Medicine and Health Sciences Commons^™

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 …

Bayer Ag V. Housey Pharmaceuticals: Protection For Biotechnological Research Tools Under Section 271(G) Found Wanting, Matthew Barthalow

The University of New Hampshire Law Review

[Excerpt] "Research tools, a subset of biotechnological inventions protected by process patents, are “tools that scientists use in the laboratory, including cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, laboratory equipment and machines.” Many companies base their business models on the ability to find pharmaceutical products using their proprietary drug discovery research tools. Research tools used for drug discovery ‘include bioinformatic methods for identifying the interaction of certain proteins and their association with disease, methods for confirming protein targets, screening assays to identify molecules active against …

Historical Development Of The Linear Nonthreshold Dose-Response Model As Applied To Radiation, Ronald L. Kathren

The University of New Hampshire Law Review

[Excerpt] "Despite the nearly universal adoption of the linear nonthreshold dose response model (LNT) as the primary basis for radiation protection standards for the past half century, the LNT remains highly controversial and a contentious topic of discussion among health physicists, radiation biologists, and other radiological scientists. Indeed, it has been pointed out that the LNT has assumed the status of a paradigm, synonymous with an ideal, standard, or paragon or perhaps to some, a sacred cow. Reduced to its very basics, the LNT postulates that every increment of ionizing radiation dose, however small, carries with it a commensurate increase …

Review Of "The Human Embryonic Stem Cell Debate: Science, Ethics, And Public Policy (Basic Bioethics)," Edited By Suzanne Holland, Karen Lebacqz, And Laurie Zoloth, James Steele

The University of New Hampshire Law Review

[Excerpt] "Perhaps like others, I started "The Human Embryonic Stem Cell Debate" not knowing many of the finer points of embryonic stem cell research, but I certainly had an opinion. This issue is far more complex than I had initially imagined. The editors do a commendable effort of compiling a sample of the innumerable arguments surrounding the debate."

Bse: Risk, Uncertainty, And Policy Change, Enda Cummins, Pat Grace, Kevin Mcdonnell, Shane Ward

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

The authors discuss how, in our "risk society," a range of potential risks and uncertainties are associated with new technologies and new diseases, such as BSE. These risks bring with them worries about human health, while the ability to assess and manage new health scares is an essential skill for government and related industries.

Workplace Pollution: Nuclear Safety, Ethics, And The Exploitation--Avoidance Argument, Kristin Shrader-Frechette

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

The author reviews evidence of poor worker health and safety practices in United States Department of Energy nuclear facilities in contending that less protective standards for workplace hazards constitute an environmental injustice not rectified by a hazard pay premium.

Looking Back At Fluoridation, Allan Mazur

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

The author reviews the 50-year history of the debate over fluoridating drinking water as a public health measure.

Over A Decade Of Comparative Risk Analysis: A Review Of The Human Health Rankings, David M. Konisky

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

The author reviews a method for undertaking a cross-project comparison of comparative risk analyses to understand which environmental problem areas have been cited most as often posing the severest risks.

Review Of: Dangerous Places: Health, Safety, And Archaeology (David A. Poirer & Kenneth L. Feder Eds.), Natalie Duval

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

Review of the book: Dangerous Places: Health, Safety, and Archaeology (David A. Poirier& Kenneth L. Feder eds., Bergin & Garvey, Greenwood Publishing Group, Inc. 2001). Introduction, bibliographic references, index. ISBN0-89789-632-7 [264 pp. $65.00. Cloth, 88 Post Road West, P.O. Box5007, Westport, CT 06881-5007.

Review Of: Health And Disease In Human History (Robert I. Rotberg Ed.), Terry Cromwell

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

Review of the book: Health and Disease in Human History: A Journal of Interdisciplinary History Reader (Robert I. Rotberg ed., MIT Press 2000). ISBN 0- 262-18207-6 [345 pp. $25.00 Paper, 5 Cambridge Street, Cambridge, MA 02142].

Review Of: The Human Genome Project And Minority Communities - Ethical, Social, And Political Dilemmas (Raymond A. Zilinskas & Peter J. Balint Eds.), Craig Steven Jepson

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

Review of the book: The Human Genome Project and Minority Communities -Ethical, Social, and Political Dilemmas (Raymond A. Zilinskas & Peter J. Balint eds., Praeger Publishers 2001). Preface, index, about the contributors. LC 00-032390; ISBN 0-275-96961-4 [160 pp. $54.50.Cloth, 88 Post Road West, Westport, CT 06881].

Food Safety In The United States And The European Union: Sequel To A Case Study, Bryan Harris

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

The author reports on recent regulatory and legislative developments in the United States and European Union relating to toys imbedded in candy.

A Case For Caution: An Evaluation Of Calabrese And Baldwin's Studies Of Chemical Hormesis, Kevin C. Elliott

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

Suggesting a need for more research, Mr. Elliott argues that it is too soon for risk-assessment policy to account for recent challenges to a toxicological linear dose-response assumption.

Comparing The Epa Indoor Air Quality Personal Computer Model And Field Data, Arash Behravesh, Wilbur A. Spaul

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

The authors recommend caution in using an EPA model for reconstructing past exposure events as well as for predicting future exposures.

Frequency Of Use And Perceived Credibility Of Information Sources And Variations By Socioeconomic Factors Among Savannah River Stakeholders, Bryan L. Williams, Alex Vallei, Sylvia Brown, Michael Greenberg

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

The authors examine the factors effecting credibility of risk communication in the communities surrounding the Savannah River Nuclear Weapons Site.

Media Coverage Of Epa's Draft Dioxin Reassessment Report, Sharon M. Friedman, Megan A. Fitzpatrick, Brenda P. Egolf

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

Using content analysis, the authors examine the utility of news media in democratic decision making.

Review Of: Lewis' Dictionary Of Toxicology (Robert A. Lewis, Ed.; Lewis Publishers 1998), Dana E. Evans

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

Review of the book: Lewis' Dictionary of Toxicology (Robert A. Lewis, ed.; Lewis Publishers 1998). About the author, acknowledgments, alphabetical listing of terms defined. ISBN 1-56670-223-2; [1127 pp. $84.95. Hardbound. 2000 Corporate Blvd. N.W., Boca Raton, FL 33431.]

Genetic Monitoring In The Workplace: A Tool Not A Solution, Lillian Trettin, Catherine Musham, Richard Jablonski

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

The authors differentiate between genetic monitoring and screening, and discuss the potential risks and benefits of predictive testing technologies.

Review Of: Allan Mazur, A Hazardous Inquiry: The Rashomon Effect At Love Canal, Thomas G. Field Jr.

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

Review of: Allan Mazur, A Hazardous Inquiry: The Rashomon Effect at Love Canal (Harvard University Press 1998). Abbreviations,, appendices: Chron- ology and The Basics of Toxicology, bibliography, chronology, figures, index, photos, references. LC 97-44639; ISBN 0-674-74833-6 [255+xiv pp. $26.00 Cloth, 79 Garden Street; Cambridge MA 02138.]

A Method Of Identifying Hazardous Highway Locations Using The Principle Of Individual Lifetime Risk, Paul J. Ossenbruggen

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

Dr. Ossenbruggen presents a scientific framework for identifying hazardous highway locations that may be more easily understood by non-scientists and has potential for comparing highway with other risks to health.

Managing The Iatrogenic Risks Of Risk Management, Jonathan Baert Wiener

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

Analogizing to concerns that led the practice of medicine to shift from a specialist to a team-based approach, Dr. Wiener suggests that public and environmental health objectives would be better served if, e.g., regulatory jurisdiction were less atomized.

Anthropogenic Electromagnetic Fields And Cancer: A Perspective, Charles Tomljanovic, Maxine Wright-Walters, Jules Stephensky

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

The authors review findings of a recent National Research Council report and conclude that, e.g., until a cancer promotion model can be identified for effective testing, the EMF issue will remain open to debate.

Book Review Of Baruch A. Brody, Ethical Issues In Drug Testing, Approval, And Pricing, Annalee Abelson

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

Review of Baruch A. Brody, Ethical Issues in Drug Testing, Approval, and Pricing (Oxford University Press 1995). Conclusions, index, introduction, preface. LC 94-4479; ISBN 0-19-508831-X. [268 pp. Cloth $35.00. 200 Madison Avenue, New York NY 10016.]

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.]

Book Review Of Clovis E. Semmes, Racism, Health, And Post-Industrialism: A Theory Of African-American Health, Jerry Haynes

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

Review of Clovis E. Semmes, Racism, Health, and Post-Industrialism: A Theory of African-American Health (Praeger Publishers 1996). About the author, acknowledgements, index, introduction, selected bibliography. LC-95-34440; ISBN 0-275-95428-5 [178 pp. Cloth $59.95, paper $18.95. 88 Post Road West, Westport CT 06881.]

Review Of: Science Advice To The President (William T. Golden, Ed. Aaas Press 2d Ed. 1993)., Timothy Van Dyke

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

Review of: Science Advice to the President (William T. Golden, ed. AAAS Press 2d Ed. 1993). Acknowledgments, index of names, introductions, notes, tables. ISBN 0-87168-509-4 [340 pp. $29.95 paper. American Association for the Advancement of Science, 1333 H St. NW, Washington DC 20701.]

Genome Research And Traditional Intellectual Property Protection -- A Bad Fit?, Kate H. Murashige

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

Dr. Murashige addresses the need for a patent system more closely tailored to the needs of biotechnology. For example, the obviousness requirement may interfere with using patents to recoup high costs of work when it could arguably be done by researchers of ordinary skill.

Impact Of The Human Genome Project At The Interface Between Patent And Fda Laws, Brian C. Cunningham

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

Mr. Cunningham stresses the broad scope of biotechnological innovations. Besides endorsing the need for a new oversight commission to deal with potential social issues, he suggests, for example, that some products should be treated like biologics rather than new drugs.

Social Issues Of Genome Innovation And Intellectual Property, Elaine Alma Draper

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

Dr. Draper's focus is the use of personal information derived from genome research. She identifies several potential problems, including access to and control of genetic information, employment discrimination and social stratification. She also recommends possible solutions.

Development Of Vaccines To Meet Public Health Needs: Incentives And Obstacles, Phillip K. Russell

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

Dr. Russell explains how such matters as high 'costs of regulation, lack of an effective plan for delivery (particularly abroad) and politics can interfere with providing globally needed vaccines.