World Intellectual Property Organization

Public Health and Patents

Introduction

Although scientific and technological innovation has contributed to significant improvements in health conditions, health crises, relating, in particular, to HIV/AIDS, malaria, tuberculosis, and, most recently, avian influenza, continue to create major problems in many parts of the world. In various national and international fora, solutions are sought in respect of the role of patents in pharmaceutical innovation and fair and affordable access to health care.

The patent system is designed to promote innovation and, at the same time, offer a mechanism ensuring that the fruits of that innovation are accessible to society. In the contexts of public health, the challenge for policy makers is to find an optimal balance between the rights of patent owners, who provide technological innovations to improve health conditions, and the needs of the general public.

In general, the development of new drugs requires heavy investment and long-term research, coupled with expensive clinical trials and regulatory approval procedures. The exclusive right conferred by a patent is one of the incentives for developers of new drugs to make the necessary investments into that research. Clearing issues, such as ownership and licensing policies for innovation derived from public research, would contribute to the promotion of a more effective deployment of public funds and public R&D programs. At the same time, the patent system also contributes to society by making available patent information, which is freely available to other researchers to further improve existing technologies. With a view to facilitating commercialization and ensuring access to patented technologies, the patent system is primarily based on conferring an exclusive right, in conjunction with a voluntary licensing mechanism. However, taking into account the public interest and policy objectives beyond the patent system, there are a number of flexible mechanisms built in the patent system, such as the possibility of issuing compulsory licenses, research exceptions and parallel imports.

On the other hand, some consider that the current patent system does not adequately address public health crises. It is argued that the commercial incentives provided by the patent system are not sufficient to ensure the development of new products in certain areas, for example, in respect of neglected diseases, and that patent rights, which are enforced on the basis of commercial and market-based considerations, prevent access to, or increase prices of, essential medicines. Some criticize that the safeguard mechanisms built in the patent system, such as compulsory licenses or research exceptions, are not sufficiently broad to cover existing needs. Further, the number and, at times, the broad scope of patents granted in the field of early fundamental research have raised concerns about patent thickets and royalty stacking. In particular, reach-through claims in respect of research tools are considered a potential obstacle to further research and development.

Studies and Articles

Links on these pages, including those to studies commissioned for WIPO, do not imply the agreement of WIPO, its Member States or the International Bureau with the views expressed.

Date Source Title
March 2009 EPO

Comments from the EPO on EC Preliminary Report on Pharmaceutical Sector Inquiry [PDF]

March 2009 ICTSD Fight over Generic Drug Seizure Takes Centre Stage at TRIPS Council Meeting
2009 Stockholm Network The UK Pharmaceutical Industry: Current Challenges and Future Solutions, Ross Carroll and Stuart Carroll [PDF]
November 2008 European Commission Preliminary Report on Pharmaceutical Sector Inquiry [PDF]
November 2008 South Centre South Perspective – A Guide to Pharmaceutical Patents
May 2008 WHO Sixty-first World Health Assembly, Resolution WHA 61.21: Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property [PDF]
May 2008 European Generic Medicines Association Patent-related Barriers to Market Entry for Generic Medicines in the European Union
2008 Stockholm Network The Special Regime of Intellectual Property for the Pharmaceutical Industry, James Killick et al. [PDF]
2007 Stockholm Network Developing Countries and Pharmaceutical Intellectual Property Rights: Myths and Reality, Felix Rozanski [PDF]
2007 WHO Working Paper: Patent Issues Related to Influenza Viruses and their Genes
2007 MIHR-PIPRA IP Management in Health and Agricultural Innovation: A Handbook of Best Practices
April 2006 South Centre The Use of Flexibilities in TRIPS by Developing Countries: Can they Promote Access to Medicines? 

April 2006

WHO

CIPIH Report: Public health, innovation and intellectual property rights

July 2005

World Bank

Compulsory licensing for public health - a guide and model documents for implementation of the Doha Declaration Paragraph 6 Decision, Abbott, Frederick M. Van Puymbroeck, Rudolf V.

May 2005

CIPIH/WHO

Follow-on innovation and intellectual property, WIPO’s submission to CIPIH/WHO

December 2004

IIPI

West Africa and Intellectual Property: Policy Priorities to Foster Economic Growth, Public Health and Culture, Sofitel Teranga Dakar
 

November 2004

Bulletin of the WHO

Has the implementation of the TRIPS Agreement in Latin America and the Caribbian produced intellectual property legislation that favours public health?, Maria Auxiliadora Oliveira, Jorge Antonio Zepeda Bermudez, Gabriela Costa Chaves, Germán Velásquez

April 2004

South Centre

Utilizing TRIPS Flexibilities for Public Health Protection Through South-South Regional Frameworks

2004

United Nations Millennium Project

Genomics and Global Health

July 2003

IIPI

Counterfeit Goods and the Public’s Health and Safety, Michele Forzley

September 2002

Commission on IPRs

Integrating Intellectual Property Rights and Development Policy [PDF]

August 2002 South Centre Protection and Promotion of Traditional Medicines: Implications for Public Health in Developing Countries, Carlos M. Correa

July 2001

World Bank

Parallel imports of pharmaceutical products in the European Union, Mattias Ganslandt, Keith E. Maskus

April 2001

WIPO

Parallel Imports in Pharmaceuticals: Implications for Competition and Prices in Developing Countries, Keith E. Maskus [PDF]

2000

WIPO

Patent Protection and Access to HIV/AIDS Pharmaceuticals in Sub-Saharan Africa, International Intellectual Property Institute [PDF]

May 2001

Health Action International

Public-private "partnerships": Addressing public health needs or corporate agendas?

October 2000

South Centre

Integrating Public Health Concerns into Patent Legislation in Developing Countries

2000

UNAIDS, WHO

Patent situation of HIV/AIDS-related drugs in 80 countries, Report 1/1/2000 (search keyword "intellectual property")

 

IPRsonline

Various articles and contributions on the subject

 

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