Key Implications and Best Practices
Summary and Overview
Krattiger A, RT Mahoney, L Nelsen, JA Thomson, AB Bennett, K Satyanarayana, GD Graff, C Fernandez and SP Kowalski. 2007. 4: The IP Toolbox. In Executive Guide to Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (Krattiger A, RT Mahoney, L Nelsen et al.). MIHR (Oxford, UK), PIPRA (Davis, USA), Oswaldo Cruz Foundation (Fiocruz, Rio de Janeiro, Brazil), and bioDevelopments-International Institute (Ithaca, USA). Available online at www.ipHandbook.org.
© 2007. A Krattiger et al. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.
Best practices in the management of intellectual property require a basic understanding of the various forms of IP protection that are available. The forms of IP rights in most countries include patents, trademarks, geographical indications, copyrights, and trade secrets. Special provisions for plants are also offered in many countries in the form of plant variety protection, or plant breeders’ rights. A further emerging type of protection is that related to regulatory data, which can be protected from disclosure or acquisition for a certain period of time and offer data exclusivity. Although each of these statutory mechanisms of IP rights protect different forms of intellectual property, thus conferring different IP rights, when used alone or in combination, they provide a set of options for organizing and then making the most out of an organization’s IP assets.
All of the above are reviewed in detail by Dodds and Krattiger1 in Chapter 4.1, which includes short sections on institutional aspects including employee agreements, how to integrate the various rights, and how to identify infringement. Importantly, 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 intellectual property that will be subject to IP rights protections.
A utility patent is a type of statutory IP protection covering inventions, that is, a grant by the government to an inventor for any invention that is a new and useful process, machine, article, manufacture, or composition of matter or any new and useful improvement thereof. The invention, that is the intellectual property itself, is a product of the inventor’s mind. The patent, then, confers certain rights to this property; it is the right to exclude others from making, using, selling, or importing the invention in the country where the patent is granted, normally for a period of 20 years from the date of the patent application.
In patents, many aspects of inventions are disclosed. Patents should thus not be seen as the exclusive domain of lawyers. Scientists in particular are well advised to be up-to-date on patents issued in their field of endeavor, and Nottenburg2 in Chapter 4.2 provides a comprehensive guide to patents, using biotechnology patents as an example, that instructs scientists and others how to read utility patents.
Trademarks are a form of IP protection that serves to distinguish the products or services of one individual, company, or organization from the products or services of others. A trademark can be a word, phrase, symbol, design, or a combination thereof. Trademarks can even be sounds or colors, if they are in some way distinctive, that create an immediate association in the mind of the consumer between the trademark and the good. IP protection for a trademark confers an exclusive right to use the mark in commerce.
Trademarks are an often overlooked and undervalued form of intellectual property by the public sector and this is well argued by Needle3 in Chapter 4.3 on the basis of many colorful examples. Trademarks should be a valuable component of any IP management strategy, complementing the protection afforded by other forms of statutory IP protection. Trademarks can complement other forms of IP protection, and, as in the case of many pharmaceuticals, serve to strengthen the period of proprietary rights to a product.
Geographical indications are signs used on goods that have specific geographic origin and possess qualities or a reputation that are derived from their place of origin. Geographical indications are another type of intellectual property, similar to trademarks in that they are source indicators. Most commonly, a geographic indication consists of the name of the place of origin of the particular goods (for example, Roquefort cheese or champagne).
Copyright is a type of statutory IP protection for the original works of authors, such as the chapters in the Handbook. Such works include literary, musical, dramatic, and architectural works. The copyright protects the work immediately after it is fixed in a tangible medium, for example, words on a page (what you are reading at this very moment) are copyrighted. The owner of the copyright, for example, we, the authors of this chapter, have certain rights to the work. Typically, these rights include moral rights (that is, having our names associated with the work) as well as the right to reproduce the work, to prepare adaptations of the work, and to distribute the work to the public. However, these rights can be either licensed or assigned to others. In the case of this chapter, we agreed to make it freely available to all through the Internet.
Trade secrets (in certain circumstances and jurisdictions called know-how) are an important form of intellectual property. Trade secrets protect know-how and any confidential information so designated. To be protected as a trade secret, the inrellectual property must, of course, be kept secret, and must also confer some sort of commercial advantage to the holder. Enforcement of IP rights for trade secrets is possible when a competitor has misappropriated and/or stolen the trade secret.
A point often raised is when one should file for a patent or maintain the information as a trade secret. What is important to note is that patents and trade secrets are not in conflict with each other but are complementary IP assets. Depending on the nature of the know-how, or the invention, the organization may choose to either file a patent or to continue to hold as a trade secret. Dodds and Krattiger in Chapter 4.1 discuss trade secrets briefly, but they are fully discussed in the context of licensing in another section of the Handbook.4
The protection of intellectual property related to plants, germplasm, and varieties is covered in several chapters because there are many dimensions to the topic. Kesan5 in Chapter 4.4 describes the various forms of intellectual property applicable to plants. These are utility patents (available in a few countries only), plant variety protection (or plant breeders’ rights), plant patents, trade secrets, geographic indications, and trademarks. The strengths and weaknesses and pros and cons of each are discussed. It is worth noting that the use of one form of protection is not necessarily exclusive, in that a single plant may be simultaneously covered by several forms of IP protection.
Plant variety protection (PVP) is the most common tool for protecting varieties, and many countries have legislated and implemented a PVP system. Lesser6 describes the PVP system in Chapter 4.5. PVP regimes are implemented in order to:
- provide breeders (both public and private sectors) with an opportunity to receive a reasonable return on past investments
- provide an incentive for continued or increased investment in future breeding research
- recognize the legal right of the innovator to be recognized as such
- acknowledge the economic right to remuneration for his or her efforts
In general, there are two exemptions to the protection provided: 1) a research exemption and 2) a farmer’s exemption (this is not to be confused with farmers’ rights). A research exemption allows for breeders to develop a new variety by using a protected variety; a farmer’s exemption allows for the saving of seed for the sole use of replanting the farmer’s land.
Given the advantages of a PVP system in attracting private investments and offering farmers a broader range of improved varieties, countries may gain substantially in internationally harmonizing their PVP regimes, as it lowers costs for users, simplifies the introduction of new varieties, and thus leads to the availability of more varieties and choices for farmers.
Lesser also points out that those countries that are members of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreed to implement special protection for plants (the so called sui generis protection). Many elect to follow the principles of the International Convention for the Protection of New Varieties of Plants (UPOV), an international treaty that provides an effective framework for PVP.
Plants can also be protected through trade secrets, trademarks, and geographical indications. Geographical indications might be used to communicate to consumers the association between a plant’s special characteristics and the territory from which it originates. Trademarks can have particular value if the variety has market potential, and consumers come to specifically associate the trademark with desirable characteristics and qualities of the variety. Such value has important implications for developing countries that are exporters of agricultural commodities and products, as it can add significant additional value to their exports.
The management of intellectual property related to crops and germplasm is an essential function of a technology transfer office (TTO) and is the focus of Chapter 4.6 by Dodds and colleagues.7 They also discuss specific issues related to IP management involving genebanks and practical aspects on the establishment of a PVP office. Blakeney8 in Chapter 4.7 reviews international aspects, including the international exchange of germplasm. A working knowledge of the relevant international treaties related to genetic resources is important for anyone dealing with genetic resources as they increasingly affect the international exchange and use of germplasm.
One such treaty is UPOV. Significantly, the latest revisions of 1991 expanded the scope of protections that could be granted to include essentially derived varieties. This has important implications for genetically modified organisms. These revisions also allow countries to limit farmers’ rights, allowing them only to save seeds for use on their own land.
Another agreement is the Convention on Biological Diversity, particularly the provisions concerned with informed consent to use of biological materials and equitable benefit sharing following access. Some people argue that these requirements may be in conflict with this requirement of TRIPS. In practice, however, whereas UPOV and related sui generis systems focus on plant varieties, the Convention on Biological Diversity essentially deals with wild genetic resources. Exceptions include the reach of the Convention into genetically modified crops through the Cartagena Protocol on Biosafety, but this is not related to intellectual property.
The International Treaty on Plant Genetic Resources for Food and Agriculture (the Treaty) is a recent addition to international agreements. The Treaty establishes a multilateral system that embodies a sort of genetic commons within which the exchange of germplasm in major crop varieties between member states is facilitated. Conditions limit the rights of recipients to seek IP rights in material obtained and support the rights of donors to share in some form of benefit. The Treaty further recognizes the contribution of farmers and indigenous peoples’ traditional knowledge to agricultural biodiversity. This is accomplished through the development and conservation of landraces, in primitive varieties developed to deal with local climate and diseases and to appeal to local tastes, by interbreeding locally occurring undomesticated plants with cultivated plants, as well as by exchanging different genotypes among farmers and farms. Again, some argue that certain terms of the Treaty may not be compatible with UPOV standards but overall this assessment seems unlikely.
A distinct but closely related topic is that of information resources. These include computer software and systems, databases, geographic information systems (GIS), remote sensing (RS) information, and library resources. The integration of these is increasingly prevalent in advanced agricultural systems such as the forecasting of disease and harvests. Dodds and colleagues9 in Chapter 4.8 discuss the various IP elements related to information resources and how they can be managed effectively. The chapter also addresses licensing elements.
A very different topic is that of data protection and data exclusivity. These systems of protection are especially important in pharmaceuticals and agricultural chemicals. Two chapters review these complex topics, Chapter 4.9 by Clift10 and Chapter 4.10 by Cook.11 In short, regulatory data are the data that the researcher or manufacturer of a product must provide to the appropriate regulatory agency in order to prove that the product is safe and efficacious. Regulatory data are protected from disclosure or acquisition for a certain period of time, usually five to ten years from the product’s first authorization to market, during which time no other applicants are allowed to use it to obtain marketing authorization for the same product.
Regulatory data protections are substantively different from other sorts of intellectual protection, including confidential information protection and patents. The provisions in Article 39.3 of TRIPS, concerning the protection of regulatory data, are broad and subject to interpretation. Both the United States and the European Union have interpreted and implemented the obligations in different ways (as explained in Chapter 4.10).
The chapters by Clift and Cook also examine data exclusivity from the perspective of specific TRIPS requirements (Article 39) which essentially include three obligations on governments:
- protect data on new chemical entities, the collection of which involved considerable effort, against unfair commercial use
- protect such data against disclosure, except where necessary to protect the public
- protect such data against disclosure, unless steps are taken to ensure that the data are protected against unfair commercial use
It is important to note that these requirements do not create new IP rights (other than defining the reach of trade secrets). Article 39.3 only articulates widely accepted trade secret and unfair competition law and is not an invitation to create new IP rights per se for test data.
1 Chapter 4.1 by J Dodds and A Krattiger titled The Statutory Toolbox: An Introduction, p. 337.
2 Chapter 4.2 by C Nottenburg titled How to Read a Biotech Patent, p. 351.
3 Chapter 4.3 by W Needle titled Trademark Primer, p. 361. Trademarks and trademark licensing are further discussed in detail in Chapter 11.6 by WT Tucker and GS Ross titled Use of Trademarks in a Plant-Licensing Program, p. 1059.
4 Chapter 11.5 by KF Jorda titled Trade Secrets and Trade-Secret Licensing, p. 1043.
5 Chapter 4.4 by JP Kesan titled The Statutory Toolbox: Plants, p. 371.
6 Chapter 4.5 by WH Lesser titled Plant Breeders’ Rights: An Introduction, p. 381.
7 Chapter 4.6 by J Dodds, A Krattiger, and SP Kowalski titled Plants, Germplasm, Genebanks, and Intellectual Property: Principles, Options, and Management, p. 389.
8 Chapter 4.7 by M Blakeney titled Plant Variety Protection, International Agricultural Research, and Exchange of Germplasm Legal Aspects of Sui Generis and Patent Regimes, p. 401.
9 Chapter 4.8 by J Dodds, S Somersalo, SP Kowalski, and A Krattiger titled IP and Information Management: Libraries, Databases, Geographic Information Systems, and Software, p. 419.
10 Chapter 4.9 by C Clift titled Data Protection and Data Exclusivity in Pharmaceuticals and Agrochemicals, p. 431.
11 Chapter 4.10 by T Cook titled Regulatory Data Protection in Pharmaceuticals and Other Sectors, p. 437.