Law Commons^™

Antimicrobial Resistance (Amr) And Multidrug Resistance (Mdr): Overview Of Current Approaches, Consortia And Intellectual Property Issues, Andrew Jenner, Niresh Bhagwandin, Stanley P. Kowalski

Law Faculty Scholarship

The supply of new diagnostics and treatments is insufficient to keep up with the increase in antimicrobial resistance (AMR) and multidrug resistance (MDR) as older medicines are used more widely and microbes develop resistance to them. At the same time, significant quantities of antibiotics are used on patients and animals that do not need them, while others who do need them lack access.

Effective responses to AMR/MDR require effort by both the public and private sectors to develop and disseminate new diagnostics, vaccines and treatments on a global scale, as well as to adapt them to local needs. This calls …

Brief For Professor Albert E. Scherr As Amicus Curiae In Support Of Petitioner, Albert E. Scherr

Law Faculty Scholarship

INTRODUCTION AND SUMMARY OF ARGUMENT Professor Scherr agrees with petitioner that review is warranted because the Maryland Court of Appeals decision is erroneous. The Fourth Amendment does not sanction police harvesting of DNA without probable cause and a warrant and without the subject’s knowledge or consent, to be used however the authorities deem appropriate and without restriction. The Maryland Court of Appeals’ decision is contrary to the Supreme Court’s jurisprudence as articulated in the Riley v. California – Maryland v. King – United States v. Jones trilogy. This case fits squarely in the center of the triangle formed by that …

Kingswood Lake Management Plan, Sarah Martina Tierney

Honors Theses and Capstones

High water quality and natural buffers exist on Kingswood Lake located in Brookfield, New Hampshire. A comprehensive lakes inventory (CSI) was recorded and health of the land, wildlife, and waterways were observed. Educational outreach was taken to inform the local community and to instruct them on proper stewardship of the land. A completed watershed management plan was constructed including key recommendation of limiting nitrogen loading in the area, checking septic systems for leaching, stabilizing shoreline from erosion, and establishing man-made rain gardens to help preserve water quality. The Kingswood watershed management plan acts as a guide for the town of …

Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice, Michael Mccann

Law Faculty Scholarship

There exists increasing concern that the Dietary Supplements Health and Education Act (DSHEA) has proven ineffective. Much of the concern regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Namely, while pharmaceutical drugs must undergo years of costly pre-market testing, most supplements, like foods, can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration (FDA) remove them. Such a framework appears to belie both consumer expectations and marketing strategies, as supplements tend to be most perceived for their apparent medicinal qualities. This philosophy of waiting for a …

Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen

Law Faculty Scholarship

[Excerpt] "The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice. Patients should get all the information and the drugs they want; the FDA should do what it can to enforce some basic standards but should otherwise get out of the way. On the other hand, a paternalist view values the FDA’s role as an expert agency standing between patients and a set of potentially dangerous drugs and potentially unscrupulous or …

Overcoming India’S Food Security Challenges: The Role Of Intellectual Property Management And Technology Transfer Capacity Building, Stanley Kowalski, Aarushi Gupta, Ifica Mehra

Law Faculty Scholarship

The growth of the Indian economy after Independence has had little impact on the food security of the country. The paper analyses the development of advanced crop varieties through the use of agricultural technologies (hereinafter "agbiotech") within the technology transfer system, a framework which comprises of the interactions of intellectual property rights law and agricultural research and development in India. Through this, the author argues that agricultural innovation in India is failing due to the absence of connections within the technology transfer system and advocates for the creation of a national program aimed at advancing IP and tech-transfer capacity in …

Genetic Privacy And The Fourth Amendment: Unregulated Surreptitious Dna Harvesting, Albert E. Scherr

Law Faculty Scholarship

Genetic privacy and police practices have come to the fore in the criminal justice system. Case law and stories in the media document that police are surreptitiously harvesting the DNA of putative suspects. Some sources even indicate that surreptitious data banking may also be in its infancy. Surreptitious harvesting of out-of-body DNA by the police is currently unregulated by the Fourth Amendment. The few courts that have addressed the issue find that the police are free to harvest DNA abandoned by a putative suspect in a public place. Little in the nascent surreptitious harvesting case law suggests that surreptitious data …

Intellectual Property And Opportunities For Food Security In The Philippines, Jane Payumo, Howard Grimes, Antonio Alfonso, Stanley P. Kowalski, Keith Jones, Karim Maredia, Rodolfo Estigoy

Law Faculty Scholarship

By 2050, the Philippine population is projected to increase by as much as 41 percent, from 99.9 million to nearly 153 million people. Producing enough food for such an expanding population and achieving food security remain a challenge for the Philippine government. This paper argued that intellectual property rights (IPR) can play a key role in achieving the nation’s current goal to be food-secure and provided examples to illustrate that the presence of sound intellectual property (IP) helps foster research, development, and deployment of agricultural innovations. This paper also offered key recommendations about how the IP system can be further …

Patent Landscape Of Helminth Vaccines And Related Technologies, Jon R. Cavicchi, Stanley P. Kowalski, John Schroeder, Rayna Burke, Jillian Michaud-King

Law Faculty Scholarship

Executive Summary This report focuses on patent landscape analysis of technologies related to vaccines targeting parasitic worms, also known as helminths. These technologies include methods of formulating vaccines, methods of producing of subunits, the composition of complete vaccines, and other technologies that have the potential to aid in a global response to this pathogen. The purpose of this patent landscape study was to search, identify, and categorize patent documents that are relevant to the development of vaccines that can efficiently promote the development of protective immunity against helminths. The search strategy used keywords which the team felt would be general …

The New England Food System In 2060: Envisioning Tomorrow's Policy Through Today's Assessments, Margaret Sova Mccabe, Joanne Burke

Law Faculty Scholarship

This Essay analyzes how the New England states' planning processes are envisioning revitalized local, state, and regional food systems. This Essay has five parts. First, it begins with examining compelling reasons for promoting more sustainable food systems based on national and global trends, and identifies strategies for promoting regional food systems approaches with a brief introduction to the major influences on the national and New England food system. Second, it describes the states' planning efforts and their enabling legislation or source of authority.

The Essay then introduces the New England Food Vision 2060 (the Vision) an emerging discussion of food …

Superweeds And Suspect Seeds: Does The Genetically-Engineered Crop Deregulation Process Put American Agriculture At Risk, Margaret Sova Mccabe

Law Faculty Scholarship

The federal government’s regulatory approach to genetically engineered (GE) crops, known as “The Framework”, is now twenty-five years old. Despite two and half decades of a consistent regulatory regime, GE crop and food regulation remains controversial. This article suggests that regulatory science and its tenets of independence, transparency, and public science should guide reforms of The Framework so that it is an efficient and reliable regulatory system. The article has four parts: 1) it provides a brief overview of the history of GE crop regulation; 2)it describes the key attributes of The Framework and related regulatory documents, with particular focus …

Managing Intellectual Property To Foster Agricultural Development, Sara Boettiger, Robert Potter, Stanley P. Kowalski

Law Faculty Scholarship

Over the past decades, consideration of IPRs has become increasingly important in many areas of agricultural development, including foreign direct investment, technology transfer, trade, investment in innovation, access to genetic resources, and the protection of traditional knowledge. The widening role of IPRs in governing the ownership of—and access to—innovation, information, and knowledge makes them particularly critical in ensuring that developing countries benefit from the introduction of new technologies that could radically alter the welfare of the poor. Failing to improve IPR policies and practices to support the needs of developing countries will eliminate significant development opportunities. The discussion in this …

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 …

Foodshed Foundations: Law's Role In Shaping Our Food System's Future, Margaret Sova Mccabe

Law Faculty Scholarship

[. . .] This symposium Article analyzes how we can rethink the architecture of law based on a foodshed model to provide a greater role for local, state, and regional government in the American food system. In turn, greater roles for different levels of government may help America achieve greater efficiencies in domestic food safety, nutrition and related public health issues, sustainability, and international trade.

Americans need a greater voice in the food system. The foodshed model is a powerful vehicle that allows us to conceptualize change, allowing greater citizen participation and a more nuanced approach to food policy. The …

Balancing Consumer Protection And Scientific Integrity In The Face Of Uncertainty: The Example Of Gluten-Free Foods, Margaret Sova Mccabe

Law Faculty Scholarship

In 2009, gluten-free foods were not only "hot" in the marketplace, several countries, including the United States, continued efforts to define gluten-free and appropriate labeling parameters. The regulatory process illuminates how difficult regulations based on safe scientific thresholds can be for regulators, manufacturers and consumers. This article analyzes the gluten-free regulatory landscape, challenges to defining a safe gluten threshold, and how consumers might need more label information beyond the term "gluten-free." The article includes an overview of international gluten-free regulations, the Food and Drug Administration (FDA) rulemaking process, and issues for consumers.

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 …

Got Controversy - Milk Does, Margaret Sova Mccabe

Law Faculty Scholarship

This article analyzes ongoing controversy over how to best label rBST-free milk. Recombinant bovine somatotropin is a genetically engineered drug administered by some farmers to their dairy herds to increase milk production. FDA first approved its use in 1994, despite great controversy. The FDA also issued labeling guidelines that allowed voluntary disclosure of rBST-free milk, so long as it carried the disclaimer that no difference could be detected between milk produced with rBST and rBST-free. The controversy continues today as consumers express a preference for rBST-free milk and many rBST-free producers label their milk this way. "Conventional" milk (with rBST) …

Loco Labels And Marketing Madness: Improving How Consumers Interpret Information In The American Food Economy, Margaret Sova Mccabe

Law Faculty Scholarship

America's current food labeling scheme, as illustrated by the example of salt, is flawed when examined from the consumer and public health perspective. While the Food, Drug, and Cosmetic Act has sound scientific standards, those standards as currently applied to labels do not efficiently signal health information to consumers. Without better information on labels, consumers will continue to make poor choices at the grocery store. However, there are promising new ways to label. Both the United Kingdom and the domestic supermarket chain Hannaford’s have implemented simple health labeling on food packaging or grocery shelves to improve the amount and location …

Franklin Pierce Law Center Educational Report: Patent Landscape Of Dna Vaccines For Hiv, Jon R. Cavicchi, Stanley P. Kowalski

Law Faculty Scholarship

No abstract provided.

U.S. Patent Literature Survey Of Agrobacterium-Mediated Transformation Of Sweet Potato (Ipomoea Batatas), Jon R. Cavicchi, Stanley P. Kowalski, J. Jaya Murthy, Rahul R. Vartak

Law Faculty Scholarship

A team of researchers and patent information scientists at Franklin Pierce Law Center were asked to evaluate the patent and literature landscape related to the Agrobacterium-mediated transformation in sweet potato with respect to the U.S. patents and patent applications. This report provides a patent landscape of the Agrobacterium-mediated transformation of sweet potato. The report includes the applicable methods of transformation and has also included certain patents and patent applications which claim a transformed plant by virtue of these methods. In certain cases, the claim structure covers Agrobacterium-mediated transformation technology via system and composition of matter claims and not the more …

Freedom-To-Operate In The Crop Sciences: Procedure, Stanley P. Kowalski

Law Faculty Scholarship

Freedom to operate (FTO) is the ability to proceed with research, development and commercialization of a crop science product, while fully accounting for any potential risks of infringing activity, that is, whether a product can be made, used, sold, offered for sale, or exported, with a minimal risk of infringing the unlicensed intellectual property rights (IPRs) or tangible property rights (TPRs) of another. An FTO analysis begins with the ‘FTO team’ systematically dissecting the crop science product into the components, combination of components, processes and germplasm that went into its research and development. This is followed by generating a series …

Intellectual Property Management In Health And Agricultural Innovation: A Handbook Of Best Practices, Vol. 2, Anatole Krattiger, Richard T. Mahoney, Lita Nelsen, Jennifer A. Thomson, Alan B. Bennett, Kanikaram Satyanarayana, Gregory D. Graff, Carlos Fernandez, Stanley Kowalski

Law Faculty Scholarship

Prepared by and for policy-makers, leaders of public sector research establishments, technology transfer professionals, licensing executives, and scientists, this online resource offers up-to-date information and strategies for utilizing the power of both intellectual property and the public domain. Emphasis is placed on advancing innovation in health and agriculture, though many of the principles outlined here are broadly applicable across technology fields. Eschewing ideological debates and general proclamations, the authors always keep their eye on the practical side of IP management. The site is based on a comprehensive Handbook and Executive Guide that provide substantive discussions and analysis of the opportunities …

Intellectual Property Management In Health And Agricultural Innovation: Executive Guide, Anatole Krattiger, Richard T. Mahoney, Lita Nelsen, Jennifer A. Thomson, Alan B. Bennett, Kanikaram Satyanarayana, Gregory D. Graff, Carlos Fernandez, Stanley Kowalski

Law Faculty Scholarship

Prepared by and for policy-makers, leaders of public sector research establishments, technology transfer professionals, licensing executives, and scientists, this online resource offers up-to-date information and strategies for utilizing the power of both intellectual property and the public domain. Emphasis is placed on advancing innovation in health and agriculture, though many of the principles outlined here are broadly applicable across technology fields. Eschewing ideological debates and general proclamations, the authors always keep their eye on the practical side of IP management. The site is based on a comprehensive Handbook and Executive Guide that provide substantive discussions and analysis of the opportunities …

Intellectual Property Management In Health And Agricultural Innovation: A Handbook Of Best Practices, Vol. 1, Anatole Krattiger, Richard T. Mahoney, Lita Nelsen, Jennifer A. Thomson, Alan B. Bennett, Kanikaram Satyanarayana, Gregory D. Graff, Carlos Fernandez, Stanley Kowalski

Law Faculty Scholarship

Prepared by and for policy-makers, leaders of public sector research establishments, technology transfer professionals, licensing executives, and scientists, this online resource offers up-to-date information and strategies for utilizing the power of both intellectual property and the public domain. Emphasis is placed on advancing innovation in health and agriculture, though many of the principles outlined here are broadly applicable across technology fields. Eschewing ideological debates and general proclamations, the authors always keep their eye on the practical side of IP management. The site is based on a comprehensive Handbook and Executive Guide that provide substantive discussions and analysis of the opportunities …

Rational Risk/Benefit Analysis Of Genetically Modified Crops, Stanley P. Kowalski

Law Faculty Scholarship

Safety concerns over the use of molecular biotechnology in the improvement of crops has generated substantial, heated and confusing debates, often driven by ideology and hysterics. Modification of crops is not new, and biotechnology (in its broadest sense) has been used for over a century to accelerate the development of new crops for food, feed and fibre, so as to meet the demands of a growing global community. The introduction of crops developed via molecular biotechnology [Genetically Modified Crops (GMCs)] represents the latest step in this inexorable innovative progression of technology. However, misinformed concern has led to a broad embrace …

Ip And The Global Public Interest: Challenges And Opportunities, Jon R. Cavicchi, Stanley P. Kowalski

Law Faculty Scholarship

[Excerpt from article] Intellectual property (IP) capacity is essential for economic development, particularly as countries transition into the higher technology sectors, for example biotechnology. For developing countries, a commitment to minimal IP rights protection will determine inclusion in the World Trade Organization (WTO), facilitate access to foreign-direct investment, and accelerate economic development. However, on a more fundamental level, capacity in IP management will affect whether a country can provide basic health and nutritional needs for its citizens. For example, sustainable food security presents a serious challenge in many developing countries; as their economies rapidly emerge, urban centers expand, arable land …

Intellectual Property Management Strategies To Accelerate The Development And Access Of Vaccines And Diagnostics: Case Studies On Pandemic Influenza, Malaria And Sars, Anatole Krattiger, Stanley P. Kowalski, Robert Eiss, Anthony Taubman

Law Faculty Scholarship

Achieving global access to vaccines, diagnostics, and pharmaceuticals remains a challenge. Throughout the developing world, intellectual property (IP) constraints complicate access to critically essential medical technologies and products. Vaccines for malaria and pandemic strains of influenza, as well as diagnostic and vaccine technologies for SARS, are not only relevant to global public health but are particularly critical to the needs of developing countries. A global access solution is urgently needed. This article offers a timely case‐by‐case analysis of preliminary patent landscape surveys and formulates options via patent pools and other forms of creative IP management to accelerate development and access. …

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 …