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ipHandbook Blog

Your source for expert commentary on IP management issues.
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About

Editor-in-Chief,   Anatole Krattiger

Editorial Board

Concept Foundation

PIPRA

Fiocruz, Brazil

bioDevelopments-   Institute

Site Guide for Government Policymakers

As a government policymaker, it is essential to have a realistic understanding of both the opportunities and the constraints that lie before you in proposing and implementing innovation policies.

This Site Guide for Government Policymakers presents you with an executive overview of the general principles of IP as well as policy precedents from countries around the world. It only discusses specific mechanics of IP management when necessary to illustrate important policy implications. This Site Guide also recommends selections from among the 175 chapters and case studies of this Handbook that are most likely to be informative and helpful to you as a government policymaker.

Key Implications and Best Practices for Government Policymakers

The Intellectual Property–Innovation Nexus

  • Whether viewed as a legal concept, a social construct, a business asset, or an instrument to achieve humanitarian objectives, intellectual property is an important driver of innovation. (more>>)
  • The use of the IP system, via balanced patenting and sound licensing strategies, can serve the public interest through private rights. This has profound implications for the management of innovation, technology transfer, market competition, and economic development in every country. (more>>)
  • Innovation is a complex process, stimulated by coordinated and structured policies and programs. An IP management system is one of six important factors in determining a country’s, or institution’s, ability to innovate. Others are R&D capacity of the public and private sectors; safe and effective regulatory systems; the ability to produce new products to high standards of quality; a national distribution system in both the public and private sectors; and international distribution systems and trade in technologies. (more>>)
  • Policies promoting the management of intellectual property by public sector institutions can advance the missions of these institutions, fostering creativity and innovation. (more>>)

Public Sector Institutions and Intellectual Property

  • When public research institutions own IP rights, they can use licensing to control how technology is deployed, meeting both commercial and noncommercial goals. (more>>)
  • Best practices in IP management will facilitate global access, provided the entire innovation process is considered from the outset. This includes a mission-driven mindset to establish optimum goals for the public sector. (more>>)
  • An important best practice by the public sector is incorporating humanitarian use reservation provisions in commercial licenses whenever possible. (more>>)
  • Public sector institutions should have IP policies and institutional capacity for implementing best practices in IP management. Licensors are more likely to grant licenses to institutions that respect and protect third party IP rights. (more>>)
  • Public sector institutions need strategies that balance the public domain and IP rights. Commercial and humanitarian objectives are not in conflict, but rather are complementary, indeed mutually reinforcing, aspects of best practices in IP management. (more>>)

Building IP Management and Technology Transfer Capacities

  • Technology transfer converts scientific findings into useful products or services for society. In the increasingly global economy, technology transfer collaborations are particularly effective when spanning geographic boundaries. (more>>)
  • Strategies for establishing and operating a TTO must be grounded in realistic economic expectations. Technology transfer will not make an institution rich. It takes time (ten years or more) to build an IP portfolio, establish contacts, and develop skills in technology transfer. Furthermore, a critical mass of R&D activity is necessary to justify the costs of a fully functioning TTO. (more>>)
  • Alternative models for an institutional TTO are possible. For example, costs can be shared among a consortium of universities or research institutions. Such hub-and-spokes configurations allow essential policy decisions and scalable functions to be centralized, while keeping essential context-specific functions localized. (more>>)
  • Technology transfer is a talent-based business. Building networks is essential for success. Governments should encourage the creation and operation of national technology transfer associations that concurrently build international linkages. (more>>)
  • Putting pressure on TTO officers to break even or to generate revenues can constitute a perverse incentive, forcing a TTO to go with up-front payments. (more>>)

Statutory IP Considerations

  • The statutory tools of IP (patents, copyright, trademarks, trade secrets, plant variety protection) are per se neutral; what matters is how these tools are used. (more>>)
  • Membership in the Patent Cooperation Treaty (PCT) will provide national institutions (public and private) with greater opportunities for international technology transfer, licensing, product development and penetration of global markets. Membership in the PCT can also provide for cost-effective examination of patent applications. (more>>)
  • Providing for legislation, or for amendments to current statutes, that facilitates patent filing by foreign entities can be an important component of technology transfer and development. (more>>)
  • Patent licenses are most valuable when coupled with access to associated know-how. Trade secret laws are thus conducive to the transfer of know-how through licensing. Patents and trade secrets are thus complementary forms of IP protection. (more>>)
  • Successful licensing of crop varieties (and of accessing improved varieties from other countries) increasingly depends on the strength of plant variety protection legislation. Such legislation can support the interests of the variety owner and the farmer and also facilitate the transfer of technology and provides incentives for further investments. (more>>)
  • Trademarks allow public and private institutions to capture value. To benefit from trademark strategies, internationally harmonized legislation is important, as is the maintenance of high quality standards and stewardship, since trademarks (and geographical indications) serve as indicators of source and quality. (more>>)
  • Although IP rights are governed by national statutory protection, contract law is also important, as contracts are the legal mechanisms that structure the orderly exchange of intellectual property. (more>>)
  • A functioning court system is essential to encouraging partnerships and to accelerate national and foreign investments. Indeed, suppliers of biological materials (and of confidential information and intellectual property) will be encouraged to enter into agreements if the suppliers are confident that their property rights will be protected and that agreements will be enforced. (more>>)
  • Pursuant to the TRIPS Agreement and the Doha Declaration provisions on parallel trade, countries can implement patent rights exhaustion regimes that either permit or restrict parallel importation. Despite the evident benefits of parallel trade, there are also disadvantages. (more>>)

Public and Private Sector Intersections

  • Product development partnerships (PDPs), essentially alliances between the public and private sectors, facilitate and accelerate the flow of public and philanthropic investment through the innovation pipeline. The ultimate measure of success should not be maximum profit but maximum social benefit. (more>>)
  • PDPs enable industry to invest and apply its expertise to address the needs of the poor. In many contexts PDPs are now driving the drug-development pipeline in neglected-disease R&D. National institutions in developing countries should be encouraged to participate in PDPs. (more>>)
  • Negotiating agreements between public and private sectors is an opportunity to forge a long-lasting and mutually beneficial relationship. But every partnership is different. National institutions need much latitude and flexibility to craft appropriate deals. (more>>)
  • Negotiation and technology marketing skills are fundamental for successful licensing and technology transfer. People working in the public sector generally need better negotiating skills, thereby enabling institutions to take advantage of their own R&D efforts and to realize broad public sector and commercial goals. (more>>)

Commercialization of Public Sector R&D

  • Rather than venture capital driving the creation of new companies, it is usually the creation of new companies that attracts venture capital. (more>>)
  • While a government cannot legislate entrepreneurship, it can encourage entrepreneurship by providing a favorable environment for creating and growing new companies. (more << here and here>>)
  • Policies and legislation that benefit biotechnology companies and start-ups can accelerate the pace of innovation, particularly when it comes to commercializing publicsector- generated inventions. (more>>)
  • Much of the success of a spinout or start-up will depend on the entrepreneurial spirit at the institution. The more entrepreneurial, the more likely it will be that someone wants to set up a new company. Spinouts can create jobs, enhance economic development and create international opportunities. (more>>)
  • Cluster formation fosters the movement of new technologies into existing industry. This requires a commitment to science education and research, a strategically situated anchor institution with a technology transfer office, and reliance on market forces as the engine for technology transfer. (more>>)
  • Governments can encourage regional economic development by fostering and financing business incubators. (more>>)
  • As intellectual property becomes more prevalent in health and agricultural research, public sector institutions need to consider the intellectual property of third parties. Knowledge of “who owns what” is needed. That is what a freedom to operate (FTO) analysis provides, facilitating the handling of products for further development or commercialization, even if the goal is to address the needs of the poor. (more>>)

IP Dispute Resolution

  • A country’s statutory code, combined with a reliable system of adjudication and enforcement, is the basis for enforcing IP rights. (more>>)
  • Alternative dispute resolution procedures for settling differences between parties to an agreement can be an effective strategy for public sector institutions. These procedures are particularly important in international contract dispute resolution. (more>>)
  • Governments and public institutions can help make arbitration or mediation procedures accessible by identifying and supporting neutral institutions that can provide costefficient, timely dispute-resolution services. The World Intellectual Property Organization offers such services through the WIPO Arbitration and Mediation Center. (more>>)
  • IP protection mechanisms depend upon effective and equitable enforcement by national governments. This requires effective, transparent, and enforceable contract law. (more>>)

Biodiversity, Traditional Knowledge and Bioprospecting

  • Indigenous communities often play a significant role as gatekeepers to a country’s biodiversity wealth. They are the regional specialists with respect to the flora and fauna. Their knowledge can often exceed that of leading scientists. (more>>)
  • Patent laws per se do not “create” biopiracy. Rather, biopiracy is a form of misappropriation, unfair acquisition, and inequitable sharing of benefits with respect to biological resources. (more>>)
  • Formulate procedures for equitable access to traditional knowledge held by indigenous societies. However, this requires balance: access should be granted only via authorized permission, yet the price that is assessed for permission to bioprospect should not dissuade potential development. (more>>)

Recommended IP Topics for Government Policymakers:

Recommended Case Studies for Government Policymakers:

The African Agricultural Technology Foundation Approach to IP Management

A Better Tuberculosis Vaccine: Aeras and Vanderbilt University

Biodiversity and Benefit-Sharing: University of Illinois at Chicago

Building Healthy Forests with Early-Stage Propagation: University of Saskatchewan

Current IP Management Issues for Health and Agriculture in India

Current Issues of IP Management for Health and Agriculture in Japan

Current Issues of IP Management in Health and Agriculture in Brazil

Cyclofem® Contraceptive: Upjohn, WHO, and the Concept Foundation

Diagnostic Tests for Cervical Cancer: PATH

DNA Hepatitis B Vaccine: International Vaccine Institute, Korea

Experiences from the European Union: Managing Intellectual Property Under the Sixth Framework Programme

From Science to Market: Transferring Standards Certification Know-How from ICIPE to Africert Ltd.

From University to Industry: Technology Transfer at Unicamp in Brazil

Fundación Chile: Technology Transfer for Somatic Embryogenesis of Grapes

Gastrointestinal Medicines from African Aloe: Baylabs (Pty) Ltd.

Golden Rice: A Product-Development Partnership in Agricultural Biotechnology and Humanitarian Licensing

The Groundnut Story: A Public-Private Initiative Focused on India

HIV/AIDS Vaccine: Indian Council of Medical Research

How Public–Private Partnerships Handle Intellectual Property: The PATH Experience

Improved Production of a Natural Product Treatment for Malaria: Oneworld Health, Amyris, and the University of California at Berkeley

IP Management at Chinese Universities

IP Management in the National Health Service in England

The IP Management of the PRSV-Resistant Papayas Developed by Cornell University and the University of Hawaii and Commercialized in Hawaii

Lapdap Antimalarial Drug: GlaxoSmithKline, WHO-TDR, and the U.K. Department for International Development

Lessons from the Commercialization of the Cohen-Boyer Patents: The Stanford University Licensing Program

The Making of a Licensing Legend: Stanford University’s Office of Technology Licensing

Malaria Vaccine: Malaria Vaccine Institute and GlaxoSmithKline Biologicals

A Model for the Collaborative Development of Agricultural Biotechnology Products in Chile

The New American University and the Role of “Technology Translation”: The Approach of Arizona State University

Partnerships for Innovation and Global Health: NIH International Technology Transfer Activities

Patent Consolidation and Equitable Access: PATH’s Malaria Vaccines

Pragmatic and Principled: DNDi’s Approach to IP Management

Reduced-Duration Tuberculosis Treatment: TB Alliance and Bayer HealthCare

Rotavirus Vaccine: NIH Office of Technology Transfer

Somatic Embryogenesis of Grapes: Fundación Chile

Specific IP Issues with Molecular Pharming: Case Study of Plant-Derived Vaccines

Successful Commercialization of Insect-Resistant Eggplant by a Public–Private Partnership: Reaching and Benefiting Resource-Poor Farmers

Technology Transfer in South African Public Research Institutions

Typhoid Vaccine: NIH Office of Technology Transfer and the International Vaccine Institute