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How Do The Social Benefits And Costs Of The Patent System Stack Up In Pharmaceuticals?, Daniel J. Gifford Oct 2016

How Do The Social Benefits And Costs Of The Patent System Stack Up In Pharmaceuticals?, Daniel J. Gifford

Journal of Intellectual Property Law

This paper explores the workings of the patent system in the context of the generation of new pharmaceutical products. First it identifies the relevant characteristics of the patent system and its relation to the market. The paper concedes that, in general, the patent system is probably the best way of generating new technology, in substantial part because that system uses the market to provide both incentives and rewards. The paper also identifies downsides of this patent/market system: deadweight loss and the unresponsiveness of that patent/market system to the needs of the poor. The paper then explores the social costs and …

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Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova Dec 2015

Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova

Robin C Feldman

The FDA’s citizen petition process was created in the 1970s as part of an effort to fashion more participatory regimes, in which ordinary citizens could access the administrative process. The theoretical underpinnings hypothesize that a participatory structure will prevent regulatory agencies from being captured by the very industries they were intended to police. Anecdotal evidence suggests, however, that the FDA’s citizen petition process may have taken a different turn. This empirical study explores whether pharmaceutical companies are systematically using citizen petitions to try to delay the approval of generic competitors. Delaying generic entry of a drug — even by a …

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Regulatory Property: The New Ip, Robin C. Feldman Dec 2015

Regulatory Property: The New Ip, Robin C. Feldman

Robin C Feldman

For thirty years, a new form of intellectual property has grown up quietly beneath the surface of societal observation. It is a set of government-granted rights that have the quintessential characteristic of intellectual property and other forms of property — that is, the right to exclude others from the territory. 

The impact of this form of IP on the US health care system, in particular, is enormous. In 2014, more than 40% of all new drugs approved by the FDA came through just one of these portals, with the companies collecting regulatory property rights along the way. 

Some forms of …

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Exhausted Or Unlicensed: Can Field-Of-Use Restrictions In Biotech License Agreements Still Prevent Off-Label Use Promotion After Quanta Computer?, Kristal M. Wicks Dec 2010

Exhausted Or Unlicensed: Can Field-Of-Use Restrictions In Biotech License Agreements Still Prevent Off-Label Use Promotion After Quanta Computer?, Kristal M. Wicks

The University of New Hampshire Law Review

[Excerpt] “In the biotechnology (biotech) industry, companies must be increasingly aware of their intellectual property and how their licensing strategies can impact their rights. When licensing patented technology, it is common practice for biotech companies to include restricted field-of-use provisions in their license agreements. Such provisions permit a licensee to only use licensed technology in a defined field and restrict use or development in another field. This licensing strategy plays an important role within the biotech industry because it allows companies to more effectively control their intellectual property and to more efficiently research and develop pharmaceutical products.

A problem that …

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Book Review Of Michael D. Green, Bendectin And Birth Defects: The Challenges Of Mass Toxic Substance Litigation, Stefan Oglevee Jan 1997

Book Review Of Michael D. Green, Bendectin And Birth Defects: The Challenges Of Mass Toxic Substance Litigation, Stefan Oglevee

RISK: Health, Safety & Environment (1990-2002)

Review of Michael D. Green, Bendectin and Birth Defects: The Challenges of Mass Toxic Substances Litigation (University of Pennsylvania Press 1996). Acknowledgements, index, preface, selected bibliography. LC 95-42306; ISBN 0-8122-3257-7 [368 pp. $29.95 Cloth. 1300 Blockley Hall, 418 Service Drive, Philadelphia PA 19104-6097.]

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Decision Analysis And Fda Drug Review: A Proposal For Shadow Advisory Committees, John M. Mendeloff Jun 1995

Decision Analysis And Fda Drug Review: A Proposal For Shadow Advisory Committees, John M. Mendeloff

RISK: Health, Safety & Environment (1990-2002)

The FDA seems to acknowledge that sometimes different standards of proof for assessing drug efficacy should be used. Dr. Mendeloff thus proposes a methodology that might illuminate the FDA's decision-making and help better to assess its decisions.

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