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Recently, foreign interference has emerged as an important compliance issue for U.S. research institutions, due to efforts by foreign governments to misappropriate intellectual property and research. Consequently, federal funding agencies are now requiring research institutions to ensure compliance with foreign component regulations and to implement protections against foreign interference. This paper offers an analysis of foreign interference cases and recommendations from national committees and leading academic institutions, summarizing the geopolitical context, compliance risks, risk management strategies, and future challenges in this area. The key risks identified were the diversion of IP and research and non-disclosure of foreign sponsorship. Recommended compliance and risk management strategies include centralized work groups, monitoring and auditing, integration of foreign component compliance into research misconduct and conflict of interest and commitment policies, staff training, and security controls. Special attention should be paid to future regulations and industry standards for dual appointments and foreign talent recruitment programs and compliance with federal deemed-export and equal employment opportunity laws. Finally, foreign interference management programs should also include measures to prevent racial profiling and xenophobia, while emphasizing a commitment to international collaboration, a diverse workforce, and America's open academic system.

In Safe Harbor for the Innocent Infringer in the Digital Age (Safe Harbor), I argued that certain classes of direct innocent infringers of copyright--namely, accidental and mea culpa infringers--should be afforded safe harbor from liability in light of current accepted online practices of users deemed essential for the proper functioning and progress of the Internet and digital technology. I offered a statutory amendment to Section 512 of the Copyright Act, one that would apply specifically to direct users and protect them in ways similar to the protections currently available to online service providers. In this Article, I approach the same topic from the damages phase and argue that a user's actual or constructive knowledge of a copyright holder's rights should be a factor in determining whether the holder's damages award should be limited to the currently discretionary minimum award. Knowledge could even serve to create a presumption of culpability during the damages phase after liability has been determined. However, notice of copyright alone should not serve as a complete bar to a defendant's ability to assert an innocent infringement defense that triggers a minimum statutory damage award. This approach is fairer and more just, especially in light of the fact that copyright infringement is a strict liability offense and exposes even the ordinary, low-level infringer to damage awards that are often questioned by commentators and judges alike as egregious and, in some cases, unconstitutional. Accordingly, I argue that in lieu of--or in addition to--my user safe harbor proposal in Safe Harbor, Congress should adopt a more meaningful minimum statutory damage award under Section 504(c) for certain classes of noncommercial infringement and commercial infringement causing little or no economic harm. This proposal would apply in cases where liability is established and the use is not otherwise legally permitted or excused. It would reduce statutory damage awards for technically infringing uses that support progress because they are socially beneficial, technologically desirable, or both. In light of the Department of Commerce's 2016 Internet Policy Task Force report on statutory damages and the Copyright Office Section 512 Roundtables on the same topic, I discuss the report's findings, as well as Canada's approach to user rights for illustrative purposes, against the backdrop of my own recommendations. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this paper is to assess the financial and intellectual issues facing the university sector as many institutions in the UK pursue alternative revenue streams. As a consequence to the increasing financial pressures, university departments are increasingly exposed to new forms of potential litigation and also face the risk to the prestige of their university and departmental brand. Design/methodology/approach: A theoretical and analytical approach is adopted whereby an introduction to the topic of revenue streams is presented before a review is conducted of the two most prominent and important streams available to the higher education sector--teaching and technology transfer. The paper furthers this analysis through a discussion of the accompanying legal consequences to UK universities and offers strategies to be adopted by such institutions to avoid these pitfalls. Findings: The investigation has identified that the pursuit of additional sources of money from teaching and technology transfer pose significant risks and should only be considered after a rigorous analysis of the associated cost by institutional and departmental management structures. Originality/value: The paper offers an insight into the experience of litigation and the intellectual problems encountered by university departments in the USA. This evidence is utilised to consider how it may provide UK-based counterparts with a guide to avoid similar problems. It will be of relevance to practitioners, managers and strategic planners in the university sector.

Introduction: In 1999-2000, a Norwegian youth cracked a DVD-access code and published a decryption program on the Internet. He was sued by the US DVD Copy Control Association (DVD-CCA) and the Norwegian Motion Picture Association (MAP), allies of the US Motion Picture Association of America (MPAA), arrested by Norwegian police and charged with data crime. Two Norwegian court rulings in 2003 unanimously ruled that the program did not amount to a breach of Norwegian law, and he was fully acquitted. In the US, there have been related cases, some with other outcomes. Method: Based on a theoretical framework developed by Zwass, the paper discusses these court rulings and the wider issues of intellectual property rights versus public access rights. Analysis: The DVD-Jon case illustrates that intellectual property rights can conflict with public access rights, as the struggle between proprietary software and public domain software, as well as the SPARC and Open Archives Initiative reflect. Results: An assessment of the DVD-Jon case based on the Zwass framework does not give a clear information ethics answer. The analysis depends on whether one ascribes to consequentialist (e.g., utilitarian) or deontological reflection, and also which side of the digital gap is to be accorded most weight. Conclusion: While copyright interests are being legally strengthened, there may be ethically-grounded access rights that outweigh property rights.

Research Summary: Today's innovations rely on scientific discoveries of the past, yet only some corporate R&D builds directly on scientific output. In this article, we analyze U.S. patents to investigate how firms generate value by building on prior art "closer" to science. We show that patent value is decreasing in distance‐to‐science. Overall, we find a science premium within firms ranging from 5.0 to 18.3%. If we allow for firm sorting into different modes of R&D based on their relative advantage, that is, when we do not control for firm fixed effects, we find an even larger science premium: patents building directly on scientific publications are 4.0–42.3% more valuable than patents in the same technology that are not directly based on science. Managerial Summary: Building on scientific research allows firms to capture significantly more value from their inventions. By analyzing U.S. patents and their linkages to scientific publications, our paper describes the relationship between invention "proximity" to the scientific literature and public firm valuations—as measured in abnormal stock market returns. Our findings indicate that patents building on science are 5.0–18.3% more valuable. If we account for variations in R&D strategies among firms, the premium becomes even larger, ranging from 4.0 to 42.3%. Further, the results show that the value‐enhancing benefits of integrating scientific insights into R&D are greater for firms with more experience building on science. Together, the results underscore the competitive advantages of using science as a foundation for corporate innovation. [ABSTRACT FROM AUTHOR]

According to the Food and Agricultural Policy Research Institute, the demand for edible oils and fats is growing. Tucumã is a native Amazonian fruit with high lipids content in the pulp and kernel. The pulp oil has a high content of unsaturated fatty acids and carotenoids, mainly β‐carotene, a pro‐vitamin A. Kernel fat has high oxidative stability as it is rich in saturated fatty acids, with a predominance of lauric acid. Tucumã pulp oil and kernel fat can formulate functional fats due to their physicochemical, nutritional, and sensory properties. This paper aims to provide an overview of intellectual property and academic production about tucumã oil and fat. The increase in scientific production from 2001 to 2020 indicates that the research institutes have expanded interest in tucumã fruit. However, intellectual property using tucumã oil and fat for industrial applications is still modest. Using the selected keyword combinations, nineteen and ten papers related to pulp oil and kernel fat are met, respectively. The United States leads the patents publications related to tucumã fruit, oil, and fat (45%). Most patents are directed to the cosmetic and pharmaceutical sectors (59%), demonstrating the necessity for studies focused on applications in the food industry. Practical Applications: Tucumã pulp oil and kernel fat can be used to formulate functional fats due to their physicochemical, nutritional, and sensory properties. The tucumã pulp oil has a high content of unsaturated fatty acids and carotenoids, mainly β‐carotene, a pro‐vitamin A. The tucumã kernel fat presents high oxidative stability as it is rich in saturated fatty acids, with a predominance of lauric acid. Most patents are directed to the cosmetic and pharmaceutical sectors, which demonstrate the need for studies focused on the food industry. The small number of patents favors promising partnerships between companies and scientific institutions for the transfer of academic knowledge of new technologies applied in the food industry. [ABSTRACT FROM AUTHOR]

The article presents Economic Department working paper titled "Capturing Nanotechnology's Current State of Development via Analysis of Patents," by Masatsura Igami and Teruo Okazaki. It aims to capture current inventive activities in nanotechnologies based on the analysis of patent applications to the European Patent Office (EPO). It states that the U.S., the European Union, and Japan have almost the same share in nanotechnology patent applications to the EPO, which relies strongly on countries' existing technologies and accumulated scientific knowledge.

The article deals with the White Paper, officially known as the Intellectual Property and the National Information Infrastructure released by then U.S. president Bill Clinton on September 5, 1995. Particular focus is given on implications on visual resources collections. The factors that should be used in determining whether or not a use is fair that are covered in Section 8 of the Copyright Act are discussed. The White Paper also offers ways of protecting copyrighted works on the National Information Infrastructure (NII).

This study focuses on the scientific output of firms of different sizes in different industries m the U.S. Both patents, and papers and publications are used as measures of technical output. Data from two samples of firms, one consisting of 225 large firms (annual sales at least $250 million and minimum annual R&D budget of St million) and the other consisting of 248 small and medium sized firms (annual sales between $10 to $200 million and annual R&D budget at least SW thousand) have been presented here. The study shows that determinants of R&D expenditure are different in finns of different sizes. For the large firms, R&D expenditure depends on net income as well as its size, measured in terms of annual sales. For small size firms, R&D expenditure is closely related with sales, rather than the net income. For large firms, R&D expenditure is related to both sales and income, the latter being more important than the former. The two output measures, patents and papers are correlated, but the correlation is not a very strong one for small firms. Patent and papers are correlated significantly with both R&D expenditure as well as annual sales. The firm's growth is not linked with patents. On the contrary, there is a negative relationship between patent and R&D growth and patent and income growth in the case of small firms. Papers are not linked with growth variables for small firms. Finally. this study confirms the hypothesis that small firms are more productive in innovation than the large firms. Small firms are more efficient than their larger competitors in terms of patents and papers per million dollars of R&D expenditure. [ABSTRACT FROM AUTHOR]

Intended as a brief guide to the cultural differences associated with an East-West academic exchange, this paper discusses customs and cultural norms likely to be encountered. Chinese economic growth has been accompanied by rapidly increasing East-West study abroad opportunities. Over the past decade, China has sent more students to study abroad than any other country and the number of American students studying in China has increased exponentially (Laughlin). In many cases, both U.S. and Chinese students and faculty participating in an American academic study abroad program are inadequately prepared for, and indeed surprised, by the differences in customs they encounter. Professors and students participating in an East-West exchange were interviewed. Cultural differences are discussed and examples are presented intended to help prepare students and professors for successful "guanxi" (networking). (Contains 3 tables and 1 figure.)

Repurposing is considered an attractive approach for developing new drug products. However, it consists of challenges relating to intellectual property (IP) protection, and regulatory approvals. This study aimed to analyze the recent trends in repurposed drugs approved by USFDA from 2010 to 2020 and to assess the challenges connected with bridging study requirements, patent protection, and exclusivities. Out of 1001 NDAs, 570 were approved via 505(b)(2) pathway. Of 570 NDAs, the highest number of approvals are allied to type 5-new formulations (42.4%), followed by type 3-new dosage forms (26.4%) and type 4-new combinations (13.1%). Of 570 NDAs, 470 are considered to examine the patent and exclusivity protection of which 341 have patent and/or exclusivity. A total of 97 type-3 and type-5 and 14 type-4 drugs have been approved based on human bioavailability/bioequivalence (BA/BE) data. For 131 type-3 and type-5 and 34 type-4 drugs, the applicants conducted new clinical (efficacy and/or safety) studies along with BA/BE (100 drugs) or without BA/BE (65 drugs) studies. In this review, mechanistic reasons for conducting new clinical investigations, IP and regulatory considerations along with broader perspective on new pharmaceutical approaches employed in 505(b)(2) drugs are illustrated that provide guidance for development of reformulations and combinations., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

Many jurisdictions, including the European Patent Office (EPO), have opposition proceedings in which an interested third party can challenge the validity of the claims of an issued patent. The United States Congress is considering legislation that would introduce opposition proceedings in the USA. This paper reviews the existing EPO and proposed US opposition procedures and provides practical suggestions for dealing with oppositions. (Contains 16 notes.)

Focuses on the White Paper on Intellectual Property in the National Information Infrastructure. Educational uses of copyrighted works; Library uses of copyrighted works; Reproductions for the visually impaired; Transmissions as displays; First sale doctrine; Liability for online services operators; Devices that circumvent copyright management systems.

This paper describes the network of Patent and Trademark Depository Libraries (PTDLs), a collaborative partnership with the United States Patent and Trademark Office (USPTO) for disseminating patent and trademark information in every state plus the District of Columbia and Puerto Rico. Typical information sources and services provided at PTDLs are given, followed by suggestions of areas on which to focus in the future for PTDLs to continue to be vital links of information that spur economic growth, business competitiveness, and the continued discovery of new scientific and technological knowledge and applications. (Contains 2 tables.)

Since the mid-1980s, the percentage of the population in the United States owning a personal computer has grown from just over 8% to well over 50%, and nearly 60% of the population uses a computer at work. At the end of 2004, there were over 820 million personal computers in active use worldwide, and projections indicate that the number will surpass one billion by 2007. What was traditionally a data processing tool has increasingly become a hub of multimedia entertainment, commerce and communication. The catalyst for this continuing evolution is software, which is the interpreter that speaks to the computer on the user's behalf, and also returns visual and textual messages on behalf of the hardware. Quality software is essential, and the continued innovation of software is vital for nearly every industry and personal endeavor that has come to rely upon personal computers. Alarmingly, abuses of intellectual property laws have put software innovation in jeopardy. In the United States, the phenomenon of "software patents" has caused an increasing shift in the software industry away from an environment of rapid advances and creativity, toward a minefield of litigation, anti-competitive behavior and questionable ethics. The topic of software patents touches on a wide range of subjects including law, information and communication technology, economics, computer science and personal and professional ethics. Although the focus of this paper is the ethical issues raised by software patents, a brief background on the topics of software development, intellectual property and ethical frameworks will be presented to provide a context for the argument.

The objective of this paper is to investigate if downsizing contributes to, or impedes, a firm's intellectual capital performance (ICE) based on a longitudinal analysis of 56 United States publicly listed companies that significantly downsized their workforce during the mid-1990s. Empirical analysis indicates that for the majority of firms, ICE consistently declined annually for the first 3 years, following downsizing with a moderate increase in the fourth year. Findings provide several interesting insights and conclusions. Most importantly, downsizing appears to have a negative impact on a firm's ICE following the reduction in workforce number. The impact of downsizing appears to be more significant amongst IC resource rather than traditional (physical capital) based firms. It is recommended that corporate directors and managers seek alternative strategies to address poor performance and competitive results than immediately downsizing their workforce as such action affects ICE.

A discussion of the legal and social implications of collaboration between Australia industry and higher education institutions for the development of new technologies focuses on the forms of collaboration and the disposition of intellectual property rights between employer and employee or customer and contractor. (MSE)

This section is intended for occasional contributions from on-the-ground practitioners. Our hope is that the definition of this category of paper will inspire practitioners to submit notes and articles – typically in the range of 2,000 to 10,000 words – to the World Trade Review. As with all notes and articles submitted to the World Trade Review, manuscripts in this category will be reviewed by independent referees. However, the focus is intended to be practice oriented and at least one of the two referees will be a fellow practitioner. [ABSTRACT FROM PUBLISHER]

From 1790 to 1891, the United States prevented foreign authors from obtaining domestic copyright protection, implicitly subsidizing a domestic reprinting industry. With foreign works a "free" and unprotected resource, American publishers created a system of voluntary norms, known as "trade courtesy" to create and enforce pseudo-property rights in uncopyrighted foreign works, simulating the effects of legal copyright protection. This paper analyzes this system using the Bloomington School's institutional design principles to understand its effectiveness and pitfalls in managing the commons of unprotected foreign works in nineteenth Century America. [ABSTRACT FROM AUTHOR]

The article offers information about U.S. Patent Rights for scientists. Topics discussed include grant applications for accessibility of scientific process under Freedom of Information Act (FOIA); using of own granted application of scientists considered by Trademark Office (USPTO) Patent Trial and Appeal Board (PTAB); and inventor's submission of an advanced proof to symposium obtained from U.S. is also considered by UPSTO.

The Bayh-Dole Act of 1980 enabled American universities to engage in technology transfer. Thirty years of research has investigated the legislation's effectiveness and derivative university practices, such as the establishment of technology transfer offices. Unfortunately, the technology transfer literature has focused primarily on patenting as the primary transfer vehicle for protecting intellectual property in universities, overlooking other forms of IP ownership, such as copyrights. Legal scholarship shows, however, that universities are increasingly using copyrights to protect their intellectual property and that the number of university-held copyrights exceeds patents. This paper examines the use of copyrights to protect and transfer university IP. It does so by reviewing underlying legal and policy concepts associated with copyrights and offers contemporary examples of copyright issues within universities. The paper therefore provides a foundation for future research on the role of copyrights in technology transfer. [ABSTRACT FROM AUTHOR]

This article discusses the misalignment of the drug innovation model in the US with broader societal goals. The paper calls for a reconfiguration of this model to prioritize the common good and ensure equitable access to health innovations. The article stresses the importance of adopting a mission-oriented approach to shape the drug market, including reforming intellectual property rights. [ABSTRACT FROM AUTHOR]

This study looks at the United States biotechnology industry as a community of practice caught between two evolutionary logics by which valuable scientific knowledge and valuable innovations are selected. We analyze the publications and patents of 116 biotechnology firms during the period 1988-1995. In models that link scientific capabilities to patent citations, we show that scientific ideas are not simply inputs into inventions; important scientific ideas and influential patents follow different and conflicting selection logics. Publication, collaboration, and science intensity are associated with patented innovations; however, important scientific papers are negatively associated with high-impact innovations. These results point to conflicting logics between science and innovation, and scientists must contribute to both while inhabiting a single epistemic community. We identify individuals listed on patents and scientific papers and find they effectively integrate science with innovation, leading to more successful innovations. Our findings suggest that the role of the small, research-intensive firm is to create a repository of knowledge; to act as an organizational mechanism to combine the capabilities of versatile scientists within and outside the boundaries of the firm; and to manage the selection of scientific ideas to produce valuable technical innovations. [ABSTRACT FROM AUTHOR]

This paper examines the impact of intellectual property rights (IPR) infringement on the input (R&D spending) and output (patents) of the research process. The extant literature proxies IPR enforcement via composite indices or indicators of institutional quality, whereas this paper employs a direct (hard) measure of IPR crimes. Using data across U.S. states, results show that IPR crimes reduce research spending but do not impact patenting. Upon comparison with a broader measure of weak institutional quality (corruption), we find that greater corruption has a robust negative effect on patenting, but not on R&D spending. Quantitatively, the elasticities of R&D spending with respect to IPR crimes are greater than those of patents with respect to corruption, suggesting that studies that proxy IPR crimes via other measures are likely underestimating their impacts on technological change. [ABSTRACT FROM AUTHOR]

This paper examines how foreign intellectual property rights (IPRs) affect US bilateral exports of genetically modified crops (GMOs). We apply the structural gravity model to examine GMO trade between the United States and the countries that comprise the rest of the world. Our econometric method includes the Poisson Pseudo Maximum Likelihood estimator. We use panel data including measures of countries' IPR regimes, plant patentability, plant variety rights, GMO regulations and asynchronous approvals of GMOs. Results show the United States tends to export fewer GMO crops to countries with strong IPR regimes, plant patentability and plant variety rights. These results are consistent with the market power effect, where the United States restricts exports to countries with strong protections to extract monopoly prices. Second, enforcement of IPRs strengthens the market power effect. Third, the market power effect is strong alongside with GMO regulations and asynchronous approvals. Fourth, the market power effect is larger for self‐pollinating crops vs. hybrids. These findings are robust across a variety of specifications. However, we also find a price premium in countries with less ease of US market access, with more domestic production of GMOs, and with weak traceability requirements. These features play a stronger role than IPRs in determining price. [ABSTRACT FROM AUTHOR]

Innovation inducement prizes have been used for centuries. In the United States, a recent federal policy change-the America COMPETES Reauthorization Act of 2010-clarified and simplified a path by which all federal agencies can offer innovation inducement prizes, thus intensifying interest in how government agencies can most effectively design and apply such prizes. This paper aims to review and synthesize the academic literature on innovation inducement prizes, to clarify what has been learned that is relevant to current policy discussions, and to highlight unresolved questions that would be fruitful areas for future academic research and policy experimentation. Relative to the existing literature, this paper aims to bridge two gaps. First, I synthesize the academic literature in this area with an eye toward drawing lessons for the types of innovation inducement prizes under consideration by federal agencies under the America COMPETES Reauthorization Act. Second, I discuss the problem of how to evaluate the success or failure of innovation inducement prizes, arguing that careful empirical evaluations of innovation inducement prizes are needed in order to provide guidance to federal agencies (and others) on how to most effectively apply and design innovation inducement prizes. [ABSTRACT FROM AUTHOR]

Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS) was laid on the premises of rewarding monopolistic patent rights to the innovator. Stronger patent protection was advocated to promote technology transfer from developed nations to the rest of the world. To boost domestic innovative potential and to maintain trade ties, most developing countries signed the TRIPS agreement. Impact of patent laws in the pharmaceutical industry was crucial as it posed threat to access health. This paper aims to analyze the impact of pharmaceutical product patent laws incorporated under the TRIPS agreement using 65 countries panel dataset from 1995 to 2016. The data is empirically analyzed using negative binomial regression and Poisson regression. Results clearly indicate that the number of pharmaceutical patents filed in US Patent and Trademark Office (USPTO) has decreased after TRIPS compliance in both low and middle income countries. However, the decline is larger in upper middle and lower middle income countries than in low income countries. The phenomenon of low patent activity has an increasingly declining trend across low and middle income countries. Hence the claimed hypothesis that stronger patent rights would increase innovative potential does not seem to stand true, which raises serious affordability concerns of bringing patents in the pharmaceutical sector. [ABSTRACT FROM AUTHOR]

In this paper, we derived a high-efficiency formula for calculating the precision of carrier phase relative positioning, analyzed the various factors that affect the positioning accuracy using the carrier phase, and proposed the concept of using a frequency dilution of precision to describe the quantitative effect of different frequency combinations on the positioning precision. To this end, we computed and plotted the global spatial distribution map of the relative positioning dilution of precision for single-day solution, half-hour solution, and single-epoch solution of the global positioning system (GPS), regional Beidou navigation satellite system (BDS2), future global Beidou navigation satellite system (BDS3), and their fusion systems. Using processing software with autonomous intellectual property rights (GCN and VENUS/ARSNet), we solved the measurement data and examined the positioning precision of the single-day solution and single-epoch solution of GPS and BDS2. The analysis demonstrated that the B1/B2 frequency positioning precision of BDS2 was better than that of L1/L2 frequency positioning of GPS, but the positioning precision of the BDS2 is worse than that of GPS over most of the service region of the BDS2. Further, the positioning precision of BDS3 is better than that of GPS in the Asia-Pacific region, while it is the opposite in other regions. Based on these conclusions, we put forth some optimization recommendations regarding the signal frequency of the navigation system and GPS measurement standards to serve as references for optimizing the system performance and formulating standards. [ABSTRACT FROM AUTHOR]

Patent rights are recognized as a property asset with an attendant right to exclude. However, recent policy developments highlight that the right to exclude is not inviolable. This paper explores two rapidly evolving exceptions to patent exclusivity, both of which take the form of compulsory licenses. First, under the international Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS"), national governments can compel patent owners to out-license technology in service of greater good. These egalitarian compulsory licenses improve access to technology but undermine patent value. Second, compulsory licenses are increasingly relied upon as an equitable remedy in U.S. patent litigation. Typically referred to as "ongoing royalties," these court-mandated compulsory licenses are a modern alternative to injunctions against adjudged infringers. TRIPS compulsory licenses and ongoing royalties arise under independent legal frameworks, but necessarily invoke parallel economic considerations. While the wisdom of each has been discussed at length by others, this paper explores principles of royalty determination employed in each context. Considering both frameworks, an analysis of where each succeeds and fails is provided, together with an exploration of optimized royalty frameworks.

In copyright law, the useful articles doctrine plays a significant role in defining the limits of copyright's domain and the boundary between copyright and patent. But the implicated notion of "conceptual separability" has proved to be difficult to define, and the Supreme Court's effort to define it in the recent case Star Athletica, L.L.C. v. Varsity Brands, Inc. is unsatisfying. In an effort to resolve this challenge, the present paper puts forth a novel test for conceptual separability, one that draws inspiration from the philosopher's idea of conceivability. The test is the following question: "When you conceive of the relevant useful article as lacking the design element in question, is the article you imagine functionally identical to the actual article?" If the answer to this question is yes, then the design element is conceptually separable from the article's utilitarian aspects; if not, then the element has failed the test, and it is not entitled to copyright protection. The present paper explores why this novel proposal avoids many of the pitfalls of existing tests (including the Court's own in Star Athletica), why it best achieves the aims of the useful articles doctrine, and what questions remain once the challenge of conceptual separability has been resolved. [ABSTRACT FROM AUTHOR]

Purpose Antimicrobial resistance is a public health threat even in countries exercising aggressive antimicrobial stewardship. A market failure is also causing lackluster innovation in antimicrobial medicines development. At the heart of the issue are antimicrobial stewardship guidelines that, rightfully, reserve innovative antimicrobials for emergency situations that arise due to multidrug-resistant organisms. This suppresses revenues and research and development (R&D) investment incentives of manufacturers. The public policy makers and researchers have taken aim at the problem. The researchers have published strategies to encourage the production of innovative antimicrobials, while policy makers have taken legislative steps to address the issue. Most notably, the USA enacted the Generating Antibiotic Incentives Now (GAIN) act in 2012 and the EU created a commission to formally study possible policy solutions. The paper aims to discuss these issues.Design/methodology/approach In this paper, the authors describe incentives that drive pharmaceutical R&D and review the impact of a number of R&D stimulus policies in other pharmaceutical markets. The authors also discuss which policy levers are useful to boost R&D of new antimicrobials.Findings The authors find that a policy focused on extending intellectual property rights, as implemented in the GAIN act, are unlikely to be impactful. Instead, the authors see a need for the revision of the procurement policy to move away from paying per prescription and toward licenses and advanced market commitment models. Further, the authors note that the importance of steadfast public investment in basic biomedical research as it has been repeatedly shown to boost innovation.Originality/value The authors hope that the work can support the refinement of the GAIN act and the EU efforts. [ABSTRACT FROM AUTHOR]

U.S. IP law has grappled with the issue of non-human authorship and inventorship since the middle of the twentieth century when computer systems were first used in the generation of music and imaginative ideas. Today's advanced Artificial Intelligence (AI) systems have "created" numerous works including musical compositions, art, writings, recipes, and potentially patentable inventions. However, common-law, along with the policies and procedures of the U.S. Copyright Office and the U.S. Patent and Trademark Office, rejects the idea of non-human authorship or inventorship. These doctrines are not based off statutory requirements but on assumptions about computer capabilities stemming from an analysis done in the midtwentieth century, almost 40 years ago. Other contributors to this question have denied that AI authorship should ever be allowed or that AI should be treated as inert tools of creation no different than cameras or photocopiers. However, both approaches fail to appreciate the independent creation of modern AI's that process information in ways much like human brains--well beyond simple mechanical devices using simple mathematical algorithms. Thus, this paper argues for recognition of AI authorship and inventorship. To that end, this paper presents a framework to analyze when such rights should be recognized based on (1) the subject matter (i.e., independence of the work) and (2) the causation (i.e., independence of the AI). In addition, the framework introduces an IP rights assignment regime like "work-for-hire" and "employed-to-invent" based on the nexus between the AI and the natural persons programming and/or using it. This approach avoids the complication of naming an AI as a legal or natural person under the law. [ABSTRACT FROM AUTHOR]