IIPI - International Intellectual Property Institute


  Topics
 

Arts, Culture and Music
Congressional Education
Enforcement and Judicial Training
Health, Pharmaceuticals and Biotechnology
Information Technology
Regional Intellectual Property Integration
Technology Transfer and National Innovation

  Regions
 

Africa
Asia
Caribbean
Europe
Latin America
Middle East
Russia/NIS
United States

Conference on Intellectual Property and International Public Health

Conference
Agenda


The Leavey Center, Georgetown University
Washington, DC
October 6-8, 2003
 

Day I: Monday, October 6, 2003                          
06:00 Opening Reception

Introductory Remarks
Professor George Brenkert, Director Georgetown Business Ethics Institute

Introduction to Ambassador Rita Hayes
Ms. Suzanne Stoll Coordinator, WIPO Office, Washington, DC

Remarks by Ambassador Rita Hayes
Ambassador Rita Hayes, Deputy Director General, WIPO
 
Day II: Tuesday, October 7, 2003                       
8:00 Registration and Coffee
 
8:30 Welcoming Remarks
Jon W. Dudas, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office

Dr. John Mayo, Dean, Georgetown University McDonough School of
Business
 
9:00 Introduction: 
The Relationship Between Pharmaceutical Innovation and Public Health


Honorable Bruce A. Lehman, President, International Intellectual Property Institute
 
9:15 The Economics of Pharmaceutical Innovation in the Developed World

Professor Martin Adelman, The George Washington University Law School

Professor Louis Galambos, Institute for Applied Economics & the Study of Business Enterprise, Johns Hopkins University
Paper:  Intellectual Property and Pharmaceuticals: A Brief Excursion through History (PDF, 154 KB)
 
10:00 The Impact of Pharmaceutical Innovation on Health:
This session will include an overview of the role of pharmaceutical
innovation on public health.

Professor Henry Grabowski, School of Economics, Duke University Presentation (PDF, 98 KB)

Professor Michael Kremer, Faculty of Arts and Science, Harvard University
Presentation (PDF, 64 KB)
 
10:45 Question and Answer Session

Led by Professor Michael Ryan

 
11:00 Coffee Break
 
11:15 Bringing New Medicines to the Marketplace:
This session will discuss administrative and regulatory processes,
including the patent and market approval processes as well as the relationship between publicly-funded research and new drug
development.

Ms. Minna Moezie, Attorney-Adviser, Office of External Affairs, USPTO
Presentation (PDF, 2.5 MB)

Mr. Robert P. Brady, Partner, Hogan & Hartson
Presentation (PDF, 128KB)

Ms. Nalini P. Anand, Science and Legal Policy Analyst, Fogarty International Center, National Institutes of Health
Presentation (PDF, 584 KB)
 
12:15 The Generic Industry - Its Role and Co-existence with the
Patented Pharmaceutical Industry:

This session will include a discussion on United States policy and
legislation.

Mr. Michael Gollin, Partner, Venable LLP; Adjunct Professor, Georgetown
University McDonough School of Business
Paper:  Generic Drug Companies: Competing at the Boundaries of
Time and Geography
(PDF, 216 KB)
Presentation (PDF, 473 KB)

Mr. Raymond A. Kurz, Partner, Hogan & Hartson
Presentation (PDF, 48 KB)
 
12:45 Lunch

Remarks:
Dr. Joseph Mazzolo, Executive Dean, McDonough School of Business

Keynote speech:
Mr. Robert Mallett, Senior Vice-President, Corporate Relations, Pfizer
 
1:45 Pharmaceutical Innovation and Social Responsibilities

Introduction to speakers by Professor George Brenkert, Director, Georgetown Business Ethics Institute

Professor Klaus Leisinger President and Executive Director,
Novartis Foundation
Paper:  The Corporate Social Responsibility of the Pharmaceutical Industry - Idealism Without Illusion and Realism Without Resignation (PDF, 304 KB)
Presentation (PDF, 304 KB)

Professor Richard DeGeorge, University Professor of Philosophy & Business Administration University of Kansas
Paper:  Intellectual Property and Pharmaceutical Drugs: An Ethical Analysis (PDF, 180 KB)
 
2:30 Global Impact of Regulatory Policies on Pharmaceutical Distribution and Innovation:
A discussion of regulatory and pricing policies, technology transfer and partnerships and their impact on global innovation and investment in patent-based research.

Mr. John R. Graham, The Fraser Institute
Paper:  Global Impact of Regulatory Policies on Pharmaceutical Distribution and Innovation: Canadian Prescriptions for American Patients (PDF, 235 KB)
Presentation (PDF, 424 KB)

Professor W. Duncan Reekie, E.P. Bradlow Professor of Business Economics, University of the Witwatersrand, South Africa
Paper:  Drug Price Controls: Regulations Without a Cause

Dr. Ben Prickril, National Cancer Institute, National Institutes of Health
Paper:  Technology Transfer at the National Cancer Institute: Priming the
Innovation Pump
(PDF, 148 KB)
Presentation (PDF, 143 KB)
 
4:30 Coffee Break and Networking Opportunity
 
5:00 Question and Answer session

Led by Professor Michael Ryan and Ms. Mary Critharis, Attorney-Adviser with the Office of International Relations of the USPTO.

Day III: Wednesday, October 8, 2003             
 
8:30 Coffee and Continental Breakfast
 
9:00 National Public Health Systems and Pharmaceutical Distribution - Market Breakdown Issues:
This session will focus on public health infrastructures in developing
counties and patient access to valuable therapies

Mr. Juan Rovira, Public Health Specialist, The World Bank
Paper:  Generics Policies and Access to Drugs in Developing Countries (PDF, 154 KB)
Presentation  (PDF, 1.74 MB)

Professor Jillian Clare Cohen, Assistant Professor, Faculty of Pharmacy,
University of Toronto
Paper:  Government and Market Failures in the Pharmaceutical System: Partial Explanations towards Understanding the Troubling Drug Gap (PDF, 233 KB)
Presentation (PDF, 115 KB)
 
9:45 Question and Answer session

Led by Professor Michael Ryan and Ms. Mary Critharis, Attorney-Adviser with the Office of International Relations of the USPTO.
 
10:00 Global Views on Intellectual Property and Meeting Public
Health requirements


Mr. Maher Matalka, Economic Counselor, Embassy of the Kingdom of Jordan

Mr. Alvaro Diaz, Vice-Minister of Economy, Chile

Mohamed Eldawy University of Tanta, Egypt
Presentation (PDF, 1.19 MB)

Mr. Alberto Carlo Frati, Ministry of Health, Mexico

Mr. Richard Wilder, Partner, Sidley, Austin, Brown & Wood
 
11:15 Coffee Break
 
11:30 Intellectual Property and the Developing World:
This session will discuss the role of patent incentives in
addressing public health issues in developing countries, research
and manufacturing capacity in developing countries and funding
of pharmaceutical markets in developing countries

Professor F.M. Scherer, Aetna Professor Emeritus at the Kennedy School of Government, Harvard University Power Point Presentation
Paper:  Global Welfare in Pharmaceutical Patenting (PDF, 825 KB)

Dr. Michael Einhorn, Economist
Paper:  Health Care, Intellectual Property and Economics: Pharmaceuticals and the Developing World (PDF, 242 KB)

Mr. Amir Attaran, Fellow, Royal Institute of International Affairs
Presentation (PDF, 372 KB)
 
12:45 Lunch
 
1:30 Pricing Practices and their Impact on the Distribution of
Patented Pharmaceuticals


Introduction to speakers by
Honorable Bruce A. Lehman, IIPI

Professor John Barton, George E. Osborne Professor of Law,
Stanford University
Paper:  Differentiated Pricing of Patented Products (PDF, 291 KB)

Mr. Harvey Bale, Director General, International Federation of
Pharmaceutical Manufacturers Associations (IFPMA)
Presentation (PDF, 105 KB)
 
2:15 Question and Answer session

Led by Professor Michael Ryan

 
2:30 Promoting Access to New Therapies and Improving
Public Health infrastructures in the Developing World


Mr. Thomas Bombelles, Director of International Government Relations,
Merck
Presentation (PDF, 562 KB)

Dr. Cathy Garner, Chief Executive Officer, Centre for the Management of
Intellectual Property in Health Research & Development (MIHR)
Paper:  Intellectual Property Management Approaches to Promoting Access to New Therapies in Developing Countries (PDF, 435 KB)
Presentation (PDF, 98 KB)
 
3:30 Coffee and Networking
 
4:00 Discussion of Conference Themes

Professor Patricia Werhane, Ruffin Professor of Business Ethics, Darden
School of Business, University of Virginia, Chairholder De Paul University
Presentation (PDF, 78 KB)

Professor Michael Ryan, Professor, Georgetown University McDonough
School of Business
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Speaker Biographies


Professor Martin J. Adelman is professor of law, co-director of the Intellectual Property Law Program; and Director of the Dean Dinwoody Center for Intellectual Property Studies. He received his B.A., M.S.,and J.D. from the University of Michigan. Before joining the GW Law faculty in 1999, Professor Adelman had been a member of the faculty of Wayne State University Law School since 1973, specializing in intellectual property and antitrust law. Prior to that, he practiced as a patent attorney in the Detroit area for several years, serving as lead counsel in a number of patent infringement actions including for Motor City in the Kolene v. Motor City litigation. He has written many law review articles on patent law, the economics of patent law, and patent-antitrust law subjects. From 1977 to 1988 Professor Adelman was a co-author, and currently is the sole author, of the continuously updated eight-volume Patent Law Perspectives. He is a co-author of Cases and Materials on Patent Law (1998). He has testified in more than 150 patent infringement cases either by deposition or as a trial expert in patent law and practice. A regular speaker at intellectual property law conferences, Professor Adelman has lectured on patent law subjects throughout the United States, Europe, and Asia.


Ms. Nalini Anand received her B.A. from Cornell University, worked at the Institute of Medicine and co-edited a report addressing policy issues in childhood vaccine development. Nalini then graduated from Stanford Law School, and went on to practice health law at Hogan & Hartson in Washington, D.C. Her areas of practice included human subjects protection regulation and medical privacy issues. Nalini now works for the National Institute of Health's Fogarty International Center (FIC) and provides research and policy support to FIC on a variety of legal issues related to global health, including the role of intellectual property and licensing in promoting health in the developing world.


Dr. Harvey E. Bale, Jr. is Director General of the International Federation of Pharmaceutical Manufacturers Associations, IFPMA. Created in 1968 as an non-profit, non-governmental organization, the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) represents the research-based pharmaceutical industry and other manufacturers of prescription medicines, through over 55 industry member associations worldwide. IFPMA is the main channel of communication between this sector of the industry and the World Health Organization (WHO), the World Trade Organization (WTO) as well as other international organizations that are concerned with health and trade-related issues. Since Dr. Bale's arrival, IFPMA has engaged in developing new private-public partnerships, including the Global Alliance for Vaccines (GAVI), the Medicines for Malaria Venture (MMV) and the WHO Industry Roundtable process which is looking at joint actions in the areas of drug access, drug development and drug quality and counterfeiting. As Director-General, he also serves as President of the Pharmaceutical Security Institute an organization dedicated to combating counterfeiting. Dr. Bale had prior experience with the Pharmaceutical Research and Manufacturers of America from 1989 as Senior Vice President for International Affairs. Prior to that he was International Public Policy Manager at Hewlett-Packard, and before joining HP in 1987, he served 12 years in the Office of the U.S. Trade Representative. At USTR he served as a senior member of the U.S. negotiating team in Geneva to the Tokyo Round of Multilateral Trade Negotiations; as the lead USTR staff person on the improvement of the protection of intellectual property abroad; and as a senior U.S. delegate in 1986 to the Punta del Este Ministerial meeting that launched the Uruguay Round of Trade Negotiations under GATT. For several months in 1980 Dr. Bale participated in the Camp David negotiations on the settlement of Israeli/Palestinian issues. In 1986 he received the Distinguished Service Award from the President of the United States, the highest award given to senior government executives. He has served on governmental trade, investment and intellectual property advisory committees, on the boards of the Georgetown University Landegger Program in International Business Diplomacy and the University of Maryland Graduate School of Management and Technology. He was also an Adjunct Professor at Georgetown University, teaching a post-graduate course on intellectual property and technology strategy before he took his position in Geneva. Dr. Bale has a B.A. from the Temple University and a Ph.D. in Economics from the University of Maryland, and has authored a number of articles on international trade policy, intellectual property, investment policy and pharmaceutical industry issues.


Professor John H. Barton is the George E. Osborne Professor of Law at Stanford University Law School and the co-director of the Stanford Center for Law and Technology Policy. He teaches courses in contract, international business transactions, law and high technology, international environmental law and international antitrust law. He has been a visiting professor at the University of Michigan and Harvard University. In addition, he has been chair of the National Genetic Resources Advisory Council, a member of the National Academy Panel on Genetic Diversity and the NAFTA dispute settlement panels with Canada and Mexico. Professor Barton received his B.S. from Marquette University and his J.D. from Stanford University, where he was a member of the Law Review. Before attending law school, Professor Barton worked as an engineer for Sylvania Electronic Defense Laboratories. Before joining the Stanford Law faculty, Professor Barton worked as an attorney for Wilmer, Cutler and Pickering.


Mr. Thomas Bombelles is Director, International Government Relations, for Merck & Co., Inc. His responsibilities include definition and advocacy on important international business and policy issues for the company focusing on government agencies and other institutions in Washington, DC. Prior to joining Merck, Mr. Bombelles was the Assistant Vice President International at the Pharmaceutical Research and Manufacturers of America (PhRMA), the professional association representing the American research-based pharmaceutical industry globally. He has also worked as a private sector consultant, as a trade analyst in the Department of Commerce, and in the US Congress. He received an M.A. degree from the Paul H. Nitze School of Advanced International Studies at Johns Hopkins University, and a B.A. degree from the honors program at the University of Michigan, Ann Arbor.


Mr. Robert Brady is a partner in the Washington, D.C. office of Hogan & Hartson L.L.P. and a member of the Food, Drug, Devices, and Agriculture Group. He focuses on pharmaceutical, biological product and food law. In his private practice, Mr. Brady counsels companies, individuals and associations on a wide range of legal and regulatory matters involving the U.S. Food and Drug Administration (FDA) and related state and federal agencies. In the areas of pharmaceutical and biological products (including such products derived from biotechnology), he counsels clients on all aspects of product development and clinical investigation, product approvals, involving NDAs, NADAs, PLAs, ELAs (including license suspensions and revocations), and ANDAs, product promotion and post-approval requirements, including compliance with GMPs, and on a wide array of civil and criminal enforcement issues. He counsels companies on all aspects of marketing and promoting OTC drug products and cosmetics as well. In the food and dietary supplement areas, Mr. Brady counsels companies and associations on a variety of issues, including labeling, safety and enforcement matters. He also counsels trade associations on all aspects of their activities. In 1986, Mr. Brady, after having served as vice president and general counsel for two years, was elevated to the position of executive vice president of the Cosmetic, Toiletry and Fragrance Association. From 1981 to 1983, he served as the executive assistant to the commissioner of the FDA and was awarded the Food and Drug Administration Award of Merit in 1982. His government career with the FDA's Office of Chief Counsel began in 1975, when he served in several positions, including associate chief counsel for Biologics; associate chief counsel for Foods and associate chief counsel for Enforcement. Mr. Brady is a frequent writer and speaker on his areas of concentration. He was a member of the Editorial Board of the Food and Drug Law Journal from 1988 through 1994 and was chairman of its Editorial Advisory Board in 1994. He received his law degree with honors from George Washington University Law School in 1972. He is a member of the Bar of the District of Columbia.


Professor Jillian Clare Cohen, is an Assistant Professor at the Leslie Dan Faculty of Pharmacy, University of Toronto. Her research is focused on drug access issues, the politics of international pharmaceutical policy, and ethics and corruption in pharmaceutical systems. In addition to her academic experience, Dr. Cohen has extensive "hands-on" experience in international pharmaceutical issues. She has worked on pharmaceutical policy for UNICEF in New York City, the World Bank in Washington, DC, and she was the first person to be responsible for coordinating pharmaceutical policies between the World Bank and the World Health Organization in Latin America and the Caribbean. She has advised myriad governments on pharmaceutical policy issues including the Governments of Brazil, Bulgaria, Ecuador, Haiti, India, Ontario and Romania. She received her BA and MA in Political Science from McGill University and her PhD in Politics from New York University. She is a frequent lecturer on pharmaceutical policies in both Canada and abroad.


Ms. Mary Critharis is an attorney in the Office of International Relations at the United States Patent and Trademark Office. Her responsibilities in the International Office include negotiating bilateral and multilateral intellectual property treaties; assessing whether other countries have fully met their intellectual property obligations under GATT and NAFTA; advising other agencies on intellectual property matters, i.e., patents, industrial designs, trade secrets, and data exclusivity; and preparing federal register notices, speeches, policy reports, and testimony for congressional hearings on intellectual property issues. Ms. Critharis initially joined the United States Patent and Trademark Office (USPTO) in 1992 as a patent examiner in the Chemical Group. In addition to her current legal experience, Ms. Critharis worked at the Solicitor's Office where she was responsible for defending the USPTO on patent and trademark matters. Furthermore, Ms. Critharis served as counsel to the Senate Judiciary Committee where she handled a variety of patent, trademark, and copyright issues. Prior to joining the USPTO, Ms. Critharis worked at John Wiley & Sons, Inc. as a trademark associate. Ms. Critharis is currently working towards her Master's Degree in Biotechnology at Johns Hopkins University. Her educational accomplishments include a B.A. in Chemistry and Political Science and a M.S. in Physical Chemistry from New York University. She also received her law degree from Brooklyn Law School where she was the executive editor of the international law journal.


Professor Richard T. De George is University Distinguished Professor of Philosophy, of Russian and East European Studies, and of Business Administration, and Co-Director of the International Center for Ethics in Business at the University of Kansas. He received his Ph.D. from Yale University and he has been a research fellow at Yale University, Columbia University, Stanford University, and the Hoover Institution. He was the Charles J. Dirksen Professor of Business Ethics at Santa Clara University in 1986, and a Visiting Professor at the Graduate School of Business at the University of St. Gallen, Switzerland in 1985. He has written widely in the fields of political and social philosophy, ethics, and applied ethics, with an emphasis on business ethics and most recently computer ethics. He is the author of over 160 articles and the author or editor of twenty books, including The Ethics of Information Technology and Business (2003); Academic Freedom and Tenure: Ethical Issues (1997); Business Ethics (1999), now in its fifth edition and also available in Japanese, Chinese and Russian; and Competing With Integrity in International Business (Oxford, 1993), also translated into Chinese. He has been the President of several academic organizations, including the American Philosophical Association, the Metaphysical Society of America, and the Society for Business Ethics, and he is currently President of the International Society for Business, Economics, and Ethics. He has given invited lectures on six continents at a great many universities and keynote addresses to a variety of organizations both here and abroad, including such places as Tokyo, Como, Barcelona, Rio de Janeiro, and Perth. In November, 1996, he received an honorary doctorate from Nijenrode University in the Netherlands together with Bill Gates and Nelson Mandela.


Deputy Undersecretary Jon W. Dudas, was appointed Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office on January 11, 2002. Prior to this appointment, Mr. Dudas served as the Counsel for Legal Policy and Senior Floor Assistant to Speaker of the House J. Dennis Hastert. In that capacity, Mr. Dudas was responsible for managing legislation on the floor of the House of Representatives. He also served as the primary advisor to the Speaker on issues ranging from intellectual property policy to counterterrorism. From 1997 to 2000, Mr. Dudas was the Deputy General Counsel and Staff Director for the House Judiciary Committee, where he was responsible for advancing legislation relating to intellectual property, technology law, antitrust, legal reform, judicial administration, commercial law, immigration, criminal law and constitutional law. His duties also included managing congressional oversight of the United States Patent and Trademark Office, the Copyright Office and the Department of Justice. Before being named Deputy General Counsel to the House Committee on the Judiciary, Mr. Dudas served as a Counsel to the Subcommittee on Courts and Intellectual Property and as Legislative Counsel to Congressman Henry Hyde. Prior to his employment with the House of Representatives, he practiced law in Chicago at Neal, Gerber & Eisenberg, where he represented clients in a variety of areas including intellectual property, antitrust, professional malpractice, product liability, and white collar crime. He is a member of the Illinois State Bar and the Bar of the United States District Court for the Northern District of Illinois. Mr. Dudas holds a Bachelor of Science degree in Finance, summa cum laude, from the University of Illinois and a law degree from the University of Chicago, with honors. He lives in Northern Virginia with his wife and their three children.


Dr. Michael A. Einhorn is an economic expert active in the areas of antitrust, copyright, patents, media, entertainment, licensing, valuation, and competition advocacy. He is a senior advisor to a prominent international consulting firm, and the author of the forthcoming book Media, Technology, and Copyright: Integrating Law and Economics (Edward Elgar Publishers, UK), Dr. Einhorn received a B.A. from Dartmouth College and a Ph.D. in Economics from Yale University. He taught at Rutgers University and worked at the U.S. Department of Justice, Broadcast Music, Inc., and Bell Laboratories. He served as an Adjunct Professor of Communications and Media in the Graduate School of Business at Fordham University and a Research Fellow and Adjunct Professor at Columbia University. He will be listed in the 2003 edition of Who's Who in America? and can be reached at mae@mediatechcopy.com, 973-618-1212.


Professor Louis Galambos is professor of History and Editor, The Papers of Dwight David Eisenhower, at The Johns Hopkins University. Professor Galambos has taught at Rice University, Rutgers University, Yale University, and has served as President of the Business History Conference and the Economic History Association. A former editor of The Journal of Economic History, he has written extensively on U.S. business history, on business-government relations, on the economic aspects of modern institutional development in America, and on the rise of the bureaucratic state. The Eisenhower Project has now published seventeen volumes of The Papers of Dwight David Eisenhower and will complete this major project in 2001. Professor Galambos' central interest for some years has been the process of innovation in public and private organizations. His recent publications include Networks of Innovation: Vaccine Development at Merck, Sharp & Dohme, and Mulford, 1895-1995 (coauthor), and Pharmaceutical Firms and the Transition to Biotechnology: A Study in Strategic Innovation, Business History Review, 72 (Summer 1998), 250-78 (co-author). Other books and articles include Theodore N. Vail and the Role of Innovation in the Modern Bell System; Competition and Cooperation; The Public Image of Big Business in America; America at Middle Age; The Rise of the Corporate Commonwealth (co-author); and The U.S. Corporate Economy in the Twentieth Century, in volume 3 of The Cambridge Economic History of the United States. In addition to editing The Papers of Dwight David Eisenhower, he has edited the Cambridge University Press series Studies in Economic History and Policy: The United States in the Twentieth Century. At Johns Hopkins University Press, he edited The Johns Hopkins/AT&T Series in Telephone History and has published extensively on the historical development of America's telecommunications system. Professor Galambos has an A.B. from Indiana University and a Ph.D. from Yale University and is a former Senior Fellow of the National Endowment for the Humanities. He has been a Business History Fellow at Harvard University's Graduate School of Business Administration and a Fellow at the Smithsonian's Woodrow Wilson Center and Princeton University's Davis Center.


Dr. Cathy Garner is Chief Executive Officer of (MIHR) Center for the Management of Intellectual Property in Health Research & Development. For the past five and one half years, as Director of Research and Enterprise (R&E) at the University of Glasgow, Cathy has led the University's research development and commercialization unit. Under Cathy's direction the 50-person R&E unit was successfully established to create a gateway between the private sector and the University's world-class scientific research base. The University of Glasgow has the largest medical school in Europe outside of London and is internationally recognized for its work in the fields of cancer research, vaccines, and cell and tissue engineering and is a recognised leader in bioinformatics, nanotechnology and optoelectronics. The R&E unit spearheads the University's effort to identify technologies with potential commercial applications, provides guidance and assistance to protect and patent intellectual property, and helps nurture the growth of the raw entrepreneurial discoveries of the University to a level where private sector technology companies are interested in licensing or purchasing them. Some of R&E's primary tasks include: licensing of intellectual property to the private sector; helping patent technology; creating startup companies from University patented technology; providing consultation (information, advice, and assistance) to University research staff wishing to pursue commercial application of their discoveries; and marketing and promoting the University. Cathy has also held a range of non-executive positions. She was a founder director of the Scottish North American Business Council, a member of the Scottish Executive's Knowledge Economy Taskforce, and she served as Adviser to the Minister for Enterprise and Lifelong Learning on the Review of the Scottish Enterprise Network. She holds a volunteer position on the Committee of management of the Glasgow Housing Association, the UK's largest ever housing stock transfer. In international work, she is currently the Vice-President for International Relations for the Association of University Technology Managers (AUTM) and an adviser to Canadian funding bodies on intellectual property and international research. She has served on numerous UK Government Boards on Innovation and Good Practice and has worked extensively with the World Bank on issues of higher education and healthcare in Latin America. She has lectured on technology transfer policy and practice in Argentina, Italy, Japan, and South Africa. Earlier in her career, Cathy was Director of Policy at the Housing Corporation in London where she was responsible for the establishment and management of an annual £10m Innovation grants program. While at Scottish Homes she directed the first Scottish House Condition Survey and set up new research and innovation programs. Her research career at Edinburgh University spanned 10 years and focused on educational attainment, school effectiveness, performance indicators, and statistical modeling. She has been elected a Fellow of the Royal Statistical Society.


Mr. Michael Gollin, a partner in Venable LLP, has two decades of experience as a practicing patent attorney, prosecuting patents and trademarks, negotiating licenses, and litigating patent, trademark, copyright, and trade secret cases. His clients include pharmaceutical, biotechnology, and medical device companies, and research institutions, for whom he handles global IP portfolios. He obtained a bachelor's degree in biochemical sciences from Princeton University, a master's degree in zoology and molecular biology from the University of Zurich, and a law degree from Boston University. Mr. Gollin is an adjunct professor at Georgetown University's McDonough School of Business where he teaches Strategic Management of Intellectual Property. He has co-authored several books and published numerous articles, and has been interviewed by Time Magazine, National Public Radio, and Fox News Channel. Mr. Gollin's work has taken him to Asia, Africa, and Latin America. With support from Venable and many others, Mr. Gollin founded Public Interest Intellectual Property Advisors (PIIPA), a global non-profit resource for developing countries and public interest organizations who need expertise in intellectual property matters to promote health, agriculture, science, culture, and the environment. PIIPA provides worldwide access to a network of IP professionals who can advise and represent such clients pro bono publico (as a public service).


Professor Henry Grabowski of the Health Sector Management Program Faculty at Duke University, is Professor of Economics and Director of Duke University's Program in Pharmaceuticals and Health Economics. Dr. Grabowski received his Ph.D. from Princeton University. Dr. Grabowski has published numerous studies on the pharmaceutical industry with his principal research involving the economics of the innovation process, business regulation, industrial organization, and developing therapies for Southern countries. Dr. Grabowski is a member of a number of professional organizations including American Council on Science and Health and American Enterprise Institute for Public Policy Research. Dr. Grabowski serves as an associate editor for The Quarterly Review of Economics and Finance and Journal of Research in Pharmaceutical Economics.


Mr. John R. Graham is Director of Pharmaceutical Policy Research at The Fraser Institute. He earned his B.A. (Hons) in Economics and Commerce at the Royal Military College of Canada and his MBA at the London Business School, University of London. He has worked as a management consultant and investment banker in Canada and Europe, and served as an infantry officer in the Canadian Army in bases across Canada, as well as in Germany and Cyprus. Works published by the Fraser Institute include a series of papers on price differences for prescription drugs between Canada and the US, and The Fantasy of Reference Pricing and the Promise of Choice in BC's Pharmacare. He has written for many periodicals, including the Wall Street Journal.


Ambassador Rita Derrick Hayes is presently Deputy Director General of the World Intellectual Property Organization (WIPO), a post she held since December 1, 2001. Ms. Hayes was appointed by President Clinton and unanimously confirmed as Ambassador by the U.S. Senate in November 1997, to serve as the first woman Deputy U.S. Trade Representative in Geneva, Switzerland, and U.S. Permanent Representative to the World Trade Organization (WTO). In this capacity as a sub-cabinet level official, Ambassador Hayes has been responsible for conducting trade negotiations and assisting the United States Trade Representative in developing and implementing U.S. trade policy. In January 2001, Ms. Hayes returned to Washington as Acting U.S. Trade Representative to manage USTR in Washington, D.C. and facilitate the transition between administrations. She subsequently resumed service in Geneva as U.S. Ambassador to the World Trade Organization. Ambassador Hayes continuously met and worked with private sector groups and other international organizations on various matters related to WTO. She was particularly instrumental in her work informally with the Directors General of the WTO and the World Intellectual Property Organization to reach agreement between them on enhanced assistance to developing countries that will need to implement their TRIPS intellectual property right obligations by the year 2000. Prior to her appointment as Deputy U.S. Trade Representative, Ambassador Hayes was U.S. Chief Textile Negotiator and Ambassador in the Senior Executive Service, appointed by President Clinton, with the advice and consent of the U.S. Senate. In that capacity, she successfully negotiated approximately 30 trade agreements with several countries in Europe, Eastern Europe, Asia, Africa and Latin America. Serving under Department of Commerce Secretary Ronald Brown, Ambassador Hayes was the first woman Deputy Assistant Secretary for Textiles, Apparel and Consumer Goods Industries for the United States Department of Commerce in Washington, D.C., and Chair of the Committee for the Implementation of Textile Agreements (CITA) also at Senior Executive Service level. At Commerce, Ambassador Hayes was responsible for implementation of the U.S. textile and apparel program and supervision of the textile provisions of the North American Free Trade Agreement (NFTA) and was responsible for policy initiatives, domestic and international, that encouraged competitiveness of American fiber, textile, apparel, consumer products and businesses. She also negotiated bilateral textile agreements on textile matters during the Uruguay Round negotiations leading up to the Marrakech Agreement establishing the WTO, and launching several multilateral agreements, including the new Agreement on Textiles and Clothing (ATC). Before the advent of the WTO and conclusion of the Uruguay Round, Ambassador Hayes was the Commerce Department and CITA chief representative before the GATT Textiles Surveillance Body. Ms. Hayes holds a B.A. from the University of Georgia, Athens, Georgia; Degree of Doctor of Humane Letters awarded by the College of Charleston and a Degree for Outstanding Public Service awarded by the University of South Carolina.


Professor Michael Kremer is currently Professor of Economics at Harvard University and Senior Fellow at the Brookings Institution, received his A.B. from Harvard University in 1985, and his Ph.D., also from Harvard, in 1992. Kremer previously served as a teacher and administrator at the Eshisiru Secondary School, Kakamega District, Kenya (1985 1986), founded and was the first executive director of WorldTeach, a non-profit organization which places one hundred volunteer teachers annually in developing countries (1986 1989), and served as a Visiting Assistant Professor at the University of Chicago and Assistant Professor and Professor of Economics at MIT. He served as a National Fellow at the Hoover Institution at Stanford University (1994 1995), and is a recipient of a MacArthur "genius" fellowship and a Presidential Early Career Award for Scientists and Engineers. Kremer's recent research includes work on the evaluation of health and educational programs in developing countries; incentives for research and development on malaria, tuberculosis, HIV, and other diseases affecting developing countries; and sovereign debt.


Mr. Raymond Kurz is a partner resident in the Washington, D.C. office of Hogan & Hartson L.L.P., and the director of the firm's Washington, D.C. Intellectual Property Group. His practice covers a broad spectrum of intellectual property matters, including lead counsel roles in complex patent, trademark and copyright litigation; patent, trademark, trade secret and copyright counseling; trademark and copyright prosecution; and patent, technology, trademark, copyright, and character licensing. Mr. Kurz has particular experience in applying his broad based intellectual property knowledge in connection with medical device/bioscience matters, computer software, e-commerce, online/Internet, and multimedia works. Mr. Kurz has applied his extensive intellectual property expertise in assisting companies in establishing comprehensive intellectual property strategic plans.In addition to practicing before federal and state courts, Mr. Kurz is experienced in practice before the U.S. Court of Appeals for the Federal Circuit. Mr. Kurz also handles ex parte and inter partes trademark matters before the U.S. Patent and Trademark Office and has substantial experience in Copyright Office practice. Mr. Kurz has authored numerous articles and has lectured frequently in connection with intellectual property matters. The following are representative: "Supreme Court Sees Festo Bar and Says, 'Absolutely' Not" in the Legal Times June 17, 2002; "The Impact of Festo: A Primer" in the Institutional Investor News Corporate Finance Yearbook June 2002; "Medical Device FDA/Patent Law Interplay" in The Patent Journal 2002; "Navigating a New Domain" in the International Legal Strategy 2001; "Patents 'R' Us?" (discussion of the patent issues involving CIPRO®) in the Legal Times November 5, 2001; "State Street Revisited A Funny Thing Happened to the Business Method Patent on the Way to the U.S. PTO" in the International Legal Strategy 2001; "Whose Mind Is It Anyway? Intellectual Property Is a Key to Corporate Success" in the Washington Business Forward 1999; co-chair and lecturer, Internet and the Law Conference, Washington, D.C. 1998; "Lawyering in Cyberspace" in the Washington Lawyer July/August 1998; "Changes in the law regarding copyright notice in the United States;" I.R.D.I. Intellectuele Rechten Droits Intellectueles, 1996-2000; and Mr. Kurz is also the editor and principal author of the book Internet and The Law: Legal Fundamentals for the Internet User (1996). Mr. Kurz received his B.A., magna cum laude, from the State University of New York at Albany and his J.D. from The George Washington University. He is a member of the District of Columbia Bar, and is admitted to practice before the U.S. District Court District of Columbia, U.S. Court of Appeals for the District of Columbia Circuit, U.S. Court of Appeals for the Federal Circuit, and the U.S. Supreme Court. Mr. Kurz is a member of the District of Columbia Bar Association (Member, Patent, Trademark and Copyright Law Section); American Bar Association (Member, Patent, Trademark and Copyright Law Section); International Trademark Association; and the American Intellectual Property Law Association.


Professor Klaus M. Leisinger has been President and CEO of the Novartis Foundation for Sustainable Development since 2002. Before he has served as Executive Director and Delegate of the Board of Trustees for 12 years. He was born in 1947 in Lörrach, Germany, and studied economics and social sciences at the University of Basle, Switzerland. His post-graduate work focused among others on health policy, international development issues and private investment in developing countries. Prior to joining the Foundation, Klaus Leisinger served as Manager of Ciba Pharmaceuticals in East Africa and thereafter as Head of the Department "Relations with Developing Countries" at Ciba, Basle. In addition to his position at the Novartis Foundation, he is Professor of Development Sociology at the University of Basle and serves as an advisor to different national and international organisations dealing with sustainable development. In 2002, Leisinger became member of the Group of Eminent Persons which serves as advisory panel for the preparation of the Human Development Report published by UNDP. Klaus M. Leisinger has contributed extensively to the development policy discussions and publications. The focus of his research work ranges from population policy and sustainable development to business ethics and globalisation.


The Honorable Bruce A. Lehman is founder and president of the International Intellectual Property Institute (IIPI), a non-partisan, not-for-profit institution, based in Washington, D.C. As an international development organization and think tank, IIPI is dedicated to increasing awareness and understanding of the use of intellectual property as a tool for economic growth, a mechanism for funding new treatments for disease, and as a means of preserving and promoting cultural heritage, particularly in developing countries. Since 1998 the Institute has been engaged in a wide range of activities both abroad and within the United States, including research, public education, policy and training workshops, technical assistance, institution building and consultative services. Mr. Lehman is a frequent speaker at conferences and seminars involving intellectual property rights. During the past year he has been a featured speaker at conferences in the United States, Europe, China, the Philippines, Vietnam, and South Africa. He has published numerous articles in legal and trade publications which can be read at IIPI's website, www.iipi.org. In addition to his involvement with IIPI, Mr. Lehman is a member of the Policy Advisory Commission to the Director General of the World Intellectual Property Organization (WIPO), the specialized United Nations agency headquartered in Geneva, Switzerland. He is President of the U.S. Committee for the WIPO and is a member of several corporate Boards. He is often called upon to provide consulting services in the field of intellectual property as well as to provide expert testimony on USPTO policies and procedures in patent cases. From August 1993 through 1998, he served as Assistant Secretary of Commerce and United States Commissioner of Patents and Trademarks. At the request of the President, he served concurrently in the fall of 1997 as Acting Chairman of the National Endowment for the Humanities (NEH), which fosters the work of America's artistic and creative community. In 1994 the National Law Journal, the largest selling weekly publication for lawyers, named Mr. Lehman its "Lawyer of the Year". In 1997, another publication, the Washington-based national magazine of public policy, the National Journal, named Mr. Lehman one of the 100 most influential men and women in Washington. Earlier in his career he was a partner in the Washington, D.C., law firm of Swidler & Berlin (1983-1993) and Counsel to the Committee on the Judiciary of the United States House of Representatives (1974-1993). Bruce Lehman is a member of the Bar of the District of Columbia, a graduate of the University of Wisconsin (B.S. 1967) and its Law school (J.D. 1970), and a veteran of the United States Army.


Mr. Robert L. Mallett is Senior Vice President for Corporate Affairs for Pfizer Inc. He has direct supervision of Pfizer's global policy and industry economics group, philanthropy and corporate giving department, multilateral institutions and alliance development unit, as well as serving as the coordinator for the company's intellectual property policy positioning. He serves as a member of the Pfizer Management Council and is an elected officer of the corporation.  Prior to joining Pfizer in April 2001, Mr. Mallett served as Deputy Secretary of the U.S. Department of Commerce where he oversaw the administrative and policy operations of a number of key federal agencies, including, among others, the International Trade Administration, Economic Statistics Administration, Minority Business Development Agency, Census Bureau, and the U.S. Patent and Trademark Office. By appointment of the President, he served on the Board of the Overseas Private Investment Corporation and was a member of the 3-member Federal Steel Loan Guaranty Board.  Prior to his federal executive service, Mr. Mallett was a shareholder and associate attorney of major Washington, D.C. based law firms. He has also served as City Administrator and Deputy Mayor for the District of Columbia and Legal Counsel to former United States Senator Lloyd Bentsen. He has been an adjunct professor at Georgetown University's Law Center, and most recently was a Visiting Professor at Harvard University's John F. Kennedy School of Government. He served as a law clerk to the Honorable John R. Brown of the United States Court of Appeals for the Fifth Circuit. Mr. Mallett is a member of the Council on Foreign Relations, an elected Fellow of the National Academy of Public Administrators, Chairman of the U.S.-South Africa Business Council, a member of the Board of Directors of AFRICARE, the Appleseed Foundation, and Medical Education of South African Blacks. He is the former Chairman and a member of the Board of Governors of Wesley Theological Seminary. He also serves as a member of the Board of the Journal of Communication Management. Mr. Mallett graduated from Morehouse College in 1979 and received his law degree from Harvard University in 1982. He now lives in New York City.


Dean John Mayo is a professor of economics, business and public policy and Director, the Center for Business and Public Policy at Georgetown. He served as Senior Associate Dean of the business school from 1999 - 2001. He is also a Zaeslin Fellow of Law and Economics at the University of Basel in Switzerland. Dr. Mayo's research interests include the areas of industrial organization, regulatory and antitrust policy, and applied microeconomics. He has published more than 35 articles and is co-author of six books and monographs, including "Government and Business: The Economics of Antitrust and Regulation." In addition to his academic endeavors, Dr. Mayo has served as an advisor and consultant to both public and private agencies including the U.S. Department of Justice, the Federal Trade Commission, the Tennessee Valley Authority, the U.S. Department of Energy and Oak Ridge National Laboratory. In this capacity Dr. Mayo has participated in regulatory and antitrust proceedings and has testified before federal and state legislative and regulatory bodies on issues including monopolization, price fixing, mergers and regulatory pricing policy. Prior to joining the faculty at Georgetown, Dr. Mayo taught at the University of Tennessee. Early in his career he served as chief economist for the staff of the U.S. Senate's Small Business Committee. Dr. Mayo received his bachelor's degree in economics from Hendrix College and his Master's and Ph.D. in economics from Washington University in St. Louis.


Ms. Minna Moezie attended pharmacy school at the Medical College of Virginia and law school at The Catholic University of America. Currently, Ms. Moezie is an attorney-advisor in the USPTO's Office of External Affairs, International Relations Division. In 1992, she began working at the USPTO as a patent examiner in the pharmaceutical arts. After more than seven years in that position, Mrs. Moezie became a supervisor for an examining unit handling pharmaceutical applications. She was a supervisor for nearly two years prior to accepting her current position.


Dr. Ben Prickril is currently a senior technology transfer specialist in the Technology Transfer Branch of the National Cancer Institute (NCI) at the U.S. National Institutes of Health. His work covers a wide range of technology transfer issues, including negotiation of Cooperative Research and Development Agreements (CRADAs) and other transactional agreements between the NCI, industry, universities, and non-profit institutions. He has consulted on biotechnology issues with Euram Consultants LLP. Prior to joining NCI he was a patent examiner for the U.S. Patent & Trademark Office in Arlington VA, specializing in biotechnology. After receiving his Ph.D. in bioinorganic chemistry from the University of Georgia in 1992 he studied behavioral genetics at the NCI in the laboratory of Dr. Dean Hamer. He has published widely in the area of biotechnology.


Professor Duncan Reekie is the E.P. Bradlow Professor of Industrial Economics at the University of the Witwatersrand in Johannesburg, South Africa, previously Lecturer and subsequently Reader in Business Economics at the University of Edinburgh, 1969-1983. He held the position of Dean of the Faculty of Commerce in his current university from 1989-1994. Educated at the Universities of Edinburgh and Strathclyde he has held Visiting Professorships in the USA, Canada, and the UK. A specialist in industrial organization he has published in, among others, The Economic Journal, The Journal of Industrial Economics, Applied Economics, The South African Journal of Economics and The Australian Economic Papers. He founded, and for ten years edited, the journal Managerial and Decision Economics. In the United Kingdom he served on the Pharmaceutical Industry Working Party of the National Economic Development Committee. In South Africa he was a member of the Commission of Enquiry into the Manner Providing for Medical Expenses under the Chairmanship of the Right Honorable Justice McLamet. From 1995-1997 he was President of the Economic Society of South Africa.


Mr. Juan Rovira, Senior Health Economist (Pharmaceuticals) Health, Nutrition and Population Sector at the The World Bank was formerly, Professor at the Department of Economics, University of Barcelona, where he has been lecturing and doing research and consulting mainly in the areas of economic evaluation of health technologies, pricing and financing of pharmaceuticals, drug market regulation and the economics of tobacco. He worked as a short term professional at the WHO European Office in Copenhagen, as acting Officer for Health Economics. He has also worked as a consultant on health policy and economics for the WHO, the PAHO, the IDB and the European Commission. His experiences with developing countries include Eastern European (Moldova, Romania) and Latin American countries (Panama, Brazil), Burkina Faso and Indonesia. He has been President of the Spanish Health Economist Association, and recently served at the Board of Directors of ISPOR. His present areas of interest include drug financing, differential pricing, patent protection systems, efficient procurement mechanisms, local production, and other topics related to the accessibility of the people in developing countries to quality drugs.


Professor Michael Ryan teaches and conducts research regarding international political economy, management, and social responsibility at the Georgetown University McDonough School of Business where he specializes in the law, policy, public administration, diplomacy, management, and ethics of intellectual property. He is the author of Knowledge Diplomacy: Global Competition and the Politics of Intellectual Property (Brookings Institution Press, 1998) and Playing by the Rules: American Trade Power and Diplomacy in the Pacific (Georgetown University Press, 1995). His co-authored Knowledge Management: Technology, Intellectual Property, and Organization in the World Economy will be released in 2003; his Knowledge Ethics: Intellectual Property and Social Responsibility in the World Economy is underway. Professor Ryan is presently leading a multi-year, multi-country project regarding judicial capacity regarding intellectual property enforcement and commercial dispute settlement in developing and transitioning countries. He recently lectured to Chinese engineers and public administrators in Beijing, Dalian, and Shenzhen under the auspices of its Ministry of Science and Technology and is advising the government, business community, and academy in New Zealand regarding its biotechnology strategy. He assisted the Hashemite Kingdom of Jordan's government with the drafting of new patent and industrial design laws and is presently assisting with the policy and management issues regarding the Aqaba Technology Hub. He conducted for the government of Peru a study of the public administration of its intellectual property laws and policies and advised the government and business community of the Dominican Republic regarding the development of its software and music industries. During the past few years he has lectured in Argentina, the Balkans, Brazil, Chile, China, the Dominican Republic, Japan, Jordan, Malaysia, New Zealand, Peru, the Philippines, Singapore, and South Africa. Professor Ryan teaches in the undergraduate, MBA, and executive education programs at Georgetown. His courses on international business and the world economy have received among the highest teaching ratings at Georgetown's School of Business and School of Foreign Service and at the University of Michigan Business School, where he began his teaching career, and his co-taught executive MBA course was named number 1 for global business by Business Week magazine. At Georgetown Professor Ryan established the first intellectual property course for public affairs students in 1994 and for MBA students in 1998. He has been a guest lecturer at China University of Political Science and Law, a guest scholar at the Brookings Institution, and is a member of the Academy of International Business, the American Political Science Association, the American Society of International Law, the Cosmos Club, and the Society for Business Ethics. He earned a PhD in political science at the University of Michigan, where he studied at its Law School and was a researcher in higher education at its School of Education.


Professor F. M. Scherer is Aetna Professor Emeritus at the John F. Kennedy School of Government, Harvard University, and lecturer at the Woodrow Wilson School of Princeton University. In 1974-76, he was chief economist at the Federal Trade Commission. His undergraduate degree was from the University of Michigan; he received his M.B.A. and Ph.D. from Harvard University. His research specialties are industrial economics and the economics of technological change, leading inter alia to books on Industrial Market Structure and Economic Performance (third edition with David Ross); International High-Technology Competition; Mergers, Sell-offs, and Economic Efficiency (with David J. Ravenscraft); Innovation and Growth: Schumpeterian Perspectives; and New Perspectives on Economic Growth and Technological Innovation. His web home page is found at www.fmscherer.com.


Professor Patricia H. Werhane, the Ruffin Professor of Business Ethics teaches Ethics courses in the Darden MBA program. She is the Co-Director of the Olsson Center for Applied Ethics and heads the school's Doctoral Program Operating Committee. Her research focuses on global business, employment, leadership and values, and the ethics of health care organizations. She has written or edited 15 books and numerous academic journal articles on these subjects and is Founding Editor of Business Ethics Quarterly, the journal of the Society for Business Ethics. She also edits a series on International Business Ethics for Kluwer. Before joining the Darden faculty in 1993 Werhane served on the faculties of Loyola University Chicago and Dartmouth College. She was a visiting scholar at Cambridge University and the University of Canterbury in Christchurch, New Zealand. Professor Werhane received ber B.A., from Wellesley College; and M.A., Ph.D., from Northwestern University.


Mr. Richard Wilder focuses his practice on counseling U.S. and foreign business, governments and intergovernmental organizations on intellectual property policy and protection. He also counsels e-commerce and other clients in dispute resolution. Mr. Wilder has over a decade of experience in senior policy-making positions in the private sector. For three years, Mr. Wilder served in the World Intellectual Property Organization (WIPO), where he was Director of the Global Intellectual Property Issues Division. There he was responsible for various WIPO programs dealing with diverse issues, including biotechnology, genetic resources, health care, traditional knowledge, folklore and human rights. As Director-Advisor of the Office of Legal and Organization Affairs, Mr. Wilder had responsibility for relations between WIPO and the non-governmental organizations and the private sector. Earlier in his career, Mr. Wilder served in the Office of Legislative and International Affairs of the U.S. Patent and Trademark Office (USPTO), where he participated in a number of bilateral and multilateral negotiations involving international intellectual property obligations including under the TRIPS Agreement. Mr. Wilder also served as the chief negotiator for the U.S. on what became the Geneva Act of the Hague Agreement for the International Registration of Industrial Designs. In the private sector, Mr. Wilder practiced intellectual property law in both law firm and corporate legal department settings. In that capacity, he has dealt with a wide variety of technologies, including optics, semiconductor products and fabrication equipment, mechanical devices and biotechnology. Mr. Wilder has also taught law as a visiting lecturer in intellectual property and torts at the University of Malaya in Kuala Lumpur, Malaysia.


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