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Food and Drug Law Commons™

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Articles 31 - 39 of 39

Full-Text Articles in Food and Drug Law

Unpredictability In Patent Law And Its Effect On Pharmaceutical Innovation, Christopher M. Holman Jan 2011

Unpredictability In Patent Law And Its Effect On Pharmaceutical Innovation, Christopher M. Holman

Faculty Works

In recent years, the major innovator pharmaceutical companies have experienced two pronounced and significant trends: a decreasing output of innovative new drugs and cutbacks in research and development (R&D) investment. The two phenomena probably are not unrelated and raise significant concerns for a society intent upon providing affordable health care for an aging population. While the root causes of these trends are complex and diverse, we should not overlook the critical role patents play in creating the necessary incentives for the substantial investment required to develop pharmaceutically-interesting chemical compounds into actual drugs and to take them through the clinical trials …

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"Per Se Illegality For Reverse Payment Settlements?" Review Of "Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Daniel A. Crane Jan 2010

"Per Se Illegality For Reverse Payment Settlements?" Review Of "Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Daniel A. Crane

Reviews

Congratulations to Mike on a very fine book. I will confine my comments to Mike's chapter on patent settlements (Chapter 15), which I understand will also be coming out as an article in the Michigan Law Review. Patent settlements involving "reverse payments" are a huge topic on which I and many others have spilled much ink already. Representative Bobby Rush (President Obama's erstwhile nemesis from Chicago's South Side) has just introduced legislation that would ban reverse payments.' I will not regurgitate my entire spiel on patent settlements here, but instead just try to highlight my essential disagreement with Mike …

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Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman Jan 2010

Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman

Faculty Works

Much like tort reform, the debate over recently enacted legislation on biotech drugs — and particularly regulatory supplements to patent protection — has taken on a significance that dwarfs its impact on prescription drug expenditures. Under the Health Care Reform legislation, Congress enacted two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics (FOBs), which are the analogues of generics for biotech drugs. Second, establishment of a twelve-year “data exclusivity” period in which clinical testing data collected by brand-name innovators cannot be used by producers of FOBs to satisfy FDA testing requirements. …

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Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier Oct 2009

Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier

Michigan Law Review

A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed them, explaining …

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Knowledge Commons: The Case Of The Biopharmaceutical Industry, Arti K. Rai Jan 2007

Knowledge Commons: The Case Of The Biopharmaceutical Industry, Arti K. Rai

Faculty Scholarship

No abstract provided.

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2004 Update - 180-Day Exclusivity Under The Hatch-Waxman Amendments To The Federal Food, Drug, And Cosmetic Act, Erika Lietzan Jan 2004

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.

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The Battle Over Life-Saving Pharmaceuticals: Are Developing Countries Being Tripped By Developed Countries, Michelle M. Nerozzi Jan 2002

The Battle Over Life-Saving Pharmaceuticals: Are Developing Countries Being Tripped By Developed Countries, Michelle M. Nerozzi

Villanova Law Review (1956 - )

No abstract provided.

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Sustainable Agriculture, Patent Rights, And Plant Innovation, Mark D. Janis Oct 2001

Sustainable Agriculture, Patent Rights, And Plant Innovation, Mark D. Janis

Indiana Journal of Global Legal Studies

No abstract provided.

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Pharmaceutical Patent Protection: More Generic Favored Legislation May Cause Pioneer Drug Companies To Pull The Plug On Innovation, Mandy Wilson Jan 2001

Pharmaceutical Patent Protection: More Generic Favored Legislation May Cause Pioneer Drug Companies To Pull The Plug On Innovation, Mandy Wilson

Kentucky Law Journal

No abstract provided.

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