Filed Patent Applications Research Articles

Patent Portfolios Protecting 10 Top-Selling Prescription Drugs

Brand-name drugs are sold at high prices in the US during market exclusivity periods protected by patents. Multiple overlapping patents protecting a drug are known as patent thickets and can effectively delay the emergence of price-lowering generic competition for many years. To evaluate the composition of patent thickets of 10 top-selling prescription drugs in the US and compare the characteristics of drug patents filed during development with those filed on these products after US Food and Drug Administration (FDA) approval. This cross-sectional study examined US patent thickets of the 10 prescription drugs with the highest US net sales revenue in 2021 using information on issued patents and patent applications as of June 30, 2022, obtained from a public database by the Initiative for Medicines, Access, and Knowledge. Data were analyzed from September 2022 to June 2023. Prevalence of patents filed before and after FDA approval; types of claims present in issued patents (ie, chemical composition, method of use, process or synthesis, formulation, and delivery device); and patent thicket density (number of active patents at a given time). The 10 top-selling prescription drugs in the US for 2021 included 4 small-molecule drugs and 6 biologics. These 10 drugs were linked to 1429 patents and patent applications: 742 (52%) issued patents, 218 (15%) pending applications, and 469 (33%) abandoned applications. Almost three-quarters of patent applications (1028 [72%]) were filed after FDA approval. The postapproval proportion was higher for biologics (80%) than for small-molecule drugs (58%). Postapproval filing of patent applications peaked in the first 5 years after FDA approval for small-molecule drugs and 12 years after FDA approval for biologics. Of 465 patents issued for applications filed after FDA approval, 189 (41%) had method of use claims, 127 (27%) had formulation claims, and 103 (22%) had process or synthesis claims, while 86 (19%) had chemical composition claims and 46 (10%) had device claims. Patent thicket density peaked 13 years after FDA approval, at which time these 10 drugs were protected by a median (IQR) of 42 (18-83) active patents, 66% of which were filed after FDA approval. This study found that among the 10 top-selling prescription drugs in the US in 2021, patents filed after FDA approval and containing claims covering aspects other than the active ingredient of the drug contributed to patent thickets. Scrutiny of patent applications and of patents filed after FDA approval is needed to facilitate timely generic or biosimilar competition.

Divide and conquer: Relating patent quality and value in a conceptual framework based on a systematic review

AbstractPatents as intangible assets are subjects of burgeoning empirical research. However, there is limited knowledge of how patent quality and patent value can be conceptualized, distinguished, and related. Distinguishing these concepts and relating them in a theoretical framework would enable the assessment and improvement of patent quality, which has implications for all the stakeholders in patents. We ground this study in the emergent ex‐ante theory of patent value and conduct a systematic review of 340 papers that investigate patent quality or value. Based on a comparative analysis of the patentability standards adopted by the patent offices in the United States, Europe, and Japan, we delineate four dimensions of patent quality—subject matter, utility, non‐obviousness or inventive step, and sufficiency of disclosure. Our study contributes to theory by providing an elaborated conceptual model that relates the different dimensions of patent quality and patent value and mapping the different types of indicators of patent quality and value onto the corresponding patent quality or value dimensions. Our study suggests that patent policymakers can incentivize innovators to file patent applications of high quality, which would reduce the incidence of poor‐quality patents in the system and improve the efficiency and reputation of the patent office.

Diagnostic and therapeutic approaches for endometriosis: a patent landscape.

The aim of this review is to analyze the patent filings and to systematize the main technological trends in patent protection for the diagnosis and therapeutics for endometriosis. Patent literature has also been explored to identify active inventors and applicants in this field. Patent search was carried out in the freely accessible patent search databases namely, patentscope using various combinations of the keywords "Endometriosis OR Adenomyosis" AND "Diagnostic OR Therapeutics" were used along with wildcard search queries in the "Title", "Abstract" and "Descriptions" fields. A patent search revealed 144 patents describing inventions for diagnostic and therapeutic purposes of endometriosis. These patents include 26 patent applications in the diagnostic utility and 116 patent applications under the therapeutic approaches. Out of these 116 patent applications, 43 describe traditional medicines for endometriosis. Two patent applications describe inventions that can fall into both categories. Efforts are being made to improve current diagnostic instruments.Hormonal alteration methods is the most common field of invention, followed by surgical interventions for therapeutics. A general trend of increase in patent application filings has been observed with a slight decrease in recent years.

Solar panels overheating protection: a review

Reduced energy consumption is a direct result of building optimization. Solar panels and heat detectors can provide the necessary power. After years of refinement and development, methods for regulating solar panels' output are finally finding their way into everyday life, where they are having a dramatic impact on the foundations of sustainability. This document provides an up-to-date assessment of several strategies for preventing solar panels from overheating, all of which serve to boost their efficiency and prolong their service life. It begins with a brief background on protection technologies before moving on to a survey of recently filed patent applications that address this topic. The study concludes with a proposed assessment of the strengths and shortcomings of these safeguards. We anticipate that the information included in this review paper will be an invaluable tool for scholars and researchers.

Abandoning innovation projects, filing patent applications and receiving foreign direct investment in R&D

Foreign direct investment in R&D is one of the popular channels indigenous firms use to upgrade their technological capacities and improve market intelligence following innovation setbacks. Firms often employ various signals to secure higher levels of foreign direct investment in R&D. However, the majority of research on this topic focuses on the role of positive rather than negative signals. Firms are often conservative about communicating negative information regarding their innovation projects due to concerns around competition and managerial performance appraisal. Drawing on signaling theory, this study investigates the impact of a negatively valenced signal – the experience of abandoning innovation projects – on attracting foreign direct investment in R&D. Moreover, although firms are known to send multiple signals simultaneously, little is known about how the interactions between oppositely valenced signals (specifically, the experience of abandoning innovation projects, which is a negative signal, and the filing of patent applications, which is a positive signal) affect foreign direct investment in R&D. A study of 11,354 Spanish firms from the Spanish Technological Innovation Panel during the period 2008–2015 found that the experience of abandoning innovation projects has a positive effect on foreign direct investment in R&D. However, this positive effect is weakened by patent applications due to the signaling of conflicting messages. These results have important theoretical and practical implications for the advancement of signaling theory and the management of innovation setbacks.

The influence of intellectual capital and innovations on the economic development of the world and national economy

We consider in the study that the existing economic model will inevitably be replaced by a new effective model of creative and competitive economic development. Technological innovations have caused the rapid growth of the world economy. As the result, production costs have been reduced and the profits of corporations in many sectors of the world economy have increased. Innovation is a factor of rise in Kondratiev cycles. Innovations give an impetus to increase the value added of a country’s economy. The article asserts that intellectual capital is the basis and is becoming an increasingly important component of national and world development. The article has investigated in which way innovation activities affect real GDP and has suggested the answer to the question on what stage of the Kondratiev cycles the world economy is. Innovation as an object of intellectual capital is introduced in the form of patents and other intellectual property. We have analyzed the relevant trends for 2004-2020. The research has determined that by 2030, a significant increase in the number of patent applications is expected. The article has examined the dependence of the world real GDP on the number of filed patent applications in the world by constructing trend lines. It has been found that the largest approximation with a coefficient of determination greater than 0.92 is a polynomial trend line, in which the dynamic growth with a small number of patent applications is inhibited by a sharp increase in their number. The research has defined that the phases of the cyber revolution correlate with Kondratiev waves. The modern phase is characterized by the rapid generation and dissemination of innovations. The article has examined the filing of patent applications in the top 20 countries around the world, among which the leading positions are occupied by China, the USA, and Japan. By constructing trend lines, the research has analyzed the dependence of Ukraine’s real GDP on the number of innovations and has shown that there is no such clear dependence. This indicates the raw material orientation of the Ukrainian economy. The article states that it is extremely important for Ukraine to make the transition from the triad model (with state-monopoly capitalism) to the national economic model, which corresponds to the approaches of the people’s capitalism.

Low IFN-Gamma Response to Phytohemagglutinin in Mitogen Tubes of the QuantiFERON TB Gold Plus Assay During the COVID-19 Pandemic

Background: The clinical implications of abnormal immune responses in COVID-19 for latent tuberculosis infection screening and potential reactivation are unclear. Since December of 2019, we have observed an unusual increase in the number of QuantiFERON TB Gold Plus (QTF-Plus) indeterminate results and low IFN-γ responses to phytohemagglutinin (PHA) in the mitogen tube. This fact coincides with the COVID-19 pandemic evolution. We hypothesized that these low IFN-γ responses to PHA were related to a biological effect of COVID-19 or its treatment.Methods: We reviewed QTF-Plus results (30,092 patients) from July 2016 until November 2020. We also studied a cohort of ninety hospitalized patients with suspected/confirmed COVID-19 pneumonia for two weeks in March 2020 (first pandemic wave), and a group of elderly hospitalized patients with COVID-19 who underwent serial QTF-Plus and immune profiling testing.Findings: The indeterminate QTF-Plus results rate went from 1·4% (from July 2016 to November 2019) to 3·9% during the COVID-19 pandemic (first and second waves). Forty-nine out of 90 patients (54·4%) had low/very low IFN-γ response to PHA; 22/90 (24·4%) had confirmed severe/critical COVID-19 pneumonia; none received immunosuppressants prior to testing. Abnormal radiological findings (P=0·01) but not COVID-19 severity were associated with low PHA response. The number of EMRA CD8+ T-cells showed a direct correlation with IFN-γ response to PHA (P=0·03).Interpretation: Low IFN-γ responses to PHA often occur in COVID-9 pneumonia. A low number of effector CD8+ T-cells subset but not disease severity or immunosuppressants were associated with this finding. The clinical implication is unclear.Funding: None.Declaration of Interests: P.E. and his institution have filed two patent applications related to immunodiagnostic laboratory methodologies for latent tuberculosis infection, which are not included in this manuscript. To date, there has been no income or royalties associated with those filed patent applications. P.E. participated in a short-term advisory scientific board for DiaSorin Molecular, and honorarium was paid to his institution. P.E. has no other conflicts to declare. The other authors have no conflicts of interest to declare.Ethics Approval Statement: Ethical clearance was approved by the Comité de Ética de la Investigación del Principado de Asturias, Spain

Industrial Production of Acetic Acid: A Patent Landscape

This work presents an overview of the patent activity and filing trends on acetic acid industrial processes. Data were obtained with Orbit Intelligence patent database, using both keywords and classification codes (IPC, CPC, and C-sets). The complete search strategy has been reported. Data analysis reveals that methanol carbonylation is the most patented process, while fermentation methods are the most attractive technologies. The filing of new patent applications shows a decreasing trend in the period comprising 2016 and 2020 for all technologies.

Case study on strategic patent application filings of specific company - Intellectual property strategy of S corporation in bicycle component market -

Case study on strategic patent application filings of specific company - Intellectual property strategy of S corporation in bicycle component market -

An Initial Look at Federal Offices of Research and Technology Applications.

In Science-The Endless Frontier, Vannevar Bush wrote that reaping the potential benefits of science conducted at federal laboratories requires the discoveries made in the laboratories be transferred to society. In federal laboratories, Offices of Research and Technology Applications (ORTAs) are tasked with transferring laboratory-developed technologies to the market, allowing society to reap the benefits provided by scientific investments. In fiscal year 2016, the Technology Partnerships Office of the National Institute of Standards and Technology (NIST) conducted a first-of-its-kind survey of the ORTAs of more than 50 federal laboratories to obtain information on their organization and operation. We present descriptive analyses of the responses to this survey in two topical areas: organizational characteristics and technology transfer characteristics. We disaggregated the data across the dimension of budget size to describe similarities and differences in responses across the budget categories. Among the relationships we observed, we found that ORTAs with larger technology transfer budgets report higher frequencies of conducting internal technology transfer activities, such as patent prosecution (e.g., drafting patents, filing patent applications, and responding to actions from the patent office) and market analysis. Additionally, we provide context to the data by summarizing the relevant research on ORTAs at universities, and we present potential inferences that may be drawn from that body of research and applied to the data on ORTAs at federal laboratories.

Simulated Colonic Feces Reveals Novel Contraction Patterns

Simulated Colonic Feces Reveals Novel Contraction Patterns

When the Invented Becomes the Inventor: Can, and Should AI Systems be Granted Inventorship Status for Patent Applications?

Artificial Intelligence (“AI”) systems have become vastly more sophisticated since the term was first used in the 1950s. Through the advent of machine learning and artificial neural networks, computers utilizing AI technology have become so advanced that a team of attorneys in the United Kingdom claim that their AI machine, DABUS, actually created patentable inventions. The team went so far as to file patent applications with the European Patent Office,the UK Intellectual Property Office, and the US Patent and Trademark Office. All applications named DABUS as the inventor. This sparked a heated debate within academic and legal communities that centered around whether AI can be an inventor, and, if so, what this might mean for the current state of patent law. This paper discusses the purposes of patent law through a brief look at its history, in an effort to highlight why patent law as it stands may no longer be one- size-fits-all. It considers the evolution of AI systems to explain how one might determine that a machine could be “creative” and therefore justifiably named as inventor. It surveys popular opinions and organizes them on a spectrum ranging from those who believe that patent law should stay as it is and that AI cannot be an inventor, to those who, more dramatically, advocate for the abolition of patent protection for AI inventions. This paper suggests that legislators be proactive in traversing this technological minefield rather than reactive, as technology will continue to outpace, and trample, law if left to its own machinations.

Surveyed impact of intellectual property training in STEM education on innovation, research, and development

AbstractThis paper analyzes the findings of an international survey questionnaire to which responses were received from over 500 members from different technical societies of the Institute of Electrical and Electronics Engineers (IEEE). The survey is primarily intended to uncover members' perceptions of patent filing and research‐driven innovation. Our thesis statement is twofold. First, the introduction of basic intellectual property (IP) courses to university Science, Technology, Engineering, and Mathematics curricula would teach students valuable basics of IP and associated issues, technology protection; and possibly stimulate novel/innovative R&D outcomes. Second, studying relevant active/lapsed/expired patent documents could provide stimulating input for ongoing academic research. After analyzing the survey results we conclude that IP coursework could be a catalyst for students and researchers to explore patent opportunities related to their specific interests. The resulting knowledge would further enable researchers to prepare more compelling funding applications. In our experience, IEEE conference publications are often closely aligned with inventions to solve pressing technical problems. Conference papers typically comprise of cutting‐edge research/industry findings, with a short time between paper submission and presentation. Furthermore, conference organizers choose themes representing the forefront of technologies that often lead to inventions. These could fuel patent developments, but academic research environments often provide little if any incentives for academic researchers to prepare and file patent applications. Indeed, the attainment of high impact journal publications remains the primary metric by which research activity is judged and future academic tenure achieved.

Antimicrobial Peptides From Lycosidae (Sundevall, 1833) Spiders.

Antimicrobial peptides (AMPs) have been found in all organism taxa and may play an essential role as a host defense system. AMPs are organized in various conformations, such as linear peptides, disulfide bond-linked peptides, backbone-linked peptides and circular peptides. AMPs apparently act primarily on the plasma membrane, although an increasing number of works have shown that they may also target various intracellular sites. Spider venoms are rich sources of biomolecules that show several activities, including modulation or blockage of ion channels, anti-insect, anti-cancer, antihypertensive and antimicrobial activities, among others. In spider venoms from the Lycosidae family there are many linear AMPs with a wide range of activities against several microorganisms. Due to these singular activities, some Lycosidae AMPs have been modified to improve or decrease desirable or undesirable effects, respectively. Such modifications, especially with the aim of increasing their antibiotic activity, have led to the filing of many patent applications. This review explores the abundance of Lycosidae venom AMPs and some of their derivatives, and their use as new drug models.

Transferência de conhecimento entre universidade e empresa (U-E): influência das condições universitárias

The objective of the research was to analyze the influence of university conditions on the performance of knowledge transfer (KT) between the largest federal public university of Minas Gerais and its partner companies. Qualitative research was developed based on the instrumental case study method applied at the largest federal public university in Minas Gerais (elected in 2016 the Brazilian institution that most filed patent applications at the National Institute of Industrial Property). The results of the study lead to the understanding that some organizational conditions of the investigated University favored KT, while others represented challenges in the process. It has been noted that an intense effort, in the investigated institution, has been made to improve the interaction of the university with the productive sector based on policies and actions promoted, in particular, by the Technological Transfer Coordination of the University. However, there are still internal challenges regarding the transfer of knowledge from the University to the productive sector, a situation that is also noticeable in other Brazilian universities. The research results also indicate that the transfer performance is hindered when there is less flexibility of the rules related to the KT and the absence of incentive policies in the university context that encourage the teacher to transfer his knowledge to the productive sector. Regarding its theoretical contribution, the study advances by pointing out critical factors of knowledge transfer between UE, contributing to elucidate how university context factors influence the performance of this process, a research topic considered contemporary.

Estratégia de patenteamento de derivados de Cannabis sativa para obtenção da anuência prévia da ANVISA

O uso de Cannabis sativa de forma medicinal tem aumentado a cada ano, principalmente pela capacidade de proporcionar alívio imediato dos sintomas de problemas de saúde, tais como convulsões, depressão e insônia. A potencialidade dos fitocanabinoides da espécie para regulação da saúde mental e física tem sido comprovada por meio de estudos publicados em artigos científicos e patentes. O objetivo deste artigo é apresentar estratégias de patenteamento de produtos e processos à base de fitocanabinoides para obtenção da anuência prévia de pedidos de patentes, pela Agência Nacional de Vigilância Sanitária (ANVISA) e prosseguimento ao exame pelo Instituto Nacional da Propriedade Industrial (INPI). A busca foi realizada na base de dados do INPI, por meio de palavras-chaves Cannabis e fitocanabinoides. Foram triados os pedidos depositados no INPI e encaminhados para anuência prévia da ANVISA, no período de janeiro de 2018 a julho de 2019. Foram encontrados 87 documentos, sendo apenas 5 pedidos enviados para análise da ANVISA. Ficou demonstrado que as tecnologias pleiteadas estão entrando em domínio público pela não anuência da ANVISA e consequente arquivamento definitivo dos pedidos de patentes pelo INPI, o que pode acarretar em perda de informação e de oportunidades de mercado.

The Business of DNA Nanotechnology: Commercialization of Origami and Other Technologies.

It is often argued that DNA nanotechnology has a multitude of possible applications. However, despite great advances in the understanding of the fundamental principles of the field, to date, there has been comparatively little commercial activity. Analysis of patent applications and company case studies suggests that this is now starting to change. The number of patent application filings is increasing, and new companies are being formed to exploit technologies based on nanoscale structures and devices made from DNA. There are parallels between the commercial developments in this field and those observed in other areas of innovation. Further commercialization is expected and new players will emerge.

Patent Activity as an Indicator Determining the Vector of Development of the World Economy

Analysis of the change in the number of annually filed patent applications is a new method for studying the patterns of economic development. The article considers two trends. Firstly, the growth of patent applications is decreasing in the whole world with the exception of China since the 1980s excluding the short – term interval of 1997–2002, after 2002 does not exceed 1.5% per year. In China, the annual 20% increase in the number of patent applications over 25 years led to an increase in its share in the patent applications of the world by more than 40%. At the same time, the distribution of patent applications in various areas in China almost completely correlates with the global vector of scientific and technological development. Secondly: there was a change in the nature of the movement in the direction of diversification of the global scientific and technological development, as indicated by the dynamics of the Herfindahl – Hirschman index. At least from 1980 to the end of the 20th century, the monopolization index had been decreasing. The change occurred in 1997–2002, and since 2002 the monopolization index has been growing. There is an increase in the share of patent applications in the areas of Computer technology, Digital communication, Electrical equipment apparatus, Energy, Measurement. At the same time, the share of both wellformed areas, the share of which is above 2–3% (these are Telecommunications, Textile and paper machines, Audiovisual technology, Machine tools, Organic fine chemistry, Chemical engineering), and those at the initial stage (basic communication, Micro-structural and nano-technology) are decreasing. The analysis of the dynamics Revealed Technological Advantage performed. For the leading economies of the world, directions of technological development have been revealed, along which the most successful development takes place. It is shown that the directions in which the share of patent applications in Russia is ahead of its average world level, namely Food chemistry, Micro-structural and nanotechnology, Analysis of biological materials, have had a negative dynamics in the world over the past five years. Therefore, the adjustment of the domestic vector of scientific and technological development and the transfer of efforts to the development of computer technology, medical technology, civil engineering, computer technology is required.

Patent Application Trends of Induced Pluripotent Stem Cell Technologies in the United States, Japanese, and European Applications

Patent application trends were investigated for induced pluripotent stem cell (iPSC) technologies, particularly disease-specific cell technologies related to iPSCs, in the U.S., Japanese, and European applications during 2017. The number of patent applications for iPSC technologies was 1516 in the United States, 895 in Japan, and 420 in Europe, with 5% of applications for disease-specific cell technologies. In contrast, the percentages of patent applications for iPSC preparation and differentiation technologies were 17% and 23%, respectively. Patent applications for disease-specific cell technologies were classified into four technical fields and 14 disorder groups. In the technical fields, patent applications for genetically engineered cell technologies were prominent, accounting for 63%, 50%, and 65% of the U.S., Japanese, and European applications for 11, 8, and 7 disorder groups, respectively. In the disorder groups, the percentages of patent applications for neurological disorders were 40%, 32%, and 40% of the U.S., Japanese, and European applications, respectively, which were filed in four technical fields in the U.S. and Japanese applications. The U.S. patent applications for disease-specific cell technologies were filed by applicants in the United States, Japan, France, Belgium, Italy, Korea, and Canada; however, patent applications filed by those in Belgium, Italy, and Canada were not found in the Japanese and European applications. The percentages of patent applications filed by the U.S. applicants were 72%, 55%, and 65% of the U.S., Japanese, and European applications, respectively. Most patent applications filed by the U.S. applicants were in the field of genetically engineered cells for 11 disorder groups, which mostly included neurological and blood disorders. Japanese applicants mainly filed patent applications for drug screening technologies; subjects included five disorder groups, particularly neurological and bone/articular disorders. French applicants filed patent applications for neurological disorders in the field of genetically engineered cells and drug screening technologies. Korean applicants filed patent applications for patient-derived cell technologies for neurological, metabolic, and chromosomal/genetic disorders. In conclusion, more than half of patent applications were for genetically engineered cells for 11 disorders, most of which were filed by U.S. applicants.

Patent retrieval: a literature review

With the ever increasing number of filed patent applications every year, the need for effective and efficient systems for managing such tremendous amounts of data becomes inevitably important. Patent Retrieval (PR) is considered the pillar of almost all patent analysis tasks. PR is a subfield of Information Retrieval (IR) which is concerned with developing techniques and methods that effectively and efficiently retrieve relevant patent documents in response to a given search request. In this paper we present a comprehensive review on PR methods and approaches. It is clear that, recent successes and maturity in IR applications such as Web search cannot be transferred directly to PR without deliberate domain adaptation and customization. Furthermore, state-of-the-art performance in automatic PR is still around average in terms of recall. These observations motivate the need for interactive search tools which provide cognitive assistance to patent professionals with minimal effort. These tools must also be developed in hand with patent professionals considering their practices and expectations. We additionally touch on related tasks to PR such as patent valuation, litigation, licensing, and highlight potential opportunities and open directions for computational scientists in these domains.