Intellectual Property 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 …

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

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 …

Patent Landscape Of Influenza A Virus Prophylactic Vaccines And Related Technologies, Jon R. Cavicchi, Stanley P. Kowalski, David L. Pflugh, Jeremy Barton, Jeffrey Janovetz, John Schroeder

Law Faculty Scholarship

Executive Summary: This report focuses on patent landscape analysis of technologies related to prophylactic vaccines targeting pandemic strains of influenza. These technologies include methods of formulating vaccine, methods of producing of viruses or viral 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 pandemic influenza virus strains.

The search strategy used keywords which the …

Preliminary Report On Patent Literature, Search Methodology And Patent Status Of Medicines On The Who Eml 2009, Jon R. Cavicchi, Stanley P. Kowalski

Law Faculty Scholarship

Over the past several decades the World Health Organization (WHO) has produced the Essential Medicines List (EML) to assist countries in deciding what medicines should be essential and available in National Essential Medicine Lists.1 WHO, through the work of regional offices, supports nations using the EML to ensure the quality, availability, and affordability of pharmaceuticals required to promote and advance public health in nations across the globe. However in some cases, access to EML pharmaceuticals might be complicated by existing patents, i.e., where issued, patent rights might pose obstacles to access and inclusion in national EMLs. Indeed, in developed and …

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 …

Intellectual Property, Medicine And Health: Current Debates, Stanley P. Kowalski

Law Faculty Scholarship

Johanna Gibson’ s “Intellectual Property, Medicine and Health: Current Debates” is an ambitious attempt to bridge the gap between IPR (largely patents) and the ethical, moral and philosophical issues which should influence global access to innovations in health. This intent is noteworthy and timely, as the complexities are important to address and there is an urgent need for clear-headed strategy. However, disappointingly, the book largely fails, as it is a rambling polemic that lacks focus, clarity and originality. Wading through the thicket of verbiage becomes so daunting that whatever message might be present is lost. The book also is flawed …

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 …

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. …

Pierce Law Participates In Pandemic Influenza Vaccine Ip Management Meeting, Stanley P. Kowalski

Law Faculty Scholarship

On April 18, 2006 several members of the greater Pierce Law community participated in an important meeting held at the World Intellectual Property Organization (WIPO) in Geneva, Switzerland. Organized by The Centre for the Management of Intellectual Property in Health Research and Development (MIHR), the meeting “Intellectual Property Management Strategies to Facilitate Early Access and Global Health Benefits: Case Studies in Pandemic Influenza and Malaria” had the objective of exploring and discussing IP issues which impact the distribution of vaccines to developing countries, a topic of heightened worldwide importance given the potential threat of a global influenza pandemic. In an …

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 …

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.

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.

Overview Of Potential Intellectual Property Protection For Biotechnology, Kate H. Murashige

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

Dr. Murashige compares the function and value of copyright, patent and trade secret laws in recovering investments in developing genome-related biotechnology.

[Introduction] The Science Court Is Dead - Long Live The Science Court, Thomas G. Field

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

[Excerpt] "It is a pleasure to introduce this symposium issue with its range of current thoughts about what Arthur Kantrowitz invented a little over twenty-five years ago and has since come to be known as the "Science Court." The pleasure is enhanced by being able to include papers by Dr. Kantrowitz, Allan Mazur (who worked closely with him), Carl Cranor, Itzhak Jacoby and Sheila Jasanoff - as well as an extensive list of citations to other discussions. In approaching these papers, readers may find it helpful to consider what Kantrowitz invented, he and others have attempted to improve, and the …

Pharmaceuticals And Intellectual Property: Meeting Needs Throughout The World, Thomas G. Field Jr.

Law Faculty Scholarship

To the extent that most people think about patents and other forms of intellectual property at all, they tend to be aware that the owners of such property may have the legal capacity to limit market entry--without fully appreciating the extent to which products or processes that can be easily copied might otherwise be unavailable. Focusing on their function in recouping risk capital, this article will survey the types and functions of intellectual property. Then it will attend to the situation in developing countries, particularly the role of intellectual property in meeting their needs for medical products.