The Conflict Between the FDA’s Pre-Launch Activities Importation Request Program and the Hatch-Waxman Act

by Alex Cheng and Matthew Avery   –  

In 2008, the Food and Drug Administration (FDA) implemented the Pre-Launch Activities Importation Request (PLAIR) program.  The FDA exercises its enforcement discretion under the guise of the PLAIR program to permit drug manufacturers to import unapproved drugs into the United States so the manufacturers can expedite their commercial launches when they finally receive official FDA approval.  But the ability to import unapproved finished drug products into the United States ahead of anticipated FDA approval conflicts with certain provisions of the Hatch-Waxman Act that permit brand-name companies to use permanent injunctions to prevent the importation of generic equivalents of their drugs before patent expiration.  This article analyzes the conflict between the PLAIR program and the Hatch-Waxman Act and discusses solutions to the conflict.

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An Insight into the Apparel Industry’s Patent Troll Problem

by Ashli Weiss   –  

Patent trolls have increasingly targeted the end users of patent-encumbered technology rather than suing the companies that created the allegedly infringing products themselves. Apparel companies provide a useful example of the predicament faced by a variety of similarly situated, non-technology-oriented companies targeted by troll litigation.  As high-profile end users of a variety of commercial technologies, apparel companies have proven to be popular targets for troll litigation.  This article examines the apparel industry’s patent troll problem through the lens of historical context, in order to describe how non-technology companies expose themselves to liability by becoming dependent on third-party technology.  It then uses lessons derived from the experiences of the apparel industry to make legislative recommendations.

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Mental Health Parity: The Patient Protection and Affordable Care Act and the Parity Definition Implications

by Suann Kessler   –  

At least twenty-eight percent of American adults suffer from a mental or addictive disorder.  However, even today, health insurance coverage for mental health services differs drastically from that of other medical services.  Nonetheless, although it has yet to achieve parity with other medical services, health insurance coverage for mental health services has improved over time.  Because the recent enactment of the Patient Protection and Affordable Care Act (“PPACA”) appears to have filled the parity gaps left by the Mental Health Parity and Addiction Equity Act of 2008, many claim that mental health parity has finally been achieved.  While the PPACA may superficially appear to have plugged all the gaps, the ultimate questions are whether it provides actual mental health parity, and whether it facilitates access to mental health services for those who truly need them.  This note takes deeper look into these questions, and reveals that the PPACA may fall short of providing actual parity between mental health and other medical services.

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Normative Avoision: Revising the Copyright Alert System to Circumvent Normative Backlash

by Timothy L. Yim   

Content rightsholders in the film and music industries previously spearheaded a legal campaign that, though highly successful in the courts, has resulted in significant normative backlash and overall has been counterproductive to their intended goal of increased copyright enforcement.  In July 2011, when these rightsholders signed an agreement with five major national internet service providers to create the Copyright Alert System (“CAS”), a new and entirely private mechanism for copyright enforcement, they seemed poised to make that same mistake again.  However, in a prime example of “normative avoision,” content rightsholders have finally taken note of the normative consequences of their enforcement methods and, through subsequent changes to CAS, have deftly sidestepped the normative backlash dilemma.

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What Can Medicine Teach the Social Sciences?

by Lee McIntyre    

In a field as slow to change as the law, it is often helpful to inject fresh perspectives from other disciplines.  As different as legal analysis might be from that found in the medical and social sciences, they are all ultimately concerned with the pursuit of objectivity.  Furthermore, in each of these fields, the pursuit of academic and practical goals are permeated and influenced by the values of those that seek to achieve them.  Indeed, both the law and the social sciences in particular are fundamentally concerned with finding ways of distilling logic and order from the complexities of human behavior.  Thus, there is much to be learned from how medicine and the social sciences reconcile these often competing goals, a comparison artfully explored by Lee McIntyre in this editorial.

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The E-Books Price Fixing Litigation: Curious Outlier or Harbinger of Change in Antitrust Enforcement Policy?

by Evan D. Brewer    

In 2012 the Department of Justice brought suit against Apple and five major US publishing houses for conspiring to fix the price of e-books.  The complaint contained many detailed factual allegations, including the sort of high-level executive collusion commonly seen in criminal price fixing cases.  The charged conduct, horizontal price fixing, is per se illegal under the Sherman Act and among the “hardcore” violations that under Antitrust Division policy merit criminal charges.  Yet instead the government brought a civil case against Apple and the publishers.  This note analyses the details of the Antitrust Division’s case, viewed in light of current antitrust law, antitrust policy, and public perception of the players and the case, and suggests a number of possible explanations for the choice of a civil action.

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Three-Parent IVF and Its Effect on Parental Rights

by Padmini Cheruvu    

Three-parent in vitro fertilization (“IVF”) is a controversial procedure that offers the possibility of preventing the inheritance of genetically caused mitochondrial disease, sparing future generations from a range of incapacitating conditions.  Due to the use of a controversial form of cloning technology, the procedure is currently banned in both the United Kingdom and the United States.  If the procedure was to be made legal in the United States, it is unclear how the states would legally view the donor parent.  This note argues that the rights that donor parents in three-parent IVF procedures receive will most likely parallel the rights afforded to surrogate parents. It then proposes ways to change existing law or incorporate three-parent IVF into the existing law using current surrogacy law as a model.

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