Patent Issues Research Articles

Development of national specialization in 5G technologies within the European Union

Nowadays the efforts of not only companies, but also governments in different countries are aimed at the development of 5G technologies. On the one hand, the introduction of 5G is an expensive process that requires investments in the development, deployment and maintenance of infrastructure, the involvement of a large number of market participants and service providers, the creation of a stimulating and regulatory legislative framework, the provision of radio frequencies of a more efficient spectrum, the solution of patenting issues. On the other hand, the introduction of 5G technologies will be aimed at developing the economy of many industries, creating social benefits, reducing energy intensity, and will create new opportunities for companies. Currently, the benefits of the digital economy can be most used by the United States, the Republic of Korea and China, which have the highest rates of 5G adoption in the world. The countries of the European Union are also interested in the development of 5G technologies. We analysed key 5G technologies for 74,940 related patents for 23 EU countries for the period 2012–2021. It is shown that the leaders in the number of 5G patents were Sweden, Germany, Finland, France, the Netherlands and Ireland. It is noteworthy that countries can either focus on developing a small number of technologies, or develop a wide range of them. Since 2018, France, Estonia and Germany demonstrate the greatest number of technological specializations primarily creating inventions related to 5G data processing. At the same time, the USA, the Republic of Korea and China still retain their competitive advantages in fields of basic electric elements and electric communication technique for fifth generation networks. To improve positions in the global technology market the EU countries need to specialize in rarer and more complex technologies and develop national policies in this area.

Market-based patent value of green transformation technologies

This paper employs the green technology classification published by the Japan Patent Office to estimate the values of green and non-green innovations. By computing patent values based on stock price reactions to the announcement of patent issuance, this paper finds that, on average, green patents have higher values than non-green patents in the pooled sample. However, results from the matched sample indicate the presence of selection biases.

Патентоспособность бизнес-методов: невозможное возможно

The article deals with the issue of business methods patentability. Rapid development of information technology stimulates the creation of new business models based on the use of artificial intelligence and modern technological advances in data processing and transmission. The author concludes that there are conditions for business-methods patent protection in Russia by analysing the examples of Russian and Japanese patent and judicial practices, as well as by way of systematic law interpretation. She offers the definition of the notion of business-method for the purposes of patent protection seeking and reveals the factors influencing the acknowledgement of subject patentability.

The legal basis fot the application of patent waiver settlements in the covid-19 pandemic

Background: The research on the role of the World Trade Organization in solving the vaccine patent waiver problem related to the 2019 coronavirus disease pandemic will address each issue one by one. Seeing the waiver applications that were made from the end of 2020 to 2022, it is necessary to further study the legal basis and enforcement of patents. Coupled with its relation to public health and equality for the global world to achieve. This study aims to provide an understanding of the role of the WTO in the patent waiver application process and the continuity of current and future patent law enforcement. Method: This research is a normative research with a descriptive method that will explain with the aim of obtaining a description of the events of the patent waiver application. The data that has been obtained will be analysed qualitatively. Conclusions will be obtained from various descriptive data collected from primary and secondary sources that have been analysed. In this regard, this research will be descriptive-analytical in nature which will reveal existing regulations and their implementation. Findings: The results of this study are that the WTO has carried out its roles and functions in accordance with applicable international legal instruments. However, this research emphasises further on the principles of the WTO itself which emphasises justice for developing and less developed countries on the other words called Special and Differential Treatment of Developing Countries (SDT). Coupled with the existence of the Doha Declaration which should emphasise that public health should take precedence over intellectual property rights, including patents. Conclusion: Regarding the WTO's role in resolving vaccine patent issues during the COVID-19 pandemic, it can be concluded that the actions taken by the WTO, including its internal bodies and councils, adhere to applicable legal principles and the TRIPs Agreement. However, the decisions must fully align with the WTO's principles, particularly the Special and Differential Treatment of Developing Countries (SDT). Novelty/Originality of this study: This study analyzes the role of the WTO in resolving vaccine patent issues during the COVID-19 pandemic, focusing on the SDT principles and the Doha Declaration. It reveals the gap between international law and global health needs, offering a framework for balancing intellectual property rights with public health needs.

The pharmaceutical patent process: National Health Surveillance Agency and National Institute of Industrial Property act differently in the process

The National Institute of Industrial Property (INPI) is the government body responsible for granting patents in the national territory; in the case of medicines, they need to be registered with the National Health Surveillance Agency (ANVISA) in order to be marketed. There was a divergence in legal interpretation (of Art. 229-C of the IPL) which caused damage to entrepreneurs, laboratories and the community in general, as there was no express provision as to whether ANVISA's opinion would be binding on the INPI's decision on patent issues. The aim of this research was to analyze this problem, raising its main points and demonstrating how dangerous and damaging bureaucracy and inefficient and obscure normative acts that give rise to dubious interpretation can be, based on the application of hermeneutic and dialectical methods. In 2021, the Superior Court of Justice (STJ), in Special Appeal n. 1543826, held that ANVISA's opinion would be a valid prerequisite for granting patents for pharmaceutical products or processes. It was found that the STJ decision increased ANVISA's "powers", but with the repeal of Art. 229-C of the IPL, the dilemma was extinguished and the competencies of each body re-established. It is therefore of the utmost importance to fill legal gaps and issue clear and specific laws so as not to leave room for harmful interpretations, guaranteeing original competences and legal certainty.

Agricultural technology as a driver of sustainable intensification: insights from the diffusion and focus of patents

Sustainable intensification (SI) responds to the concurrent challenges of increasing food production while reducing the environmental impacts of agriculture. As an early disclosure of innovation, patents are a useful indicator of technology market potential. However, we lack understanding of the extent to which current agricultural technology patents relate to the goals of SI and which kinds of technologies can potentially address SI. Here, we analyzed the diffusion and focus of more than one million patents issued during the period 1970–2022. We explored the degree to which the patents relate to SI through the co-occurrence of efficiency and environmental friendliness targets. Our results reveal that while the rate of patent issuance has dramatically increased over the past five decades, the rate at which patents diffused to different countries had decreased over time. The USA was the biggest net exporter of patents and had produced by far the most high-impact patents (in the top 1% most-cited patents). Since 1970, only 4% of agricultural patents and 6% of high-impact patents were related to SI targets (i.e., promoting both agricultural efficiency and environmental friendliness), but the attention to SI has increased over time. The most highly cited SI-related patents had become more diverse over time, shifting from digital, machine, and energy technologies in 1980s to the current era of agroecology, information, and computer networking. Our results provide an early indication of promising technologies that may play a greater role for SI in the future, subject to the challenges of market transfer and farm adoption and complemented by non-technological innovations in farm management and institutional support.

Current Regulatory Framework and Challenges for the Approval of Complex Generics in the US and the EU

Abstract: The pharmaceutical industry is witnessing a growing demand for complex generic products, which are generic versions of drugs that possess complex formulations, delivery systems, or active ingredients. However, the approval process for these complex generic products poses unique challenges compared to traditional generics. There is no specific regulatory procedure available for the approval of complex generics, unlike smallmolecule generics and biosimilars. This led to controversial arguments in the past about the scientific evidence needed for applications, which led to lengthy approval processes. The regulatory frameworks that are currently being used for complex generics are debatable and unclear. Complexity in the molecular structure, mechanism of action, route of delivery, and complex manufacturing process makes proving bioequivalence and pharmaceutical equivalence difficult. There is a need for harmonization of the regulatory framework by the agencies to help the generic manufacturers by providing scientific advice, defining the submission requirements for complex products, and fastening the approval process. : This review begins by discussing the regulatory landscape surrounding complex generic products in various regions, including the United States and Europe. It examines the specific guidelines and requirements set forth by regulatory authorities to ensure the safety, efficacy, and quality of these products. Additionally, the review explores the differences in terminology and definitions used to classify complex generics across different jurisdictions. Furthermore, it delves into the challenges faced by both regulatory agencies and pharmaceutical companies in evaluating and approving complex generic products. These challenges include establishing appropriate bioequivalence criteria, determining interchangeability with the reference product, addressing patent and exclusivity issues, and ensuring consistent quality throughout the product lifecycle. The impact of these challenges on market entry and competition is also discussed. The review highlights the need for harmonization and streamlining of regulations for complex generic products worldwide. It emphasizes the importance of clear and consistent guidelines to enable timely approvals, foster innovation, and facilitate patient access to affordable alternatives.

The rebirth of epitope-based patent claims.

Patent protection of therapeutic antibodies and T cell receptors is an important tool to enable the path to the market. In view of the substantial spendings for R&D and regulatory approval, sponsors expect exclusivity for their drug for a given period of time. Different categories exist to protect therapeutic antibodies and T cell receptors. One of these categories are epitope-based patent claims, with regard to which in the different jurisdictions, different patentability standards exist, which, furthermore, are constantly changed by courts and lawmakers. This article tries to explain the patentability issues related to epitope-based patent claims. For this purpose, an overview is given on the respective legal provisions and court decisions. The study reveals that the respective patentability standards are constantly changed by courts and lawmakers. Companies developing therapeutic antibodies or T cell receptors need to consider these developments in their strategic planning.

Patent and Bibliometric Analysis of the Scientific Landscape of the Use of Pulse Oximeters and Their Prospects in the Field of Digital Medicine.

This study conducted a comprehensive patent and bibliometric analysis to elucidate the evolving scientific landscape surrounding the development and application of pulse oximeters, including in the field of digital medicine. Utilizing data from the Lens database for the period of 2000-2023, we identified the United States, China, the Republic of Korea, Japan, Canada, Australia, Taiwan, and the United Kingdom as the predominant countries in patent issuance for pulse oximeter technology. Our bibliometric analysis revealed a consistent temporal trend in both the volume of publications and citations, underscoring the growing importance of pulse oximeters in digitally-enabled medical practice. Using the VOSviewer software(version 1.6.18), we discerned six primary research clusters: (1) measurement accuracy; (2) integration with the Internet of Things; (3) applicability across diverse pathologies; (4) telemedicine and mobile applications; (5) artificial intelligence and deep learning; and (6) utilization in anesthesiology, resuscitation, and intensive care departments. The findings of this study indicate the prospects for leveraging digital technologies in the use of pulse oximetry in various fields of medicine, with implications for advancing the understanding, diagnosis, prevention, and treatment of cardio-respiratory pathologies. The conducted patent and bibliometric analysis allowed the identification of technical solutions to reduce the risks associated with pulse oximetry: improving precision and validity, technically improved clinical diagnostic use, and the use of machine learning.

Influence of Social Overhead Capital Facilities on Housing Prices Using Machine Learning

The South Korean residential real estate market is influenced by both the traditional dynamics of demand and supply and external factors such as housing policies and macroeconomic conditions. Considering the proportion of housing assets in individual wealth, market fluctuations can have significant implications. While previous studies have utilized variables such as GDP growth rate, patent issuance, and birth rate, and employed models such as LSTM and ARIMA for housing price predictions, many have overlooked the influence of local factors. In particular, there has been insufficient investigation into the impact of subway stations and living social overhead capital facilities on housing prices, especially in metropolitan areas. This study seeks to bridge this gap by analyzing the usage trends of subway stations, evaluating the impact of living social overhead capital facilities on housing values, and deriving the optimal machine learning model for price predictions near subway stations. We compared and analyzed a total of eight machine learning regression models, including Linear Regression, Decision Tree, Random Forest, LightGBM, Ridge, Lasso, Elastic Net, and XGBoost, all of which are popular regression models, especially in the context of machine learning and data science. Through comparative analysis of these machine learning techniques, we aim to provide insights for more rational housing price determinations, thereby promoting stability in the real estate market.

PATENTABILITY OF HUMAN EMBRYONIC STEM CELLS IN INDIA

The hESC research with recent developments has become one of the most desirable research fields for the scientist. The reason behind such an approach is basically the great potential to treat and cure the human race of very incurable diseases. Countries around the world have amended their policies with regards to stem cells in such a way as to enhance the advantage as the stem cell market is a trillion-dollar market. The research procedure involving patentable invention is time-consuming and requires many expenses, so the investor is always keener to know if they will get any monetary benefit. Though the medical field promises about importance of stem cell and biotechnological research, there are concerns in some countries, such as India, about potential policy implications that would affect the patenting innovations in this industry. As India lacks a coherent legislative policy regarding stem cell patenting, it is creating more confusion for research in stem cell research. Often, researchers do not want to be involved in the said research because India lacks any specific laws in said fields apart from so-called guidelines provided in 2017 with an amendment to Drug and Cosmetic Act in 2019. Patent laws play a vital role in industrial advancement, thus helping a country's economy. To enter the race of development, countries worldwide have developed their patent laws so that they achieve maximum benefits out of it. In India, with patent laws, moral, cultural and religious beliefs also play a vital role in granting a patent, specifically in the Human Embryonic Stem Cell patent. The Article discusses topics that a researcher must be familiar with when discussing patentability issues. A few of these topics include the morality debate, stem cell and biotechnological research, and Stem cell research's patentability. Additionally, this Article identifies the discrepancies between the laws governing stem cell research within India.

Cocrystals by Design: A Rational Coformer Selection Approach for Tackling the API Problems.

Active pharmaceutical ingredients (API) with unfavorable physicochemical properties and stability present a significant challenge during their processing into final dosage forms. Cocrystallization of such APIs with suitable coformers is an efficient approach to mitigate the solubility and stability concerns. A considerable number of cocrystal-based products are currently being marketed and show an upward trend. However, to improve the API properties by cocrystallization, coformer selection plays a paramount role. Selection of suitable coformers not only improves the drug's physicochemical properties but also improves the therapeutic effectiveness and reduces side effects. Numerous coformers have been used till date to prepare pharmaceutically acceptable cocrystals. The carboxylic acid-based coformers, such as fumaric acid, oxalic acid, succinic acid, and citric acid, are the most commonly used coformers in the currently marketed cocrystal-based products. Carboxylic acid-based coformers are capable of forming the hydrogen bond and contain smaller carbon chain with the APIs. This review summarizes the role of coformers in improving the physicochemical and pharmaceutical properties of APIs, and deeply explains the utility of afore-mentioned coformers in API cocrystal formation. The review concludes with a brief discussion on the patentability and regulatory issues related to pharmaceutical cocrystals.

Reproducibility challenges in robotic surgery.

Reproducibility of results is, in all research fields, the cornerstone of the scientific method and the minimum standard for assessing the value of scientific claims and conclusions drawn by other scientists. It requires a systematic approach and accurate description of the experimental procedure and data analysis, which allows other scientists to follow the steps described in the published work and obtain the "same results." In general and in different research contexts with "same" results, we mean different things. It can be almost identical measures in a fully deterministic experiment or "validation of a hypothesis" or statistically similar results in a non-deterministic context. Unfortunately, it has been shown by systematic meta-analysis studies that many findings in fields like psychology, sociology, medicine, and economics do not hold up when other researchers try to replicate them. Many scientific fields are experiencing what is generally referred to as a "reproducibility crisis," which undermines the trust in published results, imposes a thorough revision of the methodology in scientific research, and makes progress difficult. In general, the reproducibility of experiments is not a mainstream practice in artificial intelligence and robotics research. Surgical robotics is no exception. There is a need for developing new tools and putting in place a community effort to allow the transition to more reproducible research and hence faster progress in research. Reproducibility, replicability, and benchmarking (operational procedures for the assessment and comparison of research results) are made more complex for medical robotics and surgical systems, due to patenting, safety, and ethical issues. In this review paper, we selected 10 relevant published manuscripts on surgical robotics to analyze their clinical applicability and underline the problems related to reproducibility of the reported experiments, with the aim of finding possible solutions to the challenges that limit the translation of many scientific research studies into real-world applications and slow down research progress.

Directions of Statistical Study of the Implementation of Advanced Production Technologies in Russia

The paper deals with certain aspects of the statistical study of how advanced production technologies are implemented at the present stage of scientific and technological progress in Russia. This matter is addressed from two perspectives: statistics on the development and use of advanced production technologies and statistics on stimulating the greatest possible return on the results of the introduction of advanced production technologies in the shortest period of time possible.The author formulates proposals to improve the system of accounting indicators by improving the quality of the selection of organizations that develop and use advanced production technologies, as well as the quality of accounting for unaccounted technologies at all levels of management. Recommendations are given for adjusting each of the main areas of use of the evaluation indicators, as well as improving the methodology for the formation of the evaluation indicators themselves, in particular, by applying a score to each of them.The statistics of advanced production technologies implementation is evaluated. Particular attention is paid to accounting for the formation of applications and their implementation in such areas as patent issuance, registration of trademarks and industrial designs. The article considers activity of the World Intellectual Property Organization (WIPO) in the area of patent statistics.The author explains the need to gradually combine the two forms of statistical accounting – state (Rosstat) and WIPO statistics – into a single form, which will allow, at the early stages of development and use of technologies, to assess their quality and take appropriate measures to improve them.

К вопросу об инновационном развитии России

The article discusses issues concerning various points of view on the problems associated with the development of innovative potential both at the level of the Russian Federation and at the regional level. The analysis of statistical data concerning the number of personnel engaged in scientific research and development; the level of innovative activity of organizations, the share of innovative goods, works, services in the total volume of goods shipped, works performed, services; the number of organizations performing research and development; the number of patent applications and the issuance of patents in the Russian Federation. The study found that the innovation system in the Russian Federation is going through a new stage of development and there are a number of challenges that do not allow it to fully function both at the regional and federal levels. The analysis of the strategy for the development of science, technology and innovation of the Tula region until 2030 was carried out. According to the results of the study, the relevant conclusions were formed.

Patent Issues and Traditional Knowledge: Special Refrence to Neem, Basmati Rice and Turmeric Case

Patent Issues and Traditional Knowledge: Special Refrence to Neem, Basmati Rice and Turmeric Case

Patentability of Computer Program Algorithms in the G20 States

Ubiquitous computerization and digitalization are contributing to the unprecedented growth of the software market. Computer programs are protected as subject of copyright law in international law and domestic legal systems. However, copyright law does not protect the interests of the copyright holder from borrowing ideas and algorithms which often have agreat commercial value. This circumstance has prompted the legal science and law enforcement practice of the most developed states to justify the possibility of protecting computer programs and their algorithms. The leading states chosen for in this paper are the G20 states. The relevance of this choice is due to the following: 1) The G20 states account for 86% of global GDP; 2) All world leaders in computer software development are G20 members; 3) All BRICS states are G20 members; 4) The law-and-orders of the G20 states are relevant to all existing traditions of the legal protection of intellectual property in the world. The legal systems of the G20 states follow one of three approaches according to the criterion of patentability of computer programs and their algorithms. We call the first approach “neutral.” It includes States which legislation does not explicitly prohibit the patenting of computer programs, but computer programs themselves are not mentioned among the subject matters of inventions. The second (“positive”) approach includes those states which legislation explicitly classifies computer programs as patentable inventions. On the contrary, the third (“negating”) approach includes states where it is legally established that computer programs as such are unpatentable. The results of the research demonstrate that there is no direct correlation between the way of solving the issue of patentability of computer program algorithms in different legal systems and the state’s place in the global IT market. For example, the United States and China take aneutral approach, Japan takes apositive approach, the EU Member States and India take anegating approach. We believe that the most flexible approach is aneutral approach from the point of view of patent law policy. The most liberal and consistent approach is the positive approach presented by the Japanese legal system. Finally, the negating approach is the most controversial and at the same time widespread among the G20 and BRICS states.

The challenges and opportunities for the development of COVID-19 therapeutics and preparing for the next pandemic

The disease which is today known as COVID-19 is caused by severe acute respiratory. Syndrome coronavirus 2 (SARS-COV-2), was first reported in Wuhan, China in December 2019. The disease has claimed well over six million lives from over 500 million cases. Vaccine hesitancy militates against successful mass vaccination. There is the rapid emergence of new SARS-COV-2 variants, constituting a challenge to the effectiveness of vaccines. Moreover, none of the available vaccines offers 100% protection and even the protection offered is of short duration necessitating booster doses to be taken. Moving forward, the development of plant-based edible vaccines will be a remarkable strategic approach to overcome vaccine hesitancy and improve vaccine uptake. So far only about nine drugs for COVID-19 treatment have approvals by either or both the European Medicines Agency and the FDA. While drug repurposing to address the emerging need in the early period of the COVID-19 pandemic has been contextually very useful, investment in it remains relatively low for commercial reasons arising from patenting issues. Embarking on new drug discovery and development strategies targeting both the virus and host factors is a very appealing option. Targeting druggable targets that are present across viruses, particularly the coronaviruses, for drug discovery and development represents an important strategy for pandemic preparedness. Natural products are an important reservoir of chemical scaffolds with huge potential for the discovery of novel chemical entities for development of novel therapeutics. Phytopharming is an available technology that can be used for mass and accelerated production of therapeutic molecules that will be required within short periods of time as is the case in pandemic outbreaks. Nanotechnology provides excellent platforms for formulating multivalent vaccines and pan-viral medicines for the treatment of COVID-19. Taken together, this review discusses the potential for the development of therapeutics by using the tools of biocomputing, nanotechnology, and phytopharming for accelerated therapeutic development to achieve effective COVID-19 treatment and associated complications, including new and emerging variants of SARS-COV-2 and other viral pandemics that may emerge or re-emerge.

Strategy for Patent Protection in Crowdfunding: A Case Study in Malaysia

Crowdfunding has become the alternative way for many inventors to raise fund for their business. However, online crowdfunding raises some patent issues that relevant to the inventors. Hence, this paper examines the patent protection issues in crowdfunding practices and the strategies to resolve the issues in the context of Malaysia. For that purpose, interviews were conducted with six experts from crowdfunding operators and fundraisers. The findings showed that the largest obstacle perceived was a lack of awareness amongst the users of crowdfunding pertaining to the importance on how to protect the patent and project confidentiality during the crowdfunding process. Most of the project owners do not prioritise patenting their invention before disclosing the information on the crowdfunding platform, this might lead to patent infringement issues. Furthermore, the disclosed invention may not be patentable, and public disclosure also may put them at risk of infringement allegation by a third party. Crowdfunding users also should be more aware of the importance of intellectual property rights before they launch their crowdfunding campaign through an online basis. A proper patent protection strategy is important to protect inventors in the crowdfunding practices in Malaysia.

Ownership, liability, patentability, and creativity issues in artificial intelligence

ABSTRACT While Artificial Intelligence technologies find increasing use in different industries such as transportation, healthcare and other services, it gives rise to legal complexities in respect of ownership and liability of AI, patentability of AI inventions, and creativity & ownership of AI-generated works attributable to various components of AI. The autonomous decision-making ability of AI challenges the existing IP framework. Since AI machines can “think” and “act” without any human effort, if any damage or harm occurs to the properties, does the current model of tort liability (product liability, negligence, strict liability) adequately address the legal concerns? Robust regulatory bodies and institutional mechanisms are required to develop rigorous safety standards and establish safety certification processes for AI. Even though AI inventions can be patented, many jurisdictions recognize only a “human” as an inventor and not the AI. With the increasing capability of AI to generate works without human intervention, there seems to be a strong case for granting copyright protection to AI-generated works. Exploring a separate legal framework for AI to reduce ambiguity and increase accountability would be in order.