Introduction to Essential Data Governance and Management System(EDGS)
Introduction to Essential Data Governance and Management System(EDGS)
2022/12/30
I. Background
Along with organizations face the industrial, social and economic level of Digital Transformation trend brought by the development of emerging technology or the occurrences of disasters or emergencies(such as COVID-19), and so on. Inducing the increasing demand for transformation of digital governance and management. Including the board of directors and the top managements’ decision making, supervision to internal audit, internal control etc. It is necessary to establish and implement the digitized management measure of content or process step by step. Strengthening the reality, integrity and full disclosure of data, in order to improve the efficiency of organizational decision making, execution, supervision and management.
Although implementing the digitization process, brings convenience and efficacy to the organization, accompanied by risks. Digital data has characters of being easy to modify and spread. This often results in difficulty for the original version owner in proving the originator’s identity and then impacts rights protect. Additionally, when cooperating with others, the organizations may provide essential digital data to others, or receive others’ essential digital data. When data breaches or controversies occur, it is required to have measures assisting in the identification or prove the origin of the data. In order to delineate the responsibilities and enhance mutual trust.
Essential Data Governance and Management System(hereinafter referred to as, EDGS) is a management model which is to be introduced at the discretion of each organization. Looking forward to improve the degree of the ability in organizations’ digital and governance level progressively. Starting to improve the protected process of the digital data in the first place, reinforcing the long-term preservation of validity of the essential digital data. In order to guarantee the evidence capacity and reinforce the probative value by the time litigations has been instituted or the related competent authority investigates.
II. Setting Objectives
The purpose of EDGS is to help organizations consolidate with existing internal auditing, internal control or other management process and then implement tweaks that establish an organizations’ essential data governance and management system that meets the requirements of EDGS. In order to attain the following benefits(as shown in Figure 1 below):
a. Improve the digitalization level of governance and management in internal control, internal auditing or surveillance.
b. Improve organizations’ cooperation, trust and the chance of digital transformation.
c. Reinforce organizations to identify and manage the self-generated, provided or received external digital data.
d. Reinforce organizations’ validity of evidence presented in litigation or the inspection certification of competent authority.
Figure 1: Setting Objectives of EDGS
III. Scope of Application
EDGS is designed to be applicable to all organizations, regardless of their type, size, and the products or services they provide. In addition, the requirement of EDGS are centered on the organizations’ essential data governance and management system process (as shown in Figure 2 below). The so-called organizations’ essential data governance and management system process refers to from the digital data process of generation, protection and maintenance to the digital evidence preservation information process of acquisition, maintenance and verification by setting management objectives in accordance with the management policies established by the organization.
Figure 2: The Conceptual Flow Chart for the Organizations’ Essential Digital Data Governance and Management System Process
IV. Process of Application
EDGS encourages organizations to link and reinforce the existing “process management” approach and “PDCA management” cycle(as shown in Figure 3 below) in developing, implementing and improving their essential data governance and management system.
Figure 3: The “PDCA management” Cycle of EDGS
V. Table of Contents
Chapters 0 to 4 of EDGS are the description of the system structure, scope of application, definition of terms and consideration factors; Chapters 5 to 10 are important management items.
| 0. Introduction 0.1. General Description 0.2. Target 0.3. Process Management 0.4. Management Cycle 0.5. Setting Objectives 0.6. Compatibility with other management systems |
| 1. Scope of Application |
| 2. Version Marking |
| 3. Definition of Terms 3.1 Organization 3.2 Digital record 3.3 Identification Technology 3.4 Metadata 3.5 Hash Function 3.6 Hash Value 3.7 Time-Stamp |
| 4. Organization Environment 4.1 Internal and External Issues 4.2 Stakeholders |
| 5. Management Responsibility of Digital Governance and Management 5.1 Management Commitment 5.2 Management Policy 5.3 Management Objective Planning 5.4 Management Accountability and Communication |
| 6. System Planning 6.1 Basic Requirements 6.2 Response to Risks and Opportunities 6.3 Change Planning |
| 7. Support 7.1 Resources 7.2 Personnel 7.3 Equipment or System Environment 7.4 Communication Channels |
| 8. Practice Process of Essential Digital Data Governance and Management 8.1 Generation, Maintenance and Protection of Digital Data 8.2 Acquisition, Maintenance and Verification of Digital Evidence Preservation Information |
| 9 Performance Evaluation 9.1 Basic Requirements 9.2 Data Analysis 9.3 Internal Audit 9.4 Management Review |
| 10 Improvement |
For the full text of the EDGS(Chinese Version), please refer to：
https://stli.iii.org.tw/publish-detail.aspx?d=7198&no=58
Background Taiwan industries have been facing an increasing pressure from the competitive global market. To assist the Taiwan industries, the Government has approved the “National Intellectual Property Strategy Guideline” (the “Guideline”) on 17 October 2012. The Guideline stipulates six major strategies and twenty-seven relevant enforcement criteria in relation to intellectual property (“IP”). The six major strategies are as follows: (a) creation and utilization of high-value patents; (b) enforcing cultural integrity; (c) creation of high agricultural value; (d) support free flow of IP for academics; (e) support system of IP trade flows and protection; and (f) develop highly qualified personnel in IP. Under the “innovation of high-value patents” strategy, the relevant enforcement criterion, being “establishing academia-industry collaborative system for IP management”, is to support the Taiwan’s current and future technology development program on R&D planning, IP management and technology commercialization. In other words, this enforcement criterion can greatly improve the ambiguity and inadequacy of Taiwan’s research infrastructure which have caused inefficient research operation. Furthermore, this enforcement criterion can also improve network collaboration between organizations on IP management, allowing more efficient process for managing IP and thus achieving the purpose of “creation and utilization of high-value patent”. In light of the above, this article studies Japan’s practice on integrating the IP network resources and improving their IP management under the University Network IP Advisors Program (“IP Advisors Program”). University Network IP Advisors Framework Outline A. Policy background, goals and methodology National Center for Industrial Property Information and Training (“INPIT”) initiated the IP Advisors Program and commissioned Japan Institute for Promoting Invention and Innovation (“JIII”) to implement and carry out the new policy in year 2011. Prior to the implementation of the new policy by JIII, INPIT has assisted with establishing proper IP management systems for more than 60 Japanese universities by dispatching IP experts and advisors (“IP Advisors”) to each of the universities during 2002 to March 2011. After the implementation of the initial policy, review has suggested that by expanding the network collaboration, such as establishing intervarsity IP information sharing system within their university networks, the universities can fully aware of and identify technologies that were created by them and are beneficial to the industrial sector. In addition, expanding the network collaboration can also help the universities to quickly develop mechanisms that will enable them properly protect and utilize their acquired IP rights. Accordingly, after 2011, the initial policy has expanded its scope and became the current IP Advisors Program. Japan is expected to improve its nation’s ability to innovate and create new technologies. To attain this goal, Japan has identified that the basis for industry-academia-government R&D consortiums is through obtaining information on universities’ and other academic organizations’ research technologies and IP so that Japan can appropriately place these universities in the appropriate wide-area network. This will allow the universities within the wide-area network to establish IP management policy to properly protect and utilize their IP rights. The current IP Advisors Program is conducted through application from the universities in established wide-area network to JIII. Upon review of the application, JIII will then dispatch the IP Advisor to the applicant university of that wide-area network. IP Advisors not only can provide solutions to general IP related problems, they can also provide professional advice and service on how to establish and operate IP management system for all the universities within the wide-area network. B. IP advisors’ role In principle, IP Advisors are stationed to the Administrative School or Major Supporting School within the wide-area network. IP Advisors can be dispatched to other member schools (“Member Schools”) or provide telephone inquiry service by answering IP related questions. In other words, IP Advisors are not stationed in any Member Schools to manage their IP management affairs, rather, IP Advisors advise or instruct the IP managers of the Member Schools on how to establish and utilize IP management system based on the Member School’s infrastructure. The contents of IP Advisors roles listed are as follows: (a) Assist with activities within the wide-area network. 1. assist with establishing information sharing system between universities within the wide-area network; 2. assist with solving region-based or technology-based IP problems; 3. provide inquiry service for planning activities within wide-area network; and 4. provide inquiry service on other wide-area networks activities planning. (b) Provide services for Member Schools (Type 1) with undeveloped IP management system. 1. investigate or analyze the available IP management system in the Member Schools; 2. assist with drafting a plan to establish IP management system (through an assisting role) and provide instructions or advices accordingly; 3. direct personnel training (i.e. provide education on invention evaluation, assessment on applying for patent and contracts); 4. advocate different regimes of IP; and 5. collect relevant information on new developing technologies. (c) Provide services for Member Schools (Type 1) with developed IP management system 1. investigate or analyze the available IP management system in the Member Schools; 2. provide advices or instructions on the application of IP management department; 3. provide advices or instructions for solving IP management problems; 4. direct personnel training (i.e. provide education on invention evaluation, assessment on applying for patent and contracts); 5. advocate different regimes of IP; and 6. gather relevant information on new developing technologies. (d) Provide services for Member Schools (Type 2) 1.Share and exchange information through network conference. C. Recruitment process and criteria JIII adopts an open recruitment process without a set number of allocated IP Advisor positions. Working location is based in Member Schools of wide-area network in Japan. In principle, IP Advisors are stationed in Administrative Schools or Major Supporting Schools within the wide-area network and can only provide telephone inquiry service or temporary assignment for assistance to the Member Schools (Type 1). However, it is noted that IP Advisors do not belong to any specific university within the wide-area network, they are employed by JIII under an exclusive contract. Based on 2013 example, IP Advisors’ employment contract started from 1 April 2013 and expires on 31 March 2014. IP Advisors’ salary and travelling expenses are paid by JIII. However, expenses for Members School (Type 1) establishing a working environment and any other disbursements should be paid by the Member School (Type 1). Furthermore, under the implementation of the current policy with respect to IP Advisors who are unable to comply with the new criteria, previous contract is considered as a non-periodical contract for the IP Advisors to continue to station in the university. However, if IP Advisor is stationed in a specific university, it must be limited to a maximum of 3 years. Due to the IP Advisors’ work, they must comply with the privacy law and keep any obtained information confidential. D. IP advisors’ qualification 1. Require a high level of professional knowledge on IP management system IP Advisor candidates must have relevant experience working in the industry with IP management system department, operation planning department, R&D department (collectively refer as “IP Management Related Departments”). 2. Have relevant experience in directing trainings in IP Management Related Departments IP Advisor candidates must have the ability to train personnel in IP Management. 3. Can provide IP strategies based on the demands. IP Advisor candidates must have the ability to plan and utilize IP strategies to achieve optimal outcomes in R&D base on the circumstances and needs of different universities. 4. Have referral from the supervisors. IP Advisor candidates who are currently employed must be able to obtain a referral from their current positions’ supervisor, IP manager or personnel from higher up. IP Advisor candidates who are current unemployed must be able to obtain a referral from their previous employment. E. IP advisors’ selection process Based on JIII’s “University Network IP Advisors Adopted Standards” (“Adopted Standards”), IP Advisors are selected first through written application followed by interview. After a comprehensive assessment, all qualified candidates will be compared based on their compatibility of the essential criteria and other non-essential criteria, and finally selecting the most suitable candidate for the wide-area network. F. Application criteria for IP advisors services 1.Common requirements for Member Schools of wide-area network (a) must be an university or educational organization pursuant to the School Education Act (No. 26 of 1947) and must be able to conduct research and have set number of entry students and graduates per year;and (b) university must have developed IP related technology or design. 2. Criteria for wide-area network (a) Must have minimum of 3 and maximum of 8 Member Schools (Type 1) and 10 or less Member Schools (Type 2) combined, and have Member School (Type 1) entering wide-area network; (b) Must clearly state the nature of network as region-based or technology-based; (c) With Administrative School as base, the network must have collaborative system to plan network events; (d) Administrative School must be able to propose and carry out network events which can benefit Member Schools (Type 1) and the society through annual business plan. (e) Must be capable to provide indirect assistance to IP Advisors who are limited by time and region such that there is a proper environment to conduct wide-area network events. 3. Entry requirement for Member Schools (Type 1) (a) Must include in the university’s policy that they will become a Member School (Type 1) in the network and provide assistance to IP Advisors accordingly; (b) IP management and IP utilization system must be clearly implemented; (c) must clearly state the scope of responsibility in relation to the collaboration with the Administration School; (d) Propose and carry out an annual business plan which can improve IP management and utilization system to a certain level on their own; and (e) Has the facility to allow IP Advisors to provide assistance and service. 4. Entry requirement for Member Schools (Type 2) (a) Must include in the university’s policy that they will become a Member School (Type 2); (b) Same as paragraph F(3)(b) in this article; and (c) Same as paragraph F(3)(c) in this article. G. Current status quo The original aim was to establish the initial IP Advisors Program to assist with university’s IP management system by dispatching IP Advisors to 60 and more universities from 2002 to March 2011. The current wide-area university network IP Advisors Program started on April 2011. Since then, JIII has dispatched IP Advisors to 8 wide-area networks. In addition, IP Advisors have also been dispatched to wide-area network with art and design colleges/universities. During year 2011, IP Advisors has achieved and completed several IP management policies as follows: 7 IP policies, 3 academia-industry collaboration policies, 2 conflicting interest policies and 2 collaborative research policies etc. Recommendation This article is based on a legal perspective view point, taking Japan’s IP Advisors Program as a reference to provide the following recommendations on the topic of network for academia-industry collaboration in Taiwan. A. Separate levels of collaboration base on needs Using Japan’s policy as an example, universities within the wide-area network require different content of services tailored to each university individually, and the universities can be categorized into two types of member schools based to the content of services. Accordingly, it is recommended that the Government should consider a similar approach to the Japan’s policy when establishing IP management alliance and forming network of IP management system. For instance, design different levels of content and collaboration, and thus expand collaboration targets to gradually include major legal research institute, technology transfer centre for universities, and IP services in northern, center and southern area of Taiwan. This will allow collaboration of these organizations to coordinate IP programs such as IP northern, application and utilization with ease. B. Emphasis on the idea of establishing and maintaining IP basic facilities Based on Japan’s past experience, it is recommended that before expanding IP Advisors related policy to solve regional IP problems, universities must first be assisted to improve their own IP management system, which has taken Japan almost 10 years to improve their universities’ IP management system. From the current IP management system policy, it can be observed that the establishment of IP management system has a certain relevant importance. Furthermore, there is an emphasis on IP Advisors’ experience in training IP managers. Accordingly, it is recommended that the Government in future planning of network IP collaborate system should set short term and long term goal flexibly, such that the basic IP facilities within the members of the network can develop continuously. For example, short term goal for a legal research institute can be growing to a certain size for it to adjust or implement IP related policies. As for longer term goal, it can be a requirement to set up a unit or department to operate and manage IP. C. Expanding the definition of ‘Networks” Taiwan and Japan are high populated country on an island with limited land. Thus, if Taiwan and Japan insist on maintaining the geographic position for networking concept and adopting such concept on the regional economics for cluster effects, then it is difficult for Taiwan and Japan to compete with American Silicon Valley or other overseas universities. In light of the above, on establishing network of IP collaborative system, the Government should take reference from Japan’s practice in 2012 and combine same industry such as medicine industry or art industry in the definition of network. This will accelerate the integration of IP experience, information, and operation management capability within the network of same industry. Conclusion In conclusion, in order to establish academia-industry IP collaboration system and efficiently improve Taiwan’s IP management system in research organizations, first must focus on various policies tailored for different levels of collaboration so that it can be integrated and expand the integration of IP resources such that there is a good foundation to develop IP basic facilities. Following the establishment of good IP foundation, it can then be further develop to more complex IP programs such as IP landscape, planning and strategizing etc.
The Dispute on WTO TRIPS IP Waiver Proposal and the Impact on TaiwanThe Dispute on WTO TRIPS IP Waiver Proposal and the Impact on Taiwan 1. IP Waiver proposal On October 2, 2020, South Africa and India summit a joint proposal (IP/C/W/669) (hereinafter as “first proposal”) for TRIPS council of the World Trade Organization(WTO), titled “Waiver from Certain Provisions of the Trips Agreement for the Prevention, Containment and Treatment of Covid-19”, called for temporary IP waiver of intellectual property in response for Covid-19 pandemic. In first proposal, it supported a waiver from the implementation or application of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19, which directs to copyright and related rights, industrial designs, patents and protection of undisclosed information. All enforcement measures under part III of the TRIPS agreement such as civil and administrative procedures and remedies, border measures and criminal procedures for protecting aforesaid intellectual property shall also be waived until widespread vaccination is in place globally, and the majority of the world's population has developed immunity[1]. On May 25, 2021, the first proposal was revised (IP/C/W/669/Rev.1, hereinafter as “second proposal”) and resubmitted for WTO by the African Group, The Plurinational State Of Bolivia, Egypt, Eswatini, Fiji, India, Indonesia, Kenya, The Ldc Group, Maldives, Mozambique, Mongolia, Namibia, Pakistan, South Africa, Vanuatu, The Bolivarian Republic Of Venezuela and Zimbabwe[2]. In the second proposal, the scope of IP waiver was revised to be limited to "health products and technologies" used for the prevention, treatment or containment of COVID-19, and the minimum period for IP waiver was 3 years from the date of decision. 2. The Pros and Cons of IP Waiver proposal The IP waiver proposal is currently supported by over 100 WTO members. However, in order to grant the waiver, the unanimous agreement of the WTO's 159 members would be needed[3], but if no consensus is reached, the waiver might be adopted by the support of three-fourths of the WTO members[4]. The reason for IP waiver mainly focus on the increase of production and accessibility of the vaccines and treatments, since allowing multiple actors to start production sooner would enlarge the manufacturing capacity than concentrate the manufacturing facilities in the hands of a small number of patent holders[5]. Médecins Sans Frontières (MSF) also support IP waiver proposal to prevent the chilling effect of patents as hindrances of the introduction of affordable vaccines and treatment in developing countries[6], and urges wealthy countries not to block IP waiver to save lives of billions of people[7]. Most opponents against IP waiver proposal are rich countries such as European Union (EU), UK, Japan, Switzerland, Brazil, Norway, Canada, Australia[8]. On May 5, 2021, United States Trade Representative (USTR) announced its support the IP waiver, but only limited into vaccine[9]. EU was the main opponent against IP waiver proposal at the WTO[10]. On June 4, 2021, EU offered an alternative plan to replace IP waiver proposal. Specifically, EU proposed that WTO members should take multilateral trade actions to expand the production of COVID-19 vaccines and treatments, and ensure universal and fair access thereof. EU calls for WTO members to ensure that COVID-19 vaccines, treatments and their components can cross borders freely, and encourage producers to expand their production and provide vaccines with an affordable price. As to IP issues, EU encourages to facilitate the exploitation of existing compulsory licensing systems on TRIPS, especially for vaccine producers without the consent of the patent holder[11]. Many pharmaceutical companies also express dissent opinions against the IP waiver proposal. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) indicated that the proposal would let unexperienced manufacturers, which are devoid of essential know-how, join into vaccine supply chains and crowd out the established contractors[12]. The chief patent attorney for Johnson & Johnson pointed out that since the existing of IP rights not only promote the development of safe and effective vaccines at record-breaking speed, but also allow the IP owner to enter into agreements with appropriate partners to ensure the production and distribution of qualitied vaccines, the problem resides in infrastructure rather than IP. Thus, instead of IP waiver, boosting adequate health care infrastructure, vaccine education and medical personnel might be more essential for COVID-19 vaccines equitably and rapidly distributed[13]. Pfizer CEO warned that since the production of Pfizer’s vaccine would require 280 different materials and components that are sourced from 19 countries around the world, the loss of patent protection may trigger global competition for these vaccine raw materials, and thus threaten vaccine production efficiency and affect vaccine safety[14]. Moderna CEO said that he would not worry about the IP waiver proposal since Moderna had invested heavily in its mRNA supply chain, which did not exist before the pandemic, manufacturers who want to produce similar mRNA vaccines will need to conduct clinical trials, apply for authorization, and expand the scale of production, which may take up to 12 to 18 months[15]. 3. Conclusion The grant of the IP waiver proposal might need the consensus of all WTO members. However, since the proposal might not be supported by several wealth countries, which might reflect the interest of big pharmaceutical companies, reach the unanimously agreement between all WTO members might be difficult. Besides, the main purpose for IP waiver is to increase the production of vaccines and treatments. However, when patent protection was lifted, a large number of new pharmaceutical companies lacking necessary knowhow and experience would join the production, which might not only result in snapping up the already tight raw materials, but also producing uneven quality of vaccines and drugs. Since patent right is only one of the many conditions required for the production of vaccines and drugs, IP waiver might not help increase the production immediately. Thus, other possible plans, such as the alternative plan proposed by EU, might also be considered to reduce disputes and achieving the goal of increasing production. As to the impact of the IP waiver proposal for Taiwan, it can be analyzed from two aspects: 1. Whether Taiwan need IP waiver to produce COVID-19 vaccine and drugs in need Since there is an established patent compulsory licensing system in Taiwan, the manufacture and use of COVID-19 vaccine and drugs might be legally permissible. To be specific, Article 87 of Taiwan Patent Act stipulates: “In response to national emergency or other circumstances of extreme urgency, the Specific Patent Agency shall, in accordance with an emergency order or upon notice from the central government authorities in charge of the business, grant compulsory licensing of a patent needed, and notify the patentee as soon as reasonably practicable.” Thus, in response to national emergency such as COVID-19 pandemic, Taiwan Intellectual Property Office (TIPO) could grant compulsory licensing of patents needed for prevention, containment or treatment of COVID-19, in accordance with emergency order or upon notice from the central government authorities. In fact, in 2005, in response to the avian flu outbreaks, TIPO had grant a compulsory licensing for Taiwan patent No.129988, the Tamiflu patent owned by Roche. 2. Whether IP Waiver would affect Taiwan’s pharmaceutical or medical device industry In fact, there are many COVID-19 related IP open resources for innovators to exploit, such as Open COVID Pledge[16], which provides free of charge IPs for use. Even for vaccines, Modena had promised not to enforce their COVID-19 related patents against those making vaccines during COVID-19 pandemic[17]. Therefore, currently innovators in Taiwan could still obtain COVID-19 related IPs freely without overall IP Waiver. Needless to say, since many companies in Taiwan still work for the research and development of COVID-19-related medical device and drugs, sufficient IP protection could guarantee their profit and stimulate future innovation. Accordingly, since Taiwan could produce COVID-19 vaccines and drugs in need domestically by existing patent compulsory licensing system, and could obtain other COVID-19 related IPs via global open IP resources, in the meantime IP protection would secure Taiwan innovator’s profit, IP waiver proposal might not result in huge impact on Taiwan. [1]Waiver From Certain Provisions Of The Trips Agreement For The Prevention, Containment And Treatment Of Covid-19, WTO, Oct 2, 2020, https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True (last visited July 5, 2021) [2]Waiver From Certain Provisions Of The Trips Agreement For The Prevention, Containment And Treatment Of Covid-19 Revised Decision Text, WTO, May 25, 2021, https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669R1.pdf&Open=True (last visited July 5, 2021) [3]COVID-19 IP Waiver Supporters Splinter On What To Cover, Law360, June 30, 2021, https://www.law360.com/articles/1399245/covid-19-ip-waiver-supporters-splinter-on-what-to-cover- (last visited July 5, 2021) [4]The Legal Framework for Waiving World Trade Organization (WTO) Obligations, Congressional Research Service, May 17, 2021, https://crsreports.congress.gov/product/pdf/LSB/LSB10599 (last visited July 5, 2021) [5]South Africa and India push for COVID-19 patents ban, The Lancet, December 5, 2020, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32581-2/fulltext (last visited July 5, 2021) [6]MSF supports India and South Africa ask to waive COVID-19 patent rights, MSF, Oct 7, 2020, https://www.msf.org/msf-supports-india-and-south-africa-ask-waive-coronavirus-drug-patent-rights (last visited July 5, 2021) [7]MSF urges wealthy countries not to block COVID-19 patent waiver, MSF, Feb. 3, https://www.msf.org/msf-urges-wealthy-countries-not-block-covid-19-patent-waiver (last visited July 5, 2021) [8]Rich countries are refusing to waive the rights on Covid vaccines as global cases hit record levels, CNBC, Apr. 22, 2021,https://www.cnbc.com/2021/04/22/covid-rich-countries-are-refusing-to-waive-ip-rights-on-vaccines.html (last visited July 5, 2021) [9]Statement from Ambassador Katherine Tai on the Covid-19 Trips Waiver, May 5, 2021, https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver (last visited July 5, 2021) [10]TRIPS waiver: EU Council and European Commission must support equitable access to COVID-19 vaccines for all, Education International, June 9, 2021, https://www.ei-ie.org/en/item/24916:trips-waiver-eu-council-and-european-commission-must-support-equitable-access-to-covid-19-vaccines-for-all (last visited July 5, 2021) [11]EU proposes a strong multilateral trade response to the COVID-19 pandemic, European Commission, June 21, 2021, https://trade.ec.europa.eu/doclib/press/index.cfm?id=2272 (last visited July 5, 2021) [12]Drugmakers say Biden misguided over vaccine patent waiver, Reuters, May 6, 2021, https://www.reuters.com/business/healthcare-pharmaceuticals/pharmaceutical-association-says-biden-move-covid-19-vaccine-patent-wrong-answer-2021-05-05/ (last visited July 5, 2021) [13]J&J's Chief Patent Atty Says COVID IP Waiver Won't Work, Law360, Apr. 22, 2021, https://www.law360.com/ip/articles/1375715?utm_source=rss&utm_medium=rss&utm_campaign=section (last visited July 5, 2021) [14]Pfizer CEO opposes U.S. call to waive Covid vaccine patents, cites manufacturing and safety issues, CNBC, May 7, 2021, https://www.cnbc.com/2021/05/07/pfizer-ceo-biden-backed-covid-vaccine-patent-waiver-will-cause-problems.html (last visited July 5, 2021) [15]Moderna CEO says he's not losing any sleep over Biden's support for COVID-19 vaccine waiver, Fierce Pharma, May 6, 2021, https://www.fiercepharma.com/pharma/moderna-ceo-says-he-s-not-losing-any-sleep-over-biden-s-endorsement-for-covid-19-ip-waiver (last visited July 5, 2021) [16]Open Covid Pledge. https://opencovidpledge.org/ (last visited July 7, 2021) [17]Statement by Moderna on Intellectual Property Matters during the COVID-19 Pandemic, Moderna, Oct. 8, 2020, https://investors.modernatx.com/news-releases/news-release-details/statement-moderna-intellectual-property-matters-during-covid-19 (last visited July 7, 2021)
Mainland China changes domestic regulation for game consolesIn 2000, the General Office of the State Council of the People’s Republic of China issued “the Notice on Launching a Special Campaign against Illegal Electronic Game Rooms”(國務院辦公廳轉發文化部等部門關於開展電子遊戲經營場所專項治理意見的通知). From then on, Mainland China has strictly enforced prohibition on gaming consoles, however in December 21, 2013, “the State Council released the Comprehensive Plan for the China (Shanghai) Pilot Free Trade Zone, the State Council’s Decision to Temporarily Adjust Relevant Administrative Laws and State Council Regulated Special Administrative Measures for Approval or Access in the China (Shanghai) Pilot Free Trade Zone”(國務院關於在中國(上海)自由貿易試驗區內暫時調整有關行政法規和國務院文件規定的行政審批或者准入特別管理措施的決定). As a result of the thirteen year long prohibition on game consoles, the development of the game consoles market has been limited in Mainland China, while mobile phone and online games have dominated the video games market in the country. Mainland China’s lifting of the ban on game consoles will lead to a reshuffling of the gaming market, and is certainly worth a deeper look. This following article will review the evolution of the gaming regulatory policy in Mainland China over the recent years, and identifies the changes and problems that may arise during the deregulation process. The sale of game consoles has been prohibited in Mainland China since 2000 According to “The Notice on Launching a Special Campaign against Illegal Electronic Game Rooms” issued by General Office of the State Council in 2000, “companies and individuals were prohibited from the manufacture or sale of game consoles, as well as the production or sale of related accessories”. As a result, the mobile game consoles and the television game consoles both lost their legitimacy in the video game industry in Mainland China. The stated intent of the ban against video arcades was to protect the youth and ensure public order. And yet, in spite of potentially impacting youth in a similar manner, the online game sector has been listed as a key industry for development and has been strongly supported by the government. This has clearly contradicted the reason of banning the game consoles. Thus, the major console manufacturers, Sony, Microsoft, and Nintendo, have been trying in various ways to enter the Chinese market, and have called on the Mainland China government to open their domestic market for the sale of game consoles. Announcement of reopening the sale of game consoles in China (Shanghai) Free Trade Zone in 2013. After thirteen long years, the State Council issued the “the Comprehensive Plan for the China (Shanghai) Pilot Free Trade Zone”, permitting foreign enterprises to produce and sell game equipment in the Free Trade Zone. Five days later, Blockbuster that under Shanghai Media Group announced a cooperation with Microsoft in a joint venture company within the Free Trade Zone, claiming their main business as " design, development, production games, entertainment applications and derivative products; sales, licensing, marketing and production for third-party games and entertainment applications software; technical advice and services related to video games ". In December 21, 2013, “the State Council released the Comprehensive Plan for the China (Shanghai) Pilot Free Trade Zone, the State Council’s Decision to Temporarily Adjust Relevant Administrative Laws and State Council Regulated Special Administrative Measures for Approval or Access in the China (Shanghai) Pilot Free Trade Zone”, officially lifted the prohibition on game consoles in the Free Trade Zone, and also opened the gates to investors. Potential problems facing China’s game consoles market As the case study above describes, Microsoft chose to enter the Mainland China market through a joint venture, the main reason being that foreign investment in entities engaged in internet data operations is still prohibited in China (Shanghai) Free Trade Zone. Thus, Microsoft will need to rely heavily on Blockbuster for the data operation and set-top box business license, which was the main subject as the Internet service content provider. In addition, apart from the joint venture between Blockbuster and Microsoft, there are two other companies in the industry: Sony and Nintendo, which retain a large part of the game consoles market, but have not taken action at the moment. These two companies have a pivotal position in the game consoles industry, and therefore it is predicted they will likely follow the Blockbuster and Microsoft example to look for a license holder vendor as a way to enter the mainland China market. On the other hand, at the end of June 2014 the updated announcement regarding the China (Shanghai) Free Trade Zone “negative list”, still clearly stated that foreign enterprises in the Free Trade Zone are “prohibited from direct or indirect participation in online game operations and services”. Due to the trend among game consoles towards online connectivity, the classification of related games as online games, and prohibition of foreign enterprises from entering this space, domestic game developers have enjoyed a safe monopoly over the industry in Mainland China. But if the industry is not restricted under the scope of foreign operation of online games, and foreign enterprises may be allowed involvement in the management of their operations directly or indirectly, “fully localized” online game industry in Mainland China may be challenged in a noticeable way. In addition, although Mainland China has begun to loosen control over game consoles, the publication of electronic publications licensed by a foreign copyright owner (including online gaming works) will be determined under the General Administration of Press and Publication (新聞出版廣電總局). An enterprise who wishes to enter the Mainland China market has to create content which is able to pass a content review, at the same time maintaining the original integrity of the game. Moreover, consumers in Mainland China have long been accustomed to "cheap" or "free" Internet games, so are they going to change their behavior and be willing to pay for their games? These are big obstacles to be overcome by the industry.
Review of Singapore IP Dispute Resolution DevelopmentReview of Singapore IP Dispute Resolution Development Preface In recent years, advantage of capital and productivity are not enough for company to stand out from the business battle. Innovation and creation become the driver of business growth. Intellectual Property (“IP”) Right turns out to be the power to boost international competitiveness. In March 2013, Singapore submitted 10-year IP Hub Master Plan to guide Singapore’s development as a Global IP Hub in Asia. Six Strategies are identified from IP Hub Master Plan. This article focuses on strategy 4, developing Singapore as a choice venue for IP dispute resolution through a strong IP Court and deep IP alternative dispute resolution capabilities, to understand how Singapore attracts various stakeholders and hence create a hive of IP activities by adopting tailored processes to facilitate the resolution of IP cases and promoting alternative dispute resolution. Key Points of IP Dispute Resolution When it comes to IP issue, oblige will take either marketplace or area of IP application into account for choosing jurisdiction of dispute resolution. The major IP war occurs in America and China. Although Singapore deals with less IP case, the government considers itself as a transparent, efficient and neutral justice system, coupling with lots of transnational divisions in Singapore, which creates an opportunity to develop IP dispute resolution. To achieve the goal, Singapore puts its hand to enhance capabilities of IP Court and IP alternative dispute resolution for bringing more IP litigations and IP alternative dispute resolution to Singapore. 1. Enhance Capabilities of IP Court (1) Efficiencize Processes In September 2013, the Registrar of the Supreme Court released Circular 2 of 2013 on the issuance of the IP Court Guide, which will apply to all cases under the IP docket of the Supreme Court with immediate effect. An IP Judge will be assigned to hear all interlocutory appeals, milestone pre-trial conferences (“PTCs”) and the trial on liability. The IP Court Guide provides for two milestone PTCs before set down for trial whereby the lead counsel must personally attend to address the IP Judge on certain specified issues. All other PTCs will be heard by the senior assistant registrar managing the IP docket. Subject to certain exceptions, an assistant registrar will hear all interlocutory applications arising in each IP case. In addition, to support the IP Court’s adjudication functions, the IP Court Guide provides for the appointment of assessors (for technical expertise) and amicus curiae (for legal expertise) for IP cases. Parties are encouraged to propose a single candidate by agreement. Otherwise, parties should agree on and propose a shortlist of candidates. Due to improvement, it is more convenient for parties to track trail status. For IP Judges, they can get familiar with cases and related evidence through PCTs before entering trail process. On the whole, this change increases trail efficiency and quality. (2) Set Up Singapore International Commercial Court The Ministry of Law proposed amendments to the Constitution of the Republic of Singapore and the Supreme Court Judicature Act in October 2014. The new legislation and regulations laid the foundation of Singapore International Commercial Court (“SICC”), which was set up in January 2015. The SICC, the only one International Commercial Court in Asia, is a division of the Singapore High Court and part of the Supreme Court of Singapore designed to deal with transnational commercial disputes including business issues and patent suits. Key Features of the SICC: A. SICC matters will be heard by a Panel comprising High Court Judges, associate Judges and foreign associate Judges with extensive experience and highly regarded reputation. B. A party may be represented by a registered foreign counsel without any involvement of local Singapore counsel if the matter in question is considered to be an “offshore case”. An “offshore case” is defined in the amended Rules of Court as a case which has no substantial connection to Singapore either because (i) Singapore law is not the law applicable to the dispute and the subject matter of the dispute is not regulated by or otherwise subject to Singapore law, or (ii) The only connection between the dispute and Singapore are the parties’ choice of Singapore as the law applicable to the dispute and the parties’ submission to the SICC’s jurisdiction (“Singapore Law-only Connection”). C. The SICC will hear cases governed by Singapore law and by foreign law, with the Court taking judicial notice of the foreign law. In addition, the SICC is not bound by the domestic rules of evidence at all and may apply other rules of evidence whether they are found in a foreign law or otherwise, if the parties make an application for it. 2.Strengthen Capabilities of IP Alternative Dispute Resolution Singapore International Arbitration Center (“SIAC”) and the WIPO Arbitration and Mediation Center Singapore Office were set up respectively in 1991 and 2001 to strengthen capabilities of IP arbitration. On the basis of these two centers, in order to enrich alternative dispute resolution, Singapore also established Singapore International Mediation Center (“SIMC”) and launched the service of arbitration-mediation-arbitration (“Arb-Med-Arb”) in November 2014. Arb-Med-Arb is a process where a dispute is referred to arbitration before mediation is attempted. If the parties are able to settle their dispute through mediation, their mediated settlement may be recorded as a consent award. If the parties are unable to settle their dispute through mediation, they may continue with the arbitration proceedings. Arb-Med-Arb is definitely a better way for parties to reach a consensus on a dispute since arbitration is more costly and mediation is less powerful. Conclusion The SIMC and the SIAC are now collectively working on mediation, Arb-Med-Arb and arbitration and providing various IP alternative dispute resolutions. Moreover, the SICC and IP Court are charged with IP litigation. These make Singapore a comprehensive IP dispute resolution system. In the process of revolution, Singapore puts itself up to breakthrough as to amendments and the Supreme Court Judicature Act, which establish legitimacy of SICC. The government also defines IP dispute resolution services, such as SIMC’s mediation, Arb-Med-Arb, arbitration as well as SICC features. Nevertheless, other than SIAC, SICC decision may be difficult to enforce transnationally due to lack of legislation. To sum up, Singapore earns recognition for aggressively proposing amendments and assigning responsibilities after setting IP target and evaluating obstacles; however, it is better to pay special attention to that if the market can keep up with administrative efficiency or if the IP strategy could accord with the demands of the market.
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