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The Dispute on WTO TRIPS IP Waiver Proposal and the Impact on Taiwan

The 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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※The Dispute on WTO TRIPS IP Waiver Proposal and the Impact on Taiwan,STLI, https://stli.iii.org.tw/en/article-detail.aspx?no=55&tp=2&i=171&d=8704 (Date:2026/04/19)
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Shih, Ya-Hsun
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Release： 2021/08
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Korea “Strategies for an Intellectual Property Powerhouse to Realize a Creative Economy” Overview

Background Since 1990, many countries like United States, Japan and EU understand that intellectual properties create higher value added than tangible assets do so these countries respectively transformed their economic types to knowledge-based economy so as to boost economic growth and competitiveness. For example, Japan has legislated “Intellectual Property Basic Act” in 2002 and established “the Intellectual Property Strategy Headquarters” in 2003. United States legislated “Prioritizing Resources and Organization for Intellectual Property Act (PRO-IP Act)” in 2008. China also announced “National Intellectual Property Strategic Principles” in June, 2008. Following the above international tendency of protecting intellectual properties, Korea government has promoted intellectual property related policies and legislated related acts since 2000, such as “Technology Transfer Promotion Act” in 2000, policy of supporting patent disputes settlements and shortened the length of patent examination procedure in 2004. Besides, on June 27, 2006, the Presidential Advisory Council on Education, Science and Technology (PACEST) announced “Strategy for Intellectual Property System Constructing Plan.” However, these policies or acts mainly focus on the protection and application of patent rights, not relate to other kinds of intellectual property rights such as trademark right, copyright etc. Until 2008, in order to advance the ability of national competition, Lee Myung-bak government had established “Presidential Council on National Competitiveness (PCNC)”. For the vision of transforming to the intellectual property based economy, the PCNC held its 15th meeting on July 29, 2009. The meeting, held at the Blue House, was attended by the president, the Chairman, and members of the Council. One of the agenda of the meeting is strategies for an intellectual property (IP) powerhouse to realize a creative economy. Three goals of the strategies includes being IP Top 5 nations (U.S., Japan, EU, Korea and China), improving technology balance of payments deficits, and enhancing the scale of copyright industry. Next, this study will introduce details of Korea IP related strategies for our nation’s reference. Introduction Korea IP strategy consists of 3 aspects (creation and application, law and regulation, infrastructure) and 11 missions. And the contents of 11 missions cover the creation, protection and application of intellectual property rights (patent, copyright, trademark, plant variety etc), namely the whole life cycle of intellectual property rights. Through announcement of IP Strategies, Korea hopes to protect intellectual property rights from every aspect and makes IP as essential driving force for national economic growth. 1. Creation and Application Aspect First, although the quantity of intellectual property rights (IPRs) of Korea is rapidly increased in recent years, the quality of intellectual property rights is not increased equally. Also, most of researchers do not receive appropriate rewards from R&D institutions, and then it might reduce further innovation. As above reasons, Korea IP strategy indicated that the government will raise “invention capital” to exploit, buy researchers’ new ideas, and make those ideas get legal protection. That is, the government will set up non-practicing entities (NPEs) with private business. The NPEs would buy intellectual properties from R&D institutions or researchers, and then license to enterprises who have need. After licensing, NPEs will share royalty which obtained from enterprises (licensees) with researchers appropriately. Besides, in order to encourage university, public R&D institutions to set up “technology holdings”, Korea government had amended “Industry Education and Corporation of Industry, Academic and Research Promotion Act”. The amendments are loosening establishment conditions of technology holdings, such as minimum portion of investment in technology has been lowered from 50% to 30%, and broadening the scope of business of technology holdings. 2. Law and Regulation Aspect Secondly, in aspect of law and regulation, in addition to encouraging creation of good quality of IP, Korea considers that intellectual property rights are needed to be protected legally. Therefore, the IP strategy especially pointed out that Korea would follow the example of Japan to legislate their own “Intellectual Property Basic Act”. According to Korea “Intellectual Property Basic Act”, it should establish a “Presidential Council on Intellectual Property”. The main work of this Council is planning and promoting intellectual property related policies. There are 5 chapters and 41 articles in Korea “Intellectual Property Basic Act”. The Act like Korea IP strategy is divided into three parts, that is, “creation and application”, “protection” and “infrastructure”. In fact, the legislation of Korea “Intellectual Property Basic Act” embodies the policies of IP strategy. Further, according to Korea “Intellectual Property Basic Act”, “Presidential Council on Intellectual Property” is to integrate IP related affairs of the administrations into one action plan and promote it. Moreover, according to Korea “Intellectual Property Basic Act”, the government should make medium-term and long-term policies and basic plans for the promotion of intellectual properties every 5 years and adjusts policies and plans periodically as well. Through framing, enacting and adjusting policies and plans, Korea expects to create a well-living environment for the development of intellectual property. 3. Infrastructure Aspect Thirdly, even if good laws and regulations are already made and more government budget and human resource are invested, Korea is still deficient in well-prepared social infrastructure and leads to the situation that any promoting means of intellectual properties will be in vain. With regard to one of visions of Korea IP strategy,” being IP Top 5 power (U.S., Japan, EU, Korea and China)”, on the one hand, Korea domestic patent system should harmonize with international intellectual property regulations that includes loosening the conditions of application and renewal of patent and trademark. On the other hand, the procedure of patent application conforms to the international standard, that is, the written form of USA patent application becomes similar to the forms of world IP Top 3 power (U.S., Japan and EU) and member states of Paten Law Treaty (PLT). At the same time, Korea would join “Patent Prosecution Highway (PPH)” to enable Korea enterprises to acquire protection of patent rights around the world more rapidly. In addition, about the investigation of infringement of intellectual property rights, Korea IP strategy stated that it would strengthen control measures on nation border and broaden IP protection scope from only patent to trademark, copyright and geographical indications. Besides, Korea uses network technology to develop a 24-hour online monitoring system to track fakes and illegal copies. In addition to domestic IP protection, Korea enterprises may face IP infringement at overseas market, thus Korea government has provided supports for intellectual property rights disputes. For this sake, Korea choose overseas market such as Southeast Asia, China, and North America etc to establish “IP Desk” and “Copyright Center” for providing IP legal consultation, support of dispute-resolving expenses and information services for Korea enterprises. Korea IP strategy partially emphasizes on the copyright trading system As mentioned above, one of visions of Korea IP strategy is “enhancing the development of copyright industry”. It’s well-known that Korea culture industries like music, movie, TV, online game industries are vigorous in recent years. Those culture industries are closely connected to copyright, so development of copyright industry is set as priority policy of Korea. In order to enhance the development of Korea copyright industry, a well-trading environment or platform is necessary so as to make more copyrighted works to be exploited. Therefore, Korea Copyright Commission has developed “Integrated Copyright Number (ICN)” that is identification number for digital copyrighted work. Author or copyright owners register copyright related information on “Copyright Integrated Management System (CIMS)” which manages information of copyrighted works provided by the authors or copyright owners, and CIMS would give an ICN number for the copyrighted work, so that users could through the ICN get license easily on “Copyright License Management System (CLMS)” which makes transactions between licensors and licensees. By distributing ICN to copyrighted works, not only the licensee knows whom the copyright belongs to, but the CLMS would preserve license contracts to ensure legality of the licensee’s copyright. After copyright licensing, because of characteristic of digital and Internet, it makes illegal reproductions of copyrighted works easily and copyright owners are subject to significant damages. For this reason, Korea Ministry of Culture, Sports and Tourism (MCST) and Korea Intellectual property Office (KIPO) have respectively developed online intellectual property (copyright and trademark) monitoring system. The main purpose of these two systems is assisting copyright and trademark owners to protect their interests by collecting and analyzing infringement data, and then handing over these data to the judiciary. Conclusion Korea IP strategy has covered all types of intellectual properties clearly. The strategy does not emphasize only on patent, it also includes copyright, trademark etc. If Taiwan wants to transform the economic type to IP-based economy, like Korea, offering protection to other intellectual property rights should not be ignored, too. As Taiwan intends to promote cultural and creative industry and shows soft power of Taiwan around the world, the IP strategy of Taiwan should be planned more comprehensively in the future. In addition to protecting copyrights by laws and regulations, for cultural and creative industry, trading of copyrights is equally important. The remarkable part of Korea IP strategy is the construction of copyright online trading platform. Accordingly, Taiwan should establish our own copyright online trading platform combining copyright registration and source identification system, and seriously consider the feasibility of giving registered copyright legal effects. A well-trading platform integrating registration and source identification system might decrease risks during the process of licensing the copyright. At the same time, many infringements of copyrights are caused because of the nature of the modern network technology. In order to track illegal copies on the internet, Taiwan also should develop online monitoring system to help copyright owners to collect and preserve infringement evidences. In sum, a copyright trading system (including ICN and online intellectual property monitoring system) could reinforce soft power of Taiwan cultural and creative industry well.

The IP Strategy of Collaboration during COVID-19 Pandemic in Taiwan

The IP Strategy of Collaboration during COVID-19 Pandemic in Taiwan 1. IP strategy during COVID-19 pandemic 　　Since the end of 2019, the coronavirus disease called “COVID-19” has become a global pandemic. World Health Organization (WHO) has announced that COVID-19 a Public Health Emergency of International Concern (PHEIC) on Feb. 12, 2020. WHO also announced that the new corona virus pandemic is requiring substantial efforts to enable regular information sharing and research, the global community should demonstrate solidarity and cooperation.[1] Dr. Mukhisa Kituyi, the Secretary-General of United Nations Conference on Trade and Development (UNCTAD), pointed out that Collaboration is the engine of global science under COVID-19 pandemic. Global community should take the experience of Ebola outbreak in 2014-15, through global collaboration can provide opportunities both to create new knowledge and to increase the impact of research by diffusing existing knowledge, quickly and at all levels. Both “openness on data” and “open science in real time” are the key factors of improving collaboration under the crisis.[2] 　　Chesbrough (2020) noted that the pandemic stimulating innovation in management of intellectual property, such as initiatives like “Open COVID Pledge” encourages companies and universities to release intellectual property for fighting against COVID-19. The IP strategy based on “Open Innovation” concept can go much further, to play an important role in recovering after the crisis.[3] There are two international famous cases in Taiwan, “National face mask production team” and “Face mask map” helped Taiwanese people to overcome the crisis lack of masks during the pandemic. Both cases show the importance of open innovation in facing the crisis, and contain the concept of IP strategy based on collaboration. 2. National face mask production team 　　Because over 80% of face masks rely on imports, Taiwanese government was aware of the lack of masks when the epidemic began. Since the first COVID-19 case in Taiwan was confirmed on Jan. 21, surgical face masks were sold out in a very short time. The government banned the export of masks on Jan. 24 for controlling the shortages, but it was still a big problem that the production lines at that time could not afford the demand of Taiwanese people. Therefore, how to obtain a large number of mask production lines in a short time and ensure the supply of raw materials had become the primary issue. The government invested NT$200 million (US$6.66 million) and recruited over 100 technicians to form the team named “National face mask production team”. The national team is composed of volunteers from industry and research institutions, especially from Taiwan Machine Tool and Accessory Builders' Association (TMBA). 　　From Feb. 5 to Mar. 5, the national team completed an estimated half a year’s workload including 62 mask production lines. And the team immediately started the second phase of work to meet the extremely large domestic demand for masks, finally they completed 92 mask production line 6 weeks[4] and continue to assist the government in anti-counterfeiting masks. The key factor for the team to complete such a large amount of work in a very short time is not only the selfless dedication of team members but they effectively utilize and share their advantages in their own industrial field. These team members are “Hidden Champions” of global supply chain, after understanding the composition and principle of each part of the mask production line, they immediately began to assign the work and contributed their skill, know-how and experience of machine tools and accessories for mask-producing collaboration. 3. Face mask map 　　In additional to the national face mask production team case, the “face mask map” is another successful case of collaboration during the epidemic in Taiwan. In the beginning of the epidemic, Taiwanese people rushed to buy surgical face masks, resulting in insufficient supply of domestic masks. The government implemented face mask purchase controlling such as limiting three per day and later only two per week through the National Health Insurance Administration (NHIA). According to the rationing system, people can buy surgical face masks at NHIA-contracted pharmacies near their home. But in fact, due to the face mask distribution information was not disclosed, people often have to go to many pharmacies to buy masks. Thus, people spontaneously developed “face mask map”, combined with pharmacy locations on Google Maps and the data of inventory quantity in each pharmacies, to help people know where to buy surgical face masks. 　　Taiwan’s Minister without Portfolio Audrey Tang was in collaboration with Taiwanese software engineers to develop a “real-time map” of local face mask supplies through connecting pharmacy locations on Google Maps and the data of mask inventory quantity in NHIA’s database. With the support of the NHIA database opened according to the license terms compatible with Creative Commons (CC) 4.0, the platform contains over 100 programs and applications was successfully created by public-private collaboration.[5] This platform is jointly maintained by the open community, each member of the community can actively report the updated version information of the applications. Even if the platform has retired due to the implementation of “Name-based Mask Distribution System 3.0”, the successful experience of public-private collaboration platform through “open data” and “open source software” becomes an important foundation of future development. 4. Collaborative IP strategy for crisis management 　　In different from the traditional IP strategy that emphasizes on excluding others from implementing the patents, the collaborative IP strategy pays more attention to the potential of community co-creation. In the face of the crisis of the epidemic, people are willing to share their IP, know-how and experience to gain more time to fight the epidemic. The collaborative IP strategy can implement the concept of open innovation through knowledge sharing, and flexibly use various IP resources in the face of crisis. Especially in the face of a crisis like COVID-19 that has never been dealt with, the collaborative IP strategy can effectively collect the knowledge and creativity of the community. Cases of “National face mask production team” and “Face mask map” can be used as models for collaboration in the face of crisis, and even continue to be used for recovery after the epidemic. 　　The open innovation theory supports open, flexible and highly interactional “creative networks”.[6] At the same time, the collaborative IP strategy serves as a means to implement the open innovation theory. Even though many open communities’ IP strategy such as “free and open source software” or “creative commons” do not originate from the open innovation theory, the theory can still provide guidance for collaborative IP strategies in times of crisis. The collaborative IP strategy should not be limited to the sharing of patents, copyrights or trademark rights but include the skill, know-how, experience and idea, which is able to effectively organize community collaboration and innovation in the face of crisis. [1]World Health Organization, Statement on the second meeting of the International Health Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus (2019-nCoV) (2020), https://www.who.int/news-room/detail/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov) (last visited Oct. 19, 2020). [2]Mukhisa Kituyi, COVID-19: Collaboration is the engine of global science – especially for developing countries, World Economic Forum, May 15, 2020, https://www.weforum.org/agenda/2020/05/global-science-collaboration-open-source-covid-19/ (last visited Oct. 20, 2020). [3] Henry W. Chesbrough, To recover faster from Covid-19, open up: Managerial implications from an open innovation perspective, Industrial Marketing Management, Apr. 16, 2020, available at https://doi.org/10.1016/j.indmarman.2020.04.010 (last visited Oct. 26, 2020). [4]Central News Agency, How a team of technicians is helping Taiwan triple mask production, Taiwan News, Mar. 25, 2020, https://www.taiwannews.com.tw/en/news/3903970 (last visited Oct. 30, 2020). [5]Keoni Everington, Taiwan platform includes over 100 apps showing mask availability in stores, Taiwan News, Feb. 27, 2020, https://www.taiwannews.com.tw/en/news/3882111 (last visited Oct. 30, 2020). [6]Ali Jazairy, Impact of Collaborative Innovation on IP and Future Trends in IP, Les Nouvelles, 47, 224 (2012).

Mainland China changes domestic regulation for game consoles

In 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.

 Utilizing TIPS 1 to Establish a Comprehensive Intellectual Property Management System

Chen 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.

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