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About
MIHR
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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Why This Topic Is Important
Once a public sector technology has been protected under IP, transferred for commercial development,
and even released on the market, its supporting contracts and relationships need to be maintained. In
some cases disputes or IP infringement by third parties may arise, issues which must be addressed and
resolved. These are responsibilities that public sector institutions must anticipate and be prepared to
uphold in order for it and its technology agreements to be perceived by the market as a credible and
reliable.
Key Implications and Best Practices: Setcion 15
Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.
- A fundamental best practice in IP management, regardless of whether an institution is public or private and whether located in a developed or developing country, is to view intellectual property as an evolving and dynamic asset requiring ongoing attention, management, monitoring, and policing. Only such an “IP cultivation” will allow institutions to protect the value and utility of the intellectual property.
- A country’s statutory code, combined with a reliable system of fair adjudication and judicial enforcement, is the requisite basis for enforcing institutions’ IP rights. Supporting policies that promote this legal infrastructure is essential.
- Court action is often stymied because of cost, length of procedure, legal uncertainty, the decision maker’s lack of expertise, confidentiality/publicity, the difficulty of seeking action in foreign jurisdictions, and the negative impact on existing business relationships. But public and private institutions alike should always have the flexibility to opt for court action if this seems to be in their best interests.
- Policymakers should strive to promote policies and advocate for laws that encourage alternative dispute resolution procedures as the best alternatives for settling differences between parties to an agreement. These procedures are particularly important in international contract dispute resolution.
- Governments and public institutions can help make arbitration or mediation procedures accessible and available by identifying and supporting neutral institutions that can provide cost-efficient, timely dispute-resolution services. The World Intellectual Property Organization offers such services through the WIPO Arbitration and mediation center.
- 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. As a result, developing countries can decide whether or not to allow parallel importation for all or for particular IP rights. Despite the evident benefits of parallel trade, there are also disadvantages, and both the benefits and the risks should be carefully considered. (Drawbacks of broad parallel importation practices include the reduction in incentives for investment in the pharmaceutical and agricultural sectors and the reduction in incentives for rights holders to donate products at low cost or free of charge to developing countries due to fear of reimportation to lucrative developed country markets. Re-importation hinders the ability of governments in different countries to maintain price controls on pharmaceutical products within their territory and reduces the willingness of rights holders or licensed local owners to supply particular markets.)
 Abstract
Administration of Technology Licenses
by Hans H. Feindt
Abstract:
The National Institutes of Health Office of Technology Transfer (NIH OTT) administers technology licenses for the NIH, generating substantial royalties (in the millions of dollars). Although this revenue flow is important, the NIH OTTs principal mission is the timely introduction of new products and technologies into the marketplace to ensure that the fruits of NIH research and development are made commercially available to serve the greater public good. The NIH OTT utilizes six types of technology licenses:
- commercial evaluation licenses (also known as options)
- patent commercialization licenses (either exclusive or nonexclusive)
- nonexclusive patent licenses (for internal use)
- biological materials licenses
- software licenses
The NIH OTT insists that licenses are drafted with well-defined financial terms and clearly delineated reporting obligations, so that both parties to the license (NIH as licensor and, for example, a biotech firm as licensee) understand their respective obligations. The NIH OTT seeks to build cooperative relationships with its licensees in order to facilitate problem solving discussions, resolve outstanding issues, and identify possible opportunities for advancing commercialization of products and/or services. As a best practices licensor, the NIH OTT carefully manages license administration by monitoring commercial development performance benchmarks, reviewing sales reports, and enforcing other license obligations. The office will also, if necessary, impose sanctions in license enforcement and implement procedures for dealing with infringement of its patents. The policies, protocols, and procedures of the NIH OTT have broad applicability to both developed and developing countries; scientists, administrators, technology managers, intellectual property professionals, and even attorneys can learn from the NIH OTT, a good example of an office operating effectively, efficiently, and profitably by employing best practices.
Abstract
Alternative Dispute-Resolution Procedures: International View
by Eun-Joo Min
Abstract:
As multinational technology-development partnerships have become more common, so have disputes between the parties. Litigation, however, is not the only option for resolving such disputes. In fact, for partnerships between entities in developing and developed countries, litigation may be a complicated, time-consuming, expensive, and doubtful process. Arbitration and mediation may offer the promise of more effectively resolving disputes, and this chapter explains how these methods work, their advantages and disadvantages, and suggests which questions should be asked (especially for a developing country institution) to begin to establish a dispute prevention and resolution strategy. The chapter offers both strategic and practical insights about how to use these mechanisms to resolve disputes and preserve partnerships.
Abstract
Parallel Trade: A User’s Guide
by Duncan Matthews, Viviana Munoz-Tellez
Abstract:
This chapter provides guidance about parallel trade to developing country policy-makers and other stakeholders in intellectual property. What is parallel trade? And how can it be utilized to promote access to medicines and support poor farmers in developing countries? Engaging in parallel trade is an option provided by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) under the World Trade Organization. Furthermore, the 2001 Doha Declaration on TRIPS and Public Health confirmed that developing countries could use parallel imports to support public health. As a result, developing countries can ensure access to lower-priced patented and/or branded products, such as medicines and basic agricultural inputs, by incorporating legislation to allow for parallel imports. When implementing measures to facilitate parallel trade, developing countries can establish and maintain an effective system by adequately regulating the quality, safety, and health of parallel imports. At the same time, developing countries need to prevent low-priced patented products available in their countries from entering high-priced developed country markets.
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