Monitoring, Enforcement, and Resolving Disputes

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: 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.

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: This chapter explains how important it is for a research institute to audit both the intellectual property (IP) that it generates and the third party IP that its researchers utilize. Such an audit will have the practical consequence of enabling the research institute (when appropriate) to secure ownership, maintain, and manage the IP for which it is responsible.

Abstract: Field-of-use licensing provides the licensor with greater control over the use of its intellectual property, while maximizing the use and value of the technology. In order to maximize the use of a given technology, managers will have some additional work to do as they identify, negotiate with, and manage more than one licensee. Special issues related to multiple licensees in distinct or overlapping fields will have to be handled with forethought and a balancing of interests. When is field-of-use licensing worth the extra effort? When more than one company is needed to fully develop a technology’s potential, when different licensees are needed to address different markets, or when field-of-use licensing has the potential to significantly increase the financial return from a technology. In all of these situations, field-of-use licensing can produce better results for everyone involved.

Abstract: In order to build an effective patent portfolio, an organization must (1) understand the dynamics of the international patent landscape: how to establish foreign priority, where to file patent applications, and the advantages and disadvantages of pursuing various filing options; (2) determine in which countries and/or jurisdictions the organization should seek patent protection based on its objectives (whether commercial or humanitarian access); and (3) anticipate the possibility of litigation and know what its options for litigation are.

Abstract: The management of intellectual property is all about managing innovation with the procedures and processes that are required to turn that innovation into valuable patent rights. A truly strategic approach to IP management will span conception to product market release. Integrating IP management into the R&D, advance development, and product development cycles seamlessly provides opportunities to gain and enhance IP protection while offering the potential to reduce risk and lower costs. The following chapter discusses some of the key elements of IP portfolio management and how the combination of the right IP tools, procedural know-how, and organizational attributes and behaviors can contribute to successful implementation.

Abstract: Much has been written about the socio-economic benefits and competitive advantage achieved by developed countries as a result of investing in scientific research and technological innovation. For developing and emerging economies, sustainable development is dependent on establishing and supporting R&D institutions that not only perform good science, but also effectively share their knowledge and technology outputs. Both the extent to which a return on an investment is realized from R&D activities and the magnitude of the resulting impact on intended beneficiaries are important to funders, policy-makers, taxpayers, government officials, development agencies, and the research institutions themselves. This chapter provides guidance on building organizational capacity to plan, monitor, evaluate, and assess the impact of R&D investments. It should be noted that the chapter does not address measuring the performance of a Technology Transfer Office to manage intellectual property, but rather focuses on determining the socio-economic impact of transferred knowledge and technology.

Abstract: Trademarks, in the broadest sense, encompass a range of indicators for goods and/or services, including service marks, collective marks, certification marks, trade names and trade dress. A trademark, which may be a name, symbol, feature, or design, functions as an indicator of source and identifies and distinguishes a good or service, enabling customers to ascertain the quality of the good (or service) based on the trademark. Unlike other forms of intellectual property rights (for example, copyrights and patents), the rights extended by trademarks are not generated from the creative activity of an author or inventor, but rather via their use in commerce, and it is the customer’s association of the trademark with a specific product (or service) that is the key factor in establishing rights. The relative effectiveness of a trademark depends on its degree of distinctiveness. By way of classifying trademarks, a hierarchy based on strength of protection, from fanciful to merely descriptive, has been established. Whereas fanciful trademarks are inherently distinctive because they are terms invented solely for a specific purpose (for example, Kotex), descriptive marks (for example, Chap-Stick) must acquire secondary meaning to become protectable. In the United States, trademarks are protected by both state and federal laws. Although federal trademark registration is not necessary to assert trademark rights, it affords many advantages and benefits to the owner, and hence is by far the preferred means of protection. It is important to remember, however, that trademarks must always be maintained, protected, and correctly used. Their strength, and therefore value, is directly linked to public perception.

Abstract: When public–sector organizations and public–private product development partnerships (PDPs) manage intellectual property (IP), they need to balance the commercial interests of private–sector manufacturers with the public sector’s mission to obtain access to products at the lowest possible cost. An important tool for achieving this balance is the detailed definition of contractual milestones, which should clearly specify the terms for pricing to the public sector, territory and exclusivity, regulatory work, and time to market. Milestones should not, however, be cast in stone. Based on detailed analyses of market conditions, milestones need to remain adjustable throughout the life of the contract. When well defined, milestones can be used to ensure the availability of the most modern healthcare products to the developing world. After all, for the public sector, successful IP management is defined by how many poor people a product will reach, how easily it will be available to them, and who and how many will be able to afford the product. Accordingly, out-licensing intellectual property from public–sector-based organizations to private–sector partners requires the licensor to actively guard public–sector interests.