Digital Commons Network^™

The Case Of The Missing Device Patents, Or: Why Device Patents Matter, Erika Lietzan, Kristina M. L. Acri, Evan Weidner

Faculty Publications

A company that earns premarket approval of its medical device is entitled to an extension of one patent claiming the device, to make up for some of the time it spent doing premarket research. Yet, surprisingly, a mere thirteen percent of those eligible for this extension (also known as patent term "restoration") ask for one. In contrast, most drug companies entitled to this same patent extension ask for one.

In this Article, we attribute the imbalance largely to differences between the two regulatory frameworks. In brief, because the FDA classifies and regulates devices based on what they do and how …

Investigation Of Innovation In Wine Industry Via Meta-Analysis, Ali Dogru, Joseph Peyrefitte

Faculty Publications

This study provides a systematic review of 76 relevant wine business studies published in the last 30 years. Our meta-analysis investigates six commonly used variables to explain wine innovation: absorptive capacity, technology adoption, sustainable practices, export orientation, firm size, and firm age. We also investigate the association between innovation and financial performance, using the reported effect sizes in the literature. Our meta-analysis reveals that absorptive capacity, technology adoption, sustainable practices, export orientation, and firm size positively correlate with innovation efforts, and innovation is positively associated with financial performance. However, we find no correlation between firm age and innovation. In addition …

Diversity In Innovation Best Practices Guide, Laura Norris, Mary Fuller, Joy Peacock, Sydney Yazzolino

Faculty Publications

In 2020, the USPTO collaborated with the HTLI to propose a study designed to increase diversity in the patenting process, specifically targeted to in-house legal / IP department and their practices. The goal of the study was simple - harvesting the collective knowledge of nationwide IP professionals and producing an “insanely practical” guide to expand inventorship to a more diverse inventor population. By “diverse” we mean underrepresented or historically marginalized groups in the United States patent system. The term "diversity" can be interpreted differently in different countries. The HTLI research team collected this extensive list of over 90 best practice …

Comments To The National Strategy For Expanding American Innovation, Colleen Chien, Ernest Fok

Faculty Publications

The United States Patent and Trademark Office (USPTO) sought input for its National Strategy for Expanding American Innovation to build a more demographically, geographically, and economically inclusive innovation ecosystem. Students in Professor Colleen Chien’s Patent Law course submitted 13 comments on how to make innovation more representative of the United States. This document contains 13 comments that draw heavily from personal and professional experience, and highlights the diversity in Santa Clara Law’s patent course. Here are excerpts:

• Erik Perez and Grant Wanderscheid, drawing from their own undergraduate and graduate experiences in science and engineering, recommend a “shift towards achievement …

Distorted Drug Patents, Erika Lietzan

Faculty Publications

Drug patents are distorted. Unlike most other inventors, drug inventors must complete years of testing to the government’s specifications and seek government approval to commercialize their inventions. All the while, the patent term runs. When a drug inventor finally launches a medicine that embodies the invention, only a fraction of the patent life remains. And yet, conventional wisdom holds — and empirical studies show — that patent life is essential to innovation in the pharmaceutical industry, perhaps more so than any other inventive industry. Congress tried to do something about this in 1984, authorizing the Patent and Trademark Office to …

Access Before Evidence And The Price Of The Fda's New Drug Authorities, Erika Lietzan

Faculty Publications

Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by the FDA or proven safe and effective to the FDA's standards. (Sometimes this happens because the FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the United States "gold standard" for new drug approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. …

Attacking Innovation, Jeffrey A. Maine

Faculty Publications

Economists generally agree that innovation is important to economic growth and that government support for innovation is necessary. Historically, the U.S. government has supported innovation in a variety of ways: (1) a strong legal system for patents; (2) direct support through research performed by government agencies, grants, loans, and loan guarantees; and (3) indirect support through various tax incentives for private firms. In recent years, however, we have seen a weakening of the U.S. patent system, a decline in direct funding of research, and a weakening of tax policy tools used to encourage new innovation. These disruptive changes threaten the …

Leadership And Innovation Within A Complex Adaptive System: Public Libraries, Darin S. Freeburg

Faculty Publications

Viewing public libraries as Complex Adaptive Systems, the current study analyzed leadership within these systems in terms of complexity and innovation. This included a leader’s capacity for ambiguity and emergence, features of leadership in different contexts, and perceptions of success and innovation. From a list of current public library directors and managers, 15 participants completed a 30-minute phone interview that followed a semi-structured guide. By analyzing the intersection of complexity of approach with complexity of context, eight leadership approaches were uncovered through coding. Results suggest that most participants engaged with most of the leadership approaches at some point. In addition, …

A Solution In Search Of A Problem At The Biologics Frontier, Erika Lietzan

Faculty Publications

This short paper comments on Professor Carrier's new article, Biologics: The New Antitrust Frontier. His article makes a profound initial contribution to a new area of scholarship, based on a large body of prior work considering antitrust issues relating to small molecule drugs. But Professor Carrier’s article, like my own forthcoming piece on innovation and competition in the biologics marketplace, is inherently speculative. We are making our best judgments about the nature of a still emerging marketplace and likely conduct in that marketplace, based on our understandings of a new regulatory framework that is itself still emerging, the broader legal …

The Guided Innovation Model: Messy Human Innovation, Darin Freeburg

Faculty Publications

This paper outlines the theoretical foundation and framework for the Guided Innovation Model, which puts nonprofit organizations in a position to increase innovation through the application of Knowledge Management tools. This is facilitated by information and knowledge professionals. It also outlines a suggested approach for implementation of the model. The purpose of the paper is to provide an in-depth foundation which future work can build upon in specific contexts. Given the complexity and constancy of social change, nonprofits must continually innovate to meet the needs of their community. This model provides a framework for how they can do this without …

Integrating A Creativity, Innovation, And Design Studio Within An Academic Library, Holt Zaugg, Melissa C. Warr

Faculty Publications

Purpose – The purpose of this paper is to describe the efforts to set up a creativity, innovation, and design (CID) studio within an academic library. This paper will describe the reasons for creating a CID studio, assessment of the pilot study, and next steps.

Design/methodology/approach – The assessment used surveys, interviews, focus groups and observations of students and faculty to determine how well the CID fits into the library.

Findings – Initial findings indicate that the CID studio is a good fit within the library space as learning activities in it support collaboration, discovery, and integration of library services. …

The Coalition Model, A Private-Public Strategic Innovation Policy Model For Encouraging Entrepreneurship And Economic Growth In The Era Of New Economic Challenges, Anat Alon-Beck

Faculty Publications

Innovation driven entrepreneurial firms have an important role in contributing to job creation, to generating technological innovation and to stimulating the United States economy. However, there is a notable recent decline in emerging growth entrepreneurial activity in the United States. The Coalition Model proposes ways to maximize opportunities for industry, academia and government to collaborate and build sustainable relationships, in order to help convert the current challenges in the U.S. market into opportunities.

Designing a new innovation strategy policy will lead the United States in generating innovation, technology and economic growth, as well as help the federal government harness new …

Enhancing Innovation In The Ugandan Agri-Food Sector: Progress, Constraints, And Possibilities, Travis Lybbert, Kritika Saxena, Julius Ecuru, Dick Kawooya, Sacha Wunsch-Vincent

Faculty Publications

No abstract provided.

A Knowledge Lens For Information Literacy: Conceptual Framework And Case Study, Darin Freeburg

Faculty Publications

Purpose The purpose of this paper is to introduce a Knowledge Lens for information literacy. This lens shifts the focus and potential outcomes of information literacy in three ways. First, it promotes self-reflection as a means of integrating information. Second, it promotes creation, emphasizing it as a social process. Third, it promotes the ability and value of working with imprecision and lack of direction. Design/methodology/approach The author designed a Community of Practice (CoP) with a loosely structured guidebook to operationalize the Knowledge Lens. The initial stated purpose of the CoP was to provide innovative solutions to issues of race relations …

Let There Be Light: Social Enterprise, Solar Power, And Sustainable Development, Tonia Warnecke

Faculty Publications

Energy poverty is a major problem in the developing world, with nearly 1.3 billion people lacking household electricity. Strikingly, the electrification rate is not only low, but is falling in many countries as population growth outpaces efforts to give more people access to electricity. Seizing the opportunities presented by rapid changes in technology and the availability of renewable energy at continually falling costs, social enterprises have begun to light the darkness and fill in the gap between the public and private provision of electricity. We review the extent of energy poverty and explain why neither the public, nor the private …

Pipes, Pools And Filters: How Collaboration Networks Affect Innovative Performance, Harpeet Singh, David Kryscynski, Xinxin Li, Ram Gopal

Faculty Publications

Innovation requires inventors to have both "new knowledge" and the ability to combine and configure knowledge (i.e. "combinatory knowledge") and such knowledge may flow through networks. We argue that both combinatory knowledge and new knowledge are accessed through collaboration networks, but that inventors' abilities to access such knowledge depends on its location in the network. Combinatory knowledge transfers from direct contacts, but not easily from indirect contacts. In contrast, new knowledge transfers from both direct and indirect contacts, but is far more likely to be new and useful when it comes from indirect contacts. Exploring knowledge flows in 69,476 patents …

Exclusionary And Diffusionary Levers In Patent Law, Colleen Chien

Faculty Publications

The patent system is built on the premise that exclusion leads to innovation. But a mounting body of evidence calls into question the assumption that “innovation by exclusion” – innovation based on excluding rivals– is the only, or even primary, way innovation happens today: nearly 50% of manufacturers got the idea for their most important new product from an outside source that shared it with them, 45-60% of patentees acquire patents to access the technology of others, and over 1,300 companies, including five of the ten top holders of patents, have pledged to share their patents with others. But because …

Innovation Outcomes Of Knowledge-Seeking Chinese Foreign Direct Investment, Xianming Wu, Nathaniel C. Lupton, Yuping Du

Faculty Publications

Purpose

The purpose of this paper is to investigates how organizational learning, absorptive capacity, cultural integration, specialization of the acquired firm and characteristics of transferred knowledge impact innovation performance subsequent to overseas acquisitions.

Design/methodology/approach

Survey responses from 222 Chinese multinational enterprises engaged in overseas acquisitions.

Findings

Differences between acquiring and acquired firms’ capabilities, while having a positive direct influence, suppress the positive impact of organizational learning and absorptive capacity, suggesting that multinationals require some basic level of capabilities to appropriate value from overseas acquisitions.

Research limitations/implications

This paper investigates the impact of knowledge-seeking overseas acquisition of Chinese multinationals on innovation …

Effective Innovation Policies For Development: Uganda, Julius Ecuru, Dick Kawooya

Faculty Publications

No abstract provided.

'Sophisticated Robots': Balancing Liability, Regulation, And Innovation, F. Patrick Hubbard

Faculty Publications

Our lives are being transformed by large mobile “sophisticated robots” with increasingly higher levels of autonomy, intelligence, and interconnectivity among themselves. For example, driverless automobiles are likely to become commercially available within a decade. Many people who suffer physical injuries from these robots will seek legal redress for their injury, and regulatory schemes are likely to impose requirements to reduce the number and severity of injuries.

This Article addresses the issue of whether the current liability and regulatory systems provide a fair, efficient method for balancing the concern for physical safety against the need to incentivize the innovation necessary to …

Informal–Formal Sector Interactions In Automotive Engineering, Kampala, Dick Kawooya

Faculty Publications

This chapter provides findings from a Ugandan case study that examined innovation transfers between informal-sector automotive artisans and formally employed researchers at Makerere University’s College of Engineering, Design, Art and Technology (CEDAT). Th e primary site studied was CEDAT’s Gatsby Garage, an automotive workshop where it was found that the informal-sector artisans were central to innovative processes but were at the same time driven more by sharing impulses than by concern for the intellectual property (IP) implications of their work. Based on these findings, it is argued that Ugandan policy-makers need to seek policy tools to support innovation transfers between …

Informal The New Normal, Dick Kawooya

Faculty Publications

No abstract provided.

Science Diplomacy With Swissnex China: A Swiss Nation Brand Initiative, Flavia Schlegel, Olivier Jacot, Marc Fetscherin

Faculty Publications

Switzerland has a long tradition of expertise in the fields of science, research and education, with “science diplomacy” (SD) now assuming an important role for innovation economies. Past experience shows that international scientific cooperation can have valuable outcomes for the involved countries and complements traditional foreign policy and diplomacy. In Switzerland, a worldwide network of science and technology outposts under the auspices of the Swiss State Secretariat for Education and Research (SER) in cooperation with the Federal Department of Foreign Affairs (FDFA) was established in 2000. The very swissnex network around the world defines one of those established science diplomacy …

Shopping Carts And Student Employees: How Student Committees Can Bring Innovative Ideas To Academic Libraries, Quinn Galbraith, Sara D. Smith

Faculty Publications

In 1999, ABC’s Nightline asked IDEO, a well-known innovation and design consultancy, to redesign the shopping cart in five days. While the challenge of re-imagining a cultural icon “inexplicably stuck in a sort of an innovation limbo”1 drew enough interest, even more compelling was the process the IDEO team used to research, brainstorm, and design the new model. The IDEO team threw out middle-management hierarchies based on experience or seniority—the project leader, who had only worked with IDEO for six years, was chosen for his skill in leading groups. The team members came from many disciplines, including psychology, architecture, linguistics, …

Switzerland's Nation Branding Initiative To Foster Science And Technology, Higher Education And Innovation: A Case Study, Marc Fetscherin, Pascal Marmier

Faculty Publications

This article presents a case study about Switzerland's initiative to promote its science and technology, higher education and innovation environment. This is accomplished through a worldwide network of science and technology outposts run by the Swiss State Secretariat for Education and Research in cooperation with the Federal Department of Foreign Affairs. In this article, we specifically discuss the outpost located in Boston. swissnex Boston acts as a physical and virtual environment to foster closer ties between Switzerland and the Boston region in various fields of interest to academia, industry, business and society. We present the history and mission of swissnex …

Collaborative Lawyers' Duties To Screen The Appropriateness Of Collaborative Law And Obtain Clients' Informed Consent To Use Collaborative Law, John M. Lande, Forrest Steven Mosten

Faculty Publications

Collaborative Law (CL) is an innovative dispute resolution process that offers significant benefits but also poses significant non-obvious risks. This Article provides a systematic analysis of these possible risks as identified in books written by CL experts, CL practice group websites, social science research, and bar association ethics opinions. In CL, the lawyers and clients sign a "participation agreement" promising to use an interest-based approach to negotiation and fully disclose all relevant information. A key element of CL is the "disqualification agreement" signed by parties (and sometimes by attorneys) which provides that both CL lawyers would be disqualified from representing …

Imaginative Instruction: What Master Storytellers Can Teach Instructional Designers, Jason K. Mcdonald

Faculty Publications

Good instructional storytelling engages students’ attention and cognitive abilities to the end of more effective learning, and instructional researchers have discussed whether the principles of storytelling could lead to the same or similar results if applied to educational situations beyond only telling traditional stories. But despite this potential, the principles of storytelling are seemingly underutilized by today’s instructional designers. This study investigates what instructional designers might learn from another design field that is more experienced in the art of storytelling, specifically that of film production. Eight filmmakers who have successfully produced films that motivate, inspire, and educate were interviewed to …

Open Source, Openness, And Higher Education, David Wiley

Faculty Publications

With the growth of open source software and other related trends, a culture of openness is advancing from the edges of society to the core of academic culture. In this article I provide an overview of how the expansion of open source software in culture at large has affected the world of education, describe how the greater use of open source software in education has unfolded hand-in-hand with the development of open course content and open access research, and argue that this more comprehensive shift towards "openness" in academic practice is not only a positive trend, but a necessary one …

The Federal Circuit’S Cruise To Uncharted Waters: How Patent Protection For Algorithms And Business Methods May Sink The Ucita And State Intellectual Property Protection, Ralph D. Clifford

Faculty Publications

The realm of intellectual property law now changes at an incredible pace, with the courts discarding venerable concepts rapidly. This is not surprising as the transition from a goods-based society to one based on information increases the importance of intellectual property law. Nowhere has this been more apparent than the Federal Circuit’s recent reworking of the scope of federal patent law. Today, it is difficult to imagine anything for which a patent cannot be sought and received. Furthermore, the expansion of the patent law’s scope has a corresponding impact on state powers. Because the patent law serves to implicitly preempt …

Academic Library Services: The Literature Of Innovation, Jo Bell Whitlatch, Judy Reynolds

Faculty Publications

Innovation has the potential for increasing the effectiveness of information service. As a result of this interest in innovation, organizational theorists have begun to explore the effect of organizational design upon flexibility, creativity, and productivity of organizations. A review of existing literature, however, provides no comprehensive theory of organizational innovation. Research on organizational design and innovation in libraries could contribute to the systematic study of the impact of organization structure . Studies by Howard and Luquire indicate that traditional library organizations may inhibit change as well as the reexamination of values and service. Further study is needed to determine how …