Incrementalism in Pharmaceutical Research: Incentives and Policy Implications

DSpace/Manakin Repository

Incrementalism in Pharmaceutical Research: Incentives and Policy Implications

Show simple item record

dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Laughlin, Catherine en_US
dc.date.accessioned 2012-07-06T20:31:37Z
dc.date.issued 2006 en_US
dc.identifier.citation Incrementalism in Pharmaceutical Research: Incentives and Policy Implications (2006 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8965545
dc.description.abstract The tremendous commercial success of drugs which scientific data suggest are of no benefit to most patients relative to pre-existing drugs is illustrative of a phenomenon in pharmaceutical markets whereby products can become commercially successful even though their social costs vastly outweigh their social benefits. This suggests that a confluence of market failures, patent laws and FDA regulation of pharmaceuticals is creating perverse incentives that both encourage inefficient allocation of resources and decrease consumer access. In this paper, I explore this phenomenon by addressing two related questions. First, how can incremental improvements in medications be characterized so as to identify which incremental research should be encouraged or discouraged by patent and regulatory law? And second, which doctrinal or policy levers should Congress and the courts use to reduce incentives for undesirable incrementalism? Part I of this paper describes the economic and legal context that must inform pharmaceutical policy. Part II attempts to characterize pharmaceutical innovations in terms of their social value and degree of innovation, and thereby to identify the types of innovations that patent law and FDA regulations should promote. Part III presents possible policy solutions for tailoring incentives to discourage undesirable forms of incrementalism and encourage valuable forms of innovation. In particular, mandatory and voluntary comparative testing of drugs, increasing the standard of nonobviousness for patentability, improvements to the patent application process, and penalties for holders of invalid patents in paragraph IV challenges are explored as means to enhance the correlation between the social benefits and royalties derived from pharmaceutical patents. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject incrementalish en
dc.title Incrementalism in Pharmaceutical Research: Incentives and Policy Implications en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-07-06T20:31:37Z

Files in this item

Files Size Format View
Laughlin06.pdf 502.6Kb PDF View/Open
Laughlin06.rtf 408.0Kb RTF file View/Open
Laughlin06.html 290.1Kb HTML View/Open

This item appears in the following Collection(s)

Show simple item record

 
 

Search DASH


Advanced Search
 
 

Submitters