Patent Disclosure Research Articles

The Surgery Innovation and Entrepreneurship Development Program (SIEDP): An Experiential Learning Program for Surgery Faculty to Ideate and Implement Innovations in Health care

Surgeons are continually engaged in the incorporation of new technologies in their practice. In the operating room and beyond, they combine technical skill with creative problem solving to improve tools and techniques for patient care, making them natural innovators. However, despite their innovative tendencies, education on entrepreneurship and commercialization is severely lacking. Moreover, with increasing pressure to meet productivity metrics, their availability to learn the complexities of commercialization is limited. To address these challenges, we designed the Surgery Innovation and Entrepreneurship Development Program (SIEDP) with the objective to advance faculty innovations, develop new departmental innovation initiatives, and improve faculty education in the area of innovation, entrepreneurship, and commercialization. The SIEDP is a first-of-its-kind experiential learning program specifically designed for busy clinical and research faculty in a major academic surgery department. Participants ideated and formed teams around health care innovations as they progressed through a 9-month curriculum of expert guest lectures and interactive workshops. A postprogram evaluation and outcome tracking method was used to evaluate attainment of educational objectives and project development milestones. The Department of Surgery, University of Michigan Medical School, Ann Arbor, Michigan. Eleven surgery faculty of varying academic rank and surgical subspecialties. The program generated 2 faculty startup companies, 1 departmental commercial product, 3 patent disclosures, and 3 innovations that received additional funding. All participants in the program reported a significant increase in their understanding of innovation and entrepreneurship and that participation was a worthwhile faculty development activity. Despite the various challenges and time constraints of surgical practices, programs like SIEDP can educate surgeons and other academicians on innovation, entrepreneurship, and commercialization and add value to the academic mission of providing excellent education, research, and clinical care.

P2X7 antagonists for CNS indications: recent patent disclosures.

P2X7, a ligand-gated purinergic ion channel, has been at the center of intense efforts in the pharmaceutical industry in the last 15 years due to the growing appreciation of its role in inflammation. Since 2008-2009, increased focus on CNS available compounds has led to the publication of various patents on behalf of several pharmaceutical companies. This patent review aims at analyzing the recent patent literature (2008-2016) with a particular emphasis on those patents that are thought to deal with CNS penetrant compounds on the basis of their physicochemical features, the assays described in the patents and the uses these compounds are claimed for.

A new model for measuring the impact of patent value growth trajectory

Patents play a crucial role in determining the economy, industrial development, and R&D of a country. Extant patent literature has focussed on the decision model of the econometric method, which enables researchers to understand the short-term explanatory power of various factors for patent value. However, this method cannot be used to observe the degradation rate and growth trajectory of the patent value. In this study, we proposed a dynamic time-series design to further explore the growth trajectory of patent value by using the latent growth curve model. The results show that backward citation, non-patent reference, and number of claims positively affect the patent value growth rate. Patent disclosure information and characteristics are crucial for exploring the value of patents. Patent value is typically established on the basis of knowledge stock, patent breadth and international linkage. Therefore, this study applied an experimental map to validate the linkage relationship of the studied dimensions to provide governments, industries and patent assignees with some practical suggestions.

Does Patented Information Promote Progress?

The strength of patents is often seen as their greatest weakness. Patents are said to represent a “tradeoff” between the benefits of public disclosure of new technical information and the burdens of private exclusivity over use of that information. The stronger the patent the greater the private benefit, potentially at the expense of society. And, when patents are too strong, they are seen as potentially “blocking” future technological progress, undermining society’s benefit of the bargain. The patent “tradeoff” and its attendant concerns currently take center stage in the debates over access to scientific research tools, patent thickets, and resource-draining patent litigation.This paper studies the patent “tradeoff” empirically and demonstrates that the private and social benefits of patents can work together, not in opposition. We exploit the statutory criteria of patent validity to analyze the impact that valid patents have on future technological progress. We find a significant positive relationship. By analyzing over 1500 U.S. patents held valid or invalid in courts, we show that valid patents give rise to more future inventions than invalid patents. This occurs during the full term of patent exclusivity, and it holds true for future developments made by third parties other than the patent owner. Crucially, we find that this effect hinges on the quantity and quality of the patent disclosure. Patents that are invalidated for lack of novelty have the weakest impact on future development, whereas patents which disclose more information tend to promote more future inventions and are more likely to be valid. Overall, we find a robust positive connection between information disclosure, patent validity, and future technological progress. This study provides direct empirical evidence of the fact that, and process by which, the public disclosure of patents spurs future technological progress. This informs concerns about patents blocking cumulative innovation. We demonstrate that, as a general rule, as the information content of a patent increases so do both its private value and the productive benefit to society. In so doing, we also introduce new metrics for analyzing the information content of issued patents, providing tools for future research.

Patent Disclosures and Standard-Setting

A key role of standard setting organizations (SSOs) is to aggregate information on relevant intellectual property (IP) claims before deciding on a standard. This article explores the firms’ strategies in response to IP disclosure requirements — in particular, the choice between specific and generic disclosures of IP — and the optimal response by SSOs, including the royalty rate setting. We show that firms with a stronger downstream presence are more likely to opt for a generic disclosure, as are those with lower quality patents. We empirically examine patent disclosures made to seven large SSOs, and find results consistent with theoretical predictions.

WHEN A STRANGER CALLS: STANDARDS OUTSIDERS AND UNENCUMBERED PATENTS

An extensive literature exists regarding the patent disclosure and licensing commitments made by participants in standards-development organizations (SDOs), and how such commitments affect the assertion of standards-essential patents (SEPs). But this literature largely ignores the acquisition and assertion of SEPs by entities that do not participate in SDOs (Outsiders). SDO Outsiders, which are not themselves bound by the licensing and other requirements imposed by SDOs, have far greater freedom to employ a range of litigation tactics not available to SDO participants when they enforce SEPs against manufacturers of standardized products (Producers). This article describes the first study that has been conducted to collect and analyze data relating to SEP assertions by SDO Outsiders, a large number of which are so-called nonpracticing entities (NPEs). Over a fifteen-year period, the proportion of Outsider assertion of SEPs has been significant. More importantly, both SDO Outsiders and participants assert a combination of SEPs that are encumbered by SDO FRAND licensing commitments and that are unencumbered. Thus, while NPE Outsiders are responsible for numerous assertions of unencumbered SEPs, the greater threat of hold-up and rent extraction could arise from assertions of unencumbered SEPs by SDO Outsiders that are themselves Producers.

Real-time information effect of patent listing disclosure

Real-time information effect of patent listing disclosure

Patents and standardization, part 2: duties to disclose patents to standards development organizations

This article provides an overview of the patent disclosure provisions of two standards development organization patent policies and identifies issues those disclosure provisions raise for standards development organization participants and parties who own patent applications and issued patents that are subject to the patent policies. The article also presents an example to illustrate the possible consequences of failing to disclose the existence of relevant patent assets during the development of a standard.

Of Disclosure 'Straws' and IP Systems 'Camels': Patents, Innovation, and the Disclosure of Origin Requirement

This Chapter explores the validity of the assertion, by many developed country representatives, that the adoption of a patent applicant genetic resource disclosure of origin (DOO) requirement, such as is being considered in the World Intellectual Property Organization (WIPO) Intergovernmental Committee (IGC) negotiations, will impose untenable, innovation-deterring burdens and legal uncertainty on the global patent system. It also considers such a disclosure requirement in comparison to other burdens/uncertainties in the global patent system, and concludes that, far from being the straw that may break the camel’s back, a properly constructed DOO requirement need not harm, and may even enhance, innovative activity in Europe, the U.S., and beyond.

When a Stranger Calls: Standards Outsiders and Unencumbered Patents

An extensive literature exists regarding the patent disclosure and licensing commitments made by participants in standards-development organizations (SDOs), and how such commitments affect the assertion of standards-essential patents (SEPs). But this literature largely ignores the acquisition and assertion of SEPs by entities that do not participate in SDOs (Outsiders). SDO Outsiders, which are not themselves bound by the licensing and other requirements imposed by SDOs, have far greater freedom to employ a range of litigation tactics not available to SDO participants when they enforce SEPs against manufacturers of standardized products (Producers).This article describes the first study that has been conducted to collect and analyze data relating to SEP assertions by SDO Outsiders, a large number of which are so-called non-practicing entities (NPEs). Over a fifteen-year period, assertion of SEPs by non-practicing entities (NPEs) has been significant, representing 77% of the U.S. patent assertion events for seven major standards (GSM, USB, 802.11, Bluetooth, UMTS, H.264, LTE). More importantly, both SDO Outsiders and participants assert a combination of SEPs that are encumbered by SDO FRAND licensing commitments and that are unencumbered. Thus, while NPE Outsiders are responsible for numerous assertions of unencumbered SEPs, the greater threat of hold-up and rent extraction could arise from assertions of unencumbered SEPs by SDO Outsiders that are themselves Producers.

Analysis of intellectual properties on animal-derived regenerative, implantable medical devices.

This article analyses and summarizes issues of intellectual property involved in animal-derived regenerative, implantable medical devices (ADRIMD) in order to better understand global trends in patent applications and disclosures, the legal status of patent families (i.e. sets of patents filed in various countries to protect a single invention), and International Patent Classification topics such as main assignee and core expertise. Analysis of research trends will enhance and inform the decision-making capacity of researchers, investors, government regulators and other stake-holders as they undertake to develop, deploy, invest in or regulate ADRIMD.

Five Reasons Why Patent Disclosure in Standards-Setting Organizations Doesn't Work (And What to Do Instead)

Patent “hold up” is a risk associated with standard- setting, and requiring or encouraging disclosure of relevant patents by standards developers is one tool used to mitigate this risk. Disclosure has an intuitive appeal and a strong theoretical justification as a method for addressing an informational asymmetry. This paper argues that disclosure simply does not work as a practical matter, however. The paper makes five key assertions: 1. Disclosure rules create an over-disclosure problem. Only a small percentage of patents declared as essential by patent owners are in fact essential for implementation of the standard — an unsurprising fact given the incentives of some parties to err on the side of disclosure. 2. Disclosure rules also result in an under-disclosure problem. For various reasons, certain key parties will have essential patent claims but will not disclose. 3. Disclosure rules suffer from a timing problem. Information is frequently available only after critical decisions have been made. 4. Disclosure rules create an action problem: that is, standards setting organizations are ill-equipped to use the disclosed information in a productive way. 5. Disclosure rules present a complexity and cost problem. Disclosure requirements are complex, ambiguous, and differ widely across SSOs. Participants in the standards development process must bear significant associated costs.The paper concludes that disclosure is not an effective tool to address patent hold up, and suggests that other tools (such as enhanced “F/RAND” licensing obligations and improved patent valuation methodologies) should be used instead.

Social Network Norms and Intellectual Property: A Proposal for the Public Use Bar

How to draw the line between public and private is a foundational, first-principles question of privacy law, but the answer has implications for intellectual property, as well. This project is the first in a series of papers about first-person disclosures of information in the privacy and intellectual property law contexts, and it defines the boundary between public and non-public information through the lens of social science — namely, principles of trust. Patent law’s “public use” bar confronts the question of whether legal protection should extend to information previously disclosed to a small group of people. I present evidence that shows that current application of the public use bar appears to privilege the confidentiality and control norms of industry while minimizing those no less strong norms common to lone entrepreneurs. This results in a general pattern: corporate inventors tend to whin their public use cases; solo entrepreneurs tend to lose them. As a result, the public use bar has unintended negative effects, including discouraging experimentation and discriminating against inventors without the financial backing of corporate employers. This project proposes a new way of talking about, thinking through, and determining when previous disclosures bar subsequent patentability. In short, I argue that patent disclosures in contexts of trust retain their legal protection despite any ostensible loss of control or lack of formal confidentiality agreements. This proposal respects social network differences and will advance the goals of patent law and increase access to the innovation economy for all persons.

The third mission of universities: An investigation of the espoused values

An invisible revolution, known as the third mission, is claimed to be occurring within universities. Accordingly, the canonical missions associated with research and teaching have been integrated with the one aimed at territorial development. But do all universities conceive the third mission in the same way? This paper tries to elucidate which organizational orientations emerge by classifying the espoused values embedded within the statutes of 75 Italian universities. Using a qualitative content analysis, we highlighted four orientation patterns: first, need for coherence, focused on balancing public functions and third-mission activities; second, exploitation, focused on patent disclosure; third, openness, readiness to participate in external change and to satisfy external needs; and finally, old school, focused on entrepreneurial activities as a source of funding. This classification shows a more complex phenomenon for the institutionalization of the third mission with respect to a simple binary public–private opposition.

An organizational perspective to funding science: Collaborator novelty at DARPA

Research funding is known to affect the rate and direction of scientific and inventive activity. Most commonly, this is understood as occurring through the allocation of funds toward certain types of research and by altering the disclosure regime. This paper calls attention to another set of factors that likely also influence scientific and technological outcomes, but has gone largely unexamined: organizational practices at research funding organizations. I explore these factors in a mixed-methods study of the Defense Advanced Research Projects Agency (DARPA). Leveraging 39 interviews of DARPA-funded scientists and program managers, I describe DARPA’s agency-driven approach to research program development and intense interpersonal management style. Next, I investigate the impact of these organizational practices on the behaviors of sponsored researchers, in particular the tendency of scientists to form novel collaborations. Using patent disclosure data from the Massachusetts Institute of Technology (MIT) Technology Licensing Office and employing coarsened exact matching to identify a control set of collaborations, I find that DARPA-funded research is at least 6.0 percentage points more likely to involve novel collaborations. A detailed exploration of the novel collaborations presents a picture that is consistent with the paper’s description of collaboration-promoting practices at DARPA. By identifying important organizational practices and examining their impact on scientist behavior, this paper aims to highlight the potential influence of organization practices on scientific and inventive activity.

Patent disclosure and the diffusion of knowledge

Knowledge disclosure is regarded as crucial for cumulative innovation, technological progress and social welfare. In addition, it is also an important dimension with regard to firms' innovation strategies. However, there is still limited empirical evidence on the impact of disclosure on follow-on inventions. We address this gap and exploit a policy change in the US patent legislation (American Inventors Protection Act) which had an impact on the disclosure timing of patent documents. Applying a difference-in-difference methodology, we analyze how disclosure affects the diffusion of knowledge with regard to the geographical dimension. Relying on patent citation data to approximate knowledge flows, our econometric analysis suggests that early disclosure is particularly valuable for geographically distant inventors. Implications for firm managers and policy makers are discussed.

Recent patents on ophthalmic nanoformulations and therapeutic implications.

Nanoformulations (NF) are widely explored as potential alternatives for traditional ophthalmic formulation approaches. The effective treatment of ocular diseases using conventional eye drops is often hampered by factors such as: physiological barriers, rapid elimination, protein binding, and enzymatic drug degradation. Combined, these factors are known to contribute to reduced ocular residence time and poor bioavailability. Recent research studies demonstrated that NF can significantly enhance the therapeutic efficacy and bioavailability of ocular drugs, compared to the established ophthalmic drug delivery strategies. The research studies resulted in a number of patent inventions, reporting a significant increase in therapeutic efficacy for various chronic ocular disease states of both the anterior and posterior ocular segments. This article reviews these patent disclosures in detail and emphasizes the therapeutic advantages conferred by the following nanoformulation approaches: Calcium Phosphate (CaP) nanoparticles, Liposomes, Nanoemulsions, Nanomicelles, and Hydrogels. The nanoformulation approaches were shown to enhance the ocular bioavailability by reducing the drugprotein binding, increasing the corneal resident time, enhancing the drug permeability and providing a sustained drug release. Further, the article discusses United States Food and Drug Administration (USFDA) approved ocular drugs employing nanotechnology and future developments. It should be noted that, despite the potential therapeutic promise demonstrated by nanotechnology for ocular drug delivery, the bench to bed transition from patent inventions to marketed drug products has been insignificant. Majority of the discussed technologies are still in development and testing phase for commercial viability. Further, studies are in progress to assess ocular tolerance and nanotoxicity for prolonged use of NF.

One year ahead! Investigating the time lag between patent publication and market launch: insights from a longitudinal study in the automotive industry

Technology‐oriented companies find themselves confronted with the challenge of having to react quickly to technology‐based innovations by competitors. Especially the market launches of innovative products have the ability to change the competitive environment dramatically. This calls for the ability to discern product technologies in due time. Even though several methods of technology monitoring are based on patent information, the important time lag between patent disclosure and market launch is still unclear and volatile for reasons unknown. Therefore, we have analyzed this time lag of a respective product by way of a longitudinal case study in the field of automotive engineering. The results show that in our case, patents form a valuable information source in short‐term product technology monitoring. Hence, analyzing patents in the context of product technologies and reacting to emerging products is a race against time.

Patenting trends in enzyme related microfluidic applications

The miniaturization of continuous processes has been of interest in the academia and industry which is reflected by the increase in scientific publications and patent disclosures in the last decade. The aim of this study was to evaluate the patenting trends regarding enzyme related microfluidic applications in order to observe the progress of science and technology. The mapped patents have been classified as “immobilization method”, “biomolecule screening systems”, “integrated process development” and “microreactor design”. Half of the patent disclosures were filed by academia, whereas the other half was from industrial research which complies with the shift in microfluidics from academic and industrial research to commercial applications. Immobilization procedures carried out at room temperatures such as formulation of silica matrices using sol–gel technique, incorporation of novel hybrid materials, the integration of supercritical fluids and microfluidics, employing ionic liquids as wall-less microreactors, designing low cost, high performance microfluidic devices were the highlights which can pose challenges in various life science applications. The increasing trend is expected to continue and the presented state-of-the-art in enzyme related microfluidic applications have the potential to enhance industry's capabilities for designing innovative systems which would demonstrate significant economic, societal and environmental benefits.

Dual-Lens Electron Holography for Junction Profiling and Strain Mapping of Semiconductor Devices

Electron microscopes have been used extensively to look at structure at the nanometer scale. Most of the information obtained from electron microscopes is amplitude information. Yet, the phase information of electron microscopy, which can be obtained from off-axis electron holography, provides unique information on electronic structure and structural changes in a wide variety of materials.For the semiconductor industry, junction profiling and strain mapping in Si at high spatial resolution provide information that is critical for further scaling of semiconductor devices. Because of the complex process conditions involved to control the junction position relative to the gate position, determination of junction position at high spatial resolution can help to reduce the cost and cycle time of development. Bright-field holography can measure the phase change of electrons traversing the materials, which is directly related to the mean inner potential of Si, indicating the junction position at the nanometer scale. Furthermore, in recent years stressors have been incorporated into devices to change the semiconductor lattice constant in the channel region and thereby enhance hole and electron mobility. Like the junction definition, the extra processing steps involved to add strain in a device have increased development and manufacturing costs. One way to minimize development cycle time is to monitor, at a nanometer scale, changes in channel deformation resulting from process changes. In 2008, Hytch et al. reported that dark-field holography can provide a promising path to nanometer scale strain mapping [1]. Cooper et al. reported using dark-field holography to measure strain related to different process conditions [2, 3].The requirements of electron holography to inspect the current generation of semiconductor devices are: (1) a fringe width (fringe overlap) in the range of about 100 to 800 nm for an adequate field of view (FOV), (2) fringe spacing between 0.5 and 10 nm for meaningful spatial resolution, (3) visibility of the fringe contrast (10–30%) for useful signal-to-noise ratio, and (4) adjust-ability of both the FOV and the fringe spacing relative to the sample. In previous papers and patent disclosures, we reported that we had developed a dual-lens electron holography method on a JEOL instrument to meet the above requirements, and later we implemented the same method on FEI instruments to provide a similar operational range for electron holography [4–6]. This dual-lens operation allows electron holography to be performed from low to high magnification and provides the FOV and fringe spacing necessary for two-dimensional (2D) junction profiling and strain measurements for devices with various sizes.In this article, we describe the electron optics for this method. We also describe several examples of junction profiling and strain mapping to show how to use dual-lens electron holography to resolve semiconductor device issues at high spatial resolution.