Life Sciences 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 …

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 …

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 …

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 …

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 …

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 …

Agricultural Biotechnology In China: An Unreachable Goal?, Stanley P. Kowalski

Law Faculty Scholarship

Recently there has been much discussion about the People’s Republic of China’s (PR) investment in and commitment to agricultural biotechnology (agri-biotech). Rapid economic expansion, population growth and technological development are changing the PRC; accompanying these changes is increased demand for high-quality food and fibre. Agri-biotech is optimistically viewed as an important way to meet these demands. Whereas Chinese technological capacity in agri-biotech has advanced significantly over the past decade, it may be unable to meet these challenges. Even when this capacity is combined with good intentions, enlightened policy and large capital outlays, accelerated development of agri-biotech may nevertheless be precluded. …

Golden Rice: A Case Study In Intellectual Property Management And International Capacity Building, Stanley P. Kowalski, R. David Kryder

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

The authors examine the management of risks associated with intellectual property linked to agri-biotech products, with emphasis on the international movement of agri-biotech intellectual property from industrialized to developing nations.

Golden Rice: A Case Study In Intellectual Property Management And International Capacity Building, Stanley P. Kowalski, R. David Kryder

Law Faculty Scholarship

In order for agricultural biotechnology (agri-biotech) to play a larger role in the development of sustainable agricultural systems, intellectual property (IP) rights management must be addressed. These issues are not limited to developing countries. With increased globalization, the management of agri-biotech IP rights affects both developing and industrialized countries. In industrialized countries, for example, IP rights risk management entails protection of inventions via strong patent portfolios. For developing countries, IP rights risk management includes the acquisition of rights requisite for the use of inventions essential to the basic welfare of the population. Strategies are needed to bridge these disparate IP …

The Intellectual And Technical Property Components Of Pro-Vitamin A Rice (Goldenricetm): A Preliminary Freedom-To-Operate Review, R. David Kryder, Stanley P. Kowalski, Anatole F. Krattiger

Law Faculty Scholarship

Rice is a staple food for millions of people, predominantly in Asia, but lacks essential nutritional components such as Vitamin A. This is very important for over 180 million children and women of child bearing age who suffer from Vitamin A deficiency in Asia alone. For this reason, an improvement was made under an effort led by Profs. Ingo Potrykus and Peter Beyer by inserting several genes into rice to produce an improved product called GoldenRice. Because GoldenRice has the potential to be easily integrated into the farming systems of the world's poorer regions, the advent of GoldenRice promises to …

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.

Overview Of Federal Technology Transfer, Lawrence Rudolph

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

Mr. Rudolph reviews approximately thirteen years of legal and political developments that have contributed to laws governing the extent to which private firms may secure rights in technology at least partly developed with federal funds.

The Human Genome Project And The Downside Of Federal Technology Transfer, Christopher J. Harnett

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

Mr. Harnett argues that emphasizing technology transfer at institutions such as the National Institutes of Health will interfere with what should be regarded as their primary mission, basic research.

Technology Transfer: A View From The Trenches, Harvey Drucker

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

Dr. Drucker, who has lab-wide responsibility for technology transfer at Argonne National Laboratory, argues that transferring rights in discoveries made through tax supported research to private entities can contribute to public welfare in many ways.

Biotechnology Process Patents: Is Special Legislation Needed?, Timothy P. Linkkila, Timothy E. Tracy

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

The authors review administrative and court decisions prompting proposed changes to the patent law. After reviewing pros and cons, they argue that, on balance, pending bills can easily cause more problems than they solve.