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Patently Innovative: How Pharmaceutical Firms Use Emerging Patent Law

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ISBN13: 9781907568121
Published: December 2011
Publisher: Woodhead Publishing Ltd
Country of Publication: USA
Format: Hardback
Price: £140.00



Usually despatched in 1 to 3 weeks.

The availability of generic and brand-name drugs worldwide is a function of a combination of traditional patent law incentives and emerging 'linkage regulations', which legally tie brand and generic drug approval to drug patents through mandatory litigation for generic firms. Together, these systems of intellectual property law operate to shape the marketplace for brand and generic pharmaceuticals, and thus determine the costs of public and private drug expenditures and access to essential medications in developed and developing nations. The patent monopoly system has been in operation for about 500 years, with early patent laws in Italy and the United Kingdom. By contrast however, the linkage regime has only been in existence for 25 years following passage of the Hatch Waxman Act in the United States in 1984. By 2010, we were witnessing a global spread of the linkage regime stimulated in part by multilateral Free Trade Agreements with the United States and the European Union, which typically oblige participating nations to incorporate linkage provisions in exchange for preferential trade terms. Moreover, there appears to be movement afoot to broaden the concept of linkage outside the drug approval process to include that between patent rights and international trade regulation. Therefore, linkage regulations in respect of pharmaceuticals are emerging as a key driver of public health costs on the global stage. This book provides a review of the importance of traditional patent law and emerging linkage regulations for pharmaceutical products on the global stage, with a focus on the linkage regime in Canada. The primary focus is on how innovation in the pharmaceutical sector can be strongly regulated and how government regulation can either stimulate or inhibit development of breakthrough products. The work focuses on assessment of empirical data pertaining to: firstly, how linkage regulations, which legally the drug patenting to drug approval for both brand-name and generic pharmaceutical firms can be used by sophisticated drug companies to substantially extend monopoly protection on blockbuster drugs; and, secondly, how incentives provided by government to stimulate pharmaceutical innovation can antecedently shape the rate and direction of innovation by firms in a manner opposite to that intended as a result of unintended consequences. Particular attention is given to data relating to trends in the development of 'new' and 'follow-on' drugs and the relation of these trends to the institution of reforms in drug law and patent law intended to stimulate innovation. The book includes empirical research to relate innovation to drug law. A multidisciplinary approach is taken, including the intersection of IP (intellectual property) law, drug law and innovation. The book discusses the impact of government regulation on firm innovation. Brand vs. generic drug wars are also analyzed. The book considers the balance of IP monopoly of private firms with public health mandate. The book reviews the timeline for spread of linkage regulations worldwide and analyses the different linkage regimes in context of the policy goals predating the coming into force of legislation in each jurisdiction.

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Subjects:
Intellectual Property Law
Contents:
Introduction: an emerging paradigm for linking drug development to patent law
Drug approval: trends in drug approval - abstract
abbreviations
introduction
analysis (general
methods
results)
discussion (interpretation of data
study limitations
assessing the lifecycle approach: the long view
government as self-interested actor or representative public agent)
summary and conclusions
Drug patenting: patent protection for 'high value' pharmaceuticals - abstract
introduction
background (patents
linkage regulations)
methods (general
drug patenting
patent listing
patent class
therapeutic class
data analysis)
results (cohort (drug patenting and patent listing
patent class
therapeutic class)
most profitable, priority review, NOC/c, PR-NOC/c (drug patenting and patent listing
patent class
therapeutic class)
limitations)
discussion (drug patenting
drug approval-patenting linkage
most profitable, priority review, NOC/c, PR-NOC/c)
summary and conclusions
Drug approval-drug patenting nexus: how linkage regulations extend intellectual monopoly - introduction
background (pharmaceutical market
drug approval
linkage regulations
IPR rights and innovation policy)
methods (drug approval
drug patenting
patent listing and litigation
analytical model
data analysis)
results (drug approval
drug patenting
patent listing and litigation
limitations)
discussion (trends in global drug development
role of drug patenting and linkage regulations
convergence of economic and public health policy
analytical model: pharmaceuticals and the ecology of innovation)
Constitutional implications of empirical data - introduction
history of patent reform
NAFTA
TRIPS, original policy intent
patent specific analysis
statutory interpretation.
Global spread of linkage regulations - United States
Canada
European Union
Australia
Mexico
India
South Korea
China
TRIPS
TRIPS-Plus
Summary: shaping the future of pharmaceutical innovation
References
Index.