Best practices and models

In this section you can find out what a good system of intellectual property would look like. The papers here highlight what needs to be done to create a good model that doesn’t negatively impact on public health. We have chosen these papers as they highlight good practices (what to do) and good models (what they look like).

  • Guidelines for the Examination of Pharmaceutical Patents:

    Developing a Public Health Perspective

    This paper provides a set of guidelines for assessing common types of pharmaceutical patent claims. It is concerned with the proliferation of patents that protect minor and obvious variants to existing drugs and processes. Even when such patents are weak or invalid, they can be used to prevent generic competition and reduce access to medicines. Countries can determine their own criteria for assessing patents consistent with public health strategies.

    Download Guidelines for the Examination of Pharmaceutical Patents: Developing a Public Health Perspective (PDF)

    Author: Carlos Correa, Publisher: International Centre for Trade and Sustainable Development (ICTSD), Year: Jan 2007

  • Compulsory Licensing:

    Models for State Practices in Developing Countries, Access to Medicine and Compliance with the WHO TRIPS Accord

    This booklet covers government authorization to use patents without the permission of the patent owner. Governments can authorize compulsory licenses for certain drugs for public health emergencies like HIV/AIDS, tuberculosis, malaria or other illnesses. The TRIPS accord permits governments to authorize the use of patents without permission from drug companies. Yet developing countries have not enacted good TRIPS-compliant state practice, due to expensive litigation and cultural reluctance to sue or be sued.

    Download Compulsory Licensing:Models for State Practices in Developing Countries, Access to Medicine and Compliance with the WHO TRIPS Accord (PDF) 

    Authors: James Love, Publisher: Third World Network, Year: 2004

  • Guidelines on Patentability and Access to Medicines

    This document provides guidelines to improve transparency and efficacy of patent examinations for pharmaceutical products. It addresses the link between intellectual property and public health, and the level of flexibility allowed in TRIPS agreements. It also looks at the role of national patent offices in improving access to medicines through their examination procedures.

    Download Guidelines on Patentability and Access to Medicines (PDF)

    Author: Germán Velásquez, Publisher: South Centre, Year: March 2015

  • TRIPS, Drugs and Public Health: Issues and Proposals

    This paper discusses the TRIPS Agreement, patents and access to affordable medicines. It presents evidence of the impact that patents have on the pricing of medicines and on anti-competitive behavior of multinational pharmaceutical corporations. Ahead of the WTO Ministerial Conference in Doha in November 2001, the paper makes a series of proposals, including use of compulsory licenses and parallel imports, to enable developing countries to protect public health and ensure access to medicines.

    Download TRIPS, Drugs and Public Health: Issues and Proposals (PDF)

    Author: Cecilia Oh, Publisher: Third World Network, Year: Sept 2001

  • Patents and Access to Medicines: What Can Be Done at National Level

    This manual notes that governments can adopt a range of policies to facilitate access to affordable medicines. It describes options for importing, producing and exporting affordable medicines consistent with the TRIPS Agreement. It provides model legal provisions for national patent laws, sensitive to public health concerns. It contains proposals for appropriate institutional and administrative frameworks to implement the proposed patent laws and policy measures.

    Download Patents and Access to Medicines: What Can Be Done at National Level (PDF)

    Author: Martin Khor, Publisher: Third World Network, Year: Nov 2004

  • Patents, Compulsory Licenses and Access to Medicines:

    Some Recent Experiences

    This document provides an overview of the process of obtaining patents in the United States and internationally. The document provides definitions for key terms. It provides a summary of the patent process in the United States and abroad. It then provides a summary in diagram form of this process.

    Download Patents, Compulsory Licenses and Access to Medicines: Some Recent Experiences (PDF)

    Author: Martin Khor, Publisher: Third World Network, Year: 2009

  • Malaysia’s Experience in Increasing Access to Antiretroviral Drugs:

    Exercising the ‘Government Use’ Option

    Malaysia was the first country to issue a compulsory license to enable the production of more affordable generic drugs. This paper is written as a case study, to inform other developing countries wanting to use ‘flexibilities’ under TRIPS. It demonstrates that when health officials and ministers are informed of their rights and ‘flexibilities’ under TRIPS, and when national patent laws are designed appropriately, access to affordable drugs can become a reality.

    Download Malaysia’s Experience in Increasing Access to Antiretroviral Drugs: Exercising the ‘Government Use’ Option (PDF)

    Author: Chee Yoke Ling, Publisher: Third World Network, Year: 2006

  • Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing

    This paper looks at the patent systems in Argentina, Brazil, Colombia, India and South Africa, and notes a proliferation of patents in the pharmaceutical sector. Most of this increase is due to derivatives and improvements on existing drugs, which under more rigorous standards of patentability would not be approved. Governments should use compulsory licenses, apply rigorous criteria of ‘inventive step’ and reduce the scope of speculative patenting.

    Download Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing (PDF)

    Author: Carlos M. Correa, Publisher: South Centre, Year: Sept 2011

  • Intellectual Property in the Trans-Pacific Partnership:

    Increasing the Barriers for the Access to Affordable Medicines

    This paper considers the intellectual property components of existing free-trade agreements which may affect access to medicines. It then focuses on those aspects of intellectual property that are part of the Trans-Pacific Partnership (TPP) initiative. Most negotiating parties are concerned about the impact the agreement will have on access to affordable medicines . Some provisions have been removed or changed, but pharmaceutical protections remain stronger in the TPP than in previous free trade agreements.

    Download Intellectual Property in the Trans-Pacific Partnership: Increasing the Barriers for the Access to Affordable Medicines (PDF)

    Author: Carlos M. Correa, Publisher: South Centre, Year: Sept 2015

  • Public Health Related Trips-Plus Provisions in Bilateral Trade Agreements

    This policy guide highlights the adverse effects of bilateral trade agreements on public health and access to medicines in the Eastern Mediterranean Region. It provides policy, and technical guidance and assistance for national negotiators and implementers in the region. It argues that governments should be more proactive in setting the agenda for the global regulation of intellectual property, and provides specific advice about how governments can achieve this.

    Download Public Health Related Trips-Plus Provisions in Bilateral Trade Agreements (PDF)

    Author: Mohamed K El Said, Publisher: World Health Organization, Year: 2010

  • The Roadmap – Special Edition Report on Dolutegravir

    A Make Medicines Affordable partner, the Initiative for Medicines, Access and Knowledge (I-MAK), has published a special edition ‘Roadmap report’ on dolutegravir. The report provides current clinical, cost, and patent information in order to inform strategies to expand currently limited access to Dolutegravir. One of the recommendations is to pursue a coordinated compulsory license strategy, especially in countries in which patent barriers are unlikely to be removed because of lower patentability standards.

    Download Roadmap Special Edition on Dolutegravir (PDF)

    Publisher: I-MAK. Year: 2017