Life Sciences Commons^™

A Drug's Life: The Untapped Potential Of Secondary Pharmacology Studies In Drug Development, Christina Scott

The University of New Hampshire Law Review

The United States Food and Drug Administration has evolved over the past century to regulate new medicine and protect the public from harmful or ineffective drugs. Drug development and testing science have advanced rapidly alongside the FDA’s increased regulation, enabling pharmaceutical companies to assess a drug's potential adverse reactions by studying its reactivity with various proteins called "off-target receptors." Off-target proteins are often screened and reported in the Investigational New Drug Application as a percentage indicating the drug's binding strength to each protein, which suggests the strength of a particular adverse drug effect. Adverse drug effects often lead to unfavorable …

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 …

Cloned Meat, Voluntary Food Labeling, And Organic Oreos, Donna M. Byrne

The University of New Hampshire Law Review

[Excerpt] “In December 2006, the Food and Drug Administration (FDA) announced that it had reviewed all the available evidence and was poised to approve meat and milk from cloned animals and their progeny. I remember telling one of my colleagues, a patent law professor, who should be as comfortable with technology as anyone, about this development, and his response was, “Yuck. I’m not eating it!” To which of course I replied, “Humph. You won’t know the difference.” Meat or milk from a clone or its descendant is virtually identical to meat or milk from a non-clone, said the FDA, as …

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 …

Indivisible Injury Negligence And Nuisance Cases –Proving Causation Among Multiple-Source Polluters: A State-By-State Survey Of The Law For New England, And A Proposal For A New Causation Framework, Paul Homer

The University of New Hampshire Law Review

[Excerpt] "The skies, soil, and water of every state are polluted every day. Whether the pollutants enter the atmos phere from coal plants or the water-ways from large farms, materials a bnormal to the “natural” environment are regularly emitted by a variety of sources over wide regions of the nation. To some extent, such emissions are normal and acceptable activities in modern society."

Federal Court Adjudication Of State Prisoner Claims For Post-Conviction Dna Testing: A Bifurcated Approach, Dylan Ruga

The University of New Hampshire Law Review

[Excerpt] “Undoubtedly, there are innocent people in prison. Moreover, it is probable that the wrongly convicted, if given a chance to conduct DNA testing on evidence used against them at trial, could establish their innocence. […]

Part II of this Comment will examine the reasoning behind recent circuit court decisions concerning prisoners’ rights to post-conviction genetic testing. I will explain that a bifurcated approach is the appropriate paradigm for reviewing these claims and demonstrate why three of the four circuit courts erred in their analyses. This part also will review the Supreme Court decisions cited by the circuit courts and …

Biotechnology And The Law: A Consideration Of Intellectual Property Rights And Related Social Issues, Michael D. Mehta

The University of New Hampshire Law Review

[Excerpt] “Recent advances in biotechnology are expected by many to improve crop yield, reduce reliance on agricultural inputs like pesticides and herbicides, alleviate world hunger, improve the safety and effectiveness of pharmaceuticals, assist in the discovery of genes that trigger diseases like cancer, and make more efficient our legal institutions through DNA testing. Clearly, innovations in biotechnology are a powerful force for social change, and they pose unique challenges and opportunities for legal scholars and institutions. This section of the Pierce Law Review focuses on the interface between law and technology by examining how innovations in biotechnology accelerate debates about …

The Commons Concept And Intellectual Property Rights Regime: Whither Plant Genetic Resources And Traditional Knowledge?, Chika B. Onwuekwe

The University of New Hampshire Law Review

[Excerpt] "The classification of plant genetic resources (PGRs) as the common heritage of humankind continues to generate controversies. The debate is between developing countries that are the primary sources of these resources and industrialized, biotechnologically advanced countries that appropriate and utilize PGRs as raw materials for various commercial products, such as medicine, seed variety, or pesticides. Scholars of diverse backgrounds express various opinions on whether PGRs obtained from plants found within a territory of a sovereign state should properly be designated “common heritage of humankind” or regarded as part of the “commons,” and therefore freely accessible. The debate also extends …

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 Health Of Nations: Infectious Disease, Environmental Change, And Their Effects On National Security And Development," By Andrew T. Price-Smith, Andrew Mierins

The University of New Hampshire Law Review

[Excerpt] "Andrew T. Price-Smith, author of The Health of Nations: Infectious Disease, Environmental Change, and Their Effects on National Security and Development, provides a well documented and reasoned analysis of the need for world leaders, including the United States, to place the threat of infectious disease on the front burner of consideration when shaping both national and international policy. Professor Price-Smith has provided both empirical data and historical analysis to support the impassioned plea for this natural threat to be taken seriously. The book is geared toward the academic community and policy analysts; however, other professionals not involved in these …

Introduction To Special Issue On Radiation Effects, P. Andrew Karam

The University of New Hampshire Law Review

[Excerpt] "How dangerous is radiation? How much radiation does it take to give us cancer? Are we wasting money on overly restrictive regulations, or are we not being sufficiently protective of our radiation workers and the public? How much clean-up is necessary on our Department of Energy facilities? What about Yucca Mountain and nuclear reactor plants – can they be made safe?

These are only a few of the questions that have been asked, and will continue to be asked, about radiation. Unfortunately, these all come down, in part or in whole, to the question “What is the shape of …

Effects Of The Shape Of The Radiation Dose-Response Curve On Public Acceptance Of Radiation And Nuclear Energy, Audeen W. Fentiman

The University of New Hampshire Law Review

[Excerpt] “The public generally accepts the premise that exposure to radiation can have an undesirable effect. Furthermore, it believes that as the radiation dose increases, the magnitude of the effect will increase. On the other hand, while the background radiation dose varies from a few hundred millirem/year (a few millisieverts/yr) in some places to a few thousand millirem/yr (tens of millisieverts/yr) in others, researchers have been unable to find a correlation between the level of background radiation and incidence of cancer or other maladies attributable to radiation.

…

Because there is considerable controversy about the relationship between radiation dose and …

The Debate On The Health Effects Attributable To Low Radiation Exposure, Abel J. Gonzalez

The University of New Hampshire Law Review

[Excerpt] "Few scientific issues have aroused passions more than the dispute about the health effects attributable to low levels of exposure to ionizing radiation (or radiation in short) and the currently authoritative dose response hypothesis, termed “linear non-threshold,” or LNT. Finding out whether health effects are induced by low-level radiation exposures, and if so, what they are, has become a kind of contest rather than a serious scientific inquiry. Sometimes it seems that rationality, or a methodical examination of the unknown, has disappeared from this debate. While the confrontation of different hypotheses is typical in academic discussions – at least …

Public Perceptions Of Food Safety: Assessing The Risks Posed By Genetic Modification, Irradiation, Pesticides, Microbiological Contamination And High Fat/High Calorie Foods, Michael D. Mehta

The University of New Hampshire Law Review

[Excerpt] "In general, people in the developed world have access to a safe and varied supply of food. Instead of systemic hunger, many developed countries have problems with obesity and other kinds of eating disorders among their citizenry. It is within this context that some find public concerns about the safety of food both paradoxical and misplaced. Nevertheless, understanding how people perceive the risk associated with food is an important exercise in demonstrating accountability and in setting priorities for regulation. With the advent of technologies for producing genetically modified foods, and the development of fat blockers like Olestra, the public …

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."