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MIHR
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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The IP Toolbox
Topic Guide for Technology Transfer Managers
Why This Topic Is Important
The types of IP protection that are available constitute the fundamental toolbox that your program can use
to protect and promote the transfer and development of inventions. This section provides interpretive
introductions to each of the main types of IP protection that are relevant in agriculture and medicine,
including patents, trademarks, plant variety protections (or plant breeders’ rights), database protections,
and regulatory data exclusivity. Most chapters describe the IP laws in the context of specific countries,
while some provide more general treatments of the legal IP concepts including those developed as
international standards in TRIPS and UPOV.
Key Implications and Best Practices: Setcion 4
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.
- Intellectual property is often perceived as constraining research, particularly in public sector institutions. your role in communicating the importance of judiciously using patents, trademarks, trade secrets, and so forth, and the benefits of good IP management, is critical. Such communication should be tailor-made to senior management, and even to your institution’s board, as well as to scientists. Each responds to a different language. (And different colleagues will require different degrees of understanding. For example, your discussions on patents will necessarily differ with scientists and patent counsel. Choose your words and the level of detail you provide judiciously.)
- In many institutional settings, making better use of patents and other forms of intellectual property requires a culture change to a greater or lesser degree. This may include establishing an expectation for scientists in your institution to regularly review patents. Encouraging scientists to share a broader IP awareness and culture will be potentially powerful and valuable.
- Trademarks are a critical, and often overlooked, option for IP protection. They can be used as stand-alone IP protection, or they can be integrated into an overall strategy for integrated IP protection, for example, a strong trademark for a patented product or process.
- Your job requires a judicious balance of work that relates directly to your benchmarks and targets, and of contributing to the overall IP culture of an organization. The latter is often not spelled out in your job description but it is important nonetheless. The greater the general level of awareness related to intellectual property, the more likely it is that the value of IP assets can be captured and utilized. And your job also becomes easier when you gain a broader understanding of intellectual property.
- Genebank management and that of genetic resources, in general, is increasingly becoming a sensitive issue. An organized, stepwise approach is vital for effectively managing a genebank and for avoiding difficulties. Ownership of genetic resources can be tricky, so rigorous documentation and clear procedures on incoming and outgoing genetic resources may be critical.
- The above point applies equally to data, both incoming and outgoing. Particularly if your institution conducts research related to product development (especially clinical trials), the confidentiality of data may be critical in ensuring global access. Specific data are a valuable form of intellectual property that can be used to obtain a certain price or access terms in licensing negotiations.
Abstract
Data Protection and Data Exclusivity in Pharmaceuticals and Agrochemicals
by Charles Clift
Abstract:
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.
Abstract
How to Read a Biotech Patent
by Carol Nottenburg
Abstract:
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.
Abstract
IP and Information Management: Libraries, Databases, Geographic Information Systems, and Software
by John Dodds, Susanne Somersalo, Stanley P. Kowalski, Anatole Krattiger
Abstract:
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.
Abstract
Plant Breeders’ Rights: An Introduction
by William H. Lesser
Abstract:
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.
Abstract
Plant Variety Protection, International Agricultural Research, and Exchange of Germplasm: Legal Aspects of Sui Generis and Patent Regimes
by Michael Blakeney
Abstract:
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.
Abstract
Plants, Germplasm, Genebanks, and Intellectual Property: Principles, Options, and Management
by John Dodds, Anatole Krattiger, Stanley P. Kowalski
Abstract:
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.
Abstract
Regulatory Data Protection in Pharmaceuticals and Other Sectors
by Trevor Cook
Abstract:
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
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.
Abstract
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.
Abstract
Trademark Primer
by William Needle
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.
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