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
Antitrust Liability to the Conduct of “Refusal to License” of the Standard Essential Patent 2022/07/19 The notion of Standard Essential Patent（SEP）emerges in the era when manufacturers seek ‘‘compatibility’’ and ‘‘interoperability’’ of their products. The concept of SEPs is proposed to help manufacturers ‘‘talk’’ to each other so the collective manufacturers enjoy the advantage of economies of scales. Meanwhile, the compatibility and interoperability derived from SEPs enhance the consumers’ valuation of the product which creates the ‘‘network effect’’ of the products. There is a long-debated issue in the field of SEP—to what extent shall the SEP holders license their patents in the various level of the supply chain. This issue has much to do with the ‘‘FRAND commitment’’, and is worthy of further analysis. I. SEP and FRAND Commitment The concept of SEP is—when any certain patented technology is selected by the ‘‘Standard Setting Organization’’（SSO）as the commonly used standard, such the patented technology is categorized as a SEP. The SEP holder therefore enjoys stronger ‘‘market power’’ because market participants have no choice but to use the SEP and are required to seek license from the SEP holders. Therefore, to prevent the SEP holders from abusing their market power, SSOs usually require SEP holders to make the FRAND commitment; that is, to license on ‘‘fair, reasonable and non-discriminatory’’ terms. Once the SEP holder breaches the commitment, the SSOs might exclude that technique from the standard. II. “License to all”or“Access to all”issues under FRAND Commitment The FRAND commitment, by textual reading incorporates the wording of ‘‘non-discriminatory’’, and can infer two co-related yet debatable concepts—the ‘‘License to all’’ or ‘‘Access to all’’ arguments. The ‘‘License to all’’ argument holds that all participants in the supply chain retain the access to the specified SEP, while the ‘‘Access to all’’ argument, on the contrary, contends that FRAND commitments don’t necessarily ask SEP holder to license to all practitioners, but when a SEP holder is going to license, he must license on FRAND terms. According to observations, there is a common phenomenon in the SEP licensing practice—most SEP holders tend to license only to the End-Product manufacturers rather than to the manufacturers of the ‘‘Smallest Saleable Patent Practicing Unit’’（SSPPU）. What the SEP holders expect through ‘‘refusal to license’’ to the SSPPU manufacturers are to maximize the potential royalties. Cases inclusive of the Qualcomm case[1] and the Continental case[2] have shown such practical tendency, and only when the SSOs can well define the definitions of FRAND commitments might the issue be truly settled. There are some End-Product manufacturers that consider it ‘‘discriminatory’’ and against the FRAND commitments if the SEP holders refuse to negotiate with SSPPU manufacturers requesting to be the licensee. On the other hand, some consider it inappropriate for the End-Product manufacturers to refuse all negotiations when the SEP holder requests it to be the party to the licensing negotiations[3]. III. The ‘‘refusal to license’’ and the derived Anti-Trust Issue As generally admitted, a firm has no general duty to deal with others[4]; however, there are times when SEP holders’ ‘‘refusal to deal∕license’’ behaviors can constitute wrongful monopoly under Sherman Act section 2. The U.S. judicial practices have categorized three main ‘‘refusal to deal∕license’’ behaviors as wrongful monopoly under Sherman Act section 2; they are[5]: 1.dominant firm forces its customers not to do business with new competitors of that firm, or the dominant firm will terminate business with the customer[6]; 2.dominant firm tries to abandon or alter an existing relationship[7]; 3.dominant firm refuses to provide access to ‘‘essential facility’’ (the equipment or techniques that is indispensable when others would like to compete in the relevant market with the dominant firm). As SEP can be categorized as an ‘‘essential facility’’, this paper will only focus on the third category. The ‘‘Essential Facility Doctrine’’ is—when any monopolist withholds an essential facility and refuses to provide his competitors with the access to the said essential facility, a wrongful monopoly due to the Facility holders’ ‘‘refusal to deal∕license’’ is constituted. According to the leading case—the MCI case[8], four factors are to be proved by the plaintiff when seeking resort to ‘‘Essential Facility Doctrine’’; they are:（1）the monopolist’s control of an essential facility;（2）the inability of a competitor to duplicate that essential facility;（3）the monopolist’s denial of access to that essential facility to a competitor;（4）the feasibility of providing the essential facility to the competitor by the monopolist. As we can shortly conclude here, if a SEP holder constitute wrongful monopoly because of his ‘‘refusal to license’’ behavior, the perquisite is that the SEP holder would like to join in the ‘‘competition’’ in the relevant market himself. IV. Conclusion—the commonly seen ‘‘refusal to license’’ behavior of SEP holders doesn’t constitute wrongful monopoly As mentioned before, ‘‘competition’’ serves as the prerequisite for the ‘‘Essential Facility Doctrine’’; thus, some SEP holders’ refusal to license to SSPPU manufacturers behaviors—such as Qualcomm in the Qualcomm case and Nokia in the Continental case—are not in accordance with ‘‘Essential Facility Doctrine’’ and do not constitute wrongful monopoly. Qualcomm and Nokia chose not to license to SSPPU manufacturers merely because they want to earn more royalties by licensing to End-Product manufacturers; they didn’t make this choice because themselves would like to compete in the SSPPU markets. However, since there is no clear definition of FRAND yet, whether the SEP holders have truly breached the FRAND commitment remains unsolved puzzle and shall retain to SSO’s clearer definition and the Court’s further rulings. [1]FTC v. Qualcomm Inc., 969 F.3d 974 (9th Cir. 2020). SEP holder Qualcomm would only like to license to the cellphone OEM manufactures rather than to other chips manufacturers. [2]Continental Automotive Systems, Inc. v. Avanci, LLC, et al, No. 20-11032 (5th Cir. 2022). SEP holder Nokia and a licensing platform—Avanci (that Nokia had joined) would only like to license to car manufacturers rather than to Telematics Control Unit（TCU）manufacturers. [3]Japan Patent Office [JPO], GUIDE TO LICENSING NEGOTIATIONS INVOLVING STANDARD ESSENTIAL PATENTS (2018), https://www.jpo.go.jp/e/support/general/sep_portal/document/index/guide-seps-en.pdf(last visited July 19, 2022). [4]See United States v. Colgate & Co., 250 U.S. 300 (1919);Pacific Bell Telephone Co. v. linkLine Communications, Inc., 555 U.S. 438 (2009); Aerotec Int'l v. Honeywell Int'l, 836 F.3d 1171 (9th Cir. 2016) [5]ANDREW I. GAVIL, WILLIAM E. KOVACIC & JONATHAN B. BAKER, ANTITRUST LAW IN PERSPECTIVE: CASES, CONCEPTS AND PROBLEMS IN COMPETITION POLICY 630-654 (2002). [6]See Lorain Journal Co. v. United States, 342 U.S. 143 (1951) [7]See Image Technical Services, Inc. v. Eastman Kodak Co., 504 U.S. 451 (1992); Aspen Skiing Co. v. Aspen Highlands Skiing Corp., 472 U.S. 585 (1985) [8]MCI Communications Corp. v. American Tel. & Tel. Co., 708 F.3d 1081 (7th Cir. 1983)
Utilizing TIPS 1 to Establish a Comprehensive Intellectual Property Management SystemChen Yi-Chih, Chen Hung-Chih 2 I. Foreword Intellectual Property (IP) Management is a subject of recent focus in Taiwan . More than 1 million patents have been filed in Taiwan and each year, Taiwan dedicates NT $80 3 trillion in research and development. The estimated cost for IP prosecution, maintenance, litigation, conciliation, compensation and authorization amounts to NT $200 trillion (U.S.$6.5 trillion) 4. Even though many enterprises have gradually recognized the importance of intellectual property, the situation has not significantly improved based on the statistics stated above. Observation shows that only few enterprises in Taiwan have taken active steps to manage their IP and it was only after facing infringement lawsuits and tremendous amount of loyalty payments, most companies started to realize the important of IP management. Two main causes are believed to have negative impact on the lacking and ineffectiveness of most Taiwanese enterprises' IP management: Taiwanese enterprises have not taken proactive measures to handle IP management issues and IP management is only viewed as a mechanism to prevent IP infringement. Taiwanese enterprises have not sought ways to proactively and strategically use their intellectual property as a tool to yield profit. Due to limited professional knowledge and resources, Taiwanese enterprises do not know how to manage and exploit IP generated within their companies . Therefore, it is critical to assist these enterprises to develop and implement an effective IP management strategy under which the full potential of their IP can be utilized and the maximum value of the enterprises' IP can be realized. The Intellectual Property Office of the Ministry of Economic Affairs recognized the importance of governmental role to address this issue. Since 2003, it has collaborated with the Institute of Information Industry to work on a project for developing a standardized IP management system. In 2005, the project was handed over to the Industrial Development Bureau which then carried on the development and promotion of the Taiwanese Intellectual Property Management System (TIPS). Taiwanese enterprises 5 are able to use TIPS as a basis to establish their own comprehensive IP management systems. Based on our experiences in promoting TIPS and the feedbacks from those enterprises which have followed the TIPS's guidance to establish their IP management systems, we are pleased to find that TIPS is capable of assisting enterprises to develop a comprehensive IP management system. The system no only meets an enterprise's operational needs but also can be continuously improved owing to its adoption of the PDCA management cycle 6. II. The Introduction of TIPS A. The Origin and Overview of TIPS On December 9, 2004, The Ministry of Economics, in recognition of the needs to assist Taiwanese enterprises to better manage and more fully utilize their intellectual property, organized a “Taiwanese IP Management Standardization and Promotion Summit”. In order to establish a consensus on IP management among Taiwanese enterprises and to encourage the enterprises to implement an internal IP management system, the Taiwanese government positioned TIPS as an industry standard. In 2006, The Industrial Development Bureau (IDB) of the Ministry of Economic Affairs (MEA) established a TIPS promotion program and revised the 2004 draft of the Intellectual Property Management System Standard to become the Taiwan Intellectual Property Management System (TIPS). The industrial experts' opinions and comments were gathered and used to amend the draft, TIPS was then formally announced 7 on March 23, 2007 and consequently promoted. In hopes to protect Taiwanese enterprises and to improve their market competitiveness, IDB initiated extensive promotion program, encouraging Taiwanese enterprises and organizations to establish a convenient, efficient, and low-cost IP management system by following the TIPS's guidance The main characteristic of TIPS is the incorporation of the PDCA (Plan-Do-Check-Action) model from the ISO 9001:2000 Quality Management System. By adopting this model, not only the challenges of IP management can be resolved, but the whole system can also be continuously improved. Since TIPS shares the ISO's characteristics of being credible, comprehensive, and easily adaptable, TIPS and be easily integrated into the ISO standards within an enterprise such that the conflicts between these two systems will be minimized and it will only require minimum organizational structural changes and implementation costs. If an enterprise has already implemented ISO, implementing TIPS becomes more easily and efficient. In addition, TIPS emphasizes the concepts of using “process-oriented approach” and “systematic management” 8. Enterprises can merge their existing infrastructures and TIPS to establish a convenient, effective and efficient IP management system to reduce losses caused by IP infringement. Enterprises may also strengthen their market competitiveness and increase profits through royalty income. TIPS includes nine chapters. The first four chapters cover Summary, which describes the background of TIPS; Scope of Application and Terminologies. Clause 0.3.1 9 of TIPS states that the purpose of TIPS is to promote the utilization of IP management as one of the means to maximize an enterprise's profits. Rather than an individual or a specific department, protecting IP assets is the responsibility of all employees within the enterprises. In addition, the establishment of an IP management system is essential regardless of the scale, product or service provided by an enterprise. Clause 1.2 of TIPS clearly provides that TIPS is applicable to all enterprises, despite their types, scales, products and services provided. Therefore, TIPS is not designed solely for large enterprises. It can be applied to all kinds of organizations which include but not limit to a company, a specific department/division within a company, a laboratory or a project team. B. The Foundation of TIPS Before establishing TIPS, the government recognized that an enormous amount of resources is required to establish an IP management system. Therefore, the ISO9001:2000 quality management framework was adopted and TIPS was developed based upon the ISO's management principles. By incorporating IP managing strategies into an enterprise's operation goals and internal activities, the IP management system is no longer just a risk management system but a system that is closely aligning to the overall operations of an enterprise. Since it was found that many domestic companies implemented ISO9001:2000 Quality Management System solely for compliance purposes, people are skeptical about its effectiveness. In fact, if one understands the rigorous formulation processes behind the quality management system and its principles, one would recognize that an enterprise's IP management system can be significantly improved by adopting the management characteristics of ISO Quality Management System. The main characteristics shared between TIPS and ISO are outlined as follows: The effectiveness of an IP management system can be evaluated through clear policies and goals Chapter 5 of ISO 9001 ： 2000 discusses Management's Responsibility. It states that top management should establish an enterprise's mission, vision, policies and goals, otherwise known as Visionary Leadership. An enterprise should consider its stakeholder's needs, understand the gap between its current status and the ideal state when setting its mission, vision, policies and goals. It should also decide its operational goals by considering available resources and the external environment. Traditional way of IP management only focuses on the operational and managerial processes. Strategic issues such as strategic planning and mission/vision planning are often forgotten, which often leads to a disconnection between strategy and actual operations. The concept of setting clear policies and goals used in ISO Quality Management shall be adopted to manage IP. That is to say, clear policies and objectives should be defined by the top management followed by detailed processes and steps required to realize the goals. Clear operational processes and responsibility help to achieve IP management goals ISO9001:2000 states that quality issues are caused by process, not product and process issues are caused by management since processes are carried out by people. Therefore, all personnel who is involved in carrying out the processes (in other word, all the employees within an organization) shall have the responsibility to improve quality. This concept applies to IP management as well. It is an incorrect general belief that IP management is merely for damage control or risk prevention. It is also an incorrect belief that an IP management is the sole responsibility of the legal department that other departments have no roles to play in enhancing the added-value of IP. For enterprises intending to utilize IP to enhance its competitiveness, some suggestions as listed below should be taken into account when planning their IP strategies: Set IP management as one of the company's operational goals. Organize a team to implement the IP strategy and to determine the processes required to achieve the IP goals. Clearly identify roles and responsibilities for personnel involved in all levels of IP management. Identify tasks required to be documented. Ensure the employees understand the linkage between their assigned tasks and the corresponding organizational goals. Through careful considerations of planning the organizational goals, processes and the expected outputs derived thereupon, enterprises can determine whether the processes so planned are necessary, appropriate, and effective . Consequently, minimizing the resources required to be invested into IP management. Monitoring, evaluation, and corrective actions can help to ensure the effectiveness of an organization's IP management processes Clause 8.2.1 of ISO9001:2000, “customer satisfaction”, emphasizes that customers own the right to evaluate. In the case of IP management, customers are basically the enterprise itself, therefore the performance is evaluated based on whether the set organizational goals can be achieved. It has been observed that many companies implemented the ISO Standards purely for the purpose of obtaining ISO's certification and do not consider whether the processes implemented are, in the practical sense, effective or efficient. Under this circumstance, the enterprises would not gain any actual benefits, despite that the requirements of ISO standards are met. The goal of process management is to improve the process efficiency, effectiveness and adaptability. Clause 8.2.3 of the ISO9001:2000 discusses Monitoring and Measurement of Process and Clause 8.2.4 talks about Monitoring and Measurement of Product. They state that an organization should establish a mechanism to monitor, evaluate, and understand the organization's internal and external customers' needs. This mechanism can also help to determine whether the organization can meet or exceed the expectation of its customers (in terms of processes, products, and/or services), which is also a critical element in establishing a systematic IP management system. If the result of evaluation does not meet expectation, there is a problem. In order to prevent the problem from reoccurring, prevention is the best. The concept of prevention is to design measures to avoid the occurrence of hidden problems. Unexpected problems are inevitable to occur even if preventive measures have been taken. We should analyze the impact of the problems occurred and propose counter measures to minimize their impact. The efficiency of IP Management relies on continuous improvement There are always opportunities to improve any process. Clause 8 of the ISO9001:2000 discusses Measurement, Analysis and Improvement which includes continuous improvement processes. Clause 8.2 Monitoring and Measurement, Clause 8.3 Control of Nonconformity, and Clause 8.4 Analysis of Data discuss the issues surrounding monitoring, measurement, analysis and control of nonconformity. Clause 8.5 discusses Improvement, which covers action taken to address the causes of identified issues. There are many issues that may be identified after analysis which cannot be resolved at once. Clause 5.1 of ISO 9001:2000 Management Commitment requests that the top management team be responsible for setting policy and goals, and providing resources needed to achieve the goals. By introducing ISO9001:2000 measurement, analysis, and improvement methodologies into the IP management system, it is believed that enterprises can thus effectively manage their IP and achieve a win-win scenario with their customers. C. The expected benefits of Implementing TIPS Since TIPS shares the above mentioned characteristics of the ISO Quality Management System, it not only can reduce the risks of infringing the IP rights of the others, but also can assist an organization to achieve its operational goals provided that the organization has designed relevant processes pursuant to the requirements of TIPS and has thoroughly implemented the designed processes. Using TIPS's external evaluation mechanism 10, enterprises implementing with TIPS can prove to their customers and external stakeholders that they have the capability to manage and maintain their IP. If an enterprise follows TIPS to establish its IP management system, its expected benefits include the followings: Enhancing market competiveness and increasing the added-value of an organization An IP management system that is designed to meet the specific needs of an organization shall play a significant role in achieving the organization's operational goals. Take a fitness equipment or an automobile parts manufacturer as an example, if the manufacturer owns the IP rights (ex: new design patent or trademark) embodied within the products, it is expected that the manufacturer can profit more than a purely OEM company which does not own its own brand. This is because the IP rights embodied within the products could provide significant added-value beyond what an OEM company can offer. Increasing customer's ordering intent The guidelines of TIPS also serve as the requirements for certification purpose. A government certified IP management system will ease concerns over trade secret protection and thereby promote cooperation and trusting relationships between the suppliers and the buyers and between research collaborations which consequently would foster better research results and potentially more purchasing orders. Minimizing resource wasting and actively creating profits Most small and medium enterprises in Taiwan do not have adequate labor and financial resources to develop a comprehensive IP management system. It is the hope of the government that a simple, effective, and low-cost IP management system can be established which tailors to the specific needs of every enterprise by adopting the TIPS framework. Once enterprises are capable of systematically manage their IP, it is expected that the IP generated and their exploitation can really match the enterprises' requirements and expectations, so that no resource is wasted to produce unwantable IP. The enterprises may further increase their profits by licensing or assigning their IP rights. Fostering an organizational culture that values the importance of intellectual property and the ability to continuous improve Establishing IP management policies, coupled with ongoing IP management seminars and education and training programs for new employee would enhance the awareness of the importance of IP management to the organization among the employees. The employees may further change their attitudes from passively complying with the policies to actively participate the system such as paying particular attention to potential IP risks and offer suggestions for process improvement. One company which implemented TIPS commented that the regular and ad hoc audits requirement and the necessity of assigning roles and responsibilities as required by TIPS assist it to identify problems concerning management issues. Corrective and preventive actions can be rapidly taken to address the problems identified, allocate the liabilities and improve the whole system. As a consequence, the IP management system can be effectively carried out to ensure that the planned objectives are met. It was found that most companies do not have internal audit and continual improvement programs to detect the hidden problems concerning management. Enhancing risk management and the capability to respond Currently, the fundamental and most important goal for an enterprise's IP management is to reduce the risks of infringement. Enterprises which have implemented TIPS found that TIPS is capable of enhancing data sharing across the departments which allows the IP department to detect potential risks at the earliest time. Further, the establishment of risk management mechanism and processes in response to infringement allegations as required by TIPS helps to institutionalize an enterprise's management system in handing legal risks. III. A holistic approach to IP management The Taiwanese government hopes that enterprises can systematically manage their IP through the implementation of TIPS. In other words, following TIPS's guidance, the Taiwanese enterprises should establish an IP management system that incorporates the usage of the PDCA management cycle (Plan-Do-Check-Action) and process management approach and such system must be built by taking into account the enterprise's business operation strategies and objectives. Enterprises should have clear processes and related rules for handling all IP related issues. For example, prior to filing a patent application, there should be a plan for the ways to acquire the targeted IP and prior art research shall be conducted. Based on the search results, enterprises can then decide whether they would like to internally develop the targeted IP or to seek licensing opportunities. Effective IP management processes shall be able to answer the following questions: Whether records are stored property? Who should conduct the audit? Whether the current system meets the IP management policy or goals? What are the roles and responsibilities? The following section aims to explain how Taiwanese enterprises can establish or modify their current IP management system to achieve its full potential: A. Roles and Responsibilities for Implementation All employees within an organization shall participate in order to realize the most benefits out of the IP management system. Leadership responsibilities, roles and responsibilities allocation, training and education programs and the subsequent auditing processes on the performance of operation shall be clearly defined and planned. Establishing a successful IP management system shall not be the sole responsibility of the legal department. During the implementation stage, the following personnel should participate and complete the related tasks: Executive management team (Management executives, ex. CEO, President, COO) a. Establish IP management policy and goals; b. Communicate the importance of compliance to the IP management policy; c. Evaluate and review the effectiveness of the IP management system; and d. Ensure the readiness of the resources available for establishing the IP management system. IP Management System Representatives (Managers who have decision-making authority, ex. EVP, VP) a. Ensure that the required processes for the IP management system are established, implemented, and maintained; b. Report to the executive management team on the performance and improvement needs for the existing system; and c. Ensure employees understand the IP management policy and goals. Department Representatives (All department representatives) a. Execute tasks assigned by the IP management system representatives; b. Execute action items reached by the steering committee meetings; c. Ensure the achievement of IP management goals, and d. Responsible for the Maintaining and improving the IP management system. B. Steps of Implementation Plan Establishing a systematic IP management system requires the participation of all employees and it requires reengineering of the existing processes. It is not an easy task to be established and planned solely by the legal department. All other departments within an enterprise shall participate and offer their suggestions. The followings are the recommended stages for implementing an IP management system: Stage Tasks Description Responsibility Remark 1. Preparation 1). Review of current status Understand resources available and the status of operation Data collection; define roles and responsibilities 2). Establish implementation team Identify team members and team leader Confirm organizational structure for implementation 3). Set goals and establish all management programs Evaluate current situation to formulate IP management policy, and define measurable goals. Processes planning shall be made by taking into account the management responsibility, resource management, product development, and performance analysis and improvement. This helps to identify the position of a process within the overall IP management system and its inter-relationships between the processes themselves. Provide evaluation report; organize IP management deployment document Documentation: IP Management Manual à Procedures à Guidelines à Records 2. Training and Education & System Integration 4). Relevant training and education Understand the direction, method, and spirit of standardization. Participated by the implementation team and management representatives. 5).Drafting documentation Decide documentation framework, format, table of contents, numbering principles, and appoint editors and the completion date. Management team assigns tasks 6). Establishing documentation Drafting and revising procedural documentation Internal discussion and review IP management principles (refer to prior text) Define the scope and content of standard format. Appoint editors and the completion date. Establish standard format as an example before documenting Prepared IP management manual to aid employees and customers to understand the organization's IP management system Implementation team and management team 3.Implementation 7). Provide training & education specifically for the internal audit personnel Explain the purpose of auditing and execution details Participated by Internal audit committee Prepare checklist for auditing to be used by auditing personnel 8). Conduct system implementation and internal audits Execute documentation processes for the management system and conduct internal audits and review the performance Implementation, review, correction and prevention. Participated by all employees 9). Conduct overall examination of the intellectual property management system Implement IP management system Participated by all members of the implementation team C. Implementation Chapter five through chapter eight of TIPS define the core of the guidelines which cover the basic requirements of IP management requirements; top management's responsibilities; resource management; the acquisition, protection, maintenance and exploitation of IP, as well as performance evaluation and improvement. To facilitate Taiwanese enterprises' understanding of TIPS and how to use it to establish a comprehensive IP Management system, we provide the following main steps of establishing an IP management system based on the TIPS's requirements: Define the company's IP management goals Enterprises that would like to establish an IP Management system have to understand their unique features and future operation strategies to evaluate the needs for managing their IP. Clauses 4.1, 5.2, and 5.3.1 of TIPS stipulate that the management team has the responsibility to set clear IP management policy and goals. For example, one policy can be to increase R&D efficiency and the goal can be to reduce the product development cycle by 10%. Defining appropriate IP Management policies can help to establish a IP management system that meets an enterprise's practical needs. It can also be used as basic principles for formulating IP strategies and subsequently the implementation processes of IP management system. The management team should utilize intranet or bulletin boards to inform its employees of the organization's IP management policies, goals, and relevant responsibilities assigned to each department. This will help employees to understand their roles and responsibilities and the importance of their participation in achieving the organization's goals. Develop required processes for achieving enterprise's IP management goals The ultimate purpose of establishing an IP management system is to maximize profits and to minimize losses. To ensure successful acquisition of targeted IP, companies should plan and develop processes and operating procedures based on their needs and business development strategies. During this stage, companies should focus on the followings in order to meet TIPS's requirements: Understand statutory and regulatory requirements concerning IP The management target of TIPS is intellectual property, which includes trademark, patent, copyright, trade secrets and etc. Different IP acquisition approaches apply to different IP targets. Complying with Clause 7.1, companies must firstly understand all the statutory and regulatory requirements before a plan is made for the acquisition of targeted IP. For example, according to the relevant legislations in Taiwan, once a work is created, the authors obtain the copyright in the work. However, the right to patent or trademark can only be acquired through registration. Evaluate options for acquiring the targeted IP Enterprises shall evaluate different options (i.e. self-development, purchase or outsourcing) for acquiring their targeted IP by taking into account of their business operation objectives and the characteristics of their products as the methods of acquiring IP will influence the subsequent processes concerning the protection, maintenance and exploitation of the acquired IP. Clause 7.2 of TIPS requires enterprises to implement processes regarding to the evaluation of the options for acquiring the targeted IP. Clause 7.3.5 further requires enterprises to set up an assessment procedure for every IP application and suggests to incorporate an invention incentive program. Define roles and responsibilities After completing the feasibility study concerning various options to acquire the targeted IP, enterprises have to decide whether to establish an IP management specialized department (ex. legal or IP department) and to define clear roles and responsibilities based on the company's scale and resource available. Companies should pay particular attention on preparation work, such as conducting patent or trademark prior art search, to avoid wasting of resources and voided applications. If enterprises outsource IP management related activities to external bodies, Clause 7.4.1 of TIPS requires them to have a clear knowledge of the service quality provided by the outsourcing bodies and to establish a controlling mechanism over the outsourcing activities (ex. evaluation → outsourcing → contract → periodic evaluation…etc.). Special attention has to be paid to the contractual terms concerning obligations and ownership of IP. Determine Resources Required Enterprises that would like to establish an IP management system not only have to ensure that they have enough resources, but also need to ensure that the resources can be utilized in an effective way. The management team, in accordance of the requirements for Clauses 5.4.2 a nd 6.1 of TIPS, should provide resources (including labor and equipment) required for the implementation of the IP management system. Examples include the continual recruitment of manpower and the purchasing of computer software and hardware equipments and etc. As far as labor is concerned, enterprises, in accordance with Clause 6.2.1 , have to ensure that their employees have adequate abilities to assume their responsibility. Clause 6.2.1 states that companies should provide basic IP education and training to equip the employees with necessary knowledge. Pursuant to Clause 6.2.3, enterprises should provide their patent engineers and legal staff with advanced training, such as intellectual property litigation and arbitration, intellectual property licensing and contracts, techniques for patent design around, IP valuation and so on. In summary, enterprises should enhance the employees' (both new and existing employees) awareness of IP, the importance of complying with statutory requirements and the enterprises' internal IP policies and goals through education and training. Establish an IP Management System After determining the resources required, enterprises need to establish a basic system to manage their IP. The system shall include a documentation control system, an audit program, an internal communication channel and so on. We provide a summary explaining the details of each program required to establish a basic IP management system: Basic IP Management System (1) Documentation Control System: Enterprises should establish a systematic documentation control system based on their IP management policies and goals, such as document control procedures, internal audit process and etc. Among those, the most important one is an IP management manual. Clause 4.3 of TIPS requires the enterprises to state all the following items in their IP management manual: IP management policies and goals; roles and responsibilities; processes and procedures; and flow charts or grid charts to explain the interrelationships between the processes and procedures. Further, Clause 4.4 also states that all documents, no matter whether they are internally generated or externally acquired (ex. court notice, invitation to tender, official documents) should be properly managed. The source, level of confidence, method of management should be clearly labeled for future purposes. (2) Audit Program: Clause 5.4.2 states that top management has to be responsible or otherwise shall designate a management representative (the most senior staff that is responsible for intellectual property matters, such as vice president or director of IP management department) to manage a company's IP related issues. The top management team is also in charge of establishing a management review meeting, and setting agenda for each meeting such as discussing or revising the IP management policies and goals. Through management review meeting, pursuant to Clause 5.5, management representative must confirm that the set IP goals are met or if not, whether to revise the original policies or goals. All departments or responsible personnel (ex. legal, IP, general administration, accounting, human resource) shall participate the management review meeting. (3) Confidentiality Control Program: Enterprises in accordance with Clauses 4.4.1 a nd 7.4.4, should enhance feasible safety controls to protect their IP, such as setting document confidential criteria, physical access control, and control over replication of confidential documentation to limit exposure of important data. Supplemental IP Management System In addition to the above mentioned programs, supplemental IP management programs are required to assist in establishing an effective IP management system. They are outlined as follows: (1) Outsourcing Program: Due to cost or resource concerns, enterprises may outsource its R&D or IP prosecution activities to external professional agencies. Clauses 4.1 and 7.4.1 of TIPS require that the contracts entered into must clearly identify the ownership of IP involved and include a term of confidentiality obligation. This is to ensure that the outsourcing activities can be properly monitored and to prevent the leakage of important data. (2) Contract Review and Human Resource Management Programs: In order to prevent and avoid intellectual property infringement, in accordance with Clause 7.4.6 , enterprises should review all contractual terms of their contracts. As far as human resource management is concerned, in accordance with Clause 7.4.3, enterprises shall require new employees to sign an employment contract . Such contract shall include a term of confidentiality obligation and a non-competing clause may be included if necessary. (3) Internal Consulting and Communication Channel: During the period of establishing an IP management system, enterprises in accordance with Clause 5.5.2 must request relevant departments (ex. legal, sales, finance and accounting) to provide useful information concerning IP management. According to Clause 5.4.3, enterprises must establish communication channels (ex. dedicated mailbox, email) which is used to understand the feelings and to know the difficulties faced by the employees as it is inevitable to face challenges when a new system is being implemented, consistent communication and coordination is the only way to overcome these challenges. Ensure that Auditing and Preventive and Corrective Measures have been Taken Pursuant to Clauses 8.1 and 8.2, enterprises with IP management systems need to establish internal audit plans (including audit frequency, time, or method) to ensure that their IP management policies or goals are being met. Enterprises should ensure that their internal auditors are qualified i.e. have obtained the relevant professional certification, before conducting the internal audits. If nonconformities have been found through internal audits, corrective or preventive measures should be taken pursuant to Clauses 8.4.2 a nd 8.4.3. For instance, if the result of internal audit reveals that the R&D staff failed to keep their R&D records in accordance with the set rules and requirements, companies shall find out the causes (i.e. the reasons of the nonconformity) and then take appropriate corrective or preventive measures. An example of corrective measure can be to increase the frequency of checking the relevant records. And an example of preventive measure can be to provide incentive program to encourage the compliance of the relevant rules and regulations. Pursuant to the requirements of Clause 8.3, enterprises should collect and analyze relevant information, such as the internal audit reports, results of the corrective measures taken, and the results of market/competitors analysis. The above information can be used as input information during management review (Clause 5.5.2 ) to decide whether it is required to amend or set new intellectual property management policies and objectives. Through continual auditing and revising, a systematic IP management system can be established. IV Conclusion In the era of knowledge economy, the abilities of most domestic enterprises to manage tangible assets have gradually matured (ex. ERP system). However, the abilities to manage intangible assets which include intellectual property have yet to be developed. Management systems in most domestic enterprises are fragmented. For example, legal departments are only responsible for contract reviewing tasks; R&D staff has limited IP knowledge. The importance of IP is often overlooked and most enterprises do not see that intellectual property management is the responsibility of every employee. As a consequence, the Taiwanese government establishes and promotes TIPS to encourage domestic enterprises to adopt a systemic approach of managing their intellectual property and TIPS is also provided as a tool to assist enterprises to establish a sound intellectual property management system. The purpose of implementing TIPS is not to request enterprises to establish a separate management system. In order to maintain efficiency and competitiveness, an enterprise has to have an integrated management system to support its core operations and also to meet the requirements of different management system standards. Eliminating overlaps of the requirements between different quality management systems is an inevitable trend. TIPS incorporates IP management with the ISO 9000 quality management system, which is capable of simplifying the complicated IP management tasks into an effective and standardized IP management system. TIPS helps an enterprise to establish a systematic process for managing its IP. Through competitive analysis, market trend analysis, and periodic IP management operations review, a company can revise and amend its IP management policies and goals and continually improve its IP management system. For example, sales departments shall collect market trends, competitive information and shall also consciously avoid acquiring materials that may raise infringement concerns. Human resource departments shall focus their efforts in providing IP education and training. Finance departments shall evaluate the costs required for maintaining the existing IP rights and inform the R&D departments to conduct relevant review at the appropriate time. R&D departments shall conduct prior art search before a new research project is commenced. TIPS offers a simple, efficient, and low-cost management system which assists an enterprise to establish an IP management system that aligns to its business goals and operation activities. We hope that by promoting and encouraging domestic enterprises to adopt and implement TIPS, Taiwan can strengthen its international competitiveness and sustain the growth of its economy and the whole society. 1.Taiwan Intellectual Property Management System (TIPS). The Ministry of Economics Affairs combined the IP management principles and the PDCA (Plan-Do-Check-Action) model used in ISO9001:2000 quality management system to create TIPS. The adoption of PDCA model helps organizations to establish a systematic and effective IP management system which can be continuously improved. 2. Chen Yi-Chih is a Section Manager at the Science and Technology Law Center ; Chen Hung-Chih is a legal Researcher at the Science and Technology Law Center . 3. Data Source: http://www.atmt.org.tw/html/modules/news/article.php?storyid=135&PHPSESSID=cab6428078a0435c5af1b2e7bbe2b121 (last visited: 08/11/2007 ) 4. Data Source: http://www.cyberone.com.tw/ItemDetailPage/PDAFormat/PDAFContent.asp?MMContentNoID=36372(last visited: 08/11/2007 ) 5. “Enterprise” as defined in TIPS includes company, corporate, school, research institute, a specific department or a project team is also included. 6. TIPS was developed based on the PDCA (Plan-Do-Check Action) model, a typical ISO management process which requires continuously monitoring, evaluating, analyzing and improving the whole system. 7. The TIPS guidelines can be found at: http://www.tips.org.tw/public/public.asp?selno=236&relno=236 8. Refer to article: New Philosophy of Intellectual Property – Use ISO Quality Management to establish a systematic IP management in Intellectual Property Journal, issue 74, 02/2005. 9. http://www.tips.org.tw/public/public.asp?selno=236&relno=236 (last visited: 08/12/2007 ) 10. The guidelines of TIPS also serve as the requirements for certification purpose. The Industrial Development Bureau of the Ministry of Economic Affairs will issue a certificate to an organization if such organization has implemented an IP management system satisfying the requirements of TIPS.
Brief Overview of the Recent Progress of the TIPS Project and Important Developments of Taiwan’s IP Protection EnvironmentChien-Shan Chiu I. Introduction Taiwan, a country with limited natural resources, has been seen to create rapid economic development for the past few decades. This achievement has been praised as an “economic miracle” and making Taiwan one of Asia’s “Four Tigers1”. The success is a result of the tremendous hard work and efforts exerted by the local people and enterprises and the forward-looking national policies initiated by the government. Recognizing fast technology breakthroughs and globalization trend are going to have major impacts on the traditional ways of managing business and may as a result change the current competitive landscape, the government of Taiwan has promoted vigorously of transforming Taiwan into a “green silicon island” with high value-added production2. The goal is to make Taiwan an innovation headquarters for local enterprises and a regional research and development center for international corporations. It is hoped that eventually, Taiwan will not only be known as a country manufacturing high-quality “ Made in Taiwan” products as it is now, but also an innovative country producing products that are “Designed in Taiwan”. In order to encourage more innovation and to create more high value-added products, several national strategies were initiated by the government. One of the most important policies in today’s knowledge-based economy is certainly to provide a sound and effective intellectual property protection environment so that the results created from human intelligence can be well protected and utilized. This essay provides an overview of the recent progress of the TIPS (stands for Taiwan Intellectual Property System) project, which is currently promoted by the Science and Technology Law Center. The TIPS project is an innovative program solely developed by the Taiwanese scholars in year 2003 and has since achieved quite significant success. The second part of this essay gives a brief introduction of the recent changes made to the intellectual property system in Taiwan. II. Overview of the Recent Progress of the TIPS Project 1. The “Developmental Stage” The TIPS project has been promoted at the initiative of the Intellectual Property Office of the Ministry of Economic Affairs in 2003. The main goal of this project is to develop a set of guidelines for managing intellectual property to be implemented by the Taiwanese enterprises. At “developmental stage”, academic journal articles and relevant legislative requirements were gathered; intellectual property management experts were consulted and companies with good and effective intellectual property management practices were interviewed. All of the information and advises were collected and analyzed and formulated into a set of guidelines which basically covers the whole cycle of intellectual property management right starts from its creation, protection, maintenance and exploitation. The types of intellectual property rights managed include patent, trade mark, copyright and trade secret. A hearing for the draft guidelines was held in 2004. A pilot study was done by selecting eight representative domestic companies in 2005. All the public opinions, comments and advises from the trial companies were collected and used to revise the draft guidelines. The revised guidelines were then formally promulgated on March 23, 2007. The project then entered into a full “promotional stage” where the Science and Technology Law Centered entrusted by The Industrial Development Bureau of the Ministry of Economic Affairs was responsible for promoting the project. As the fundamental objective of TIPS is to assist companies to establish an effective internal intellectual property management system at relatively low cost, the whole system was developed based upon the ISO 9001:2000 Quality Management Standard. Since the ISO standards are widely recognized and adopted by many Taiwanese enterprises, for an enterprise with ISO system implemented, TIPS can be easily integrated into the existing ISO standards, conflicts between these two systems will be minimized and it will only require minimum organization structural changes and implementation costs. Further, by incorporating the PDCA (Plan-Do-Check-Action) model and “process-oriented approach” of ISO 9001:2000, the IP management processes implemented within an enterprise possess the feature of being able to be continuously improved. 2. The “Promotional Stage” In order to facilitate the promotion and draw more public attention to TIPS, various supplementary measures were introduced: (1) Free on-line self-assessment tool A collection of 50 questions is provided on the TIPS website3. Once a company has registered as a member of TIPS (simply by filling up some details about the company), it can use these questions to self-assess the effectiveness and adequacy of its existing (if any) IP management infrastructure. After the company has completed all the questions, the on-line tool would automatically generate few suggestions relating to the management of intellectual property based on the answers provided by the company. The company can also find out how they stand among all the enterprises which have taken the assessment previously. The on-line self-assessment tool is the initial step for those companies wanting to know more about TIPS. Once they realize that they are far behind the requirements of an effective IP management system, they can then move on to the next stage to implement TIPS. (2) On-Site Diagnostic and Consulting Service Once a company has completed the on-line self-assessment questions, it is then eligible to apply for a more detailed assessment of its internal IP management infrastructure conducted by a qualified IP service consultant. The IP service consultant will interview the managers responsible for managing IP related matters within a company and check relevant internal policies and documents. Concrete advises in relation to the implementation of TIPS will be given based on the inadequacies and problems uncovered during the on-site visit. The cost for the diagnostic and consulting service is fully covered by the government. (3) Model Companies Every year since 2004, some model companies are chosen as “demonstrative” companies for the implementation of TIPS. For instance, a total of 14 enterprises were selected as model companies this year. Among these companies, 3 “clusters of enterprises”, each of which contains 3 companies were chosen. The so-called “cluster of enterprises” is a group of companies that can be constituted by companies providing similar products or services within the same industry, or companies having the relationships as suppliers and consumers or companies within the same corporate structure. The introducing of implementing TIPS through “cluster of enterprises” is a promotion strategy that aims to disseminate the TIPS project more effectively and efficiently. For these selected model companies, certain percentage of the cost for implementing TIPS is subsidized by the government. (4) Certification After an enterprise has fully implemented TIPS, they can then apply for certification. All the prescribed documents must firstly be sent to the TIPS working team which is responsible for all the administrative works of TIPS. After a formality check, 2 or 3 (depending on the size of the enterprise) IP experts will be chosen to conduct an on-site inspection to determine whether the newly implemented IP management system meets the minimum requirements of TIPS. If the experts are satisfied with the inspection result, a certificate for the compliance of TIPS will be issued by the Industrial Development Bureau (IDB) of the Ministry of Economic Affairs. The certificate serves as government’s assurance to the public that the certified enterprise has at least the minimum ability (evaluated in accordance with government’s standard) to manage and protect its intellectual property. (5) IP Management Courses Three types of courses are provided to train IP management personnel. The basic course is an introductory course, which covers the basic principles of TIPS. The intermediate course called The Practical Implementation Course covers more detailed explanations of TIPS and how it can be implemented into the enterprise. Any person who has completed this course and passed the test will receive a certificate. The advance course called Self-Assessment Course teaches students how to evaluate and determine whether their newly developed IP management system conforms to the TIPS requirements. Again, a person who has completed this course and passed the test will receive a certificate. In order for an enterprise to be eligible to apply for a certificate for the compliance of TIPS, the enterprise must firstly furnish a self-assessment report to be completed by a “qualified person”. Such “qualified person” is the person who has successfully obtained the certificate for the completion of Self-Assessment Course. 3. Achievement The TIPS project has received wide recognition since it first launched in year 2004. To the end of 2008, 297 enterprises have completed the on-line self-assessment questions; 73 companies have received on-site diagnostic and consultation services; 618 persons have taken the IP management courses; 45 enterprises have successfully obtained the certificates for the compliance of TIPS and more than142 enterprises have either completed or in the middle of implementing TIPS. Benefits of implementing TIPS as reported by TIPS implemented enterprises are summarized as follows: (1) Company A: Implementing TIPS provides an assurance that Company A has adequate ability to protect the technology secrecy belongs to its international client. Company A thus obtained a new purchasing order worth more than NT$ 100 million. (2) Company B: TIPS assists in enhancing the level of trust on the company’s ability to protect its international client’s confidential information. A new purchasing order worth NT $ 30 million is placed by such client. (3) Company C: Through systematic IP management and IP inventory audit, Company C starts to formulate a plan for licensing out its non-core IP assets. (4) Company D: The alignment of R&D and business strategies required by TIPS ensures the accuracy of the R&D direction. The systematic way of managing the R&D projects also reduces the R&D phase to 45 days, saving R&D expenditure by 10%. (5) Company E: Implementing TIPS helps Company E to formulate a more clear and definite IP mapping strategy. Company E plans to implement TIPS into its whole corporate group in 2008. (6) Company D: Systematic IP management has reduced the number of litigation allegations. Company D plans to implement TIPS into every business unit within its corporate structure in 2008. 4. Proposed New Features of TIPS In answering to the responses receiving from the TIPS implemented enterprises, two new measures are going to be launched in 2009. First, enterprises with effective IP management system and strategies are encouraged to write up an Intellectual Property Management Report summarizing their business, R&D and IP management strategies as well as their accumulated IP assets. Second, an Experience-Sharing Platform is going to be established where enterprises can freely exchange their experiences of managing IP and how to formulate an effective IP management strategy. III. Recent Development of Taiwan’s IP Protection Environment Year 2008 can be said to be a significant year for the history of IP development in Taiwan where three completely new legislations have taken effect this year. The Intellectual Property Court Organization Act4 and the Intellectual Property Case Adjudication Act5 were both promulgated on March 28 2007 and effective as of July 1 under which a new IP Court was established with new laws to govern the adjudication of IP cases. The Patent Attorney Act which governs the qualification and registration of a new patent attorney profession was promulgate on July 11 2007 and effective as of January 11 2008. It is believed that through the commencement of these three new legislations, the accuracy, consistency as well as efficiency of resolving IP-related disputes in Taiwan are going to be significantly improved. A short introduction for each of the three new legislations is provided below: 1. New IP Court A new IP Court was established pursuant to the Intellectual Property Court Organization Act and began to hear cases on July 1 2008. This Court is given jurisdiction to hear first and second instances of a civil action, first instance of an administrative action and the second instance of a criminal action for matters concerning IP rights. For examples, interests arising under the Patent Act, the Trade Mark Act, the Copyright Act, the Trade Secret Act, the Optical Disk Act, the Species of Plants and Seedling Act, the Fair Trade Act and the Regulation Governing the Protection of Integrated Circuits Configurations. Unlike previously, where the validity issues must be determined by the administrative court, the newly established IP Court can hear and decide the validity of an intellectual property right at issue. This will significantly improve the efficiency of resolving an IP dispute. Eight experienced judges were chosen to sit on the bench of the IP Court. Since most IP related matters involve complex technical issues, nine technical examination officers with various technical backgrounds from the Taiwan Intellectual Property Office were chosen to assist and provide their technical expertise and opinions to the IP Court judges. 2. New Laws Governing IP Litigation (1) Litigation procedures The Intellectual Property Case Adjudication Act prescribes rules for adjudicating IP-related disputes. The Act recommends to try an IP infringement case through a 3-step processes. First, to determine the validity of an IP right. Second, to determine whether an IP right has been infringed and finally, to calculate the damages. The IP Court may at any state dismiss the case if it finds the IP right at issue is invalid or not infringed. In order to avoid unnecessary efforts spent on determining whether an IP right is infringed if such right is in fact invalid, the Act requires the IP Court to determine whether a right is infringed only after the invalidity defense raised by the defendant is dismissed. (2) Preliminary injunction The Intellectual Property Case Adjudication Act also introduces the criteria used by the US courts to determine whether a preliminary injunction order should be granted. Before the enactment of this new Act, the requirements for granting preliminary injunction in Taiwan were quite loose as the court could grant a preliminary injunction order without firstly reviewing the merit of the case. The new adopted US criteria require the judges to determine the likelihood of success on the merits of the case; whether a substantial threat of irreparable damage or injury would be caused if injunction is not granted; the balance of harms weighs in favor of the party seeking the preliminary injunction and the impact of the decision on public interest. As the criteria become stricter, it is believed that less preliminary injunctions will be granted. A plaintiff seeking a preliminary injunction order in the future shall put in more efforts in preparing evidences and reasons arguing that an injunction maintaining the status quo is necessary. (3) Protective orders (as to confidential information) As most IP litigation cases involve matters concerning confidential information or trade secrets, which are often crucial for the survival of an enterprise, the Intellectual Property Case Adjudication Act introduces a protective order into practice to preserve the confidentiality of specific information given by parties to the suit or a third party. A party to the suit or a third party can apply to the court to issue a protective order restraining the accessibility to the protected confidential information and restraining those who have accessed to the confidential information from disclosing it to others. Any intentional violation of the protective order is subject to a criminal liability. It is expected that by introducing the protective order, confidential information or trade secret holder may become more willing to reveal such information, which may assist improving the accuracy of resolving the disputes between parties. (4) Improved evidence preservation procedure Unlike the US court system, Taiwan, a civil law country, does not have discovery or Markman hearing procedures. Before the enactment of the Intellectual Property Case Adjudication Act, even though a judge can ask the parties to preserve evidences for the use of the trial, the judge is however, given no authority of compulsory execution. A party can refuse to comply with the judge’s request without any legal consequence. The new Act now provides compulsory execution of an evidence preservation order. Parties who are subject to the evidence preservation order are obligated to comply with the order. Furthermore, the judge may also request assistance from technical examiners or police department to provide advises. 3. New Patent Attorney Profession The Patent Attorney Act sets the requirements for becoming a qualified patent attorney in Taiwan. According to the Act, patent attorneys should be specialized in both technology and patent regulations. A candidate must firstly pass the Patent Attorney Eligibility Examination, followed by a period of prevocational training, such candidate is then able to register with the Taiwan Intellectual Property Office and join the Patent Attorneys Association. It is hoped that by introducing the new patent attorney profession, the quality of patent applications will be improved and thus reduce the ever increasing workload of patent examiners. IV. Conclusion The initiative of the TIPS project, the establishment of the IP court and the newly implemented patent attorney system all demonstrate the government’s determination to create a more sound and efficient environment for the protection of intellectual property. The overwhelming success of the TIPS project evidenced by the number of enterprises implementing the system indicates that Taiwanese companies are self-motivated, able to see the importance of intellectual property as their main source of competiveness and are ready and willing to move into the next stage of “innovative” management. It is believed that through the government’s pragmatic and foresight policies coupled with the adventurous and hard work spirits possessed by the local enterprises, Taiwan will eventually reach its goal of becoming a “green silicon island”, creating another “economic miracle”. Along with Singapore, Hong Kong and South Korea. http://www.asianinfo.org/asianinfo/taiwan/pro-economy.htm (last visited: 12/31/2008) TIPS website: http://www.tips.org.tw/ http://www.taie.com.tw/English/970520a.pdf (last visited: 12/3132008) http://www.taie.com.tw/English/970520a.pdf (last visited: 12/3132008)
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)
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