Patent Protection Research Articles

Impact of China's National Centralized Drug Procurement Policy on pharmaceutical enterprises' financial performance: a quasi-natural experimental study.

In China, the interest relationship between pharmaceutical enterprises and medical institutions has harmed the healthy development of pharmaceutical enterprises. In November 2018, the National Centralized Drug Procurement (NCDP) policy was published. The NCDP policy severs the interest relationship and significantly impacts on pharmaceutical enterprises's financial performance. Using the implementation of China's National Centralized Drug Procurement (NCDP) policy as a quasi-natural experiment, this study evaluated the impact of participation in the NCDP policy on pharmaceutical enterprises' financial performance. We developed a difference-in-difference model to estimate the change in financial performance after NCDP implementation, based on financial data on Chinese listed pharmaceutical enterprises. We found that the bid-winning enterprises' financial performance significantly improved after participating in NCDP. This may be related to lower costs, market share expansion, and increased research and development investment by the bid-winning enterprises. To further promote the high-quality development of pharmaceutical enterprises in China, the government should expand the variety of drugs on the NCDP list (NCDP drugs), while improving the drug patent protection system and the policies to support the bid-winning enterprises.

Intellectual Property Investment at the International Court of Justice After Certain Iranian Assets

In Certain Iranian Assets, the International Court of Justice (ICJ) acknowledges that the protection of patents is part of the broader remit of a corporate entity with legal personality in international law. The case was not about intellectual property investments, nor was it a case about investment protection in the proper sense of that body of law. However, when the Court, in very light form, mentions the protection of patents, the World Court raises the bar for the dynamics of intellectual property investments in international law. This comment seeks to do two things. Frist, it will map out how the ICJ came to acknowledge the protection of patent rights in corporate entities and secondly, it will set out the parameters in which the ICJ develop its own version of investment protection as such. Certain Iranian Assets is an interesting case since it covers a range of issues with a high rate of declarations, separate opinions, and partial dissent on different matters. I will try to paint a picture of intellectual property investments based on the separate opinions and declarations, and most importantly, its linkage to the meaning of a company and company assets, especially under Article III(1) of the Treaty of Amity, Economic Relations. Patent Protection, Intellectual Property Investments, World Court, Assets, Interpretation

Innovative Design and Evaluation of a Transmission Lifter

This study focuses on the design, fabrication, and evaluation of the Transmission Lifter, a specialized device tailored for the convenient, stable, and durable servicing of vehicle transmission assemblies. The research aims to address the prevalent challenges faced by automotive technicians and mechanics during transmission servicing, offering an innovative solution that meets the high-performance requirements of the automotive industry.The study meticulously follows industry standards and leverages expert feedback to ensure the Transmission Lifter's quality, performance, and safety. It goes through comprehensive testing, meticulous analysis, and critical evaluation to gauge the device's effectiveness. The results of the study lead to several key conclusions: The Transmission Lifter successfully meets industry standards and the expectations of automotive experts, ensuring that it aligns with the highest quality requirements. The device exhibits high performance efficiency as affirmed by expert evaluations, highlighting its superior capabilities. It boasts an impressive load capacity, accommodating medium to heavy-duty transmissions with ease. The device is adaptable to the diverse configurations of automobile transmissions. It maintains stability even during extended use and can handle a substantial load. The Transmission Lifter performs exceptionally well, earning an overall "Excellent" rating based on expert evaluations. This study's findings inform a set of valuable recommendations, including patent protection, material enhancements for portability, improved finishing and adherence to industry standards, instructional manuals for users, and a call for continued research in the field. The Transmission Lifter presents a significant advancement in the field of automotive technology, contributing to the safety, efficiency, and quality of transmission servicing. Its innovation serves as a testament to the commitment of the researcher and his desire to support fellow technicians and automotive enthusiasts. By addressing the critical needs of the automotive industry, the Transmission Lifter embodies innovation, safety, and a commitment to excellence, setting a benchmark for future developments in the field.Asw

Does global economic reform accentuate technological innovation? A comparative evidence around the world

Technology innovation improves efficiency, gives society new and enhanced goods and services through economic reform, and raises their living conditions. This study examined the impact of economic reform on technological innovation using the system generalised method of moments and panel quantile regressions to account for simultaneity and reverse causality. The empirical findings conclude that economic reform significantly impacted technological innovation in 79 nations from 1995 to 2017. More importantly, we verify the positive effect of economic reform on technological innovation by addressing endogenous and robustness checks via various methods and sub-samples. Furthermore, the mechanism of this relationship was explored. Therefore, the research findings offer an alternative method for national ”gove’nments to promote innovation output by reinforcing government effectiveness, financia” sec’or development, and the degree of democracy transparency. Finally, economic proposals are discussed based on the findings and estimation strategies. HIGHLIGHTS The study examines the impacts of economic reforms on technological innovation in a panel of 79 economies over 1995–2017. Using GMM and panel quantile regressions, empirical findings indicate that economic reforms promote technological innovations. The positive effect of economic reforms on innovation operates through government effectiveness, financial development, and democracy. Intellectual Patent Protection Act controls inadequate competitiveness and preserves a fair market climate.

Impact of the second-hand market on durable goods remanufacturing decisions under patent protection

PurposeThis paper explores how the existence of a second-hand market can affect remanufacturing decisions for durable goods in the presence of patent protection.Design/methodology/approachThe authors construct a dynamic decision model between a durable goods original manufacturer and a durable goods remanufacturer considering the characteristics of the multi-cycle uses of new durable goods and remanufactured durable goods.FindingsThe results show that (1) the second-hand market compresses the cost space of a durable goods original manufacturer and a remanufacturer; (2) when the second-hand market exists, the optimal pricing of new durable goods is reduced, the optimal pricing of remanufactured durable goods is increased and the patent cost of each unit of durable goods increases and (3) the presence of the second-hand market will increase the original manufacturer's and remanufacturer's profits.Originality/valueThe research conclusion has certain reference value for the production strategy selection of each enterprise in the process of patented product remanufacturing and the government's fiscal policy formulation at each stage of the remanufacturing industry's development.

A Critic on Legal, Ethical, and Regulatory Issues of Off-Label Medicines Shepardizing Intellectual Property Law towards Pharmacoeconomics: A Discussion of Pfizer’s Norvasc Patent Case

Purpose: Pharmacoeconomics is a pharmacy discipline designed to tackle issues on clinical, ethical, and safety factors leading to advocacy of healthcare corporate governance in fulfillment of the pillars of sustainable development. Thus, it is necessary to discuss illegal diversions of Intellectual Property of drug patents as these legal problems serve as impediments to Pharmacoeconomics. This paper aims to elucidate the advantages of Off-label medicines in favor of clinical, ethical, and safety aspects of Pharmacoeconomics towards patient safety and treatment for welfare.
 Methodologies: Quantitative measurement is crucial for validation of drug quality products. It is used for comparison of both legal and illegal diversions of healthcare corporate governance. Patent Law and its policy options are tools to measure the violations of the perpetrator under Intellectual Property Law. Meanwhile, the British National Formulary follows the Human Medicines of 2012 and communicate with FDA for the implementation of off-label medicines as policy for clinical practice under legal removal of patent protection for medical research and practice. This study follows a diagnostic design as a research method based on ethical, regulatory, and legal presentations to characterize problems involved in drug management system towards efficiency of evidence-based medicine practice utilizing theories, models, and frameworks towards financial intelligence. 
 Findings: The elucidation of Kano Model Framework exhibits the aberration and compliance of patent drugs towards compliance of healthcare corporate governance. Based on exhibition of intellectual property law, it can be extended to fulfill the goals of sustainable development of monetary success and hence, the human society can be reflected as their success to their financial intelligence as their inventorship is declared as non-obviousness to public welfare and safety. Moreover, the moral standard of ethical decision-making illustrated the importance of opting to off-label medicines emphasizing cost-efficiency goals of Pharmacoeconomics in drug therapy. Hence, the Shariah Jurisprudence Method for Pharmacoeconomics is the modelling of Clinical Pharmacy Practice towards Healthcare Corporate Governance in fulfillment of business ethics as public welfare and safety of human society.
 Recommendation: Kano Model Framework is an integrated tool of measuring the success of healthcare corporate governance. With the elucidation aids of modelling the importance of Pharmacoeconomics, it is recommended to develop ways of making artificial intelligence as a sole success, profit, benefit, and contribution to clinical pharmacy practice, starting from its drug development up to its intended purpose of human drug treatment in healthcare setting, in relation to its accompanied FDA regulating bodies, as British National Formulary team compliance of maintaining the crucial functions of observing and monitoring document for patient safety.

Navigating adalimumab biosimilars: an expert opinion.

The patent expiry of Humira® in 2018 opened up the current European market to eight adalimumab biosimilars - (in alphabetical order) Amgevita®, Amsparity®, Hulio®, Hukyndra®, Hyrimoz®, Idacio®, Imraldi®and Yuflyma® - for the treatment of various immune and inflammatory conditions. Amjevita, Hadlima®, Hyrimozand Yuflymahave recently become available in the USA, with others expected to reach this market in 2023 as the US patent protection for Humiraends. Although adalimumab biosimilars demonstrate efficacy, safety and immunogenicity similar to the originator, they may differ in product excipient(s) and preservatives, along with their device type(s). Physicians may find it both difficult and time consuming to navigate their way among the array of available adalimumab biosimilars when they need to make a treatment decision. This article explores the characteristics of various adalimumab biosimilars to help clinicians navigate the various options available across Europe and the USA. In addition to drug selection, effective patient-physician communication is needed to nurture realistic patient expectations and minimise potential nocebo effects when prescribing biosimilars.

FACTORS INFLUENCING CHANGES IN CHARACTERISTICS AND TYPES OF INTELLECTUAL PROPERTY OBJECTS IN CURRENT TRENDS IN INDUSTRIAL ENTERPRISE MANAGEMENT AND TECHNOLOGICAL INNOVATIONS

The management of industrial enterprises in modern trends is multifaceted, among which the use of intellectual property plays an important role, which, in turn, is a means of increasing competitiveness, efficiency and profitability. The purpose of the article is to analyze the factors of changes in the features and types of intellectual property objects in modern management trends of industrial enterprises. The article analyzes the legislative regulation regulating the protection of intellectual property in Ukraine. Objects of intellectual property are identified, including: patent, copyright, trademark and privacy protection. Factors influencing changes in the characteristics of intellectual property objects are substantiated, among which technological changes, economic and market factors, changes in patent legislation, establishment of international standards, and socio-cultural aspects should be highlighted. It is proven that the mentioned factors make up a complex network of factors that influence each other and determine the dynamics of changes in the field of intellectual property in the modern management of industrial enterprises. It was determined that digital transformation has an impact on intellectual property objects. Such means of digital transformation as the Internet of Things, artificial intelligence, blockchain technology, virtual reality and augmented reality were analyzed. An integrated model of intellectual property management at an industrial enterprise is proposed, which involves a comprehensive approach to four aspects - innovation management, protection of intellectual property rights, strategic partnership and licensing, development of internal culture and education of the enterprise's personnel. The specified model will contribute to the sustainable development of the industrial enterprise and increase the level of its competitiveness in the market.

Game Analysis of Different Source Disclosure Model for Genetic Resources and Implications for China

Inventions that rely on genetic resources are subject to different source disclosure models in the domestic laws of different countries. Different source disclosure models can indirectly affect the quantity and quality of patents issued in a country, thus resulting in different social benefits. Therefore, an analysis of which source disclosure model is applicable to the patent protection of genetic resources is of great importance. The economic approach of game theory is used to analyse the game of interests between patent applicants and the patent examination authority. It is found that the patent examination authority is required to introduce source disclosure rules and that the optimal equilibrium for patent applications can be achieved by requiring companies to comply with a voluntary source disclosure model under intense examination pressure. Based on this, the legislative policies of typical resource-rich countries are selected for analysis to verify the validity of the game conclusions. Finally, policy recommendations for source disclosure requirements for genetic resources in China are proposed based on the game conclusions. genetic resources, source disclosure, patent law, game theory, mandatory model, voluntary model, patent applications, regulatory bodies, cost-benefit perspective

Supplementary protection of intellectual property rights for medicines

The article discusses the issue of extending the legal protection of intellectual property rights for medicines. The research aims to provide a comprehensive overview of the problems related to the implementation of Supplementary Protection Certificates (SPCs) in national legislation and possible solutions. The study also seeks to draw conclusions and make proposals for improving the regulatory framework for the SPCs of medicines. The work utilizes general scientific and specialized methods of scientific cognition, including dialectical, formal-logical, systemic-structural, comparative legal, as well as modeling, analysis, and synthesis methods, which collectively contributed to the organization, planning, and conduct of the research. The study is based on scientific publications from databases and search systems (PubMed, JAMA, Scopus, Springer, BMC, Oxford Academic), international and national regulatory acts, statistical studies by international organizations (Precedence Research), patents for inventions related to medicines, recommendations by national government bodies, as well as prescriptions and guidelines from international and national experts. Considering the analysis of statistical data on the development and implementation of medicines, it has been determined that original biological medicines are a major factor in the rising prices of treating conditions such as diabetes, oncological diseases, and others. Examples of patents for medicines owned by global pharmaceutical companies (Gilead, Bayer Intellectual Property Gmbh, etc.) that have ensured their commercial success and competitive advantages are examined. It has been established that patent protection provides the right holder with the opportunity to maintain a monopoly in the market, thereby compensating for the time spent on the development and research of original medicinal products. Legislative approaches to regulating relationships concerning the supplementary protection of inventions related to medicines in the form of SPCs in Ukraine and the EU are identified. The exclusivity periods for regulatory data protection for medicines in the EU are outlined. Based on the conducted research, it is concluded that the application of the SPC mechanism is a tool to achieve a balance between the protection of intellectual property rights and access to original medicines. Timely entry of generics and biosimilars to the market contributes to reducing market prices but negatively impacts the profitability of manufacturers of original medicines. Attention is drawn to problematic aspects of the legislative implementation of the SPC mechanism in Ukraine, which leads to incorrect interpretation and implementation of relevant provisions and necessitates updating. In light of the aforementioned, there is an urgent need in Ukraine to implement, update, and improve the legislative mechanism for regulating SPCs.

Development and Promotion Strategies of Chinese Agricultural Products in the Context of International Trade: Based on the Perspective of Intellectual Property Protection

In today's globalized economy, the means of economic competition between countries has shifted from relying primarily on tariffs and quotas to relying on talent, intellectual property rights and technical standards. The decisiveness and influence of international intellectual property rights on international trade is becoming increasingly obvious. As a big agricultural country, China possesses a large number of special agricultural products and is also a big exporter of agricultural products, so the protection of intellectual property rights of Chinese agricultural products is particularly important. Since the promulgation of the Agreement on Intellectual Property Rights (IPR), the United States will be linked to international trade and intellectual property protection and as a reason to continuously improve the international intellectual property protection standards. At present, China's agricultural products in international trade there are still many difficulties, from the perspective of intellectual property rights, mainly manifested in the lack of protection of agricultural patents, agricultural products, geographical indications. This paper will start from the beginning, with intellectual property protection as the entry point, analyse in the new situation of international trade in China's agricultural products development and promotion strategy.

Biosimilars: An Emerging Therapeutic Approach

A biosimilar is an extremely similar version of an existing medication. Biologics' cost, manufacture, administration, and clinical efficacy differ from those of chemically produced medications in certain aspects. Chemical and clinical equivalency to branded, original, low molecular weight chemical pharmaceuticals whose patents have expired defines generic medications. These are offered under a generic name and are practically the same thing as the original product. By 2020, many important biologics are expected to lose their patent protection, giving other biopharmaceutical companies the chance to create comparable biologics. After the first biosimilar was approved in early 2000, the use of biosimilars and similar biologics has expanded in recent years. One of the top producers of comparable biologics is India. In 2012, India created a new regulation for the pre- and post-marketing approval of comparable biologics. The biosimilar’s mode of action mirrors that of its reference drugs and results in very comparable outcomes. Some disorders, including some forms of cancer, can be treated with biologics and their biosimilars. Additionally, numerous medical disorders are treated with biosimilars. Crohn’s disease, arthritis, and ulcerative colitis.

Analysis of impacts of climate change on the grant and protection of patents related to the water industry

Abstract Various inventions are presented in the water industry, essential for the water supply, distribution, treatment, storage, and consumption optimization. It is necessary to confirm their novelty, innovative steps, and industrial applicability to protect water-related patents. However, the impacts of climate change are not considered in the granting of patents, and water-related inventions are registered or rejected regardless of these impacts. For example, an invention that causes greenhouse gas emissions may be patented because it is new. This research addresses this significant challenge using a descriptive-analytical approach and a library-field method. Based on the results, it is necessary to impose strictness on inventions that aggravate climate change (29% of the inventions investigated) and protect inventions that adapt to climate change impacts (71%). Furthermore, it is possible to use the tool of compulsory licensing to adapt to climate change and reduce its negative impacts. Moreover, the patent offices should evaluate climate change impacts by examining innovative steps and industrial applications. An invention that has negative impacts will be deprived of patent protection and considered one of the limitations and exceptions. Also, it is necessary to provide new interpretations of protection elements of the patent system.

Smoke signal: When firms' patent strategy and local patent protection system affect equity stakes in cross-border acquisitions

A distinctive feature of many international acquisitions of firms with technology resources is the extreme uncertainty about the value of the target's resources. Such uncertainty increases the complexity of ownership decisions in target firms. Drawing from signaling theory, we articulate how international acquirers perceive the pre-emptive power of target firms' patent portfolio as a positive signal, increasing their confidence in target firms' technology and leading them to seek a higher level of equity. We further argue that the strength of the target firm's home country's patent system also acts as a positive signal that encourages investors to acquire a higher level of equity in cross-border acquisitions. However, it also weakens then impact of the pre-emptive power signal. Our findings have implications for scholars, policymakers, and managers.

Traumatology and Orthopedics in the Focus of Intellectual Property

High incidence of injuries, diseases of musculoskeletal system and connective tissue leads to a high demand for modern high-tech materials in the area of orthopedics and traumatology. Development of russian materials is an extremely relevant issue, especially under conditions of restricted supply of foreign products to the Russian Federation. Creation of new products and their subsequent launch to the market require comprehensive protection of unique information about the design, composition or production/manufacturing technology of the product. Analysis of patenting domestic solutions for trauma and orthopedic surgery in the Russian Federation has shown that there are various risks associated with the commercialization of national products. For example, russian developers in a number of cases neglect patent protection of their developments, which puts successful developments at risk of unauthorized copying or claims from other market players. On the other hand, patenting strategy of domestic developers for their products in most cases contains a number of errors, such as narrow bounds of patent protection due to incorrectly drafted patent claims. For example, these can be in formulations that can be easily bypassed in case of commercial interest in the product, preferential patenting of technological processes, lack of comprehensive patent protection of the product. Such patenting errors make the development unattractive for investors and manufacturers, which leads to low commercializability of russian inventions. Thus, russian developers, who have significant scientific potential and competencies to create highly effective national products, do not proceed with technology transfer and cannot bring their promising and in-demand products to the market.

Therapeutic antibodies in rheumatology

Emil von Behring's serum therapy for diphtheria was the first therapeutic use of antibodies. More than 100 years later, anew era in the treatment of rheumatic diseases began in 1998 with the approval of infliximab, an antibody directed against tumor necrosis factor alpha (TNF alpha). The special feature of antibody therapy is the ability to bind and neutralize antigens in ahighly specific manner. In addition, target cells can be eliminated by activation of the immune system. These properties of the immune system are exploited in rheumatology to eliminate inflammatory cytokines or antibody-producing Blymphocytes. The tolerability is usually good but potential side effects, such as reactivation of tuberculosis with anti-TNF alpha treatment must be considered. Currently, 20different antibodies and fusion proteins have been approved in Germany for the treatment of various inflammatory rheumatic diseases. Biosimilars can contribute to aprice reduction after the patent protection expires. Many additional target antigens are being investigated and further structural innovations (e.g., bispecific antibodies, nanobodies or coupling with small molecules) are being developed.

Innovative bio‐based steel envelope systems

AbstractThe INCSEB project is aimed at developing 5 ultra‐low carbon envelope systems made in steel and that incorporate innovative use of wood fiber insulation. The systems under development are: 3 sandwich panels (cladding, pitch & flat roofing), 2 claddings (double skin & façade with plank). INCSEB includes tests to study various behaviors: mechanical, fire, thermal calculation, acoustic insulation, air/water/vapor permeability. Interpretation and classification reports will be done for each type of test. 2 full scale prototypes will allow to estimate the durability in real life conditions. LCA indicators and comparison of carbon footprint (GWP) to conventional systems based on a real office building will be provided. An economic study of the projected price of the 5 systems compared to existing conventional systems is also planned. Besides, as far as the production of innovative panels is concerned, it appears that they can be integrated in current production lines. Finally, actions to facilitate the dissemination of results and industrial application will be organized: drafts of design and installation guides, publications, submission of 3 amendments to relevant EN standardization committees, workshop, BIM objects. Lastly, the manufacturers plan to apply for patents protection.

An Overview of Oral Thin Film Drug Delivery Systems with Fast Dissolving Films

Fast-dissolving oral thin films (OTFs), rather than tablets, are the product of choice for many pharmaceutical businesses. The benefits of tablets (precise dose, simple administration) and liquid dosage forms (easily swallowed, quick bioavailability) are all present in films. Four out of five patients, according to statistics, prefer orally disintegrating dose forms over traditional solid oral dosage forms. Children, the elderly, people who are bedridden, people who are emetic, and those who have CNS illnesses have trouble swallowing or digesting solid dose forms. Many of these individuals refuse to take solid dose forms because they are afraid of choking. OTFs are immediately moistened by saliva when put on the tongue's tip or base. Because of this, OTFs quickly hydrate before dissolving or disintegrating to release the drug for local or systemic absorption. This technology offers a solid foundation for the creation of patent-compliant items and for extending the patent protection of currently available goods. Fast-dissolving oral thin films can be used for a variety of purposes, including gastroprotective and sublingual delivery systems in addition to buccal fast-dissolving systems. This study emphasizes the composition, detailing the numerous natural and synthetic polymer kinds, diverse manufacturing processes, packaging materials, and assessment tests for OTFs.

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.

Magnetic Molecularly Imprinted Chitosan Combined with a Paper-Based Analytical Device for the Smartphone Discrimination of Tryptophan Enantiomers.

The separation of enantiomers plays a critical role in pharmaceutical development, ensuring therapeutic efficacy, safety, and patent protection. It enables the production of enantiopure drugs and enhances our understanding of the properties of chiral compounds. In this study, a straightforward and effective chiral detection strategy was developed for distinguishing between tryptophan (TRP) enantiomers. The approach involved the preparation of a magnetic molecularly imprinted chitosan (MMIC) for preparation of the sample, which was combined with a nitrocellulose membrane (a paper-based analytical device, PAD) integrated with D-TRP covalently grafted with polymethacrylic acid (PAD-PMA_D-TRP). Discriminating between the TRP enantiomers was achieved using AuNPs as a colorimetric probe. Indeed, the presence of D-TRP rapidly induced the aggregation of AuNPs due to its strong affinity to PAD-PMA_D-TRP, resulting in a noticeable change in the color of the AuNPs from red to purple. On the other hand, L-TRP did not induce any color changes. The chiral analysis could be easily performed with the naked eye and/or a smartphone. The developed method exhibited a detection limit of 3.3 µM, and it was successfully applied to detect TRP in serum samples, demonstrating good recovery rates. The proposed procedure is characterized by its simplicity, cost-effectiveness, rapidity, and ease of operation.