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Articles 1 - 6 of 6
Full-Text Articles in Law
Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway
Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway
Scholarly Works
This article will discuss the current state of off-label medicine, relevant legislation in the area, and a proposal designed to capture the benefits of off-label medicine while limiting its dangers when practiced perniciously. Part II will discuss the regulations in place governing off-label promotion and will detail the practice of ghostwriting and its associated concerns. Part III will analyze the costs and benefits of off-label marketing and practice of medicine, and will utilize a case study to demonstrate the predicament of drug manufacturers. Part IV will set forth a proposal to use the newly created Patient-Centered Outcomes Research Institute to …
Trips And Bits: An Essay On Compulsory Licenses, Expropriation, And International Arbitration, Peter B. Rutledge
Trips And Bits: An Essay On Compulsory Licenses, Expropriation, And International Arbitration, Peter B. Rutledge
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This essay examines the potential for arbitration to resolve disputes between private companies and developing countries over the propriety of compulsory licenses. At bottom, my thesis is that arbitration supplies the medium through which to mediate the tension between the profit-seeking goals of private multinational companies and the development goals of foreign nations, especially in the developing world. The compulsory license debate raises a clash of fundamental interests between the patent holder, the patent holder’s state, and the host state. Arbitration can play an important role in balancing those interests, albeit a highly unusual one. Arbitration provides an essential forum …
Gene Patents No More? Deciphering The Meaning Of Prometheus, Fazal Khan, Lindsay Kessler
Gene Patents No More? Deciphering The Meaning Of Prometheus, Fazal Khan, Lindsay Kessler
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When Congress enacted the United States Patent Act in 1952, it specified that patentable subject matter included anything “under the sun that is made by man.” Three decades ago the United States Patent and Trademark Office (USPTO) issued the first gene patent and ushered in a brave new gold rush. Some genes are associated with specific diseases, so being able to identify these sequences is an essential first step for developing genomic diagnostic tests and therapies. The problem with gene patents is that they allow modern-day prospectors to cordon off access to naturally occurring DNA sequences and exclude others from …
Affordable Care Act Litigation: The Standing Paradox, Elizabeth Weeks Leonard
Affordable Care Act Litigation: The Standing Paradox, Elizabeth Weeks Leonard
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The Patient Protection and Affordable Care Act (ACA) litigation presents a standing paradox. In the current posture, it appears that states lack standing to challenge the federal law on behalf of individuals, while individuals possess standing to challenge the federal law on behalf of states. This Article contends that there is no principled reason for this asymmetry and argues that standing doctrine should apply as liberally to states as individuals, assuming states allege the constitutional minimum requirements for standing and especially where the legal challenge turns on allocation of power between the federal government and states. The Article proceeds by …
The Rhetoric Hits The Road: State Resistance To Affordable Care Act Implementation, Elizabeth Weeks Leonard
The Rhetoric Hits The Road: State Resistance To Affordable Care Act Implementation, Elizabeth Weeks Leonard
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This paper provides an update and reanalysis of my previously published article, Rhetorical Federalism: The Value of State-Based Dissent to Federal Health Reform, 93 Hofstra Law Review 111 (2010). In Rhetorical Federalism, I made an affirmative case for the widespread trend of state resistance to the then-recently enacted Patient Protection and Affordable Care Act of 2010 (ACA). Before and immediately after ACA’s enactment, a significant number of states engaged in various forms of objection to the new federal Act, including but not limited to lawsuits challenging the constitutionality of the individual insurance mandate. My article focused on five targets of …
An Essay On Originalism And The 'Individual Mandate': Rounding Out The Government’S Case For Constitutionality, Dan T. Coenen
An Essay On Originalism And The 'Individual Mandate': Rounding Out The Government’S Case For Constitutionality, Dan T. Coenen
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The Supreme Court now has under advisement the landmark federal health care law case. Much attention has focused on the law’s minimum coverage provision—or so-called “individual mandate” — and, in particular, its constitutionality under the Commerce Clause and the Necessary and Proper Clause. In a separate and much lengthier article, I offer two main observations about the arguments made to the Court on that issue. First, I show that the challengers of the minimum coverage provision emphasized originalist reasoning in their briefs and oral arguments, while the federal government did not. Second, I explain why — contrary to the impression …