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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]

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.)

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]

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 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]

How do intellectual property rights influence academic science? We investigate the consequences of the introduction of software patents in the United States on the publications of university researchers in the field of computer science. Difference-in-difference estimations reveal that software scientists at US universities produced fewer publications (both in terms of quantity and quality) than their European counterparts after patent rights for software inventions were introduced. We then introduce a theoretical model that accounts for substitution and complementarity between patenting and publishing as well as for the direction of research. In line with the model's prediction, further results show that the decrease in publications is largest for scientists at the bottom of the ability distribution. Furthermore, we evidence a change in the direction of research following the reform toward more applied research. [ABSTRACT FROM AUTHOR]

Nation-states take steps to prevent the theft of domestic entities' trade secrets and other intellectual property ("IP"). The United States has issued complaints, passed laws, and implemented initiatives and sanctions targeting China's unfair and illegal economic practices, which include trade-secret theft. Although China has responded by amending its civil, criminal, and administrative trade-secret regime, foreign companies still routinely struggle with thefts connected to China. The semiconductor industry-essential to daily-life, commercial, and military needs-is one of the most brutal battlegrounds of today's IP and tech wars. A leader in the industry is the Taiwanese semiconductor sector, which, along with the Taiwanese government and like-minded democracies, must confront a particularly complex set of economic, security, and geopolitical challenges from China. Currently, poor grasp of cross-border trade secret thefts has greatly weakened sincere efforts to deal with the grave threat posed by China. In this Article, I cross-analyze empirical quantitative and qualitative data regarding U.S. and Taiwanese semiconductor trade-secret litigation to better understand the dynamics of Chinese trade-secret theft. I propose that individuals, companies, governments, and international organizations should respond to trade-secret threats by restoring trust within a geopolitical economic framework, rather than by pursuing purely legalistic IP approaches. [ABSTRACT FROM AUTHOR]

The article focuses on addressing the challenges and opportunities presented by the advancement of artificial intelligence (A.I.) technology within the context of intellectual property laws in the U.S. It argues for the inclusion of A.I. as authors and inventors within copyright and patent laws, advocating for legal recognition and protection of A.I.-generated creative works and innovations.

This study estimates the industry‐specific effects of international investment agreements (IIAs) on foreign direct investment (FDI) by focusing on how intellectual properties are intensively used in industries (i.e. knowledge intensity). It also considers the country‐level heterogeneity in the effects of IIAs by focusing on the intellectual property rights (IPR) protection in host countries and addresses the issue of why there is no consensus on the effects of IIAs among the previous studies. Using data of US outward FDI for the period 1999–2018, it finds that the IIAs between the United States and 56 countries promote FDI from knowledge‐intensive industries into countries with weak IPR protection. This result supports the hypothesis that IIAs have a positive effect on FDI if IIAs substitute for the weak legal protection of IPR in host countries. [ABSTRACT FROM AUTHOR]

In the United States and Canada, the legal framework for defining and protecting intellectual property (IP) rights has largely fallen under copyright, trademark, and patent legislation. Traditionally, the requisite requirement for IP protection was that a human contributed to creating the IP. However, the advent of artificial intelligence (AI) disrupts the existing IP frameworks. AI and machine learning systems create original IP by analyzing vast quantities of data. From there, data sets are combined, forming new IP. Without a human's contribution to the final product, the existing IP legal frameworks are inadequate to provide copyright protection to AI-generated creativity, trademark protection to AI-driven brand development, or patent protection to AI-built inventions. The gaps in legislation thus leaves room for uncertainty and exploitation of the IP. Without a legal framework, courts lack power to render consistent interpretations in the event of conflict resolution. The lack of reliable enforcement can thus impact ethical application of IP, since accountability safeguards are non-existent. [ABSTRACT FROM AUTHOR]

Contract law has lost its way. Designed as a way to allow people to agree, it has over time become a means for large businesses to unilaterally impose terms and conditions on others. Ironically, courts are more willing than ever to defer to the words of those documents even as the documents are less and less likely to reflect any agreement between the parties. That deference is not justified by the realities of modern contract law. We have a set of default rules for contracts in the Uniform Commercial Code and the common law of contracts. Parties can and should be able to agree to change some (though not all) of those rules. But doing so should require a mutual intention to do so. And in the modern world most contracts don't involve any actual agreement. I propose a presumption that standard form contracts are subject to and cannot vary the default rules of contract law. The parties can vary those rules only by express agreement and only when the parties make an informed choice to do so. Except in a negotiated contract setting between sophisticated parties, that informed choice should require the party offering the form contract to offer a choice between their proposed terms and the basic default rules of contract law. [ABSTRACT FROM AUTHOR]

On March 15, 2022, the United States, European Union, India, and South Africa reached an agreement on the waiver of intellectual property rights (IP rights) for COVID-19 vaccines. The waiver agreement has rekindled the debate on the balance between IP rights protection and equitable access to medicines during a public health crisis. India, South Africa, and other developing countries maintain that a waiver was the only way to make vaccines affordable and accessible. Leading pharmaceutical companies argue that the waiver will stifle innovation and make lifesaving medicines less accessible. Both sides have seemingly overlooked Pfizer's voluntary agreement with the Medicines Patent Pool (MPP) to share the IP rights for Paxlovid, the company's highly effective COVID-19 medicine. Based on a careful examination of Pfizer's agreement, this Article argues that the MPP presents an effective alternative to the waiver approach and concludes that the Pfizer-MPP model has the potential to reach an equilibrium between access and innovation. [ABSTRACT FROM AUTHOR]

When Michael Jackson died unexpectedly in Los Angeles, California, on June 25, 2009, his career and earnings were nearing an all-time low. Plagued by past sexual abuse allegations, scandals, and questionable health, Michael Jackson's personal finances were purported to be in complete disarray. However, following his unexpected death, the value of his estate, which was reported to be near to nothing, swelled as the world remembered his beloved contributions to the world and began to purchase accordingly. Sales of Michael Jackson's music began to soar high. The estate's value soared even higher as it signed licensing agreements and released new feature films and theatrical material of Michael Jackson. Not surprisingly, the Internal Revenue Service ("IRS") and the estate disagreed over the amount of estate tax owed. The IRS also remembered how beloved Michael Jackson had been and decided to take issue with the valuation used on the estate's tax return. There were three primary points of valuation disagreement, all of which involve intellectual property rights: (1) the estate's image and likeness rights; (2) the estate's share of the Sony/ATV music catalog; and (3) the estate's interest in Mijac Music, a music publishing catalog owning copyrights to many compositions written by Michael Jackson and other artists. With neither side willing to budge on its valuations, the dispute was to be settled in the U.S. Tax Court of Judge Mark Holmes. One would think that with the outcome of such a high-profile case resting almost exclusively on the testimony of valuation experts, the IRS would take great care with any experts selected to testify since any error on the part of an expert would have a damning effect on the entire case. However, one would be disappointed. The IRS's sole expert witness perjured himself in court testimony. In its opinion, the court reasoned that the expert's creditability "suffered greatly at trial" and his lack of creditability "affected our factfinding throughout [the case]." The article discusses: (1) the rise and fall of Michael Jackson during his life; (2) the details of the valuation battle with the IRS that took place after his death over various intellectual property; and (3) Judge Holmes' reasoning for his conclusion, including the perjury committed by the IRS' expert. [ABSTRACT FROM AUTHOR]

This paper explores the economic incentives for medical procedure innovation. Using a proprietary dataset on billing code applications for emerging medical procedures, we highlight two mechanisms that could hinder innovation. First, the administrative hurdle of securing permanent, reimbursable billing codes substantially delays innovation diffusion. We find that Medicare utilization of innovative procedures increases nearly nine-fold after the billing codes are promoted to permanent (reimbursable) from provisional (non-reimbursable). However, only 29 percent of the provisional codes are promoted within the five-year probation period. Second, medical procedures lack intellectual property rights, especially those without patented devices. When appropriability is limited, specialty medical societies lead the applications for billing codes. We indicate that the ad hoc process for securing billing codes for procedure innovations creates uncertainty about both the development process and the allocation and enforceability of property rights. This stands in stark contrast to the more deliberate regulatory oversight for pharmaceutical innovations. [ABSTRACT FROM AUTHOR]

A low-quality patent system threatens to slow the pace of technological progress. Concerns about low patent quality are supported by estimates from litigation studies suggesting that most US patents granted should not have been issued. We propose a new model for measuring patent quality, based on equivalent patent applications submitted to multiple offices. Our method allows us to distinguish whether low-quality patents are issued because an office implements a low standard or because it violates its own standard. The results suggest that quality in patent systems is higher than previously thought. Specifically, the percentage of granted patents that are below each office's own standard is under 10% for all offices. The Japanese patent office has a higher percentage of granted patents below its own standard than those from Europe, the USA, Korea, and China. This result arises from the fact that Japan has a higher standard than other offices. (JEL O34, K2, L4, F42) [ABSTRACT FROM AUTHOR]

Strength training history is an emerging academic area. The aim of the current study was to describe quantitively the history of inventions for strength training equipment. Content analysis was conducted of patent applications for strength training equipment filed with the U.S. Patent and Trademark Office before 1980. Applications were identified using relevant keyword searches in Google Patents. A total of 551 patent applications were analyzed. The earliest application identified was filed in 1860. Applications never exceed 6 per year until 1961 after which applications increased substantially, with a peak of 54 in 1979. Men invented 98.7% of all strength training devices. Lloyd J. Lambert, Jr. was the most prolific inventor, with 10 inventions. Types of inventions included mobile units (34.5%), stationary machines (27.9%), dumbbells (16%), racks or benches (8.0%), barbells (6.7%), and Indian clubs (3.8%). Common features included seats or benches (18.7%), cable-pulley systems (15.1%), weight stacks (8.2%), weight trays (4.5%), and cams (2.2%). Common types of resistance included weights or plates (33.2%), springs (11.6%), friction (9.1%), elastic bands (5.3%), and hydraulic (3.8%). Proposed invention benefits included adjustable resistance (37.4%), inexpensive (36.1%), simple to use (32.8%), compact design or easy storage (27.0%), multiple exercise options (26.1%), safety and comfort (25.4%), effectiveness (23.6%), portability (20.5%), adjustable size(15.8%), sturdiness or durability(15.8%), home use(13.6%),and light weight(13.6%). Certain aspects of strength training equipment have evolved over time. However, overall purposes and benefits of inventions have remained constant (e.g., affordability, convenience, personalization, safety, and effectiveness). [ABSTRACT FROM AUTHOR]

Policy makers and international institutions have long maintained that the global business environment is best supported when countries harmonize by adopting substantially uniform legal structures. This is particularly true in the context of intellectual property rights. When such national systems are similar, we believe that investment is undergirded and market participation is facilitated. However, this assumption may be incorrect in some cases. Marginal disharmony in certain intellectual property rights may provide countries space for experimentation while not impeding effective management of global intellectual property portfolios at the firm level. As evidence, we look to the utility model. This long‐standing form of invention right is conspicuously and surprisingly unstandardized across the world, yet our analysis, using PATSTAT data, reveals that firms are able to negotiate this disharmony effectively. We employ a novel empirical method that tracks U.S.‐priority patents to establish that firms use utility models to optimize their overall appropriability needs by region. Our study finds evidence that a firm may choose standard patent protection in one region and utility model protection in another, even though standard patent protection is available in both settings. We propose that a "zone of appropriability preference" exists when utility models and standard patents overlap, and this zone provides important strategic opportunities to firms with global intellectual property portfolios. Our study thus provides an important counter‐case for harmonization of national intellectual property laws. As a result, we suggest that such efforts be undertaken with more caution; in some cases, harmonization may do more harm than good. [ABSTRACT FROM AUTHOR]

Background: Transparency and accountability are essential components at all stages of the trade negotiation process. This study evaluates the extent to which these principles were upheld in the United States' public consultation process during the negotiation of the United States-Mexico-Canada Agreement (USMCA), with respect to public comments about the pharmaceutical sector and access to medicines.Results: The public consultation process occurred before the start of official negotiations and was overseen by the Office of the United States Trade Representative (USTR). It included both written comments and oral testimony about US trade negotiation objectives. Of the written comments that specifically discussed issues relating to pharmaceuticals, the majority were submitted by private individuals, members of the pharmaceutical industry, and civil society organizations. Nearly all comments submitted by non-industry groups indicated that access to medicines was a priority issue in the renegotiated agreement, with specific reference to price affordability. By contrast, more than 50% of submissions received from members or affiliates of the pharmaceutical industry advocated for strengthened pharmaceutical intellectual property rights, greater regulatory data protections, or both. This study reveals mixed outcomes with respect to the level of transparency achieved in the US trade negotiation process. Though input from the public at-large was actively solicited, the extent to which these comments were considered in the content of the final agreement is unclear. A preliminary comparison of the analyzed comments with the USTR's final negotiating objectives and the final text of the USMCA shows that several provisions that were advanced exclusively by the pharmaceutical industry and ultimately adopted in the final agreement were opposed by the majority of non-industry stakeholders.Conclusions: Negotiators could increase public transparency when choosing to advance one competing trade objective over another by actively providing the public with clear rationales for their negotiation positions, as well as details on how public comments are taken into account to form these rationales. Without greater clarity on these aspects, the public consultation process risks appearing to serve as a cursory government mechanism, lacking in accountability and undermining public trust in both the trade negotiation process and its outcomes. [ABSTRACT FROM AUTHOR]