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MIHR
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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Inventors and Inventions
Summary and Overview
Krattiger A, RT Mahoney, L Nelsen, JA Thomson, AB Bennett, K Satyanarayana, GD Graff, C Fernandez and SP Kowalski. 2007. 8: Inventors and Inventions. 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.). bioDevelopments-International Institute (Ithaca, USA), MIHR (Oxford, UK), PIPRA (Davis, USA), and Oswaldo Cruz Foundation (Fiocruz, Rio de Janeiro, Brazil). 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.
Universities, inventors, and inventions—and by extension intellectual property—are all inextricably intertwined. Scientists are the central force behind the research, teaching, and extension missions of universities. And inventors can be considered the central force behind intellectual property, since they generate patentable inventions. Dealing with scientists, and inventors, at least from an IP management perspective, is not always straightforward or easy, but the technology transfer process and licensing are made easier if scientists know some basics of IP management and of patenting, and are somewhat familiar with best practices. This applies equally to high-flying attention-seekers and low-key geniuses.
A university research program must frequently make decisions about whether its researchers’ discoveries should be protected. The process leading to this decision can place a tremendous strain on the relationship between the technology transfer office (TTO) and scientists. And it is one of the principal reasons why scientists should be given an opportunity, from the day they join a research institution, to learn the very basic concepts of IP management to better understand the process and the challenges faced by TTOs and TTO officers. How are decisions made as to when to patent, what to patent, and how to protect an invention? When it comes to new inventions, unclear and non-transparent procedures lead to tensions that can be costly in terms of money, time, missed opportunities, and relationships between scientists, heads of departments, and TTOs. So it is important that university leaders and administrators—and scientists—work in concert on policies and mechanisms that establish the procedures used for recording inventions, for invention disclosure, and for sharpening the interface between scientists and technology transfer and licensing offices.
Three conspicuous but usually neglected issues deserve special consideration up front. First, it is often difficult to know when an invention has actually been made. Training of scientists with respect to IP management and an institutional atmosphere that encourages inventions and invention disclosures are essential for making the most of scientific endeavors. Second, inventors need to have a clear understanding of their rights—and responsibilities—when it comes to their inventions. Unrealistic expectations that are either too high or too low will get in the way of optimally productive research and can be a source of conflicts with TTOs. Third, inventions, per se, are not necessarily innovations, though they may become innovations.1
The section’s opening chapter by Mutschler and Graff2 provides essential information that university scientists and inventors need to know in order to manage new and existing intellectual property and to deal with TTOs. University faculty and scientists anywhere need a working knowledge of what intellectual property is and what can be done with it so that they are able to make decisions about their laboratories’ IP issues. These issues range from how to start and run a research program (from an IP management perspective), how to handle new inventions produced by that research, and how to manage the property of their collaborators. Graduate students and postdoctoral scientists should also acquire a basic understanding of intellectual property, since this knowledge will be valuable to them no matter what their future careers hold, whether in government, academia, non-governmental organizations, or industry.
Universities typically have—or should have—institutional IP policies that must be complied with by all personnel. In the United States, these IP policies must conform to the guidelines outlined by the Bayh-Dole Act of 1980. This act was intended, among other purposes, to promote private sector investment in federally funded research to facilitate the transfer of federally funded research to industry. For these reasons, university employees in the United States must sign agreements that state that all intellectual property generated under the university’s aegis belongs to that university (though an inventor is typically given a share of the revenues that come from the sale of any intellectual property that he or she generates). One major exception to the policy of assigning IP rights to the university, however, is copyrighted material (books, papers, drawings, paintings, sculptures, and so forth).
A university’s IP office or TTO is typically responsible for protecting and developing commercial applications (including out-licensing patents) for inventions developed at the university. Its functions typically include:
- determining the most effective way to protect inventions
- evaluating the commercial potential of inventions
- obtaining the appropriate protection for inventions
- locating suitable commercial-development partners and marketing inventions to them
- negotiating and managing IP licenses
- encouraging and assisting the formation of new companies around university-generated intellectual property (start-ups)
In addition to briefly reviewing the above, Mutschler and Graff familiarize scientists with issues they face on a daily basis:
- how to deal with confidential information
- how to deal with materials from third parties
- what constitutes a public disclosure of scientific finding
- how the patenting process works
- understanding the basics of intellectual property
If scientists read only one chapter in the entire Handbook, Chapter 8.1 is the one they should read. But on a daily basis, a scientist’s responsibility goes further than having a basic understanding of IP management. For authoritative IP management, university faculty, staff, and students need, at a minimum, to appropriately document their research findings, use of intellectual property not owned by the university, dealings with collaborators outside the university, and places and times of public disclosures of research results. Good record keeping is not only important for preparing publications, reports, and grant proposals, it is also essential for preparing IP-protection documents and supporting IP rights. Universities must be very careful when they use materials and methods that do not belong to them, in order to avoid infringing on the property rights of others. In a worst case scenario, third-party materials may be used in research, which would mean the new intellectual property generated through use of that material would belong to that third party. Ownership would depend on how the material was obtained. Issues related to ownerships (material transfer agreement) are discussed elsewhere.3 But irrespective of the terms of access, good record keeping in general and laboratory notebooks in particular are essential to possibly later disentangle ownership issues.
Scientists should be familiar with the ins-and-outs of keeping a laboratory notebook to document research. As a matter of institutional policy, the contents of laboratory notebooks should be treated as confidential and valuable. Notebooks should be stored in a safe place and any loss or theft should be reported immediately. A laboratory notebook is owned by the institution where work is conducted (essentially by the employer of the scientist). Therefore, when a scientist leaves an institution permanently, he or she should be required to turn notebooks over to supervisors (though copies can generally be kept by departing scientists).
Thomson,4 a scientist herself, shares the practical aspects of laboratory-notebook keeping and her chapter offers a sample policy. Crowell5 examines the entire range of invention documentation. It cannot be overemphasized how important is good documentation of research. It is a critical component of best practices in IP management for the following reasons:
- Well-kept laboratory notebooks are one of the most important sources of documentation. A laboratory notebook should contain detailed records of every experiment that has been planned or executed (including the date it was performed), the reasons for performing it, the methodology used in performing it, the results of the experiment, and the significance of the results.
- Laboratory notebooks are important instruments of institutional memory. Laboratories invariably have high personnel turnovers: scientists move on, post docs move up, students graduate, and technicians are promoted.
- Consistent documentation is important to determine patentability, and may even be essential for determining inventorship, for drafting and prosecuting patent applications, and (if necessary) for protecting patents from third-party challenges such as prior-art challenges and (in the United States) patent-interference proceedings.
Once scientists think they may have patentable inventions, they should file an invention disclosure to their TTO. McGee6 examines the entire invention-disclosure process from a practical and logistical point of view and stresses the importance of involving inventors throughout the protection and commercialization process. He discusses how IP professionals can best work with inventors to develop high-quality invention disclosures. An invention disclosure is a description of something novel and nonobvious that would allow anyone of ordinary skill in the corresponding art to reproduce the invention. It may be simple in scope and include most details in an attached draft of a scientific paper (McGee also notes, quite appropriately, that carefully kept laboratory notebooks can be used in place of an invention disclosure). Importantly, an invention disclosure irrefutably establishes the date and scope of an invention, as well as the identity of the inventor(s). Disclosures are essential for managing intellectual property, preserving IP assets, “harvesting” inventions and securing IP protection for those assets, and eventually translating the inventions into innovative products or services.
Thus, an invention disclosure is the beginning of what is sometimes a long but often rewarding process that can benefit the institutions where the disclosures are made, the society at large, and the inventors in particular.
Endnotes
1 See, also in this Executive Guide, part 9: Evaluation and Valuation of Technologies.
2 Chapter 8.1 by M Mutschler and GD Graff titled Introduction to IP Issues in the University Setting: A Primer for Scientists, p. 747.
3 See, also in this Executive Guide, part 7: Contracts and Agreements to Support Partnerships.
4 Chapter 8.2 by JA Thomson titled How to Start–and Keep–a Laboratory Notebook: Policy and Practical Guidelines, p. 763.
5 Chapter 8.3 by WM Crowell titled Documentation of Inventions, p. 773.
6 Chapter 8.4 by DR McGee titled Invention Disclosures and the Role of Inventors, p. 779.
Abstract
Documentation of Inventions
by W. Mark Crowell
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
How to Start–and Keep–a Laboratory Notebook: Policy and Practical Guidelines
by Jennifer A. Thomson
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
Introduction to IP Issues In the University Setting: A Primer for Scientists
by Martha Mutschler, Gregory D. Graff
Abstract:
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.
Abstract
Invention Disclosures and the Role of Inventors
by David R. McGee
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
Conflict of Interest and Conflict of Commitment Management in Technology Transfer
by Alan B. Bennett
Abstract:
The potential for personal interests to influence institutional decisions in universities and public sector research institutions continues to grow. This is because of the increasing activity in intellectual property (IP) management and technology transfer undertaken by these institutions. The activities have the potential to generate both personal and institutional financial gain, making conflict of interest and conflict of commitment issues unavoidable. This chapter explains the nature of these conflicts and discusses the policies, regarding conflict of interest, of several universities, offering them as potential models for crafting these indispensable policies.
Abstract
Creating and Developing Spinouts: Experiences from Yale University and Beyond
by Alfred (Buz) Brown, Jon Soderstrom
Abstract:
This chapter is about university spinouts: why they are created, who founds them, and how they are developed. It also considers many of the issues that a university and its faculty have to address to successfully launch and develop new for-profit ventures. Spinouts carry risks, but they may also be the best vehicle for developing early-stage university technologies and providing a host of other benefits. The chapter offers examples from the past five years at Yale University, as well as from the private sector, that suggest ways to minimize the risks and maximize benefits.
Abstract
Dealing with Spinout Companies
by Jon C. Sandelin
Abstract:
This chapter provides a practical guide for organizations seeking to transfer their intellectual property (IP) rights to a spinout company (normally through a licensing agreement) so that the company can convert the IP into products or services that benefit the public. Based on experiences at Stanford University over the past three decades, key issues have been identified for negotiating transfer to a spinout, and guidance on best practices for reaching a successful agreement is provided. The chapter briefly reviews potential conflict-of-interest and conflict-of-commitment issues that inevitability arise when employees of public research organizations become involved in spinout companies.
Abstract
Evaluating Inventions from Research Institutions
by Lita Nelsen
Abstract:
The patenting strategies of research institutions are based on three key decisions. The first involves whether or not to file a patent. This decision must be based on sound information about the market, the uniqueness and usefulness of the invention and/or technology, the likelihood of being able to obtain patent protection, factors related to the inventor, and the potentially paradoxical impact of patenting on the institution’s social and humanitarian responsibilities. The second decision involves whether to market the invention to established companies or to develop a spinout business. The third involves how much to charge for a license. Related to all of these decisions is the key question of whether patenting is the most effective route to global access. Negotiating licensing agreements that are fair to the research institution, the private company, and developing countries can be challenging because research institutions may have difficulty determining fair market values. In addition to outlining a process for obtaining these values, this chapter offers some rough numbers for guidance. In general, the author concludes that it is far better to conclude a deal than to wait for the best agreement while fighting interminably for perfect financial terms.
Abstract
How to Select and Work with Patent Counsel
by Michael L. Goldman
Abstract:
Public sector technology transfer offices (TTOs) are in the business of “moving” technology from research and development to eventual commercialization in order to advance their missions of serving the greater public good. Intellectual property (IP) management is integral to this process, and integral to IP management is patenting. Maximal captured value for public sector technologies will be greatly affected by the quality and scope of the patent coverage and this, in turn, is greatly influenced by the quality of work done by patent counsel. It is therefore essential for a TTO to select a patent attorney whose work will enhance the institution’s prospects for obtaining optimal licensing arrangements. From selection to hiring to ongoing interactions, it is important for the TTO and the patent counsel to develop and maintain a good working relationship. Central to this relationship is ensuring that patent counsel can prepare and prosecute patent applications in a manner that achieves positive results cost effectively. This is a complex process, and there are many responsibilities that both counsel and the TTO must assume. In addition, patent attorneys can provide general counseling: resolving inventorship issues, providing licensing and agreement support, and settling disputes. The TTO will be the patent attorney’s actual client and function as the interface between counsel and the institution. By selecting qualified patent counsel and then developing a good relationship, a TTO can ease its workload and facilitate its mission. Therefore, retaining a skilled patent attorney and one that is well suited to the particular needs of the TTO is an essential element for operating a viable technology transfer program. The search for such an attorney must be approached thoughtfully.
Abstract
Intellectual Property and Technology Transfer by the University of California Agricultural Experiment Station
by Gregory D. Graff, Alan B. Bennett
Abstract:
One of the primary missions of the University of California Agricultural Experiment Station (AES) is to create knowledge and develop technologies that improve the productivity and environmental sustainability of agriculture in California. In addition to the public release of information and the educational activities of cooperative extension services, the University of California places the inventions of AES faculty directly into commerce through the process of patenting and technology transfer. This channel is particularly useful—and often essential—when further financial investments are necessary to develop the technology for practical applications or to manufacture, market, and distribute new products that incorporate the new technology. This report documents the patenting and formal technology transfer activities of the University of California Agricultural Experiment Station over the last 40 years.
More than 800 inventions have been reported by AES researchers between 1960 and 2001. These inventions are categorized into the five broad technology areas: biotechnology (49%), plant varieties (19%), chemicals (14%), equipment/machinery (13%), and environmental (1%). Biotechnology inventions were entirely absent until the mid-1980s, but the category has grown rapidly over the last 15 years. The growth in the number of biotechnology-related inventions has occurred not at the expense of inventions reported in the areas of plant varieties, agricultural equipment, or novel chemicals, all of which have shown a relatively stable level of activity.
Financial returns from the licensing of AES inventions was US$1.4 million in fiscal year 1982 (2.5 million in 2001 dollars) but had grown to US$12 million by fiscal year 2001. After accounting for expenses associated with patenting new inventions and distribution of a share of income to inventors, AES inventions returned over US$6 million to the university in fiscal year 2001. Since 1982, the cumulative financial return has totaled US$105.2 million in fees and royalties. About 87% of that income has been derived from the licensing of plant varieties in spite of the fact that they compose only 19% of the AES inventions, indicating the commercial importance of UC plant varieties. To date, relatively few biotechnology- or environmental-related inventions have been commercialized, but the extensive and growing UC portfolio in these areas should provide a strong base for future licensing activity.
Abstract
IP Strategy
by Robert Pitkethly
Abstract
Ownership of University Inventions: Practical Considerations
by B. Jean Weidemier
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
The Role of the Inventor in the Technology Transfer Process
by Anne C. Di Sante
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
The University of California’s Strawberry Licensing Program
by Alan B. Bennett, Michael Carriere
Abstract:
The strawberry improvement program located at the University of California, Davis focuses on breeding cultivars for the strawberry industry in California, yet today it supports the majority of production of fresh-market strawberries globally. Around the world, UPOV-compliant Plant Breeders’ Rights (PBR) are the most common form of IP protections sought by University of California (UC) to protect its strawberry cultivars. Inside the U.S. and Canada, cultivars are licensed on a nonexclusive basis directly to nurseries. Outside of the U.S. and Canada, UC relies on business partners, referred to as “master licensees,” as intermediaries. A master licensee is provided with exclusive rights within a defined territory that includes the right to issue nonexclusive sublicenses to nurseries within that territory. Overall, a three-tier royalty structure is utilized, with growers inside California paying the least, growers in the U.S. outside of California and in Canada pay slightly more, and all other growers pay even more, a percentage of which is shared with the master licensee. The ultimate future of the UC strawberry breeding program is tied to the continued development of competitive cultivars, but the team is highly skilled and, partly due to the licensing program, funding is stable.
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