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Quarterly Issue Mar 2009 NO.01 |
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| LATEST LEGAL NEWS |
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MOEA ESTABLISHED LOCAL DEVELOPMENTAL FOUNDATION TO STRENGTHEN THE INTEGRATION OF REGIONAL RESOURCES |
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The Executive Yuan made a resolution to develop regional industries in July 2008. It aimed to improve prosperity in economy and increase job opportunities in districts. Then the Executive Yuan published Regulations for Receipts, Expenditures, Custody and Utilization of regional developmental Foundation according to Article 21 of Budget Act on 26th December, 2008. The mentioned regulations were implemented on 1st January 2009. The outlay was defined as special fund in accordance with Article 4, Paragraph 1, Subparagraph 2 of Budget Act, and the sources of the fund are appropriation followed budgetary procedure by government, donated revenue, and interests of the fund. The goal is to subsidize the related expenses for develop distinguishing industries of regional administration.
In the past time, the guided projects executed by MOEA were planned for development of regional industries. However, because of strained budget and leadership of central government, those projects would be ineffective in achieving original goals especially under the circumstances of lacking of thoroughly understanding of regional development and without systematic integration of resources. In order to strengthen features of regional industries, MOEA set up local developmental foundation. And the emphasis of operation method is encouraging local governments to participate positively, or draw up the blueprint or scheme of industrial development, then carry out subsequent expansion by central government
Moreover, in connection with some towns or cities without adequate resources to fulfill requirement in planning, the project would be divided in four areas based on geographical positions in Taiwan. The project would set several service groups according to different scales of markets and provide substantial assistance. The following process will establish support system for local industries. Also, in anticipation of creating various possibility of industrial development, the project offered local government assistance in developing industries and combined with central supportive policies about improving characters and unity of local industries.
In accordance with Articles 5 & 12 of Regulations for Receipts, Expenditures, Custody and Utilization of regional developmental Foundation, it shall build up management committee of local developmental foundation. The budget, receipts, expenditures, custody and utilization of the fund were based on Budget Act, Financial Statement Act, National Treasury Act or other related regulations. Furthermore, it shall arrange the consideration group of advisory counselors to ensure related cases about applying for local developmental foundation fairly. With coordination functions from central government and decrease in resetting resources, local developmental foundation would bring the most large-scale efficiency. |
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MOEA CARRIED OUT PARTICULAR PROJECT TO IMPROVE COMMUNICATIONS BETWEEN THE HERBAL INDUSTRIES OF CROSS-STRAIT |
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Ministry of Economic Affairs started particular project named "Bridge-building" to establish cooperative relationship and strengthen communications between industries of Taiwan and China since November 2008. By way of "one year for interchange, two years for negotiation and three years for collaboration" between industries, government and academic institutions, the goals will be to establish cooperative system, promote international competency, improve development of industry and link with global society. Therefore, the forum "Cooperation and Technology Interchange of Chinese herbal medicine between Taiwan and China"was hold in December 2008, and it focused on the themes such as markets expanding, herbal materials providing, and R&D of technology
The mentioned forum is the first large-scale activity supported by the governments of Taiwan and China. Furthermore, it was also a significant measure for biotechnology industries after Act for Development of Biotech Medicine was come into force. With new medicines composed of plants were allowed of trading in U.S.A by FDA and Chinese herbal medicine was highly accepted in Europe and Japan, the Chinese herbal material with outstanding quality is potential for entering international markets. The core of the forum is mainly to explore the broadened applications of Chinese herbs, for instance, refer to the example of Good Agriculture Practice in China, cultivate potential compound prescriptions and guided chemical compositions, integrate development experiences of plant medicine in Taiwan, and cover the range of topic about implementation of Chinese medical system in early stage clinical.
The both sides signed letters of intent upon industry cooperation, herbal material supply, and technology cooperation. The details are as follows¡G
(1)¡@Letter of intent upon Chinese herbal medicine industry cooperation¡Gby build up communicative and developmental cooperation platform to strengthen purchase on medical materials, manufacture Chinese herbal medicine and its abstract, innovate Chinese herbal medicament, exploit new medicine, and formulate marketing routes.
(2)¡@strategic alliance of Chinese herbal medicine supply¡Gto ensure the completeness of product and marketing chain of Chinese herbal medicine supply.
(3)¡@Cooperation in technological R&D¡Gto show the inclination for cooperation in R&D of Chinese herbal medicine, new ingredients of Chinese herbal medicine, activity of Chinese herbal medicine, Chinese herbal medicine clinical, and etc
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In conclusion, the direction of progress is to combine agricultural technology of Taiwan with natural soil resources in China, and make sure the original and quality of medical materials. Furthermore, the following progresses are searching for possible new medicines and improve abroad certification system. Besides Chinese herbal medicine, the ¡§Bridge-building¡¨ project will be continued from February 2009, and expand the range of items such as solar energy optoelectronics, textile industry, electron for vehicle, communication and LED optoelectronics by MOEA.
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A POSITIVE LEGISLATIVE REFERENCE FOR PROMOTING SECURITIZATION OF R&D ACHIEVEMENT , THE LEGISLATIVE YUAN THREE READ THROUGH THE REAL ESTATE SECURITIZATION ACT AMENDMENT |
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Technology research and development (R&D) is a crucial power for growth of national economy, and then utilization of R&D achievement is also important. In addition to authorizing or selling an existent R&D achievement, technology industries are also interested in the opportunity and approach to get stable and long-term funding during R&D process.
Therefore, referring to reports about benefits of securitization in Europe and U.S., technology industries pay attention to intellectual property securitization as a funding approach. That is why they watch domestic development of Financial Asset Securitization Act and Real Estate Securitization Act, whose operating approaches and regulations might be a sample for intellectual property securitization in the future.
In January 6, 2009, the Legislative Yuan three read through the Real Estate Securitization Act Amendment, and accepted the development real estate and the rights related to the real estate as the securitization object. Accordingly, the Financial Supervisory Commission indicates that related regulations of Real Estate Securitization Act Amendment will complete in six months scheduling.
The Real Estate Securitization Act Amendment has included "unfinished real estate" as an object of securitization. That is interpreted as a sign that legislators intend to conditionally extend object of securitization from "existing properties" to "future properties". That is meaningful for intellectual property securitization. It hints that researchers might get outside funding by intellectual property securitization without any existent R&D achievement, because future properties could be an object of securitization.
Related regulations of Real Estate Securitization Act Amendment will be developed by Financial Supervisory Commission over the next six months. This amendment is meaningful for intellectual property securitization and utilization of R&D achievement. However, R&D achievement is not exactly the same as financial property and real estate property, and there are not fundamental regulations for intellectual property securitization in Taiwan. Therefore, it may be still uncertain that technology industries could get funding by intellectual property securitization. |
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THE NEW TRADEMARK IDENTIFICATION EXAMINATION STANDARD ENFORCED, THE DIFFICULTY OF APPLYING TRADEMARK INCREASES |
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The Trademark Identification Examination Standard enacted by the Intellectual Property Office came into effect on January 1, 2009, and the old Trademark Identification Examination Principal won¡¦t apply any more. The enterprises, who apply the trademark including the historical person, geographical name, slogan, surname and so on, have to prove its identification except descriptive words. Otherwise, the application of the trademark will be refused by the Intellectual Property Office.
In accordance with the Trademark Act article 19, it provides that a proposed trademark featuring a descriptive or non-distinctive word, sign, symbol, color, or three-dimensional shape, where deletion of that feature will defect the whole of such trademark, may be registered when the applicant disclaims the exclusive right for using the said feature.
According to the new Trademark Identification Examination Standard, only when the applicant can prove that the trademark is an identification mark and consumers has been very similar to it, the famous historical person like "Tong Tai Chung" and "Zhuanzi", the geographical name like "Hua Tong" and "Nanyang St.", the surname like "Tzen´ s Magi" and "Chous Shirmp Roll" can be registered successfully. The Intellectual Property Office indicated that the new standard has the same spirit with the old one but more exquisite in examples to refer for applicants. The difference is that in the future, applicants must accumulate a large mass of use evidence to get the trademark like the historical person, geographical name, slogan, surname to be registered.
In addition, the new standard has a more strict examination to surname trademark. Taiwanese love to use the surname as the product name, and the Intellectual Property Office examine it looser in the past, especially for uncommon surname. Now, only if the trademark like "Formosa Chang" give customers image besides surname, or like "Chous Shirmp Roll" has had distinguishes, has the opportunity to get trademark right.
The "identification" is the positive element of the trademark. However, the identification whether there is, does the strong and the weak, often passes through along with the trademark actual use situation and the time changes. Today, because the commercial marketing technique is changeable, and the digital media science and technology develops fast, the trademark state and the use way develop unceasingly, which affect the judgment of identification enormously. The Intellectual Property Office hopes for fulfilling this standard to establish the objective examination standard, and achieving the uniformity in the judgment as far as possible.
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EXECUTIVE YUAN PASSED THE DRAFT OF "ANTI-SPAM ACT" |
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Executive Yuan passed the draft of Anti-Spam Act proposed by National Communications Commission (NCC) on February 26th, declaring a war against the overloaded distribution of unsolicited commercial emails. Recipients of unsolicited commercial emails in the future may file an action against illegal distributors and claim for pecuniary damages from NT$500 to NT$2000 per email.
It is statistically reported that there are 105.3 billion junk mails disseminated on the internet every year in Taiwan. The average of 29 junk mails a day costs 30 hours a year for a recipient to delete those emails. In order to maintain the security in the virtual world, reduce the cost on internet service providers (ISPs) as well as consumers, and prevent an email user from the constant harassment, NCC drafted the Anti-Spam Act and now received an endorsement from Executive Yuan. Premier Chiao-shiuan Liu indicated that a proper prohibition of spamming by legislative procedure has become a modern trend around the world. Showing the determination to protect citizens¡¦ right to communicate without any burden, also addressed by the premier, our government should follow the trend to carry out the act as soon as possible.
There are several distinctive features in the draft of Anti-Spam Act, as the following:
(1) The statute adopted the default rule of implied rejection. Any recipient who does not want to receive the same kind of email again from the sender may show the rejection by doing nothing. In other words, in addition to express objections, a recipient may choose not to reply the first unsolicited commercial email she received, and the sender is no longer allowed to deliver any related email to the recipient¡¦s email box. The sender, on the other hand, must state this rule in the first email.
(2) Anti-Spam Act also requires a sender to provide links for recipients to reply for free if they are willing to do so. Moreover, a sender has a duty to mark business or commercial advertisement on the subject.
(3) For ISPs, the statute authorizes them to stop forwarding or receiving spam created by dictionary attacks, i.e., an illegal email spamming technique in which the spammer sends out a tremendous amount of emails with randomly generated addresses made by common combinations of letters in the hopes of reaching a percentage of actual e-mail addresses. The competent authority of ISPs may order ISPs to take some "necessary means," e.g., establishing a hardware to block out senders from certain IP addresses, to prevent spamming under some circumstances.
(4) In order to bring a class action against a spammer more effectively, any class action association or institution may demand information of the spammer from ISPs, advertisement vendors, or agencies so long as the competent authority consents. The association or institution, however, will be liable if that information is illegally misused.
According to NCC, the draft of Anti-Spam Act will be delivered to Legislative Yuan and scheduled on its calendar after all the documents are made. It can be actually put into practice next year if the process runs as NCC expected.
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PRESIDENT PROMULGATED ACT GOVERNING THE ISSUANCE OF ELECTRONIC STORED CARD |
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The new act governing the issuance and management of electronic monetary cards ("Act Governing the Issuance of Electronic Stored Card") was promulgated by the President of Taiwan on 23 January 2009. The Act was drafted with reference to the experience of foreign authorities in the regulation of multi-purpose stored-value cards, and appoints the Financial Supervisory Commission ("FSC") as the regulatory authority after several rounds of discussions in the Legislative Yuan (Article 2).
As the Preamble illustrates, this Act intends to stimulate development of Taiwan´s micro payment system, thereby enabling consumers to pay without carrying small changes, and making shopping even more convenient for the country´s millions of cardholders. To increase payment product availability, non-financial institutions with a capital investment over NT$300 million (approximately US$9 million) are now eligible for issuing electronic stored cards (Article 6). While relaxing previous prohibition on non-financial sectors from issuing prepaid cards, however, this Act also creates a special permission scheme to ensure the financial soundness of card-issuing institutions (Article 4-9). Additionally, a system combined both trust and performance bond is established to further secure cardholders¡¦ stored value and its redeem-ability (Article 18-20). From consumer protection perspective, standard-form contracts and cross-marketing behaviors will soon be supervised by the FSC (Article 11; Article 21). It is also worth mentioning that since the Act itself does not preclude the formerly enacted "Regulations Governing Approval of the Issuance of Stored Value Cards by Banks," a mixed regulatory regime is now adopted and slightly different statutory provisions are applied to financial vis-a-vis non-financial issuing institutions. More efforts may thus be needed to carefully watch, and provide explanatory comments on any inevitable inconsistency that may occur later under the dual-regulatory structure.
The new Act is also expected to reorganize the electronic monetary cards industry in Taiwan. Many incumbent market players have expressed great interests in this blooming market. For example, Taiwan´s largest issuer of prepaid cards¡XEasycard Corp., is widely expected to gain a large share of the newly created business opportunity. Other potential competitors include, but not limited to, President Chain Store Corp.´s I-cash cards that can be used at 7-Eleven convenience chain stores, and the ETC cards launched by Far Eastern Electronic Toll Collection Co. Ltd. for drivers traveling on the country´s highways. Lately, the I-Pass card issued by the Kaohsiung Rapid Transit Corp. also enjoys an advantageous position in the public transportation system of southern Taiwan counties. Considering the enormous investment cost of establishing a nation-wide e-payment system, leading market players may also choose to team-up and jointly materialize this initiative.
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| RECENT DEVELOPMENTS |
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"PATENT LINKAGE" - IMPEDIMENT OR STIMULANT TO PHARMACEUTICAL R&D AND COMPETITION?
AN OVERVIEW ON THE DEVELOPMENT OF THE INTERACTION BETWEEN PATENTS AND PHARMACEUTICAL REGULATORY APPROVAL
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Basically, a national drug authority approves or registers a new drug only when it meets the standards of safety, efficacy and quality required by laws. Whether an applicant infringes others´ patent rights will not be considered during drug examination procedure. The rational behind this is that the patent rights belong to private right, hence, the applicant shall implement his/her right himself/herself through court actions. The drug authority does not have such a duty to ensure his/her patent rights been protected within the regulatory review process. However, there is a tendency that the R&D-based pharmaceutical industry is eager to asking the drug authority not to approval a drug (usually a generic drug) before the not-infringement-status of the drug related patents being cleared. Such an appeal to the drug authority is named "patent linkage" or "patent-registration linkage", which was first regulated in the US Hatch-Waxman Law of 1984.
Although "patent linkage" or "patent-registration linkage" is not a TRIPS obligation, the US trade representative however, has, the tendency to ask its foreign trade partners to modify their national drug laws to include such kind of provisions. This has been showed in many of the Free Trade Agreements (FTAs) the US signed with its foreign trade partners. Since on one hand it is Taiwan Government´s endeavour to have a FTA signed with the USA; on the other hand, however, FTA provisions including a commitment to implement the "patent linkage" regime will bring enormous impact on Taiwan´s generic-based pharmaceutical industry, the government should therefore take special attention to the issues surrounding with "patent linkage". This article begins with examining the "patent linkage" regime under Hatch-Waxman Law, its abusing practices and recent rectification. Then it is followed by introducing how other countries implemented "patent linkage" regime react in their laws. It is not the intent of this article to provide detailed suggestions on how Taiwan should introduce this regime, but to identify special concerns in Taiwan while considering whether or not to introduce this regime.
Keyword: patent linkage, patent-registration linkage, generic drug, HWA, Hatch-Waxman Act, Orange Book, paragraph IV, ANDA.
<Source: Allison Huang, "Patent Linkage"- Impediment or Stimulant to Pharmaceutical R&D and Competition? An Overview on the Development of the Interaction Between Patents and Pharmaceutical Regulatory Approval (I), Science & technology Law Review Vol. 21 No. 2, February 2009, p.p. 24~37
Allison Huang, "Patent Linkage"- Impediment or Stimulant to Pharmaceutical R&D and Competition? An Overview on the Development of the Interaction Between Patents and Pharmaceutical Regulatory Approval (II), Science & technology Law Review Vol. 21 No. 3, March 2009, p.p. 32~48> |
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U.S. MEDICAL DEVICE AMENDMENT AND THE DISPUTE THEREOF |
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The Medical device is different from the daily consumer product, not only the characteristic of the medical device is danger and the treatment result is unlikely to be expected, but also the medical device has to be approval before marketing. On February 20, 2008, the Supreme Court affirmed the Second Circuit decision in Riegel v. Medtronic, holding that the preemption clause of the Medical Device Amendments bars common-law claims challenging the safety or efficacy of a medical device marketed in a form that has received pre-market approval from the FDA. The Article addresses on the development and influence of the identical case, further on the medical device classification system of the U.S., medical device warning obligation and the learned intermediary doctrine.
Keyword: Medical Device, preemption clause, product liability, FDA, MDA
<Source: Jiang Guo-Ching, U.S. Medical Device Amendment and the Dispute thereof, Science & Technology Law Review Vol. 21 No. 3, March 2009, p.p. 49~64> |
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THE DIFFERENCE BETWEEN THE VOICE OVER INTERNET PROTOCOL AND PUBLIC SWITCHED TELEPHONE NETWORK |
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This paper uses emergency call service (ECS) for an example to discuss the difference between the voice over internet protocol (VoIP) and public switched telephone network (its difference). We review literature and develop models of law and economic to analyze the present law of VoIP´s ECS in each country. From literature review, we could get that its difference would influence social welfare positively and negatively. And many countries regulate the owner of VoIP should provide ECS for public safety or remind the consumer about its difference of ECS for fair trade. From the results of models of law and economic, we could find that the reason, why the present law of VoIP´s ECS in each country are different, is the difference among the benefit of ECS, the share of VoIP in voice market, the cost of VoIP´s ECS and the cost to remind the consumer about its difference of ECS.
Keywords: Voice over Internet Protocol, Voice over Public Switched Telephone Network, Emergency Call Service.
<Source: Huang Wei-Luan, The Difference between the Voice over Internet Protocol and Public Switched Telephone Network - Emergency Call Service, Science & Technology Law Review Vol. 21, No. 2, February 2009, p.p. 38~59> |
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STUDY ON GERMAN CASES OF INTERNET FORUM LIABILITY |
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Should Internet forum Platform Provider (IPP) be responsible for users´ illegal behavior or irresponsible speech, even they have no idea about those infringements? If yes, to what extent the responsibility is? It is a quite debatable issue. With the expectation to protect users´ free speech, IPP in German normally take the approach of "notice and take down" to protect itself, which means, IPP can be exempt from liability if they "take down" material once upon receive "notice" that it may be unlawful. It is not ruled by law but general be accepted by courts in Germany. But since Telemedien law take effect in 2007, the situation has been changed.Some German courts begin to consider IPP as a media and ask them to take dangerous liability. This article will compare and discuss the change of IPP liability in German with some case judgements.
Keywords: internet forum, dangerous liability, infringement , media liability.
<Source: Kuo Chia-Mei, Study on German Cases of Internet Forum Liability, Science & Technology Law Review Vol. 21 No. 1, January 2009, p.p. 31~45 > |
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LEGAL ISSUE OF NETWORK ACCESS AND INTERCONNECTION IN EU |
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To accommodate the tendency towards convergence of technologies, European Union approved the current regulatory framework of electronic communications sector on 7 March 2002. The Access Directive harmonizes the way in which Member States regulate access to, and interconnection of, electronic communications networks and associated facilities, so as to achieve effective competition on relevant markets and to ensure interoperability of electronic communications services and consumer benefits. In the past, only the traditional public switched telephone network was subject to the Interconnection Directive, but the access measures under the Access Directive can apply to any electronic communications network or associated facility, including IP networks and broadcasting networks. In accordance the Framework Directive, national regulatory authorities should undertake a review of relevant product and service markets as defined in Commission´s Recommendation to determine whether they are effective competitive. If the operator is simply a public network operator without significant market power, its only obligation under this directive is to negotiate interconnection with other public operator, unless the operators can control access to end-users or provide conditional access system for digital television and radio services. Once an operator is designated as holding significant market power on a specific market, the national regulatory authority has broad discretion to impose asymmetric regulatory obligations as appropriate, including obligations of transparency, non-discrimination, accounting separation, access to and use of specific network facilities, price control and cost accounting. on November 2007, The Commission issued some reform proposals to amend the current regulatory frameworks, the European Parliament adopted some amendments at first reading on September 2008, and EU intended to take the " functional separation " measure to vertically integrated operator holding significant market power, in situation where there has been persistent failure to achieve the objective of the effective non-discrimination on relevant markets, and where there is little or no prospect of infrastructure competition within a reasonable timeframe after one or more existing obligations under the Access Directive has be imposed.
Keywords: Access Directive,asymmetric regulation,network interconnection,significant market power,conditional access system,functional separation
<Source: Wang I-Kao, Legal Issue of Network Access and Interconnection in EU, Science & Technology Law Review Vol. 21 No. 1, January 2009, p.p. 46~62> |
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