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Describes a survey of 33 British, French, German, and U.S. abstract journals that examined their coverage of patent specifications. The standards for the identification of patent documents developed by the World Intellectual Property Organization are discussed, and an appendix provides a listing of the patent coverage by the country of each journal. (3 references) (CLB)

We examine innovation following the Great Depression using data on a century's worth of U.S. patents and a difference-in-differences design that exploits regional variation in the crisis severity. Harder-hit areas experienced large and persistent declines in independent patenting, mostly reflecting the disruption in access to finance during the crisis. This decline was larger for young and inexperienced inventors and lower-quality patents. In contrast, innovation by large firms increased, especially among young and inexperienced inventors. Overall, the Great Depression contributed to the decline in technological entrepreneurship and accelerated the shift of innovation into larger firms. [ABSTRACT FROM AUTHOR]

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]

Purpose To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2024 in the United States, with a focus on the nonfederal hospital and clinic sectors. Methods Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2024 were reviewed—including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, endocrine drugs, generics, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2024 were based on a combination of quantitative analyses and expert opinion. Results In 2023, overall pharmaceutical expenditures in the US grew 13.6% compared to 2022, for a total of $722.5 billion. Utilization (a 6.5% increase), new drugs (a 4.2% increase) and price (a 2.9% increase) drove this increase. Semaglutide was the top drug in 2023, followed by adalimumab and apixaban. Drug expenditures were $37.1 billion (a 1.1% decrease) and $135.7 billion (a 15.0% increase) in nonfederal hospitals and clinics, respectively. In clinics, increased utilization drove growth, with a small impact from price and new products. In nonfederal hospitals, a drop in utilization led the decrease in expenditures, with price and new drugs modestly contributing to growth in spending. Several new drugs that will influence spending are expected to be approved in 2024. Specialty, endocrine, and cancer drugs will continue to drive expenditures. Conclusion For 2024, we expect overall prescription drug spending to rise by 10.0% to 12.0%, whereas in clinics and hospitals we anticipate an 11.0% to 13.0% increase and a 0% to 2.0% increase, respectively, compared to 2023. These national estimates of future pharmaceutical expenditure growth may not be representative of any health system because of the myriad of local factors that influence actual spending. [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]

This study provides a comprehensive analysis of global patent trends in battery recycling, focusing on secondary batteries and related technologies across Korea, China, and the United States. The methodology involved collecting data from various patent databases, followed by quantitative analysis to identify technology trends and guide future development. The research employed statistical tools to analyze patent activities, including the frequency and scope of patent filings, and comparative analysis to highlight differences between countries. This study reveals distinct emphases on technologies such as lithium-ion and waste battery recycling, highlighting notable differences in patent activities among key companies and countries. China's large number of patents in battery manufacturing processes contrasts with the USA's focus on electrochemical cell construction and storage systems, while Korea shows significant activity in waste battery technology. The novelty of this paper lies in its detailed comparative analysis of patent trends across these three major economies, providing insights into the technological focuses and priorities of each country. The study also identifies key challenges, such as the need for consistent innovation and broader geographic coverage in Korea, enhancing patent influence and international presence in China, and ensuring high patent quality and fostering innovation in lagging sectors in the United States. Addressing these challenges through enhanced collaboration, increased R&D investments, and supportive policies is crucial for strengthening the global position and driving further innovation in the battery recycling sector. [ABSTRACT FROM AUTHOR]

Medical devices can seek patent term extensions (PTEs), which extend market exclusivity to compensate for delays related to clinical trials and regulatory review. Pharmaceutical companies commonly use PTEs, but their use by medical device companies has not been clear. We examined the use of PTEs by medical device companies between 1984 and 2024 using a database published in the Federal Register and a list published by the Patent and Trademark Office. Only 178 medical device submissions were linked to a PTE application. They were mostly concentrated in 116 product codes associated with 15 medical specialties; nearly half were associated with cardiovascular devices. Numbers increased significantly in the past decade. Successful applications restored 987 days on average. The patent restoration opportunity appears underutilized. It is unclear whether some companies do not recognize the opportunity it promises, or whether it does not meet their needs. Different business features and marketing strategies in device versus pharmaceutical industries may decrease the usefulness of the PTE program for these types of medical products. However, the finding that a small subset of manufacturers operating in competitive markets adopted patent extension strategies more commonly suggests a significant competitive advantage when competition increases. [ABSTRACT FROM AUTHOR]

Agricultural mechanization plays a pivotal role in transforming the farming sector across the globe. The number of patents granted in the field of agricultural mechanization hold significance as they encourage innovation, protect intellectual property and drive technological advancements. The present study examined patents data collected from XLPAT database, wherein 500,000 records out of which 479,010 patent grants/applications were considered. Trajectory of patents during COVID pandemic showed there was an apparent downturn in both the quantity of patent applications submitted and the number of patents officially granted. Developed countries have exhibited varying trends in agricultural mechanization and patent activities. China, the United States and India stand as examples. China has rapidly adopted mechanization in its agriculture, contributing to higher yields and efficiency. The United States has a long history of mechanized farming, and its advancements in this field have greatly impacted global agriculture. The standardization of reaping and threshing offer better agricultural equipments by agricultural startups. Expansion of patents in farm mechanization has led to increased productivity, resource efficiency, equity for small and marginal holders, affordability, eco-consciousness and food security. [ABSTRACT FROM AUTHOR]

The geography of urban innovation in the United States has often been portrayed as dominated by a few large cities. However, emerging perspectives challenge this notion by highlighting the significance of secondary cities for innovation processes. Unfortunately, prevailing narratives and empirical evidence focus on technological invention only, measured by patents. This study aims to reevaluate the geography of urban innovation by considering various phases of the innovation process and incorporating a broader range of innovation types. In addition to conventional patent metrics, this research suggests incorporating trademarks and design rights as complementary data. The findings reveal that large cities still exhibit prominence when examining absolute counts of innovation. Instead, analysing intensities allows the identification of secondary cities that specialise in various innovation activities beyond technological invention only. Overall, the findings provide compelling evidence that urban innovation in the United States is not limited to a few large cities nor is it solely driven by technological invention. [ABSTRACT FROM AUTHOR]

Patent monetisation is an important source of revenues worldwide. This activity is increasingly carried out by patent assertion entities (PAE), which are at the origin of about 40% of infringement actions filed in the United States. This paper uses an original database of US patents reporting PAE patent acquisitions. We document two key empirical facts about the presence of PAEs in the market for patents. First, PAEs build large patent portfolios and contribute significantly to patent transfers in the US. Second, their impact on follow-on innovation is, on average, negative. With a series of dynamic diff-in-diffs analyses, we estimate a significant post-transfer drop in forward citations received by patents acquired by PAEs. This drop is not immediate but takes some years to materialise. Heterogeneity tests show that our results are driven by acquisitions of old and highly cited patents, as well as by patent acquisitions by large patent aggregators. [ABSTRACT FROM AUTHOR]

The absence of observable innovation data for a firm often leads us to exclude or classify these firms as non-innovators. We assess the reliability of six methods for dealing with unreported innovation using several different counterfactuals for firms without reported R&D or patents. These tests reveal that excluding firms without observable innovation or imputing them as zero innovators and including a dummy variable can lead to biased parameter estimates for observed innovation and other explanatory variables. Excluding firms without patents is especially problematic, leading to false-positive results in empirical tests. Our tests suggest using multiple imputation to handle unreported innovation. [ABSTRACT FROM AUTHOR]

Biosimilar market launch delays are likely costing healthcare systems billions of dollars and preventing patients accessing affordable biologic therapies sooner. Many claim these delays are mostly caused by originator biologics' large patent portfolios asserted during litigation against biosimilar developers, particularly that the manufacturing patents filed after the originator is approved is an important driver of these delays. Our objective was to investigate the accuracy of these claims. We reviewed US Court document submissions for litigation data, including the details of patents asserted against biosimilar owners, and collated biosimilar market launch dates from publicly available databases. We find that, although approximately half of all patents asserted in litigation were manufacturing patents, a greater proportion of composition, active pharmaceutical ingredient, and treatment patents are associated with longer market launch delays, whereas a greater proportion of manufacturing patents are associated with shorter market launch delays. Our results suggest that manufacturing patents were having less of an impact on market launch delays than other types of patents. Our findings have implications for both biosimilar and originator developers, as well as patent policy and its association with healthcare accessibility. • Although it has been claimed that manufacturing patents filed after the originator is approved are a key driver of biosimilar market launch delay, we lack a detailed empirical understanding of the association between the number and types of patents asserted in litigation by originator owners in the United States and how that affects litigation outcome and length of biosimilar commercial market entry delay. • It was found, unexpectedly, that manufacturing patents were having less of an impact on market launch delays than other types of patents, which is contrary to current thinking. • These findings support greater efforts at exploring and addressing biosimilar market launch delays caused not just by manufacturing patents, but also active pharmaceutical ingredient, composition, and treatment patents and the broader implications for patent policy. [ABSTRACT FROM AUTHOR]

Patent intellectual property in social informatics with entrepreneurship support creates greater opportunities to improve human life. It has the potential to open enormous innovation opportunities in various fields, such as technology, health, services, and society. This research was conducted to review the patent landscape and the main trends of patents on social informatics in all countries. Researchers applied a patent landscape analysis using data on 487 patent documents over 16 years from the Lens.org database. The study results show yearly patented development patterns related to social informatics. There is a royalty-free opportunity by using 15 patent discontinued. Patent related to social informatics was dominated by company ownership and inventors from the United States. The patent physics (G) section overwhelmed patents related to social informatics. There were 334 simple family patents on social informatics in nine jurisdictions; the United States was the highest. [ABSTRACT FROM AUTHOR]

This study aims to identify global trends in intellectual property patents and the patent landscape related to social media in education. Researchers applied a patent landscape analysis using data on 17,471 patent intellectual property documents from the Lens database. The study results show that every year, in general, the number of patents about social media in education is rising. There are entrepreneurial opportunities without paying royalties using 3,623 patent discontinues related to social media in education. Patent intellectual property related to social media in education is dominated by company ownership and inventors from the United States. Patents related to social media in education are dominated by the physics (G) and electricity (H) sections. There are 8,260 simple family social media patents in education in 7 jurisdictions of countries or regions and the highest in the United States. [ABSTRACT FROM AUTHOR]

Knowledge of patents relevant to business analytics (business analytics) is very important for entrepreneurs and companies in developing environmentally friendly business and innovation strategies. This study aims to find out the patent landscape and the main trends in patent intellectual property on the topic of business analytics around the world by using bibliometric analysis. Researchers applied an analysis of the patent landscape using data on 4,731 patent intellectual property documents from the Lens database. The results of the study show that every year in general there is an increasing trend in the number of patents related to the field of business analytics. Patents related to business analytics are dominated by the physics (G) and electricity (H) patent sections. There is an entrepreneurial opportunity without paying royalties by using 234 patent discontinues related to business analytics. Intellectual property patents related to business analytics are dominated by company ownership and inventors from the United States. There are 2,143 simple family patent business analytics in 12 jurisdictions of countries or regions and the highest is the United States. [ABSTRACT FROM AUTHOR]

In recent months, pharmaceutical manufacturers have brought legal challenges to a provision of the 2022 Inflation Reduction Act (IRA) empowering the federal government to negotiate the prices Medicare pays for certain prescription medications. One key argument made in these filings is that price negotiation is a "taking" of property and violates the Takings Clause of the US Constitution. Through original case law and health policy analysis, we show that government price negotiation and even price regulation of goods and services, including patented goods, are constitutional under the Takings Clause. Finding that the IRA violates the Takings Clause would radically upend settled constitutional law and jeopardize the US's most important state and federal health care programs. [ABSTRACT FROM AUTHOR]

The process of "knocking off" the work of others has been an integral practice of the United States ready-to-wear industry since the 1890s. In the 1930s, the Fashion Originators Guild of America (FOGA) created an internal system to protect its members' design work, but in 1941 this system was declared in restraint of trade, and the next best protection option laid in the US design patent system. This research examines the 4,523 dress patents issued in the United States between 1936 and 1942, focusing on the designers and/or manufacturers represented and the process and timing of patent applications. Analysis of select court cases of design patent infringement, including a case study of a patent for "The Perfect Dress" by leading FOGA member and ready-to-wear dress manufacturer Samuel Zahn, demonstrates the difficulty of protecting a patented dress design and the complicated nature of what constituted an original design. [ABSTRACT FROM AUTHOR]

The United States' patent system provides a framework for the protection of an inventor's intellectual property: their inventions. A valid utility patent is useful, novel, and nonobvious. Patents incentivize an inventor to disclose their invention to the public in exchange for limited-in-time, exclusive rights to practice their invention. The United States Patent and Trademark Office (USPTO) vets patent applications for validity. After the USPTO grants a patent, the patent remains subject to administrative review proceedings. These proceedings allow the USPTO to review a patent's validity. One such proceeding is inter partes review ("IPR"). An IPR is an adversarial process in which a third-party petitioner challenges a patent's validity. First, the USPTO must institute the IPR. Then, the Patent Trial and Appeal Board (PTAB) makes a final decision to determine whether the challenged patent still contains valid claims. The America Invents Act (AIA), which codified the IPR procedure, grants the USPTO's Director authority to make the institutional IPR decision and grants the PTAB authority to make the final IPR decision. However, by regulation, the Director delegated their institutional decision-making authority to the same PTAB panel that also makes the final IPR decision. This delegation of authority is problematic because it ignores Congress's legislative intent and the AIA's plain language. PTAB panel judges are susceptible to clear biases when they make both IPR decisions because of this delegation. Biases among PTAB panel judges violate a patent owner's due process rights. Further, the appearance of bias in the IPR process diminishes public credibility of the patent system. To fix blatant defects in IPR procedure, this Comment argues that the Supreme Court should bifurcate the two IPR decisions by requiring one group of PTAB judges to make institutional IPR decisions only and a separate group of PTAB judges to make final IPR decisions only. [ABSTRACT FROM AUTHOR]

This paper investigates the effect of patenting uncertainty on innovations. Although the patent system was established to provide incentives and certainty of returns to innovators, the patenting process itself contains elements of uncertainty, including pendency and variation in grant ratios. We use time series data on patent applications and patent grants from the United States and measure patent uncertainty in terms of variation in the grant ratio, i.e., the difference in the number of patent applications and the number of patent grants. Findings show that greater patent uncertainty has a depressing effect on innovation rates. Moreover, our findings reveal important differences between the short-run and long-run effects and between overall patents and utility patents. We also consider the effects of the America Invents Act and find that the Act led to more patent applications. Besides adding to the literature, these findings underscore the point that transaction costs of patenting might be undermining the intent of innovation policy by reducing innovation. [ABSTRACT FROM AUTHOR]

In the last sixteen years, software-related inventions have encompassed the majority of all utility patents issued in the United States. Further, studies estimate that spending within the global information technology market will grow to $4.6 trillion in 2023, as industries such as data security, cloud computing, and artificial intelligence continue to innovate and expand at alarming rates. Needless to say, software is a crucial and ever-expanding industry for the global economy. In a series of recent cases, however, the Supreme Court injected unpredictability into the patenting of software and computer-implemented inventions by overhauling the long-standing patentable subject matter doctrine. Embodied in § 101 of the Patent Act, the "patentable subject matter" requirement for patent protection refers to the basic substantive categories of invention that Congress and the courts have considered to be appropriate for patenting. The Supreme Court's recent jurisprudence has massively expanded subject matter eligibility restrictions under § 101, thereby making it more difficult to obtain patent protection for certain types of inventions--notably, software inventions. As software patents have become more difficult to obtain and even more difficult to protect, the current patentable subject matter jurisprudence disparately harms small-scale inventors and startups who are reliant on the patent system to obtain crucial private capital from investors to support further innovation. Such issues are made glaringly apparent when comparing the domestic patentable subject matter jurisprudence to that of other technologically developed foreign nations, whose patent systems are more predictable and rewarding for software inventors. The Supreme Court's recent pivot has been met with substantial criticism by members of the intellectual property community across the political spectrum. Politicians, academics, district court and Federal Circuit judges, inventors, and former United States Patent and Trademark Office (USPTO) Directors have criticized the Supreme Court's framework and have urged Congress to act. Sparked by a recent denial for rehearing en banc wherein the Federal Circuit was evenly divided on the contours of § 101, followed by the Supreme Court's refusal to grant certiorari, senators and prominent law organizations pitched legislative proposals on the Senate floor to abrogate the Supreme Court's framework and better protect emerging technologies, including software. This Note pushes the need for legislative revision to counteract the negative effects of the Supreme Court's recent jurisprudence on the software industry and better align the United States with consistent global standards. Specifically, this Note thoroughly analyzes the history of the patentable subject matter doctrine, domestic proposals aimed at dismantling the current jurisprudence, and the way foreign patent systems handle patent eligibility restrictions for software inventions, to argue that domestic software innovation is disparately and negatively harmed by the Supreme Court's evolving framework for evaluating subject matter eligibility. Software innovation is paramount to the development of modern society, and thus the patent system should stand to support the patentability of software inventions, rather than hinder it. [ABSTRACT FROM AUTHOR]

This study examines the current technological level and industrial/technical trends in the field of biomimicry technology, as well as recent technological and research and development trends. Patent analysis was conducted, focusing on technology that uses design elements and biological/ecological characteristics to provide solutions to technological problems. The technological scope of the analysis included the field of technologies and materials that apply to the conditions found in ecology, as well as robot machines and devices designed to mimic certain animals and ecological elements. The search for patents was conducted in Korea, the United States, Japan, and Europe from 1975 to 2021, resulting in a total of 8278 raw data cases, from which 940 valid patents were selected. The percentage of patent document and the status of both domestic and foreign applicants varied among the countries of Korea, the United States, Japan, and Europe. Based on the results of the patent analysis, it was found that biomimicry technology is in a growth phase that is expected to continue in the future and that Korea and the United States are leading the development of this technology. [ABSTRACT FROM AUTHOR]

Purpose: Technological development drives the optimization of therapeutics in ophthalmology, but quantifiable and systematic review of such innovation is lacking. To fill this gap, we characterize trends in ophthalmology-related patents in the United States from 2005 to 2020. Methods: Publicly available patent data from the US Patent and Trademark Office was analyzed with the R programming language. Ophthalmology-related patents were identified with a keyword search of their titles and claims text. Temporal trends were assessed with the Mann–Kendall trend test (α = 0.05, two-sided). Results: Of 4.5 million collected patents, some 21,000 (0.5%) were ophthalmology related. The number of annually granted ophthalmology patents increased over time (Mann–Kendall test: z = 4.91; P < 0.001), from 619 patents released in 2005 to 2,019 patents in 2020. Patent counts also increased over time for all ophthalmic subspecialties except oculoplastics, with steepest rises in retina (z = 4.91; P < 0.001) and cornea (z = 4.64; P < 0.001). The most cited patents were in biocompatible intraocular implants and implantable controlled-release drug delivery systems, which underscores particular advancement in therapeutic efficacy and safety in devices used in the treatment and management of common yet debilitating eye conditions. Conclusion: This exploratory analysis reveals hotspots for ophthalmology-related innovation in the United States that may predict current and future growth trends in device development and pharmacologic advancement in ophthalmology, paving the way for more diverse and effective treatment options for preserving vision. [ABSTRACT FROM AUTHOR]

We investigate underlying sources of the US entrepreneurial ecosystem's advantage compared to other innovative economies by assessing the benefits that Israeli startups derive from migrating to the United States. Addressing positive sorting into migration, we show that migrants raise larger funding amounts and are more likely to have a U.S. trademark and be acquired than nonmigrants. Migrants also achieve a higher acquisition value. However, their patent output is not larger. We conclude that the United States entrepreneurial ecosystem's advantage vis-à-vis other innovative economies arises from several sources producing sizeable gains for startups. These sources are investor availability as well as large consumer and acquisitions markets. [ABSTRACT FROM AUTHOR]

Firms innovate their new processes and products not only within their countries but also across national boundaries. This is known as cross‐border innovation, and many countries have initiated policies to support it. But how does government support influence cross‐border innovation? Through the lens of Porter's diamond model, this study conceptualizes government support as slack resources and investigates how it affects a firm's inventive activities in an uncertain, competitive global market. This study examines Chinese firms' patent filings in the United States under the enactment of the "innovative city" policy. We apply matching and generalized difference‐in‐differences techniques to this staggered quasi‐experimental setting and find that government support stimulates firms' cross‐border innovation. We further show that firms with higher research and development capacity take better advantage of government support. Finally, we show that government support leads to a rebalancing of exploratory and exploitative innovation such that a firm that has conducted more exploration will perform more exploitation and vice versa. Taken together, this study extends our understanding of slack from internal resources to government support in the context of global operations. Findings suggest that government actions that improve the ecosystem of innovation in one country strengthen firms' innovation and competitiveness overseas. [ABSTRACT FROM AUTHOR]

Knowledge proximity refers to the strength of association between any two entities in a structural form that embodies certain aspects of a knowledge base. In this work, we operationalize knowledge proximity within the context of the US Patent Database (knowledge base) using a knowledge graph (structural form) named "PatNet" built using patent metadata, including citations, inventors, assignees, and domain classifications. We train various graph embedding models using PatNet to obtain the embeddings of entities and relations. The cosine similarity between the corresponding (or transformed) embeddings of entities denotes the knowledge proximity between these. We compare the embedding models in terms of their performances in predicting target entities and explaining domain expansion profiles of inventors and assignees. We then apply the embeddings of the best‐preferred model to associate homogeneous (e.g., patent–patent) and heterogeneous (e.g., inventor–assignee) pairs of entities. [ABSTRACT FROM AUTHOR]

The article compares the professional responsibility campaigns against unethical intellectual property (IP) practitioners in the U.S. and China. Topics discussed are disciplinary authority and international disciplinary role of the U.S. Patent and Trademark Office (USPTO), China as a trademark and patent superpower and its consequences for the bar, evolution of U.S. and China trademark enforcement campaigns, alternatives to attorney discipline, choice of law rules and international practice.

Bibliometric analyses of the scientific literature have grown increasingly popular in the past few decades. However, patent bibliometric studies, evaluation of technological literature, have not yet been applied in neurosurgery. To perform a pilot patent bibliometric analysis of the top 100 most cited patents in cranial neurosurgery. The Lens was used to query multiple databases, to select the top 100 cranial neurosurgical patents based upon forward patent citations. These were organized into 9 categories based on technological descriptors and were evaluated based on the earliest priority date, year issued, and expiration status, among others. The top 100 most cited patents included technology underlying 3D navigation (n = 31), pharmacology and implants (n = 20), vascular occlusion (n = 5), craniotomy closure (n = 9), focal lesioning and tissue resection (n = 8), brain and systemic cooling (n = 5), neuroendoscopy (n = 8), neuromonitoring and stimulation (6), and technologies improving surgeon performance (n = 8). Ninety-six patents were filed in the United States, 72 were expired, 19 are still active, and 9 were listed as inactive. The highest number of patents was applied for from the mid-1990s to the mid-2000s. Demonstrated trends showed no meaningful correlation between patent rank and earliest priority date (linear trendline y = 0.7107 x −1367.5; R2 = 0.0671), while a very strong correlation was found between patent rank and citations per year (power trendline y = 127.93 x −1.094; R2 = 0.8579). Patent bibliometrics allow evaluation of neurosurgical advancements from the past and enable subsequent development of cutting-edge technology in the future. The described method is a reproducible and reliable technique for evaluating our field's patent literature. [ABSTRACT FROM AUTHOR]

Between 1986 and 2020 the Food and Drug Administration (FDA) approved fifty-three brand-name inhalers for asthma and chronic obstructive pulmonary disease (COPD), but by the end of 2022 only three of those inhalers faced independent generic competition. Manufacturers of brand-name inhalers have created long periods of market exclusivity by obtaining multiple patents, many on the delivery devices rather than the active ingredients, and by introducing new devices that contain old active ingredients. Limited generic competition for inhalers has raised questions about whether the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, for challenging patents is adequately facilitating the entry of complex generic drug-device combinations. For the fifty-three brand-name inhalers approved during the period 1986-2020, generic manufacturers filed challenges authorized by the Hatch-Waxman Act, which are known as paragraph IV certifications, on only seven products (13 percent). The median time from FDA approval to first paragraph IV certification was fourteen years. Paragraph IV certifications resulted in approved generics for only two products, each of which experienced fifteen years of market exclusivity before generic approval. Reform of the generic drug approval system is critical to ensuring the timely availability of competitive markets for generic drug-device combinations such as inhalers. [ABSTRACT FROM AUTHOR]

Patents take the form of public letters that the U.S. Patent and Trademark Office (USPTO) actively disseminates. Whether these documents sufficiently provide the public with notice of the technologies they describe, as well as the proprietary rights that they assert, has been subject to long-standing debate. Many commentators conclude that patents are often filed too early in the research and development cycle, are deliberately drafted in a vague or obtuse manner, or are simply too numerous. As a result, identifying the relevant patent landscape is not just difficult for technology implementers, but possibly undesirable as a matter of innovation policy. Yet prior scholarship has seldom acknowledged current statutory mechanisms to improve the notice function of patents after they issue. This Article endeavors to fill that gap. Congress has long encouraged intellectual property rights holders to identify their patents on the products they sell. Patent marking has traditionally occurred on physical products or their packaging, although it has been recently extended to Internet-based virtual marking. The marking statute stipulates that patent proprietors that fail to mark face severe remedial restrictions when challenging infringers. Congress has assigned the Food & Drug Administration (FDA) a part in providing patent notice as well. In keeping with federal legislation, the agency maintains two publications, commonly known as the Orange and Purple Books, that act as a patent clearinghouse for approved drugs and licensed biologics. The role of a patent within the marketplace provides perhaps the most valuable form of notice that that instrument may offer. Yet the marking statute and FDA publications suffer from some apparent flaws. In combination they project a failure to identify all patents that are relevant to the product, favor patent trolls, involve dubious practical workings, promote misleading advertising, and impose punitive sanctions in comparison to the notice requirements of peer intellectual property rights. For its part, the FDA has proven an untutored and unreliable patent publicist for the past four decades. This Article offers specific suggestions to improve the notice functions of patents after they issue. It calls for the USPTO to develop and populate its own virtual marking database that correlates individual patents with the marketplace. It also encourages the FDA to take further steps to counter abuses of the Orange and Purple Books and to accelerate their patent notice functions. Finally, this Article takes broader lessons from this effort, offering pathways for policymakers to look beyond the patent instrument as they endeavor to improve the patent system's notice functions. [ABSTRACT FROM AUTHOR]

The past three decades have witnessed a tremendous shift in public health policies toward marijuana legalization in the United States. Adopting the process‐based view of innovation, we hypothesize that marijuana's increased use and related consequences after its legalization affect innovators' behavior and social environment during the innovation process, which in turn impacts regional innovation. Utilizing the staggered adoption of medical marijuana laws (MMLs) by 20 states between 1996 and 2013 as a quasi‐experimental setting, we find that legalizing medical marijuana reduces the overall output of regional innovation as proxied by patents' total forward‐citation count aggregated by innovator location. Further analyses decomposing the overall output into patent quantity and quality reveal that the quantity of certain patents rises after states' medical marijuana legalization. More importantly, these analyses show that the quality of all patents, especially that of "hit" patents, deteriorates, leading to a net negative effect on the overall output. These tests further suggest that different findings concerning patent quantity and quality are related to marijuana legalization's diverse influence on innovators' individual and collaborative effectiveness during the innovation process. The decline in innovation output and quality after the adoption of MMLs is robust to the use of additional identification strategies. The evidence suggests that legalizing medical marijuana has an adverse effect on regional innovation activity. [ABSTRACT FROM AUTHOR]

The main objective of this paper is, based on the theory of complex systems (Arthur, 2009), to reconstruct the inventive activity of lead-acid batteries used in electric vehicles. Based on the information from the United States Patent and Trademark Office (USPTO) database, and based on the methodology developed by Strumsky and Lobo (2015), it is possible to represent different degrees of inventive novelty (origination, new combination, recombination and reuse), as well as measuring the increasing technological complexity of lead-acid batteries. Evidence shows that the lead-acid battery is an increasingly complex technology. It is a rival technology but is also complementary to the nickel-metal-hydride and lithium-ion batteries used by electric and hybrid vehicles. [ABSTRACT FROM AUTHOR]

We investigate whether disasters can lead to innovation. We construct a US county-level panel of hurricane damages using climate data, hurricane tracks, and a wind field model and match these to patent applications by the location of their inventor over the last century in the United States. We examine both general innovation and patents that explicitly mention the terms 'hurricane' or 'storm.' In line with the current literature that hypothesizes innovative activity driven by shocks, in particular innovation intended to mitigate future shocks, we find that hurricanes lead to temporary boost in damage-mitigating patents a few years after the event. However, we also show there is long-term, lasting over two decades, general reduction of innovation after a damaging storm. We conclude that hurricanes, and possibly other types of disasters, cannot be viewed as a 'benefit in disguise,' and that these events are unlikely to generate longer-term beneficial dynamics in an adversely affected location. [ABSTRACT FROM AUTHOR]

As a country, the United States spends significantly more on healthcare than other advanced industrialized countries, and Americans have comparably worse health outcomes. Both are developments of the last four decades. In this paper, we look at how change in antitrust and patent law and thus change in market power in the largest four subsectors of healthcare, hospitals, physician groups, prescription drugs, and net medical insurance, have contributed to the increasing cost of medical care in the United States. We show that the annual rent – the degree to which health care is overpriced as a result of market power – was between 2.47 and 4.30 percent of GDP in 2016 – truly a big cost for big medicine. [ABSTRACT FROM AUTHOR]

Pharmaceuticals, biotechnology, and technological advances are currently a new paradigm with ample potential to provide therapeutic solutions to multiple diseases. The purpose of this study was to survey granted patents related to biopharmaceutical products. The most important results show that most of these inventions are concentrated in the United States, and European and Asian countries, and that US companies are the clear leaders in this area of knowledge, reaffirming its position as one of the most important technological markets in the world. Additionally, the technological classes, established according to search criteria, that have shown the most progress over time has to do with medicinal preparations containing antigens or antibodies, as well as those associated with peptides. Finally, the role of the Latin American market is not relevant for the production of this group of technologies; consequently, it is important to define strategies for their inclusion in countries in the region and to promote cooperation in terms of research and development. This course of action will provide the region with the possibility of increasing technological capabilities that will allow it to innovate within the sector. [ABSTRACT FROM AUTHOR]

Despite an increasing number of women pursuing careers in science, engineering, and medicine, gender disparities in patents persist. This study sought to analyze trends in inventor's gender for surgical device patents filed and granted in Canada and the United States from 2015 to 2019. This study analyzed patents filed and granted by the Canadian Intellectual Property Office (CIPO) in the category of "Diagnosis; Surgery; Identification" and the United States Patent and Trademark Office (USPTO) in the category of "Surgery" from 2015 to 2019. The gender of the patent applicants was determined using a gender algorithm that predicts gender based on first names. Gender matches with names having a probability of less than 95% were excluded. We identified 14,312 inventors on patents filed and 12,737 inventors on patents granted by the CIPO for "Diagnosis; Surgery; Identification". In the USPTO category of "Surgery," we identified 75,890 inventors on patents filed and 44,842 inventors on patents granted. Female inventors accounted for 7%-10% of inventors from 2015 to 2019 for both patents filed and granted. The proportion of female inventors on patents granted was significantly lower than for patents filed for four of the 5 y analyzed for both the USPTO and CIPO. Female representation in surgical device patenting has stagnated, between 7 and 10%, from 2015 to 2019 in Canada and the United States. This underrepresentation of female inventors in surgical device patenting represents sizable gender disparity. [ABSTRACT FROM AUTHOR]

Over the last few decades, the United States has become more innovative, but the gains have been distributed unequally. In 2020, over 50% of new U.S. patents went to the top 1% of patentees, and more than 50% of all patents of U.S. origin were generated by just five states, all coastal. Less than 13% of inventors were women. The economic, geographic, and demographic concentration of innovation highlight how the intersections between two traditionally discrete topics--innovation and inequality--have become increasingly relevant. But rather than any single inequality, this Article argues, multiple inequalities--of income, opportunity, and access--have relevance to innovation. Examining the inequalities of innovation, separately and together, exposes the tensions, at times surprising, between notions of equity. When mapped onto patent law, an inequalities framework also reveals how patent law can exacerbate inequality by providing enhanced returns to "invention capital"--the role models, trust, know-how, and networks required to take advantage of inventing. But an inequalities framework also shows how patented innovation can improve conditions for the worst-off, by providing paths to prosperity and hastening the creation and diffusion of innovation across classes, even as it makes the rich richer. Building on the "inequalities" framework described above, this Article offers a set of legal and administrative proposals grounded in patent law for addressing inequality concerns. To ensure equal opportunities to participate, this Article proposes the creation of an Independent Office of the Small Inventor Advocate, akin to the National Taxpayer Advocate, that would have responsibility for outreaching to and increasing invention capital and know-how among first-time, underrepresented, and under-resourced inventors, and leveling up the inventing playing field, for example through universally accessible patent-quality technology. To expand access to innovation through partnerships and expand public understanding and oversight of the patent system, by other agencies, for example, this Article proposes the introduction of an independent Office of Public Interest and Partnerships in Innovation. Finally, introducing and centering equity metrics, like the number of first-time innovators and gaps in the rates, can support equitable growth in innovation. [ABSTRACT FROM AUTHOR]

Patents are essential for promoting scientific progress and innovation. However, the current framework for patents in outer space unduly disincentivizes U.S. patentees from obtaining patents. Importantly, these disincentives may hinder innovation for vital technologies relating to space. This Note explains why international collaboration is necessary to solve this problem and how the United States can incentivize international support for a space patent regime. Specifically, this Note advocates a patent regime consisting of a single set of substantive and procedural patent laws governing the distinct territory of space. First, Part I provides a background on current patent laws in space. Next, Part II explains how current law disincentivizes patenting and how an international patent regime could ameliorate these problems. Finally, Part III uses rational choice theory to explain how the United States could balance the competing interests of other states to create a functioning patent system for U.S. patentees. [ABSTRACT FROM AUTHOR]

The authors address government patent use to promote public health in the U.S. Topics discussed include statutes that protected new medications which includes the Hatch-Waxman Act, one way to facilitate public access to high-cost medications, and challenges facing government manufacture of patented drugs without a license.

Patent and regulatory exclusivity shall constitute incentives for pharmaceutical companies to develop new drugs. This study aims to investigate the differences in the patent term extension (PTE) and regulatory exclusivity between China and the United States, and to evaluate their potential impact on the market exclusivity period of novel drugs. Small‐molecule novel drugs with their first indication approved in China and the United States between 2018 and 2021 were evaluated regarding their PTE and regulatory exclusivity. The PTE length of the China‐approved drugs was calculated by simulation, whereas that of the US‐approved drugs was extracted from the United States Patent and Trademark Office. Thirty‐two and 107 novel drugs approved in China and the United States, respectively, were included in the study. The PTE length of the US‐approved drugs calculated by the China‐PTE method was significantly longer than that calculated by the US‐PTE method. Patent extensions should be granted for 91% of new drugs in China and 82% in the United States. The simulated median PTE length of novel drugs approved in China was significantly higher than that of the United States (5.0 vs. 2.9 years, P < 0.05). It can be expected that the implementation of the PTE policy in China would significantly extend the period of market exclusivity for novel drugs similar to that of the United States. China should fully evaluate the potential impact of the PTE policy on the market exclusivity of novel drugs and provide better incentives to the development of novel drugs in addressing unmet clinical needs when developing its regulatory exclusivity policy. [ABSTRACT FROM AUTHOR]

The article explores the need for modifications to the factors consolidated by the cases, NHK Spring Co. v. Intri-Plex Technologies Inc. and Apple Inc. v. Fintiv Inc., that guide the U.S. Patent Trial and Appeal Board's institution decisions where there is a corresponding civil case. Topics discussed include the use of inter partes review (IPR) in challenging patent validity, and the history of post-grant proceedings prior to the American Invents Act.

A decade ago, the US Supreme Court decided Association for Molecular Pathology v. Myriad Genetics, Inc. , concluding that isolated genes were not patentable subject matter. Beyond being a mere patent dispute, the case was a political and cultural phenomenon, viewed as a harbinger for the health of the biotechnology industry. With a decade of perspective, though, Myriad 's impact seems much narrower. The law surrounding patentable subject matter-while greatly transformed-only centered on Myriad in small part. The case had only a modest impact on patenting practices both in and outside the United States. And persistent efforts to legislatively overturn the decision have not borne fruit. The significance of Myriad thus remains, even a decade later, hidden by larger developments in science and law that have occurred since the case was decided.

The modern regime for balancing innovation and competition in pharmaceuticals was established through the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. This regime needs updating. The process that Hatch-Waxman established for listing patents and challenging patents on the Food and Drug Administration's Orange Book is one important area for reform. [ABSTRACT FROM AUTHOR]

Research Summary: Although the link between coordination requirements and vertical integration is theoretically well established, empirical tests of this relationship are hard to implement due to the simultaneous determination of both variables. In this study, we take advantage of regulatory changes in patent prosecution in the United States to provide plausibly causal evidence linking increases in coordination requirements with insourcing. Moreover, we examine the role of plural sourcing, that is, simultaneously making and buying, when responding to changes in coordination requirements. We find that the move toward insourcing is more pronounced for plural‐sourcing firms as compared to firms relying on outsourcing. These results are consistent with the view that plural sourcing provides firms with flexibility to switch between sourcing modes when facing changing coordination requirements. Managerial Summary: We study the sourcing of patent prosecution services in large innovative companies and show that in‐house production is more beneficial when coordination requirements between inventors and attorneys increase. Importantly, we find that plural‐sourcing firms, that is, firms that work with both internal attorneys and external law firms, are more likely to respond to these increases and move toward insourcing as compared to firms relying only on outsourcing. This suggests that plural sourcing can be regarded as a strategic investment in sourcing flexibility, allowing firms to respond to changing coordination requirements. This is an adaptive capability which is especially useful in knowledge‐intensive sectors. video abstract [ABSTRACT FROM AUTHOR]

Summary: Baking powders contain leavening acids that activate gas‐releasing agents such as sodium bicarbonate. This is a review of the patent literature on phosphate‐based leavening acids developed between 1856 and 2019. Overall, 174 patented inventions were found on 28 phosphate‐based compounds, which corresponded to more than half of the inventions disclosed on leavening acids. Inventors had a strong interest in monocalcium phosphate, sodium acid pyrophosphate and, to a lesser extent, sodium aluminium phosphate and miscellaneous acid phosphates. As cheap alternatives to tartrates, most early phosphate‐based leavening acids were difficult to keep because they had a high affinity for moisture and tended to react prematurely with gas‐releasing agents in baking powders. The evolution of phosphates in chemical leavening reflected changes in the consumption of bakery foods, especially in the United States where chemical leavening has been very popular for food preparations like prepared flours, ready‐to‐use bakery mixes and refrigerated doughs. Sodium‐free phosphates are solutions to reduce salt intake in food. Alternatives to phosphates are searched due to potential health issues. [ABSTRACT FROM AUTHOR]

The impact of the COVID-19 pandemic has been felt worldwide, and despite having several vaccines in the market at this point, there are still issues of accessibility for certain countries. International intellectual property law has been a breeding ground for the exploration of intellectual curiosity and creation as it provides strong protections to creators. These strong protections have allowed for the monopolization of certain goods, such as vaccines, under the concept of patents. While patents are important to incentivize pharmaceutical companies to create life-saving medicines, these protections have also become a barrier for access to medicines, especially in less-developed countries. This Note seeks to address the interplay between international intellectual property rights and the right to health under the international human rights framework. Specifically, it will discuss the two differing rights through the United States and Canada's efforts to promote creation of COVID-19 vaccine candidates. In order to highlight the financial driver behind patent protections, this note will compare the production and patenting process of the COVID-19 vaccines, a virus that also heavily impacted developed countries, versus the under-funded Ebola virus, which predominantly effected less-developed countries. Finally, this Note will offer recommendations on how countries, and pharmaceutical companies, can take a human rights approach by utilizing patent protection exceptions in order to make COVID-19 vaccines accessible to all countries. [ABSTRACT FROM AUTHOR]