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Full-Text Articles in Food and Drug Law
The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan
The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan
Faculty Publications
This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …
A New Framework For Assessing Clinical Data Transparency Initiatives, Erika Lietzan
A New Framework For Assessing Clinical Data Transparency Initiatives, Erika Lietzan
Faculty Publications
Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of their medicines, expecting the information to be kept confidential, as has been the practice of regulators around the world for decades. Over the last ten years, however, pressure has been mounting for regulators or industry to release this information. Legal scholars have generally taken the view that no relevant doctrines or bodies of law preclude the release of this material and that public policy considerations compel its release. This article argues that the scholarship to date has overlooked key considerations: the special issues presented by operation …
Unofficial Legislative History Of The Biologics Price Competition And Innovation Act 2009, An, Erika Lietzan, Krista Hessler Carver, Jeffrey Elikan
Unofficial Legislative History Of The Biologics Price Competition And Innovation Act 2009, An, Erika Lietzan, Krista Hessler Carver, Jeffrey Elikan
Faculty Publications
On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which created a regulatory pathway for, and scheme for litigation of patent issues relating to, “biosimilar” biological products. This article discusses the history of the BPCIA and explains its provisions. Section I provides background and a history of the regulation of drugs and biological products in the United States. Section II describes the growing interest in biosimilar approval from the early 2000s through September 2006, when the legislative debate began in earnest. Section III describes the legislative and stakeholder process from …
2004 Update - 180-Day Exclusivity Under The Hatch-Waxman Amendments To The Federal Food, Drug, And Cosmetic Act, Erika Lietzan
2004 Update - 180-Day Exclusivity Under The Hatch-Waxman Amendments To The Federal Food, Drug, And Cosmetic Act, Erika Lietzan
Faculty Publications
This article updates the author's previously published article on the topic, provides some insight into recent events in this area of the law, and specifies a few minor items that were noted incorrectly in the earlier work.
Generic Competition And Pharmaceutical Innovation: The Drug Price Competition And Patent Term Restoration Act Of 1984, James J. Wheaton
Generic Competition And Pharmaceutical Innovation: The Drug Price Competition And Patent Term Restoration Act Of 1984, James J. Wheaton
Faculty Publications
This article critiques the Drug Price Competition and Patent Term Restoration Act of 1984. Part I traces the background of the two major sections of the Act by examining the recent trend toward generic competition in the pharmaceutical industry and the need perceived by some industry observers for additional incentives to pharmaceutical research. Part II of the article describes and discusses the sections of the Act designed to benefit the two segments of the pharmaceutical industry. Part III addresses the likely effect of the Act on generic competition, and Part IV provides a parallel analysis for the research-intensive pharmaceutical firms. …