divide has surprisingly deepened as intangible prices have fallen relative to other assets. Using comprehensive US Census microdata, we document these patterns and explore a variety of factors associated with intangible investment. We find that firms invest significantly less in innovation-related intangibles when their rivals invest more. One firm\u27s investment can obsolesce rivals\u27 investments, reducing returns. This negative pecuniary externality contributes to the intangible divide and may imply substantial misallocation
We the People: A History of the U.S. Constitution
No full texthttps://scholarship.law.bu.edu/clark_speakers/1108/thumbnail.jp
How Bad is Bad Enough?: Gatekeeping a Tenant\u27s Right to 100% Habitable Housing
Get PDFTenants seeking to defend against eviction and to correct substandard conditions in their homes are hamstrung. Even in jurisdictions with “progressive housing policies,” there are steep doctrinal hurdles placed in front of tenants who try to establish a breach of the warranty of habitability and to defend against eviction. Such obstacles are baked directly into the judicial system and the standards that the judiciary applies in practice. While there are many systemic barriers to tenants vindicating themselves of the right to a fully habitable home, the most perniciously overlooked offender is a “substantiality” standard which trial court judges use to gatekeep whether code violations and other defects actually entitle a tenant to relief. For the great majority of tenants – the majority of whom are low income, of color, and without representation, an attempt to prove a substantial breach of the warranty of habitability is a high-risk bet. While large and institutional landlords bear the risk of some financial loss if tenants prove a breach of warranty at trial, tenants bear the risk of displacement and homelessness. Even tenants with representation face deep uncertainty as to whether a judge will decide (or else will instruct a jury in a manner to allow a jury to find) that the clear defects in a tenant’s home are “substantial enough” to warrant relief. This, in turn, creates undue pressure to settle an eviction case on landlord-friendly terms and to not vindicate a tenant’s rights fully. Under a standard of substantiality, the judiciary itself reifies the power imbalance between landlords and tenants by pressuring the parties to settle and by ultimately deciding that conditions in tenants’ homes are not “bad enough.” This Article draws on the Author’s experience as a practitioner in housing court to examine the substantiality standard, to explain how this standard provides a clear example of how landlord-tenant law nationwide works to stifle a tenant’s right not to be evicted from less than fully habitable housing, and ends by advocating for a reimagined standard which fully protects tenants and their rights
Administrative Law: Cases and Materials
No full textAdministrative Law: Cases and Materials is the product of a longstanding collaboration by a distinguished group of authors, each with extensive experience in the teaching, scholarship, and practice of administrative law. The Ninth Edition preserves the book’s distinctive features of functional organization and extensive use of case studies, with no sacrifice in doctrinal comprehensiveness or currency. By organizing over half of the book under the generic administrative functions of policymaking, adjudication, enforcement, and licensing, the book illuminates the common features of diverse administrative practices and the interconnection of otherwise disparate doctrines. Scattered throughout the book, case studies present leading judicial decisions in their political, legal, institutional, and technical context, thereby providing the reader with a much fuller sense of the reality of administrative practice and the important policy implications of seemingly technical legal doctrines. At the same time, the Ninth Edition fully captures the headline-grabbing nature of federal administrative practice in today’s politically divided world.
New to the 9th Edition: Extensive coverage of the Major Questions Doctrine and the decline of Chevron Expanded coverage of presidential policy initiatives including Executive Orders on immigration and Student Loan Debt Forgiveness. Updated coverage of standing to secure judicial review and the timing of judicial review especially when a party challenges an agency’s structure as unconstitutional. Updated coverage of the agency deliberation exception to the Freedom of Information Act. A new focus on issues concerning the propriety of agency adjudication and the denial of the right to a jury in private rights disputes.https://scholarship.law.bu.edu/books/1371/thumbnail.jp
Civic Education and Democracy\u27s Flaws
Get PDFToday, liberalism and democracy are beset by competitors that seek to return power to religious traditionalists or partisans masquerading as civic republicans. In such an environment, can civic education do some good, and even help bridge our society’s deepening divides?
Seana Shiffrin has characteristically brought deep learning and penetrating insight to the project of civic education in a modern democracy. Against a “dominant” model of citizenship in which “citizens vote and hand off power to their representatives”— which she believes encourages the people to maintain an unhealthy distance from government— she proposes a richer account of political community in which people see their role as “fellow duty- holders.” To facilitate this vision of legal order, Shiffrin proposes greater societal investment in developing “skills of interpretation, analogous reasoning, critical evaluation, and extension of principles to new situations.”
I begin with the conviction that democracy in the United States remains worth defending, despite a constitutional tradition that originally treated broad citizen participation in public affairs with suspicion. I also agree heartily that civic education is indispensable to the survival of democracy— not just as a technocratic enterprise, but rather as a way of life. Any disagreements I have with Shiffrin concern the level at which theory can ensure the quality of civic learning necessary to keep the American experiment alive. There’s a limit to how much philosophy can guarantee the utility of education— the rest is a matter of pedagogy and the openness of the people to self- correction.
I shall begin by briefly summarizing Shiffrin’s key arguments while emphasizing that much of the success of her proposal depends on the substance of what is taught and how political know- how is conveyed. Her analysis largely stays at a high level of abstraction, content with sketching models, attitudes, and habits to be reproduced or avoided. But I contend that what’s missing is also essential to any civic education project: honest confrontation with democracy’s deficits. Thus, while Shiffrin’s theory of democratic citizenship is admirably thicker than what many proponents of legal liberalism allow, her account of education at present may be too incomplete to equip the citizen to tackle the problems facing an aging political order. Instead, I shall suggest that what would make a meaningful impact at this historical moment is a form of education that teaches citizens the ability to diagnose democracy’s shortcomings and the capacity to reason from injustice