The IP Toolbox
Summary and Overview
Key Implications and Best Practices
 Abstract
4.1
The Statutory Toolbox: An Introduction
by John Dodds, Anatole Krattiger
Abstract:
This chapter presents the main forms of statutory intellectual property (IP) protection with emphasis on utility patents, trademarks, geographical indications, copyright, and trade secrets. Basic questions with regard to who can get protection, the subject matter of each form of protection, statutory requirements, and certain exceptions. The chapter concludes with short sections on institutional aspects including employee agreements, how to mark the protected intellectual property, how to integrate the various rights, and how to identify infringement. The authors conclude that the form of protection chosen for a given invention should be guided by the mission of the institution (whether public or private), the purpose of the work it conducts, and the nature of the invention, or other IP, that will be subject to IP rights protections.
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4.2
How to Read a Biotech Patent
by Carol Nottenburg
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This chapter provides an annotated description of a sample U.S. patent. The U.S. patent is a convenient model because its format is well laid out and is similar to the required formats of patents granted in other major jurisdictions, including Europe.
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4.3
Trademark Primer
by William Needle
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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.
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4.4
The Statutory Toolbox: Plants
by Jay P. Kesan
Abstract:
Different forms of intellectual property protection are available for agri-biotech inventions: utility patents, plant variety protection, plant patents, trade secrets, geographic indications, trademark, and copyright. Each form has its own strengths and weaknesses. In general, stronger protections require meeting more stringent requirements. The three most important regimes for agri-biotech inventions are utility patents, plant variety protection, and trade secrets. A careful consideration of the relative demands and benefits of each regime will allow custom-tailored approaches to suit the needs of the inventor and the nature of the invention.
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4.5
Plant Breeders’ Rights: An Introduction
by William H. Lesser
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Based on the averages, there is a good chance that your country has decided to fulfill its TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement commitments by selecting an “effective sui generis system” over patents for plants, something more commonly known as plant breeders’ rights. This chapter attempts to explain what plant breeders’ rights are by describing the organization and function of the plant breeders’ rights system. Covering the objectives, scope, protection requirements, and examination provisions, the chapter compares the plant breeders’ rights system with the patent system and attempts to clarify specific puzzling issues. These include concerns that the latest UPOV Act does not address farmer seed savings (the choice is left to individual countries, with virtually all countries choosing to allow seed saving). Plant breeders’ rights are less puzzling once the intent and structure of the system are understood. The system is, in fact, one with very specific, if narrow, objectives.
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4.6
Plants, Germplasm, Genebanks, and Intellectual Property: Principles, Options, and Management
by John Dodds, Anatole Krattiger, Stanley P. Kowalski
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In ever-increasing numbers, institutions are establishing technology transfer offices (TTOs). These offices serve a variety of functions, all of which must be integrated to cost effectively transfer technologies and to benefit the institutions. A critical function of the TTO is to proactively manage intellectual property (IP) issues pertinent to crops. Crops can be covered by more than one form of IP rights protection, often simultaneously. These rights protections include trademarks, trade secrets, plant and utility patents, and plant variety protection (PVP). Closely related is the importance of careful and organized gene-bank management, a critical component of an overall IP and tangible property management system. PVP provides one type of protection that allows TTOs to responsively serve clients and generate revenue. PVP is a form of IP rights protection for crops with potentially global applications, and either a PVP office, or a PVP subsection in the TTO, would be wisely established by an institution. In addition, this chapter provides important information to assist in establishing a national PVP office and in the selection and implementation of various types of IP rights protection for crops and germplasm.
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4.7
Plant Variety Protection, International Agricultural Research, and Exchange of Germplasm: Legal Aspects of Sui Generis and Patent Regimes
by Michael Blakeney
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This chapter outlines the range of plant variety protection regimes that currently exist internationally, including the International Convention for the Protection of New Varieties of Plants, the Convention on Biological Diversity, the Agreement on Trade-Related Aspects of Intellectual Property Rights, and the International Treaty on Plant Genetic Resources for Food and Agriculture. The chapter commences with a history of intellectual property laws affecting plant breeding and the genetic modification of plants. It explores the trend toward the harmonization of international standards and concludes with an examination of the impact of these developments upon germplasm exchange, international agricultural research, and food security.
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4.8
IP and Information Management: Libraries, Databases, Geographic Information Systems, and Software
by John Dodds, Susanne Somersalo, Stanley P. Kowalski, Anatole Krattiger
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The last decades have seen a revolution in knowledge management, library services, and information resource database configurations. The use of integrated computer networks and the ability to produce and distribute information have had far-reaching implications for IP (intellectual property) protection. In order to demonstrate IP laws and their application, this chapter will use, as its primary example, Geographic Information Systems and Remote Sensing (GIS/RS), a technology that presents interesting and complex IP issues.
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4.9
Data Protection and Data Exclusivity in Pharmaceuticals and Agrochemicals
by Charles Clift
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The chapter discusses the meanings of data protection and data exclusivity in the context of the provisions of the Trade-Related Aspects of Intellectual Property Rights agreement. In addition, it outlines the relationship between data exclusivity and patent protection and briefly reviews the possible costs and benefits of introducing data exclusivity laws. Finally, the chapter explains that countries need to consider the costs and benefits when negotiating bilateral trade agreements that might require the introduction of these laws.
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4.10
Regulatory Data Protection in Pharmaceuticals and Other Sectors
by Trevor Cook
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Generating data to secure regulatory approval in sectors, such as pharmaceuticals and agricultural chemicals in which product safety and efficacy is paramount, has become ever more extensive and expensive. There is thus a need to provide an incentive to undertake such data-generation efforts by protecting the investment in them against free riding. Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) recognizes as an intellectual property right the need for such protection in those sectors. This chapter discusses how certain jurisdictions, and in particular the European Community, have implemented the TRIPS requirement involving regulatory data protection regimes. Such protection is not provided by the patent system, which instead protects invention.
Abstract
Biotechnology Patents and Indigenous Peoples
by Dennis S. Karjala
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How do biotech patent systems affect indigenous peoples, particularly in relation to health products? This question raises two distinct issues. First, the question of biopiracy—to what extent do patent systems necessarily exploit traditional indigenous knowledge to produce valuable medicinal products? Second, the question of patenting gene-sequence and gene-product information taken from living organisms, especially human beings—how can we justify patenting naturally occurring substances? And how should we negotiate the myriad ethical issues that arise from doing so? This chapter argues that the core of the biopiracy problem is not the availability of patents based on traditional indigenous information but rather the unfair acquisition of knowledge and the inequitable sharing of profits derived from developing such information into a valuable product. Solving this problem requires ensuring that traditional information is fairly acquired and that fair compensation is paid to the group from which the information derives. In regards to patenting gene-sequence and gene-product information, this chapter concludes that such issues equally affect indigenous and nonindigenous populations and that the best way to address them is by making policy changes.
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Current Issues of IP Management for Health and Agriculture in Japan
by Junko Chapman, Kazuo N. Watanabe
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This chapter describes current and historical trends and issues related to intellectual property (IP) management in Japan. It gives a history of Japan’s national IP system in order to provide an understanding of the nature of the system and why and how it was established. The chapter also describes current government efforts to provide insights into the system’s future. With regard to current IP issues, two topical issues are discussed: industry-university collaboration on R&D and employees’ inventions. Japan’s efforts to resolve these issues may be helpful for other countries that are grappling with similar issues.
The chapter also details health and agricultural IP issues in Japan. It discusses and compares with the practices of other countries the patentability of medical methods and exemptions for the experimental use of patented products. Furthermore, the chapter offers an overview of Japan’s national policy on agricultural R&D and biore-source centers (the functioning of which greatly involves the transfer of materials with IP rights). RIKEN (The Institute of Physical and Chemical Research) is offered as a case study to clarify the policies and issues discussed.
Finally, for the benefit of other countries that are coming to terms with IP management issues, the chapter offers some lessons learned by Japan that have helped shape its national IP policy, strategy, and institutional IP management.
Abstract
Current Issues of IP Management in Health and Agriculture in Brazil
by Claudia Inês Chamas, Sergio M. Paulino De Carvalho, Sergio Salles-Filho
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This chapter presents Brazil’s intellectual property (IP) system and identifies relevant experiences of IP management in the fields of health and agriculture. Brazil takes advantage of the flexibilities offered by relevant international agreements, such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and attempts to implement an equitable system. During the 1990s, Brazil revised its industrial property and copyright laws, and other related laws, and enacted new legislation that includes provisions for plant variety protection and for access to biological resources.
Abstract
Defensive Publishing and the Public Domain
by Sara Boettiger, Cecilia Chi-Ham
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IP (intellectual property) rights can reward innovators and encourage investment in developing new products and services. However, the exclusionary power of IP rights can sometimes have negative effects, making technologies less accessible and, thereby, potentially impeding innovation. To make informed decisions about how to balance access and protection requires an understanding of both the traditional IP rights system (patents, copyrights, trademarks, and trade secrets) and alternative mechanisms for preserving access to technologies. This chapter provides a brief introduction to the public domain and defensive publishing and examines issues concerning the choice behind the choice of whether to publicly disclose or to patent an innovation. Discussing the strategic use of defensive publishing in IP management, the chapter considers both the utility of defensive publishing and its limitations for supporting broad innovation. After an examination of the public domain and how it relates to other open-access concepts, such as open source and the commons, the chapter focuses on the practical considerations involved when using public-domain technologies and defensive publishing to manage intellectual property.
Abstract
Filing International Patent Applications under the Patent Cooperation Treaty (PCT): Strategies for Delaying Costs and Maximizing the Value of Your Intellectual Property Worldwide
by Anne M. Schneiderman
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Obtaining international patent protection for an invention can present a significant financial commitment for an early-stage company, entrepreneurial venture or not-for-profit organization with a limited budget for intellectual property management. This chapter examines the use of patent application filings under the Patent Cooperation Treaty (PCT) to delay, consolidate, or minimize the costs of patenting overseas. Using the PCT to file internationally enables a patent applicant to delay, generally for up to 30 months after the first (priority) filing date, strategic decisions about the countries in which to pursue patent protection. The delay offers a significant advantage, since it allows the applicant more time in which to evaluate commercial demand for the invention, the likelihood of its success in overseas marketplaces, and the likelihood of obtaining a patent grant in a particular country, prior to filing national-phase patent applications in the countries in which patent protection is sought.
Abstract
Introduction to IP Issues In the University Setting: A Primer for Scientists
by Martha Mutschler, Gregory D. Graff
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Intellectual property (IP) is inherent to many of the research, teaching, and extension functions of the university, and IP issues can occur in all phases of the corresponding programs. A research program may utilize IP generated and protected by others in its planning and execution phases. As a research program advances, decisions made regarding disclosure of results may affect whether or not discoveries made by the program can eventually be protected.
A successful research program will generate discoveries—and therefore IP—and decisions must be made regarding whether to protect, and how to deploy, those discoveries. The decisions must consider the management of IP as well as the goals and priorities of the research program and the university. It is also important to consider IP in the teaching and extension functions of the university, including the creation or use of written materials, software, networked resources, or designs.
IP and IP issues are not the sole or even the primary focus of a university. However, failure to properly consider IP issues can lead to frustrating and costly problems. Fortunately, realistic and efficient management of IP in research, teaching, and extension requires only a minimal working understanding of the issues and an ability to access on-campus assistance in dealing with them.
This chapter presents basic information that any scientist should know about IP, discusses the importance of IP management in a scientist’s work, and reviews additional sources of information regarding IP. We hope, this chapter will assist the reader in avoiding simple yet costly errors in IP management.
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IP Management at Chinese Universities
by Hua Guo
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For the People’s Republic of China, intellectual property (IP) is a new legal and social concept. Formal legislation was first introduced in the 1980s and was later strengthened. Due to recent publicity, however, social awareness of IP rights in China has grown. Following a series of ministerial and commission rules concerning technology transfer, universities now usually own the IP resulting from government-funded research. Not surprisingly, the number of patent applications filed by Chinese universities has increased rapidly, exceeding 13,000 in 2004. But such numbers may reflect a trend for researchers and institutions to use patents as a way of enhancing their reputations, rather than for actually transferring or commercializing technology. Most universities still lack institutional IP policies and independent offices responsible for IP management. Rates of technology transfer and commercialization, while difficult to observe, remain low. Still, some world-class universities, such as Tsinghua University and Beijing University, have become adept at IP management. These are both an exception to and an example for other universities in China, having successfully adapted IP management policies and practices to the country’s legal and economic circumstances.
Abstract
Open Source Licensing
by Janet Hope
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This chapter provides an introduction to open source software licensing. The chapter seeks to demystify the concept of open source so that intellectual property (IP) owners and managers can decide whether an open source approach is worth pursuing. The chapter explains the principles of free and open source software licensing and outlines the decisions that an innovator must make when deciding which strategy to use for developing a new innovation. Also explained are the differences between open source and public domain, and between the uses of the terms copyleft and academic to describe open source licenses, as well as the incentives (financial and otherwise) for open source licensing. Finally, the author identifies important considerations regarding the possibilities for open source licensing in fields other than software development, particularly biomedicine and agricultural biotechnology.
Abstract
Patenting and Licensing Research Tools
by Charles Clift
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Research tools encompass a wide range of resources, including genes/gene fragments, cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools such as polymerase chain reaction, methods, laboratory equipment and machines, databases and computer software. Access to research tools is integral to advancing progress in biotechnological R&D, in both the biomedical and agricultural sciences. However, a complex web of research tool patents has arisen as a result of the revolution in molecular biology and coincident changes in public policy and patent law. These patents can pose a potential block to accessing research tools. For developing countries, several approaches can be formulated and then implemented in order to overcome potential problems associated with research tools. These include changes in patenting policies, research exemptions in patent law to reduce the risk of infringement in R&D, compulsory licensing to allow access to upstream technologies, and institutional adaptations to facilitate access to needed technologies, such as guidelines intended to promote more appropriate behavior by participants in the system. With carefully formulated, multitiered approaches, research tool patenting and licensing (and its possible impact on innovation in health and agricultural research) may be effectively managed.
Abstract
Protecting New Plant Varieties through PVP: Practical Suggestions from a Plant Breeder for Plant Breeders
by William D. Pardee
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A plant variety protection (PVP) certificate preserves a plant variety owner’s exclusive rights to sell, reproduce, import, and export a plant variety and its seed. In addition, a PVP certificate prevents others from claiming PVP or utility patent rights. This chapter walks the reader through the process of applying for a PVP certificate and describes other ways to prevent the unauthorized use or sale of protected plant varieties.
Abstract
Provisional Patent Applications: Advantages and Limitations
by Richard L. Cruz
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In the United States, provisional patent applications can provide an additional year of patent protection, for a total of 21 years from the initial filing date. With such an extension, a provisional application provides parity with foreign applicants who, pursuant to the Paris Convention, may file for a U.S. patent within 12 months of the foreign filing. Provisional applications have both advantages and disadvantages, so proper management is essential. The advantages include the preservation of a priority date immediately after an invention is conceived, a one-year delay for further developing the invention, an extra year of patent protection, and constructive reduction to practice of the invention. In addition, provisional applications provide an inexpensive way to avoid possible statutory bars and preserve absolute novelty for foreign filing purposes. They also enable the use of the phrase “Patent Pending” to mark products embodying the invention. The disadvantages include a possible increased overall cost of obtaining a patent, potential loss of trade secrets, and a false sense of security. An inventor must also file a nonprovisional application within one year, and the subject matter of a nonprovisional application is limited to subject matter in the provisional application.
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Specific IP Issues with Molecular Pharming: Case Study of Plant-Derived Vaccines
by Anatole Krattiger, Richard T. Mahoney
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The public sector is making substantially increased investments in health technology innovation through public/private partnerships to bring improved health technologies to underserved people in developing countries. These product-development partnerships, however, face a common problem: how to manage intellectual property (IP). Such management involves many issues. In relation to a case study, presented in this chapter, of plant-derived hepatitis B virus vaccine, the challenges involve obtaining freedom to operate, securing new intellectual property, and deploying intellectual property to developing countries. We conclude that while challenges abound, the IP issues are fairly clear and can be addressed with straightforward IP management approaches. The cost of managing the intellectual property is expected to be minimal on the price of the finished vaccine. In the medium term, an IP protection strategy might offset costs and generate modest income. Most important for the partnerships is to develop a clear, transparent IP policy, with emphasis on the licensing principles, so that products can be made available to developing countries at affordable prices.
Abstract
Trade Secrets and Trade-Secret Licensing
by Karl F. Jorda
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Exploiting the overlap between intellectual property (IP) categories, especially between patents and trade secrets, is an important facet of IP management. Patents (which require full disclosure) and trade secrets (which are kept confidential) are not incompatible. On the contrary, they can complement one another: patents protect inventions and trade secrets protect collateral know-how. Using patent and trade-secret protection together in a synergistic manner results in a potent exclusivity. Moreover, as licensing has become the preferred instrument for technology transfer, most technology licenses are hybrids, covering both patents and trade secrets. This situation has evolved because licenses that cover patents but do not allow access to collateral know-how usually do not permit patented technology to become commercialized. Despite the ease of obtaining trade-secret protection—immediate efficacy and low cost—this type of IP protection is too often neglected.
Abstract
U.S. Laws Affecting the Transfer of Intellectual Property
by Howard Bremer
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This chapter provides an overview of some of the legislative bills that have profoundly affected the evolution of technology transfer and intellectual property (IP) rights in the United States. The chapter references provisions of the specific bills as codified in U.S. law and explains their goals and historical circumstances. While not an exhaustive presentation of all of the bills that have contributed to laws governing IP, the codification references will provide a useful starting point for those researching the applicability of the laws to particular situations.
Abstract
Use of Trademarks in a Plant-Licensing Program
by William T. Tucker, Gavin S. Ross
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The principal forms of IP rights protection for plant varieties are plant patents, plant variety protection patents (PVPs), and utility patents. However, trademarks can also provide long-lasting and significant protection for plant varieties. One advantage that trademarks have over the statutory forms of IP protection for plants (plant patents, PVPs, utility patents) is that trademarks can be protected indefinitely, as long as the product is marketed and the trademark enforced. The most important agreements dealing with international trademark registration are the Madrid system and the Madrid Protocol (of which the United States is a signatory). Licensing of a trademark can either stand alone or be combined with another form of IP rights protection, such as with a hybrid PVP/trademark license.
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