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Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai Jan 2012

Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai

Faculty Scholarship

The Hatch-Waxman Act of 1984 aims to strike a balance between the innovation incentives provided by patents and the greater consumer access provided by low-cost generic drugs. The legislation, which relies in part on an explicit link between the FDA drug approval process and the U.S. patent system, has been controversial, particularly because of the ways in which firms producing brand-name drugs have exploited that link to delay market entry of generics as long as possible. Voluminous scholarship has focused on so-called "pay-for-delay" settlements of patent litigation between brand name and generic firms.

In contrast, this Perspective uses the ...


Introduction, Paul Finkelman Jan 2012

Introduction, Paul Finkelman

Faculty Scholarship

No abstract provided.


A Political Show Trial In The Northern District: Oberlin-Wellington Fugitive Slave Rescue Case, Paul Finkelman Jan 2012

A Political Show Trial In The Northern District: Oberlin-Wellington Fugitive Slave Rescue Case, Paul Finkelman

Faculty Scholarship

This chapter from Justice and Legal Change on the Shores of Lake Erie, examines the first important cases ever heard by the U.S. District Court for the Northern District of Ohio. The cases, known as the Oberlin-Wellington Fugitive Slave Cases -- stemmed out of the rescue of a fugitive slave from the custody of a professional slave catcher. The fugitive was seized in Oberlin, and taken to nearby Wellington, and held in hotel while the slave catchers waiting for a train to take them to Columbus. Meanwhile, a mob -- consisting mostly of Oberlin residents, including many Oberlin College faculty and ...


Fundamental Forces Driving United States And International Financial Regulations Reform, Lawrence G. Baxter Jan 2012

Fundamental Forces Driving United States And International Financial Regulations Reform, Lawrence G. Baxter

Faculty Scholarship

Multiple forces create a systemic crisis of the proportions of the Global Financial Crisis of 2008. Global and domestic financial reform is a difficult and perplexing task, one that is likely to take many years, and one that will surely continue to be shaped by a diverse range of forces. Recent measures remain incomplete and in some cases are even proving to be misdirected. This article considers seven fundamental forces shaping actions on future reform, specifically the (1) long term impact of the Crisis (and all financial crises); (2) increase in the “financialization” of the global economy, seemingly disproportionate to ...


A Current Assessment Of Some Extraterritorial Impacts Of The Dodd-Frank Act With Special Focus On The Volcker Rule And Derivatives Regulation, Lawrence G. Baxter Jan 2012

A Current Assessment Of Some Extraterritorial Impacts Of The Dodd-Frank Act With Special Focus On The Volcker Rule And Derivatives Regulation, Lawrence G. Baxter

Faculty Scholarship

As the world struggles to emerge from the Global Financial Crisis the vision of a harmonious framework of global financial regulation seems as distant as ever. Important progress made by international committees such as the Basel Committee on Banking Supervision and the Financial Stability Board notwithstanding, there seem to be increasing signs of unilateral, extraterritorial action by major jurisdictions, including the United States. This paper reviews the framework created by the US financial reforms, in particular anti money laundering provisions, the Volcker Rule and the proposed OTC derivatives margin requirements, and considers some of the dilemmas presented by modern global ...


Slavery In The United States: Persons Or Property?, Paul Finkelman Jan 2012

Slavery In The United States: Persons Or Property?, Paul Finkelman

Faculty Scholarship

No abstract provided.


“Early-Bird Special” Indeed!: Why The Tax Anti-Injunction Act Permits The Present Challenges To The Minimum Coverage Provision, Neil S. Siegel, Michael C. Dorf Jan 2012

“Early-Bird Special” Indeed!: Why The Tax Anti-Injunction Act Permits The Present Challenges To The Minimum Coverage Provision, Neil S. Siegel, Michael C. Dorf

Faculty Scholarship

In view of the billions of dollars and enormous effort that might otherwise be wasted, the public interest will be best served if the Supreme Court of the United States decides the present challenges to the Patient Protection and Affordable Care Act (ACA) during its October 2011 Term. Potentially standing in the way, however, is the federal Tax Anti-Injunction Act (TAIA), which bars any “suit for the purpose of restraining the assessment or collection of any tax.” The dispute to date has turned on the fraught and complex question of whether the ACA's exaction for being uninsured qualifies as ...


Regulating Shadow Banking, Steven L. Schwarcz Jan 2012

Regulating Shadow Banking, Steven L. Schwarcz

Faculty Scholarship

Inaugural Address for Boston University Review of Banking & Financial Law's Inaugural Symposium: “Shadow Banking” February 24, 2012.

Although shadow banking is said to be huge, estimated at over $60 trillion, it is not well defined. This short and accessible paper attempts to define shadow banking by identifying its overall scope and its basic characteristics. Based on the definition derived, the paper also conceptually examines how shadow banking can be regulated to try to maximize its efficiencies while minimizing its risks.


Not The Power To Destroy: An Effects Theory Of The Tax Power, Neil S. Siegel, Robert D. Cooter Jan 2012

Not The Power To Destroy: An Effects Theory Of The Tax Power, Neil S. Siegel, Robert D. Cooter

Faculty Scholarship

The Supreme Court’s “new federalism” decisions impose modest limits on the regulatory authority of Congress under the Commerce Clause. According to those decisions, the Commerce Clause empowers Congress to use penalties to regulate interstate commerce, but not to regulate noncommercial conduct. What prevents Congress from penalizing non-commercial conduct by calling a penalty a tax and invoking the Taxing Clause? The only obstacle is the distinction between a penalty and a tax for purposes of Article I, Section 8. In National Federation of Independent Business v. Sebelius (NFIB), the Court considered whether the minimum coverage provision in the Patient Protection ...


Qui Tam: Is False Claims Law A Model For International Law?, Paul D. Carrington Jan 2012

Qui Tam: Is False Claims Law A Model For International Law?, Paul D. Carrington

Faculty Scholarship

No abstract provided.


Accountability In Patenting Of Federally Funded Research, Arti K. Rai, Bhaven N. Sampat Jan 2012

Accountability In Patenting Of Federally Funded Research, Arti K. Rai, Bhaven N. Sampat

Faculty Scholarship

Bayh-Dole allows academic grantees to patent federally-funded research for purposes of promoting the commercialization of this research. To ensure commercialization goals are achieved, the Act requires grantees to report to funding agencies not only the existence of federally-funded patents but also utilization efforts they and their licensees/assignees are making.

Although reporting is a cornerstone of accountability under Bayh-Dole, information about grantee compliance with reporting requirements is incomplete and dated. In fact, the last significant study of the question dates back to the late 1990s and analyzes only 633 patents. Since that time, concerns have emerged that federally-funded university patents ...


American Natures: The Shape Of Conflict In Environmental Law, Jedediah Purdy Jan 2012

American Natures: The Shape Of Conflict In Environmental Law, Jedediah Purdy

Faculty Scholarship

There is a firestorm of political and cultural conflict around environmental issues,including but running well beyond climate change. Legal scholarship is in a bad position to make sense of this conflict because the field has concentrated on making sound policy recommendations to an idealized lawmaker, neglecting the deeply held and sharply clashing values that drive, or block, environmental lawmaking. This Article sets out a framework for understanding and engaging the clash of values in environmental law and, by extension,approaching the field more generally. Americans have held, and legislated based upon, four distinct ideas about why the natural world ...


Responses To The Five Questions, Charles J. Dunlap Jr. Jan 2012

Responses To The Five Questions, Charles J. Dunlap Jr.

Faculty Scholarship

No abstract provided.


Sorrell V. Ims Health And The End Of The Constitutional Double Standard, Ernest A. Young Jan 2012

Sorrell V. Ims Health And The End Of The Constitutional Double Standard, Ernest A. Young

Faculty Scholarship

No abstract provided.


The Emperor Has No Clothes: Confronting The Dc Circuit’S Usurpation Of Sec Rulemaking Authority, James D. Cox, Benjamin J.C. Baucom Jan 2012

The Emperor Has No Clothes: Confronting The Dc Circuit’S Usurpation Of Sec Rulemaking Authority, James D. Cox, Benjamin J.C. Baucom

Faculty Scholarship

In The Emperor Has No Clothes: Confronting the D.C. Circuit’s Usurpation of SEC Rulemaking Authority, Professor James D. Cox of Duke University School of Law & Benjamin J.C. Baucom, recent law clerk to Justice Don R. Willett of the Supreme Court of Texas, argue “that the level of review invoked by the D.C. Circuit in Business Roundtable and its earlier decisions is dramatically inconsistent with the standard enacted by Congress.” They conclude “that the D.C. Circuit has assumed for itself a role opposed to the one Congress prescribed for courts reviewing SEC rules.”


The Great American Tax Novel, Lawrence A. Zelenak Jan 2012

The Great American Tax Novel, Lawrence A. Zelenak

Faculty Scholarship

Reviewing, David Foster Wallace. The Pale King (Michael Pietsch ed., 2011)


Attorney General Bradford’S Opinion And The Alien Tort Statute, Curtis A. Bradley Jan 2012

Attorney General Bradford’S Opinion And The Alien Tort Statute, Curtis A. Bradley

Faculty Scholarship

In debates over the scope of the Alien Tort Statute (ATS), one historical document has played an especially prominent role. This document is a short opinion by U.S. Attorney General William Bradford, issued in the summer of 1795, concerning the involvement of U.S. citizens in an attack by a French fleet on a British colony in Sierra Leone. Numerous academic articles, judicial opinions, and litigation briefs have invoked the Bradford opinion, for a variety of propositions, and the opinion was discussed by both sides in the oral argument before the Supreme Court in the first hearing in the ...


The 2011 Diane Sanger Memorial Lecture Protecting Investors In Securitization Transactions: Does Dodd–Frank Help, Or Hurt?, Steven L. Schwarcz Jan 2012

The 2011 Diane Sanger Memorial Lecture Protecting Investors In Securitization Transactions: Does Dodd–Frank Help, Or Hurt?, Steven L. Schwarcz

Faculty Scholarship

Securitization has been called into question because of its role in the recent financial crisis. Schwarcz examines the potential flaws in the securitization process and compare how the Dodd–Frank Act treats them. Although Dodd–Frank addresses one of the flaws, it underregulates or fails to regulate other flaws. It also overregulates by addressing aspects of securitization that are not flawed.


Section 2 Is Dead: Long Live Section 2, Guy-Uriel Charles Jan 2012

Section 2 Is Dead: Long Live Section 2, Guy-Uriel Charles

Faculty Scholarship

No abstract provided.


Concentration In Health Care Markets: Chronic Problems And Better Solutions, Barak D. Richman Jan 2012

Concentration In Health Care Markets: Chronic Problems And Better Solutions, Barak D. Richman

Faculty Scholarship

Health care providers with market power enjoy substantially more pricing freedom than monopolists in other markets, for a reason not generally recognized: US-style health insurance. Consequently, monopolies in health care cause undesirable redistribution of wealth and inefficient allocation of resources, both of which burden consumers at levels beyond those of other monopolists. The unusual costliness of monopoly power in health care markets demands far more policy attention than it has received. For starters, the health sector needs a more aggressive antitrust policy that effectively prevents the creation of new provider market power through mergers, alliances, or government immunity. An immediate ...


Direct And Indirect U.S. Government Debt, Steven L. Schwarcz Jan 2012

Direct And Indirect U.S. Government Debt, Steven L. Schwarcz

Faculty Scholarship

No abstract provided.


What Is The Emperor Wearing? The Secret Lives Of Ecosystem Services, James Salzman Jan 2011

What Is The Emperor Wearing? The Secret Lives Of Ecosystem Services, James Salzman

Faculty Scholarship

No abstract provided.


The Regrettable Clause: United States V. Comstock And The Powers Of Congress, H. Jefferson Powell Jan 2011

The Regrettable Clause: United States V. Comstock And The Powers Of Congress, H. Jefferson Powell

Faculty Scholarship

In this Article, Powell argues that in Comstock, the Court encountered one of the oldest and most basic constitutional issues about the scope of congressional power-whether there are justiciable limits to the range of legitimate ends Congress may pursue. The Justices, without fully recognizing the fact, were taking sides in an ancient debate, and in doing so, they inadvertently reopened an issue that ought to be deemed long settled. Part II of the Article first addresses the question before the Court in Comstock, which was limited to a pure question of Article I law: is a specific provision of a ...


A Cautious Path Forward On Accountable Care Organizations, Barak D. Richman, Kevin A. Schulman Jan 2011

A Cautious Path Forward On Accountable Care Organizations, Barak D. Richman, Kevin A. Schulman

Faculty Scholarship

The wave of new Accountable Care Organizations (ACOs), spurred by financial incentives in the Affordable Care Act, could become the latest chapter in the steady accumulation of market power by hospitals, health care systems, and physician groups. The main purpose behind forming many ACOs may not be to achieve cost savings but instead to strengthen negotiating power over purchasers in the private sector. This would be an unfortunate sequel to the waves of mergers in the 1990s when health care entities sought to counter market pressure from managed care organizations. The possibility that ACOs might further concentrate health care markets ...


The Loophole That Would Not Die: A Case Study In The Difficulty Of Greening The Internal Revenue Code, Lawrence A. Zelenak Jan 2011

The Loophole That Would Not Die: A Case Study In The Difficulty Of Greening The Internal Revenue Code, Lawrence A. Zelenak

Faculty Scholarship

Congress and the Treasury have commissioned the National Academy of Sciences (NAS) “to undertake a comprehensive review of the Internal Revenue Code of 1986 to identify the types of and specific tax provisions that have the largest effects on carbon and other greenhouse gas emissions and to estimate the magnitude of those effects.” The hope of the proponents of the NAS carbon audit is that Congress, once informed of the results of the audit, will respond by “greening” the Internal Revenue Code. This Essay cautions that a more environmentally friendly Code will not necessarily follow from the legislative consciousness-raising of ...


The Case For Legal Regulation Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff Jan 2011

The Case For Legal Regulation Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

No abstract provided.


Who’S Afraid Of The Federal Circuit?, Arti K. Rai Jan 2011

Who’S Afraid Of The Federal Circuit?, Arti K. Rai

Faculty Scholarship

In this brief Essay, Professor Rai responds to Professor Jonathan Masur's Yale Law Journal article "Patent Inflation." Professor Masur's argument rests on the assumption that U.S. Patent and Trademark Office ("PTO") behavior is determined almost entirely by a desire to avoid reversal by the Federal Circuit. Although the PTO is certainly a weak agency over which the Federal Circuit has considerable power, Masur overestimates the extent to which high-level PTO administrators are concerned about Federal Circuit reversals and underestimates institutional influences that are likely to operate in a deflationary direction. The PTO is influenced not only by ...


The Paradoxes Of Dodd-Frank, James D. Cox Jan 2011

The Paradoxes Of Dodd-Frank, James D. Cox

Faculty Scholarship

No abstract provided.


Assessing Post-Ada Employment: Some Econometric Evidence And Policy Considerations, Christopher L. Griffin Jr., John J. Donohue Iii, Michael Ashley Stein, Sascha Becker Jan 2011

Assessing Post-Ada Employment: Some Econometric Evidence And Policy Considerations, Christopher L. Griffin Jr., John J. Donohue Iii, Michael Ashley Stein, Sascha Becker

Faculty Scholarship

This article explores the relationship between the Americans with Disabilities Act (“ADA”) and the relative labor market outcomes for people with disabilities. Using individual-level longitudinal data from 1981 to 1996 derived from the previously unexploited Panel Study of Income Dynamics (“PSID”), we examine the possible effect of the ADA on (1) annual weeks worked; (2) annual earnings; and (3) hourly wages for a sample of 7120 unique male household heads between the ages of 21 and 65 as well as a subset of 1437 individuals appearing every year from 1981 to 1996. Our analysis of the larger sample suggests the ...


International Law And The U.S. Common Law Of Foreign Official Immunity, Curtis A. Bradley, Laurence R. Helfer Jan 2011

International Law And The U.S. Common Law Of Foreign Official Immunity, Curtis A. Bradley, Laurence R. Helfer

Faculty Scholarship

In Samantar v. Yousuf, 130 S. Ct. 2278 (2010), the U.S. Supreme Court unanimously held that the Foreign Sovereign Immunities Act does not apply to lawsuits brought against foreign government officials for alleged human rights abuses. The Court did not necessarily clear the way for future human rights litigation against such officials, however, cautioning that such suits “may still be barred by foreign sovereign immunity under the common law.” At the same time, the Court provided only minimal guidance as to the content and scope of common law immunity. Especially striking was the Court’s omission of any mention ...