Patent Term Research Articles

Examining the Growth of Regional Science and Technology Clusters in the Global Economy

Relevance. Creating policies to stimulate innovation as part of national economic development requires a more in-depth understanding of the current trends, especially the role of science and technology (S&T) clusters. In this study, we use patent and publication data to identify key S&T clusters and leading countries. The lessons learned from their experiences offer valuable guidance for other nations striving for consistent progress in research and development. Research objective. The study aims to assess how well innovation processes are organized in S&T clusters; to identify the factors and drivers influencing the development of these clusters in the global economy; and to determine the competitive advantages of the top countries in terms of patent applications and publication activity. Data and methods. Using the cluster approach employed in the methodology of the Global Innovation Index, we conducted a comparative analysis of the annual data and indicators published in this index related to patent and publication activity. Results. Our analysis has revealed 20 key fields in S&T clusters, the leading positions being occupied by medical, digital, and computer technologies, as well as the pharmaceutical industry. In terms of patent and publication activity, the top countries in the ranking of S&T clusters are the USA, Japan, Germany, and China. Although these countries maintained their leadership in the given period (2017-2021), all of them, except for China, demonstrated a decrease in their share in the indicators under consideration. Conclusions. A country is included in the ranking of the Global Innovation Index of S&T clusters when it exhibits a high quality of fundamental and applied research, as evidenced by its levels of publication and patent activity. To establish successful clusters eligible for ranking, a country should primarily formulate policies aimed at improving the quality of research and development. These policies should also facilitate growth in the key performance indicators, such as the number of patent applications and publication activity.

Comparative Study of ASEAN Research Productivity

Research productivity has become one of the main indicators used by higher education institutions (HEIs) as well as the country to support their innovation capability. This study purposely describes the research productivity among ASEAN countries, which is considered to be the world’s current economic hotspot. By using SciVal database to examine the literature over the last 10 years, we describe productivity, citation impact, and economic impact metrics. The findings indicate that Singapore is superior in terms of publication quality (citation) and patents while Malaysia is leading in terms of the number of scientific research. Interestingly, Indonesia’s scientific publication growth has the highest percentage. Furthermore, Engineering & Technology and Life Sciences & Medicine are the two major contributors to ASEAN research productivity. These subjects could be the major locomotives for ASEAN countries to use to sustain their competitiveness if the leaders can transform it into successful commercialization.

과도한 의약품 시장독점 방지를 위한 연장된 특허권 존속기간의 비교

The extended patent term or exclusivity period from pharmaceuticals’ approval date is limited to 14 years in the US or 15 years in the EU. However there are no such restrictions in Korea, so the market exclusivity can be excessively extended. Therefore, the status of extension of patent term in Korea was analyzed and the patent term from the product’s approval date in Korea, the US, Japan, the UK, France, and Germany were compared. For that, the following information from NEDRUG or KIPRIS were collected and analyzed: the filing date of the patent, whether the patent term has been extended, the expiration date of the patent term, approval date, the products’ name, and representative claims. Alecensa, Xalkori, Biktarvy, and Champix were selected for the comparison. Among 597 patents in Korea, 90.1% (538) were extended and 17.1% (102) of patents exceeded 14 years from the approval date. There were 81 and 60 products that have patents whose term exceeds 14 and 15 years from the approval date, respectively. In the comparative cases of 4 products, the patent term from products’ approval date in Korea is longer than 14 or 15 years, whereas the US, the UK, France, and Germany comply with the regulated limitation. The excessive patent protection delays the market entry of lower-cost generics and leads to an increase in financial burden on healthcare cost. To address such problems, a proper limitation on the extension of the patent term from the product’s approval date needs to be established.

Patenting and patent challenges in South Korea after introducing a patent linkage system

BackgroundSouth Korea introduced the patent linkage system in 2015 as part of the implementation of free trade agreements with the United States. This study assessed trends in brand-name drug patenting and generic patent challenges in South Korea after the introduction of the system.MethodsFrom 2012–19, we constructed a novel dataset that combines information about listed patents with their corresponding brand-name drugs and patent challenges against these brand-name drugs. We analyzed brand-name drug patenting and generic patent challenges and elucidated factors in timely patent challenges using event history analysis.ResultsDuring the study period, 659 brand-name drugs listed their patents in the K-Orange Book and patent challenges against 95 brand-name drugs were initiated. The number of listed patents and their nominal patent term varied by the characteristics of the brand-name drugs. Patent challenges of generic drugs were marginal in South Korea even though the surge of patent challenges of generics were noticed right after the introduction of the patent linkage system.ConclusionsPatenting and patent challenges are critical factors when introducing generic drugs into the market under the patent linkage system. However, the impact of the patent linkage system on patenting and patent challenges could be varied by the specific form of the patent linkage system and the contexts of pharmaceutical markets.

Analysis of Historical Patenting Behavior and Patent Characteristics of Computer Architecture Companies—Part V: References

In prior parts of this series, I analyzed the 1) number of all issued patents and issued computer architecture patents; 2) the prosecution time and effective patent term; 3) the number of claims, breakdown of independent and dependent claims, and effect that excess claim fees had on the numbers of total and independent claims; and 4) the type of claims (apparatus, method, or Beauregard), and effect that the Supreme Court’s decision in Alice v. CLS Bank had on the number of independent and dependent method claims, for patents that were issued to 18 leading computer architecture companies and filed between 1996 and 2020. This article examines the 1) number of “backward” citations to previously issued/published U.S. patents and U.S. patent publications, foreign patents, and Other References and 2) the number of “forward” citations to a company’s patent by another U.S. patent or U.S. patent publication.

Second Medical Use Patents and Compensation for the Delay in Marketing Authorisations: The Curious Case of Vietnam

Abstract There has been a concern that developing countries which join new-generation FTAs might jeopardise their population’s access to medicines because those FTAs mandate TRIPS-plus patent standards. This article, however, argues that Vietnam, through its unusual legislative steps, has avoided increasing patent protection for medicines without (yet) violating international obligations. Its practice is examined via two specific patent-related issues: second medical uses and compensation for the delay in marketing authorisations. Regarding the first issue, the author finds that the law is deliberately ambiguous, as it neither rejects nor allows second medical use inventions. Regarding the second issue, Vietnam’s newly amended law in 2022 has arguably adopted a unique form of compensation: it waives the patent maintenance fees instead of extending the patent term. The paper concludes that because of the country’s sluggish local industry as well as its legislators’ struggle to keep pace with increasingly changing IP standards in the new FTAs, language ambiguity and lip service have become Vietnam’s weapons of choice.

Value added products and many health benefit of mushroom products

This paper summarised the cultivation practices of mushroom. The processing equipment method of preservative, value added based product and its nutricatical properties the review also highlight the various scientific feats achieved in term of patents and reset publication promoting mushroom as a wholesome food and health benefits.A mushroom is the reproductive structure produced by some fungi. It is somewhat like the fruit of a plant, except that the

Consolidation in Prescription Drug Markets: Impact on Pricing and Access

We examine the impact of M&A activity between drug manufacturers on drug prices and patient access. We start by collecting detailed information on acquisitions involving companies that sell on-patent branded drugs, covering the 2007–2019 period. We find that approximately one-third of branded drugs are acquired by a different company during their patent terms, but only a few “overlap” acquisitions consolidate ownership of drugs in the same therapeutic area. Next, we use a two-way fixed-effects approach to measure how prices and patient access respond to mergers. We find that all newly acquired drugs experience price growth following acquisitions. However, only those acquired by larger companies see an increase in their effective net price. Drugs involved in overlap acquisitions only see higher price growth if the acquisition was small enough to escape regulatory scrutiny, suggesting that antitrust agencies are imposing effective constraints on potentially anti-competitive agreements.

Commercial Low Molecular Weight Heparins - Patent Ecosystem and Technology Paradigm for Quality Characterization.

Heparin is a subject of ever-growing interest for laboratory researchers and pharmaceutical industry. One of the driving factors is its critical life-saving drug status, which during the COVID-19 pandemic has assumed a central role in disease treatment and/or prevention. Apart, heparin is one amongst few drugs enjoying a “demand constant” status. In 2020, heparin market size was valued to US$6.5 bn., and given the ongoing stability in the COVID-19 health crisis, it is expected to reach US$11.43 bn. by 2027 with yearly growth rate momentum (CAGR) of 3.9% during the forecast period (Pepi et al., Mol Cell Proteomics 20:100,025, 2021). As patent is a limited monopoly, every year, many patents on low molecular weight heparin (LMWH; a chemically or enzymatically degraded product of unfractionated heparin) are losing market exclusivity worldwide, inviting the generic/biosimilar drug manufacturers to capture market share with cheaper drug products. By tracking patent expiration, drugs in patent litigation, regulatory setbacks for innovator companies (such as those seeking data exclusivity or patent term extension), or other unexpected events affecting market demand and competition, generics can make investment decisions in manufacturing off-patent LMWH drug products of commercial significance. However, given the US Food and Drug Administration (FDA), European Medicine Agency (EMA), Drug Regulatory Authority of Pakistan (DRAP), and other regulatory authorities scientifically rigorous standards for generic/biosimilar LMWH drug products marketing approval, the market is secured and momentous for drug makers that could demonstrate through scientific and clinical dataset that the generic/biosimilar LMWH drug product is of the same quality and purity as the innovator drug product. This study presents an overview of the patent landscape of commercially available LMWHs and advanced analytical techniques for their structural and biochemical characterization for quality control and quality assurance during manufacturing and post-marketing. The study also covers FDA, EMA, Health Canada, and DRAP’s current approaches to evaluating the generic/biosimilar LMWH drug products for quality, safety including immunogenicity, and efficacy.

Analysis of Historical Patenting Behavior and Patent Characteristics of Computer Architecture Companies—Part III: Claims

Part I of this series analyzed the number and type of patents that were issued to 18 leading computer architecture companies for patents that were filed between 1996 and 2020. Part II analyzed the prosecution time and effective patent term length for those patents. This article builds on that work by analyzing the number and type of claims. Due to the large amount of claims-related data, Parts III and IV will focus on the claims. Part III is presented here and Part IV will be published in the September-October 2022 issue of IEEE Micro.

Board Gender Diversity, Corporate Social Responsibility Disclosure, and Firm's Green Innovation Performance: Evidence From China.

The current research investigates the interplay of board gender diversity (BGD), the quality of corporate social responsibility disclosure (CSRD), and the green innovation performance (GIP) of a firm. It examines the moderation effect of the CSRD on the relationship between corporate GIP and BGD. The study inculcates 3,736 firm-year observations of A-share listed Chinese firms from 2010 to 2019. Least square dummy variables method, generalized method of moments, and 2SLS are employed for the analysis of the study. The findings foster an affirmative and significant impact of BGD on corporate GIP in terms of green innovation patents. Moreover, the quality of CSRD is also detected for a significant moderating effect on the relationship between BGD and corporate GIP. The quality of CSRD emerges to be an indicator for social resilience and female role congruence under the purview of the social resilience theory and the role congruence theory, respectively. This research would help managers and policymakers of developing nations in formulating environmental innovation strategies for corporate sustainability.

Exploring the Patent Landscape and Innovation of Hydrogel-based Bioinks Used for 3D Bioprinting

This paper provides a comprehensive overview of the patent situation for hydrogel- based bioinks used for 3D bioprinting globally. It encapsulates information which could be used as a reference by researchers in the fields of 3D bioprinting, biomaterials, tissue engineering, and biomedical engineering, as well as those interested in biomaterials, especially in the formulation of hydrogels. It can also inform policy discussions, strategic research planning, or technology transfer in this area. The findings presented hereinafter are considered novel research aspects regarding the used hydrogels, their preparation methods, and their formulations, as well as the 3D bioprinting process using hydrogels. Furthermore, the novel part, synthesized patents, is regarded as a breakthrough in hydrogel- based bioinks. The following research aspects of this study are based on data collection from selected patent databases. The search results are then analyzed according to publication years, classification, inventors, applicants, and owners, as well as jurisdictions. Based on the earliest priority date, it is possible to precisely assume that 2004 is considered the starting year of patenting of hydrogel-based bioinks. Furthermore, 2020 was the year with the most patent documents. According to the findings, the United States, China, and the Republic of Korea are the most prolific countries in terms of patenting on hydrogel-based bioinks. The most prolific patenting companies are from the United States, Sweden, and Australia, while universities from the Republic of Korea and the United States are the academic institutions leading the way. Most inventions of hydrogel- based bioinks intended for hydrogels or hydrocolloids used as materials for prostheses or for coating prostheses are characterized by their function or physical properties. The state has been reviewed by introducing what has been patented concerning hydrogelbased bioinks. Knowledge clusters and expert driving factors indicate that the research based on biomaterials, tissue engineering, and biofabrication is concentrated in the most common patent documents. Finally, this paper, which gives a competitive analysis of the past, present, and future trends in hydrogel-based bioinks, leads to various recommendations that could help one to plan and innovate research strategies.

Analysis of Patent and Regulatory Exclusivity for Novel Agents in China and the United States: A Cohort Study of Drugs Approved Between 2018 and 2021

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. 2.9years, 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.

Patent term erosion and the availability of new medicines in Canada 2000-2022

Patent term erosion and the availability of new medicines in Canada 2000-2022 CURRENT CONTRIBUTORS Brett Skinner, PhD, Canadian Health Policy Institute (CHPI) ATTRIBUTION This legacy paper is corporately authored and edited based on proprietary template models and methods that

Fixing The FDA's Orange Book.

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.

Machine Learning Models and Videos of Facial Regions for Estimating Heart Rate: A Review on Patents, Datasets, and Literature

Estimating heart rate is important for monitoring users in various situations. Estimates based on facial videos are increasingly being researched because they allow the monitoring of cardiac information in a non-invasive way and because the devices are simpler, as they require only cameras that capture the user’s face. From these videos of the user’s face, machine learning can estimate heart rate. This study investigates the benefits and challenges of using machine learning models to estimate heart rate from facial videos through patents, datasets, and article review. We have searched the Derwent Innovation, IEEE Xplore, Scopus, and Web of Science knowledge bases and identified seven patent filings, eleven datasets, and twenty articles on heart rate, photoplethysmography, or electrocardiogram data. In terms of patents, we note the advantages of inventions related to heart rate estimation, as described by the authors. In terms of datasets, we have discovered that most of them are for academic purposes and with different signs and annotations that allow coverage for subjects other than heartbeat estimation. In terms of articles, we have discovered techniques, such as extracting regions of interest for heart rate reading and using video magnification for small motion extraction, and models, such as EVM-CNN and VGG-16, that extract the observed individual’s heart rate, the best regions of interest for signal extraction, and ways to process them.

Role of Trade-Related Aspects of Intellectual Property Rights (TRIPS) in Intellectual Property Rights (IPR) Legislation Laws in India

The world economy is growing through the development rate. Every day we come across new developments, inventions and innovations in the field of natural science, medical science, commerce and management etc. One of the main factors that are helping in these developments is strong IPR in the world by the introduction of TRIPS by the World Trade Organization (WTO). In this study, an attempt has been made to discuss the role of TRIPS in IPR legislation laws in India. The study is exploratory cum descriptive in nature. The study found that with the emergence of TRIPS it became obligatory for its member nation to follow its guidelines. In India various amendments has been done in the Patent Act, Copyrights act, Trademarks act to comply with the guideline of TRIPS. Major amendments include Abolition of exclusive market Rights, Terms of patents increased from 14 years to 20 years, Power of Government broadcasting organisations and performers in certain other countries in case of copyrights, registration of design, extension of definition of trademarks etc. Further geographical indication act came into existence where geographical indication cannot register as trademarks; protection of plant varieties and farmers’ rights also there is a three-tier body at local, state and national level that works for the preservation and conservation of biological resources. The study suggested that non-governmental organizations (NGOs) should take part in boosting the IPR.

Global Patent Landscape of Benign Prostatic Hyperplasia Drugs

ObjectiveTo characterize the changing landscape of BPH drugs by investigating patent documents derived from pipeline projects. Benign prostatic hyperplasia (BPH) drugs were first approved for the mainstream market about 20 years ago. The fixed patent term warns of possibly transforming the landscape of BPH drugs as technological and commercial substitution causes the displacement of established technologies and competitors by newer ones. However, very few studies focus on patents of BPH drugs, though many literature reviews have analyzed this topic from technological and clinical perspectives. MethodsAll available patent data relevant to BPH-related drugs were collected from the Cortellis database. Descriptive statistics, bibliometric analyses, and citation analyses were used to analyze the patent landscape. ResultsBy analyzing 1,936 patent families from 1967 to 2019, this study addresses the main results on the changing landscape of BPH drugs, involving associated indications, the shifting centers of innovation globally, notable formulation patents, and promising therapeutics. ConclusionThe results provide a significant reference for decision-making by researchers, clinicians, policymakers, and investors with an interest in BPH drugs.

Open innovation and information technology use: Towards an operational alignment view

AbstractA centralised open innovation search approach refers to setting up a dedicated and specialised sourcing unit to search external sources for knowledge, while a decentralised open innovation search approach refers to empowering employees in various functional units to search external sources for knowledge during their routine research and development work. This research examines the operational alignment of the open innovation search approach with information technology (IT) use given that open innovation search can be significantly enhanced by IT. We theorise that organisations that have a high extent of employing a centralised (decentralised) open innovation approach and a high IT use intensity for external (internal) information flows are likely to have a high extent of exploratory (exploitative) innovation. We further posit that harnessing exploratory and exploitative innovation can lead to organisational innovation performance. This theory was validated through a field survey involving 186 organisations. The findings from this study advance the IT and open innovation literature by gaining an understanding of the interplay among different open innovation search approaches and IT use, and the resulting variances in innovation performance in terms of new product sales and patents.

Innovation and Patenting within Containerized Liner Shipping

Increasingly, in many industries, companies commercialize their technology and innovations through patenting to gain an edge over competition. Within the maritime sector, while literature on innovation is expanding, issues related to the importance of intangible assets, such as patenting, for the participant firms of the industry remain unaddressed. Utilizing innovational frameworks and patent data withdrawn from European Patent Organization’s (EPO’s) database, the aim of this paper is to investigate the innovative level, in terms of patents granted, of incumbent market actors in liner shipping. Apart from patent counts, this exercise sheds light on the areas to which these patents apply, providing a classification while also investigating additional attributes which relate to patent citations, investors and applicants. Although results indicate a varying degree of utilization of the patenting system amongst liner carriers, they nonetheless affirm to some extent that knowledge creation is a valuable tool in the arsenal of some liner carriers, and that patenting is one of the various means utilized to enhance their market position and achieve a sustained competitive advantage. In addition, findings suggest that liner carriers’ innovative efforts have, based on the forward citations received, some significance, while they focus primarily the development of patented technologies which enhance the operational efficiency of their vessels. In this respect, the investigation undertaken sheds some light and provides a novel perspective on understanding the behaviour and innovative propensity of liner shipping companies.