Intellectual Property System Research Articles

Data Exclusivities in the Age of Big Data, Biologics, and Plurilaterals

The past decade has seen many new developments impacting the intellectual property system. The introduction of big data analytics has transformed the fields of biotechnology and bioinformatics while ushering in major advances in drug development, clinical practices, and medical financing. The arrival of biologics and personalized medicines has also revolutionized the healthcare and pharmaceutical industries. In addition, the emergence of bilateral, regional, and plurilateral trade agreements have raised serious, and at times difficult, questions concerning the evolution of domestic and international intellectual property standards. One topic linking all three developments together concerns the establishment of international standards to protect clinical trial data that have been submitted to regulatory authorities for the marketing approval of pharmaceutical products. During the negotiations for the Trans-Pacific Partnership (TPP), for example, the protection of clinical trial data submitted for the marketing approval of biologics was highly contentious. Although the United States’ withdrawal in January 2017 has since placed the TPP Agreement and its data exclusivity provisions for pharmaceuticals and biologics on life support, the debate on the protection of clinical trial data will continue and will emerge in future bilateral, regional, and plurilateral trade negotiations, including the renegotiations on the North American Free Trade Agreement (NAFTA). Part I of this Article reviews the protection of clinical trial data under Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) of the World Trade Organization (WTO). Even though the provision covers both pharmaceutical and agricultural chemical products, this Article focuses only on the former. Part II examines the additional protection clinical trial data have received through TRIPS-plus bilateral, regional, and plurilateral trade agreements. Part III outlines five specific recommendations to help advance the debate on such protection in the age of big data, biologics, and plurilateral trade agreements.

Protection of Design Patents in China and Comparison with European Union Law: How Foreign Companies Can Protect Their Design Patents in China

This paper is mainly focused on a specific aspect of Chinese intellectual property law: design patents and utility models related to foreign companies, especially in automotive and fashion industries. It aims to analyze and examine the protection of design patents and utility models featuring in foreground real cases in China and involving foreign companies, especially European and Italian companies. Holders of intellectual property rights and possible solutions to their cases are the focus and objective of this paper: how foreign companies can face these issues through the existing Chinese intellectual property law and, when Chinese law is not satisfactory enough or when there is a lack, trying to find new possible solutions and suggestions which might be beneficial for foreign companies. Considering interests and concerns which involve foreign companies and their products in the subject matter, Chinese intellectual property law has evolved in the past few years in order to safeguard foreign companies from infringement of their rights, which became quite frequent. Currently the aim of Chinese intellectual property law is not only to prevent lawsuits between foreign and local companies, but also the infringement itself by local companies. Comparing Chinese intellectual property law with European provisions concerning intellectual property rights system, the objective is trying to understand the differences and mostly the advantages that one system can show more than the other one, finding new strategies and remedies, such as updates and solutions that might be useful to insert in the current Chinese intellectual property system and which might be efficient and functional for foreign companies’ business in China as well as to protect their intellectual property rights in the best way.

Patents and public health

Tensions are now known between the interests of holders of patent rights over medicines and those of other groups, especially in developing countries. This work tries to deepen these interests from a point of view, mainly legal, which is accompanied by comments of an economic nature, while identifying possible legal and institutional ways to alleviate the negative social consequences of the current system. To this end, the conflicts generated by patents in the context of public health and, specifically, in relation to access to medicines, will be described, to then address the role of intellectual property systems and the concept and scope of public health. Finally, various legal channels will be presented to reconcile the affected interests and possible programmatic and institutional measures.

АКТУАЛЬНІ ПИТАННЯ ПРАВОВОЇ ОХОРОНИ ТЕЛЕВІЗІЙНИХ ПЕРЕДАЧ ТА ПРОГРАМ ЯК ОБ’ЄКТІВ ПРАВА ІНТЕЛЕКТУАЛЬНОЇ ВЛАСНОСТІ

The purpose of the article is to analyze the topical issues of legal protection of telecasts and television programs as intellectual property; to determine the characteristics of legal regulation of these objects and their place in the system of intellectual property. The research methodology consisted in the following general scientific and special methods of research: the method of theoretical generalization, the method of analogies, the system approach, the method of comparative analysis, and a number of other methods. The scientific novelty of the work lies in revealing the legitimacy of the question of the status of the television program - whether to consider it one of the types of audiovisual works or an independent object of legal protection. Conclusions. Defining telecast as one of the types of audiovisual products and granting it the right of legal protection for the appropriate term is considered quite justified, taking into account the creative contribution made during its creation. The specified intellectual property is rather complex and requires qualification, which will allow for considering television programs or telecasts one of the groups of intellectual property and defining features of their legal regulation and lawful usage. We believe that a more accurate definition of telecast needs to be added to legislation from the standpoint of its difference from other television audiovisual products, for example, television movies.

Colaboraciones y flujos de conocimiento en patentes del sector solar fotovoltaico después del ADPIC

<p>La innovación ahora es un proceso internacional, que requiere una gobernanza global del conocimiento, la cual se estableció en 1994 con la firma del Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC). Uno de los fines de este nuevo régimen de propiedad intelectual es impulsar la innovación como resultado del incremento en las colaboraciones y la revelación del sistema de patentes. El objetivo de este trabajo fue determinar si se incrementaron las colaboraciones y los flujos de conocimiento en las patentes del sector solar fotovoltaico; para esto se utiliza el Análisis de Redes Sociales (ARS) de coautorías y citas, en dos momentos, antes de la firma del acuerdo (1976-1996) y después de la firma del acuerdo (1996-2016). Los resultados muestran que las colaboraciones y los flujos de conocimiento aumentaron principalmente en los países con trayectorias tecnológicas en el sector, tanto a nivel doméstico como internacional.</p>

Framing an Islamic Vision of Intellectual Property: Maqasid - Based Approach

The Islamic scholarship on Intellectual Property (IP) has extensively investigated its affinity to Shari’a upon a rule-based approach whereby a profound analogy and reasoning eventually generated a Fiqh rule that embraced the concept. However, a lingering discrepancy vis-à-vis the philosophical underpinning is hardly addressed. This paper undertakes an approach based on Maqasid al-Shari’a (objectives of Shari’a) to explore that underpinning as it pertains to the three key elements in the making of IP, namely, creativity, property, and policy. The major premise of the paper is that the current IP framework failed to fulfil the needs and aspirations of the Islamic countries. While its underlying objective emphasizes a strong utilitarian approach that contradicts in many ways the Islamic Shari’a. Consequently, better outcomes can be reached by adopting a holistic approach that takes into consideration the practical implication of IP system according to the benefits and interest of Muslim’s societies. Whereby, IP should be comprehensively addressed according to the sources, objectives, and principles of Islamic Shari’a. These can be employed to evaluate the current application of IP and to identify the elements required in an IP system that is congruent with Islamic Shari’a. The comparative analysis of the fundamentals of the present international intellectual property system and the Islamic perspective indicated that the core aspects of IP concerning the concept of creativity and the scope of protection are delineated differently under the Islamic framework. Moreover, the policy and regulations as can be derived from the principles and Maqasid al-Shari’a have a great potential in promoting a robust Islamic IP system that is in line with Shari’a, the needs, and orientation of the society.

Territoriality in Intellectual Property Law: Examining the Tension between Securing Societal Goals and Treating Intellectual Property as an Investment Asset

By Emmanuel Kolawole Oke. The principle of territoriality is one of the foundational principles of International Intellectual Property Law. This principle allows countries to design their intellectual property laws in a manner that facilitates the achievement of specific societal goals. However, while it is true that this principle has managed to survive the incorporation of intellectual property into the international trade law system (via the WTO’s TRIPS Agreement), some scholars have expressed concern that the incorporation of intellectual property into the international investment law system via investment agreements (such as bilateral investment treaties) constitutes a potential threat to the principle of territoriality in the international intellectual property system. This paper will investigate the tension between the principle of territoriality and the global harmonisation of intellectual property standards in the context of the current iteration of intellectual property as an asset in investment agreements. Specifically, it will critically examine how this tension was resolved in two recent investment arbitration disputes. The first is the dispute between Philip Morris and Uruguay which concerned the latter’s implementation of certain measures to curb the consumption of tobacco products in its country but which Philip Morris construed as an expropriation of its trademarks. The second is the dispute between Eli Lilly and Canada which concerned the interpretation of the utility requirement under Canadian patent law. These cases will be used to assess whether there is still scope for the preservation of the principle of territoriality within the investor-state dispute settlement system.

Endogenous innovation, outward-bound international patenting and national economic development

In this paper the relationship between the pursuit of foreign patent rights by inventors or their assignees and economic development in the countries in which the respective inventors reside is examined. Outward-bound international patenting is contrasted with domestic patenting and with inward-bound international patenting. The empirical analysis establishes plausible evidence that outward-bound international patenting matters for economic development. The main conclusion, based on empirical research about the patenting profiles of 78 countries over 14 years, is that countries whose residents exhibit a relatively high proclivity for obtaining foreign patent protection for endogenous inventions are likely to enjoy relatively high levels of wealth per person. An implication of this conclusion is that the exploitation by national residents of foreign markets for the commercialization of endogenous technology through the sophisticated use of the intellectual property systems of foreign countries is an important factor for national economic development.

Enforcement of Intellectual Property Rights in Iran in the Light of TRIPS Agreement

In recent years, the Iranian government has tried to develop its national intellectual property (IP) law in order to engage with the international IP system, prepare for membership of the World Trade Organization (WTO), and fulfil its obligations under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. Iranian IP rights (IPR) contain provisions on civil and administrative procedures and remedies, provisional measures, and special requirements related to border measures and criminal procedures, which specify the procedures and remedies that must be available so that rights holders can effectively enforce their rights. This study examines the underlying concepts and reasons for IPR infringement and enforcement, and the criminal and civil remedies regarding IPR. Recommendations are provided in the conclusion of this study.

Myths of the medical methods exclusion: medicine and patents in nineteenth century Britain

AbstractThis paper explores the interaction of British medical practitioners with the nascent intellectual property system in the nineteenth century. It challenges the generally accepted view that throughout the nineteenth century there was a settled or professionally agreed hostility to patenting. It demonstrates that medical practitioners made more substantial use of the patent system and related forms of protection than has previously been recognised. Nevertheless, the rate of patenting remained lower than in other fields of technical endeavour, but this can largely be explained by the public nature of medical practice during this period. This paper therefore seeks to retell the history of the exclusion of medical methods from patent protection, an exclusion whose history has produced a substantial body of scholarship. However, its aims go beyond this in that it also seeks to illuminate how medical practitioners engaged with the broader political and policy landscape in order to secure financial remuneration for their inventions. Through an exploration of how prominent doctors interacted with Parliament around claims for a financial reward, it demonstrates that doctors sought to use reputational advantage to leverage financial success and the important role that Parliament could play in that process.

Fashion as property in traditional culture: a Maasai case study

The cognizance of traditional knowledge and culture requires a perception into the history of a people of which their roots, culture and customs are encapsulated. In Africa, tradition existed way before its naming, definition or record during the continental wave by explorers or missionaries, and with time, colonial ideology cast it into categorizations of customs and ethnic tribes.4 The pre-existing tradition in its unaltered purity was distinct from the invented traditions Ranger5 describes as having been handed to Africans through socialization in European neo-traditions. Cultural imperialism aside, the concept of traditional knowledge and cultural expressions is a probable novelty to Western intellectual property systems depending on its discovery.6 A Western restrictive notion of intellectual property may consequently be ill-suited to incorporate other forms of property like culture or folklore outside its legal context7, posing a conflict of ideologies. The Africa Regional Intellectual Property Organization (ARIPO) thorough its Swakopmund Protocol8 recognizes tangible expressions such as textile, jewellery, costumes and needlework as expressions of folklore.9 Mirrored in Kenyan legislation, the Protection of Traditional Knowledge Act10, effectuates explicit constitutional obligations on the national foundation of culture11, which requires State legislative enaction for cultural protection including compensation for such use through royalties.12

La propiedad intelectual como sistema asignativo moderno. Una genealogía crítica de las normas vigentes de acceso al conocimiento

Fil: Bonet de Viola, Ana Maria. Consejo Nacional de Investigaciones Cientificas y Tecnicas. Centro Cientifico Tecnologico Conicet - Santa Fe; Argentina. Universidad Catolica de Santa Fe; Argentina

Analysis of the performance of the brazilian intellectual property system: challenges and perspectives

The protection of intellectual property (IP) is a crucial area to support the development process of any country, as it is in this context that the biggest strategic disputes are taking place. In recent years Brazil has developed some actions to achieve greater efficiency in the public IP management system, but are we on the right track? The present study seeks to present answers regarding the performance of Brazil and to highlight the advances and challenges regarding the IP system. The methodological approach was structured based on a review in the literature, highlighting the scientific, economic and technological indicators on the development of IP and the main IP objects registered with the Brazilian national intellectual property body (INPI) in the period of 2013 to 2016, in the areas of patents, trademarks, industrial design, computer program, circuit topography, technology contracts and geographical indication.

Defining and Measuring the Institutional Context of National Intellectual Property Systems in a post-TRIPS world

Indices that approximate for the quality and strength of intellectual property (IP) systems are commonly used as variables in empirical international management studies. However, while international IP systems have radically transformed after the implementation of the TRIPS agreement, these contextual changes have not been accounted for in existing international management research approaches. This study examines the institutional context of IP systems in the post TRIPS implementation years by conceptualizing how IP Law on the books (regulations) and IP Law in practice (enforcement) combine. This enables the identification of two new contextual categories of IP systems that have not been conceptually, theoretically, or empirically captured in existing international management research. A review of the existing literature on indices measuring different aspects of national IP systems provides insights into how to improve future theoretical and empirical international management work that aims to study the effects of the context of IP systems in the post TRIPS era.

FPGA-Centric Design Process for Avionic Simulation and Test

Real-time computing systems are increasingly used in aerospace and avionic industries. In the face of power challenge, performance requirements and demands for higher flexibility, hardware designers are directed toward reconfigurable computing using field programmable gate arrays (FPGAs) that offer high computation rates per watt and adaptability to the application constraints. However, considering reconfigurable computing in the avionic design process leads to several challenges for system developers. Indeed, such technology should be validated along the verification & validation cycle starting with simulation tools, passing through the test benches and finishing with the integration phase. For each step, the FPGA can play an essential role to achieve better performances, more adaptive systems, and cost-effective solutions. In this paper, we present a seamless FPGA-centric design process for avionic equipments. Along this process, we redefine the role of the FPGA circuits to cover the simulation, the test, and the integration steps. First, reconfigurable logics are used in the frame of heterogeneous CPU/FPGA computing in order to obtain high speed-up for real-time avionic simulation. The proposed environment supports dynamic execution model enabling reconfiguration during runtime to avoid the timing constraint violation. Second, the FPGA is used as a key solution to offer versatile test benches and to converge toward unified test and simulation tools. We have designed several commercial input output intellectual property systems with dynamic runtime reconfiguration capabilities, in order to mitigate component obsolescence and to provide increased flexibility and decreased design time. Third, at the integration phase, we use the conventional tools to make profit from reconfigurable technology in embedded avionic applications in order to deliver high computation rates and to adapt their functioning mode to provide reliability, fault tolerance, deterministic timing guarantees, and energy efficiency.

Book Reviews

Christine Greenhalgh of St. Peter's College, Oxford, reviews “Creativity without Law: Challenging the Assumptions of Intellectual Property,” edited by Kate Darling and Aaron Perzanowski. The Econlit abstract of this book begins: “Ten papers explore how some creators thrive outside of traditional intellectual property (IP) law and considers what some creators' stories mean for the IP system and the innovation economy more generally.”

Cultural heritage digitization and related intellectual property issues

Abstract The role of cultural heritage for defining the national identity, sustainable development and compatibility of the creative industries is indisputable. In view of the new digital possibilities in preservation, safeguarding and popularization of the cultural heritage, the intellectual property-related issues raise serious challenges. These circumstances call for large-scale strategic planning on cultural policy including the protection of cultural heritage as intellectual property; its digitization as means for its commercial use and its recognition as creative industries’ business asset. The study researched the economic symbiosis between cultural heritage and intellectual property, it reveals the economic characteristics of cultural values and the suitability of the intellectual property system to provide them protection, and it identifies the right's holder of the intellectual property over the digitized cultural values and creates a step by step guidance for intellectual property management via digitization process.

The International System of Intellectual Property from the Perspective of the Economics of Legal Federalism

The International System of Intellectual Property from the Perspective of the Economics of Legal Federalism

Intellectual Property Evolution and Innovation Ecosystem as Effective Tools in Strengthening Indian Healthcare Sector

Despite India’s enormous technological potential, indigenous medicinal knowledge and various initiatives by the government and industry at translational cycle, the country carries a global disease burden of 21%, majorly contributed by dual disease burden. Public health faces the major anomalies of 3A (accessibility, affordability, availability) of the healthcare sector, possibly due to restrictive coordination among stakeholders, transiting disease profile, undeveloped delivery system and regulatory mechanisms. This article emphasizes the significance of integrative approach of using our research and development strength and establishing a strong intellectual property system for conducive healthcare environment, accentuating the significance of 3P (public–private partnership) in addressing the major anomalies of 3A.

Enforcing Intellectual Property Rights in Nigerian Courts

Abstract There is no point in making comprehensive provisions for the protection of various intellectual property rights without also providing a corresponding comprehensive system for enforcing the same when the rights are or about to be infringed. Therefore, an accessible, sufficient and adequate system/procedure is paramount in any worthwhile intellectual property system. Right holders must be granted means to enforce their rights just as is obtainable in other forms of tangible and intangible properties. To this end, all intellectual property systems need an effective judicial system that is empowered to deal with both civil wrongs and criminal offences while being presided over by adequate number of judges with the requisite experience in intellectual property law. This paper therefore examines: the raison-d’être for protecting intellectual property rights; the various enforcement mechanisms via the courts; sanctions and remedies for infringement of intellectual property rights amongst other incidental matters. The paper concludes with a call for the review of the sanctions for infringing intellectual property rights.