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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