Patents and Patenting: Balancing Protection with the Public Domain

Abstract: 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: 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.

Abstract: Patent applications should be organized and drafted with a long-term objective that carefully considers the multiple possibilities, and opportunities, of field-of-use licensing. This is particularly the case in the agricultural, pharmaceutical, biochemical, and chemical disciplines, as inventions can have multiple applications that are sometimes impossible to foresee. Technology managers must, therefore, focus strategically, not only on the basic idea of an invention but broadly, in order to consider the various ways such an invention might be put into more widespread and more profitable use. Therefore, the more details, examples and alternatives that are thought through and then disclosed in the patent application, the greater the opportunity for future divisional or continuation applications, as well as future claims that can be exclusively (field-of-use) licensed. By making all of the institution’s licenses, in effect, field-of-use licenses, the technology manager retains the ability to take a possible future use and license it to someone else, maximizing the benefits of the inventions and generating higher royalties for the institution.

Abstract: A comprehensive intellectual property (IP) portfolio can be of substantial value to both private and public sector entities. Patents are a key element of IP portfolios and must be managed according to the mission, objectives, and motivations of the organization that owns them. Large companies can afford an offensive patent strategy, but small companies may not have the resources for this. Therefore, it is extremely important for private sector entities, especially small- and middle-sized companies, to design and implement an effective and cost-efficient strategy for patent management. For public sector entities, patent strategies will focus on advancing social welfare, and the mission of the institution will therefore drive objectives. A key factor to consider is the method of IP protection: patent, trademark, copyright, or trade secret. The costs of maintaining each of these IP categories are different. Although research institutes and companies will likely wish to reduce costs as much as possible, key technologies still need to be protected properly. A company can reduce costs by focusing the patent protection on those geographic areas where it has business. A university can reduce costs by selectively prosecuting patent applications with broad claim structures, strategically licensing technologies, and enforcing patent rights if and when necessary. To build a strong basis of protection, several forms of IP may be used for the same invention or improvement.

Abstract: Timing and cost are two key factors involved in patent-filing decisions. This chapter explores mechanisms for delaying the high costs of filing a patent application as long as possible, so that additional information on an invention and evidence of its worthiness can be gathered. The efforts to minimize up-front costs are balanced against the potential need to secure viable patent rights at some point in the future. This chapter begins by walking through the stages of the publication process—from prior to submission, to after publication—and suggests cost-conscious patent-filing strategies that are possible at each stage. The focus is on delaying significant costs until the value of the invention is more certain. The chapter concludes with additional points to consider when making patent-filing decisions.

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Abstract: 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: 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: All biotechnology and pharmaceutical products must be approved by both the U.S. Patent and Trademark Office (PTO) and the U.S. Food and Drug Administration (FDA). To maximize the impact of a product’s market exclusivity, the time spent on getting approval should be minimized. This chapter discusses how the interplay between PTO and FDA applications affect the patent approval process, and by extension the patent term, and how these impact the commercial life of a product.

Abstract: The deposit of biological material in support of a U.S. patent application is a mechanism by which an applicant can cure what might otherwise be potentially fatal defects in a patent application and even an issued patent. A biological deposit can, in some cases, satisfy the requirements of enablement, written description, and best mode, and potentially broaden the scope of claims in the event of litigation. This chapter briefly explores the relationship between biological deposits and patentability requirements, what can be deposited, where and when a deposit can be made, and who has access to the deposit.

Abstract: 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: Documentation of research is a critical aspect of best practices in IP management. This is true because research and development activities that give rise to inventions must be thoroughly documented in order to successfully manage patents, including determining patentability, drafting and prosecuting patent applications, and later, if the need arises, protecting patents against third party challenges, for example, a patent interference proceeding. Maintaining, for each invention, a complete record of who made the invention, when it was made, and how it was made, must therefore become a formal component of a university’s policy and training programs and must be carried our according to specific protocols. An organized and methodical approach to documentation will support patent management, provide a readily accessible source of critical information, ensure the capture of maximum value of inventions, and protect patent portfolios against challenges when, and if, the need arises.

Abstract: If universities adopt sound licensing practices, the universities will not only help stimulate investment in research on diseases that primarily afflict the poor in developing countries, but also ensure that the products of the research are affordable and widely available in those countries. Ensuring global access is one of the central goals of intellectual property management. But universities confront two main obstacles in their efforts to achieve the goal. First, university administrators, technology transfer officers, and business people are too often unaware of both the need to ensure access to new health technologies in developing countries and the manner in which patenting and licensing practices can be an integral component of global access strategies. Second, there is only a short history of experience in incorporating such concerns in negotiating licenses, so no best practices have yet evolved. This chapter offers a few possible approaches to ensuring broad access to university inventions while preserving incentives to development, including patenting inventions in a select list of developing countries. The chapter concludes by urging all of the players in this field to build upon their own experience and to take creative risks in the pursuit of new solutions.

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: A laboratory notebook is an important tool that goes well beyond research management and can have important implications for issues ranging from intellectual property management to the prevention of fraud. This chapter discusses the key elements of a laboratory notebook, types of notebooks, what should be included in the notebook, ownership issues, archiving, and security. The chapter provides sample notebook pages that illustrate some of the recommended practices.

Abstract: This chapter is intended to assist intellectual property professionals, in working with inventors, to develop a high-quality invention disclosure and, eventually, to prosecute a patent application. Major topics include the importance of data records, utility and reduction to practice of inventions, understanding prior art (including the inventors’ own art), and determination of inventorship.

Abstract: Several factors help to establish who owns a university invention and what rights the university may, or may not, have. These factors include whether (1) there are express or implied agreements to assign ownership, (2) the inventor is employed by the university, (3) the invention was made within the scope of employment, and (4) where and when the invention was made. Under U.S. law, individuals own their inventions, except where there is an express agreement providing for assignment of ownership of inventions to an employer or where an implied agreement to assign is found because the employee was hired or assigned to invent or solve a specific problem or served the employer in a fiduciary capacity. Therefore, in addition to implementing clearly delineated policies, it is critically important for a university to absolutely require all employees and visitors to sign invention assignment agreements (IAAs) on their date of arrival. It is unwise to rely on policy statements to determine whether or not a university employee owns his or her invention: universities should always obtain signed (express) agreements, and both the employee and the technology transfer office should retain copies. Research contracts with the government and other sponsors should have a checklist item on the existence of IAAs for the principal investigator and other researchers (whether or not a university should have undergraduates routinely sign IAAs is up to each university). Upon termination of employment, personnel should be asked to sign an exit form indicating that they have disclosed all inventions falling within the terms of the IAA to the university licensing office.

Abstract: Without inventors, there would be no technology to transfer. But without technology transfer professionals, there would be limited transfer of technology. Good relations between inventors and technology transfer professionals are therefore essential for the commercialization enterprise to succeed. Relationships should be established long before the transfer services of the technology transfer office (TTO) are required. A healthy relationship will allow technology managers to negotiate both faculty and business concerns about licensing agreements. Making sure that the inventor is sympathetic to the aims of the TTO will also make it much easier for everyone to understand how a technology may meet market needs, recognize potential licenses, and determine whether a licensee is fulfilling its obligations. For all of these reasons and more, a TTO should always go the extra mile to educate, develop, and maintain good working relationships with inventors.

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: 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.