Monitoring, Enforcement, and Resolving Disputes
Topic Guide for Technology Transfer Managers

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: 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: 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.

Abstract: A university’s intellectual property (IP) cannot be simply shelved and forgotten. IP, with patents as a particularly cogent example, must be managed, monitored, maintained, and policed in an ongoing “cultivation” of the IP rights. For patents, it is important to be able to identify potential infringement early, by means of coordinated surveillance by the technology transfer office. If, and when, possible patent infringement is detected, it will then be necessary to evaluate the type of infringement, that is, direct or contributory, and also to assess whether the activity legally appears to be infringing, reading on each and every element of a patent claim. Strategic and business considerations must be considered as the university decides what course of action might be appropriate in response to an alleged infringement of a patent. Specifically, in the context of litigation, the university must consider whom to sue (if there are multiple infringers), when to sue (if too late, could risk loss of IP rights), and where to bring suit (for a favorable venue). An even more critical consideration is whether to even litigate at all. It may be wiser to seek one of various forms of alternate dispute resolution, for example, negotiation, mediation, or arbitration. It is important to never forget that litigation is expensive, risky, and unpredictable. Hence, it should be viewed as not the first option, but as the final one, and it should be approached as a cold business decision and not to give teeth to emotions or carry out revenge. Throughout the process of managing and policing its IP rights, a university should have access to legal counsel. Finally, proactive, good license hygiene is the best way to proceed, and the most effective way to avoid expensive litigation. By demonstrating credibility, conviction, and focus, the university will show potential infringers that it is serious about policing its IP, and that they therefore won’t be able to escape the university’s diligent surveillance. Licensing, and not infringement, will then become the only sensible route to accessing the patent rights.