Review of Taiwan's Existing Regulations on the Access to Bioloical Resources
The activities of accessing to Taiwan's biological resources can be governed within certain extent described as follows.
1 、 Certain Biological Resources Controlled by Regulations
Taiwan's existing regulation empowers the government to control the access to biological resources within certain areas or specific species. The National Park Law, the Forestry Act, and the Cultural Heritage Preservation Act indicate that the management authority can control the access of animals and plants inside the National Park, the National Park Control Area, the recreational area, the historical monuments, special scenic area, or ecological protection area; forbid the logging of plants and resources within the necessary control area for logging and preserved forestry, or control the biological resources inside the natural preserved area. In terms of the scope of controlled resources, according to the guidance of the Wildlife Conservation Act and the Cultural Heritage Preservation Act, governmental management authority is entitled to forbid the public to access the general and protected wild animals and the plant and biological resources that are classified as natural monuments.
To analyse the regulation from another viewpoint, any access to resources in areas and of species other than the listed, such as wild plants or microorganism, is not regulated. Therefore, in terms of scope, Taiwan's management of the access to biological resources has not covered the whole scope.
2 、 Access Permit and Entrance Permit
Taiwan's current management of biological resources adopts two kinds of schemes: access permit scheme and entrance permit in specific areas. The permit allows management authority to have the power to grant and reject the collection, hunting, or other activities to access resources by people. This scheme is similar to the international standard.
The current management system for the access to biological resources promoted by many countries and international organizations does not usually cover the guidance of entrance in specific areas. This is resulting from that the scope of the regulation about access applies for the whole nation. However, since Taiwan has not developed regulations specifically for the access of bio-research resources, the import/export regulations in the existing Wildlife Conservation Act, National Park Law, Forestry Act, and Cultural Heritage Preservation Act may provide certain help if these regulations be properly connected with the principle of access and benefit sharing model, so that they will help to urge people to share the research interests.
3 、 Special Treatments for Academic Research Purpose and Aborigines
Comparing to the access for the purpose of business operation, Taiwan's regulations favour the research and development that contains collection and hunting for the purpose of academic researches. The regulation gives permits to the access to biological resources for the activities with nature of academic researches. For instance, the Wildlife Conservation Act, National Park Law, and theCultural Heritage Preservation Act allow the access of regulated biological resources, if the academic research unit obtains the permit, or simply inform the management authority.
In addition, the access by the aborigines is also protected by the Forestry Act, Cultural Heritage Preservation Act, and the Aboriginal Basic Act. The aborigines have the right to freely access to biological resources such as plants, animals and fungi.
4 、 The Application of Prior Informed Consent (PIC)
In topics of the access to and benefit sharing of biological resources, the PIC between parties of interests has been the focus of international regulation. Similarly, when Taiwan was establishing theAboriginal Basic Act, this regulation was included to protect the aborigines' rights to be consulted, to agree, to participate and to share the interests. This conforms to the objective of access and benefit sharing system.
5 、 To Research and Propose the Draft of Genetic Resources Act
The existing Wildlife Conservation Act, National Park Law, Forestry Act,Cultural Heritage Preservation Act, Aboriginal Basic Act provide the regulation guidance to the management of the access to biological resources within certain scope. Comparing to the international system of access and benefit sharing, Taiwan's regulation covers only part of the international guidance. For instance, Taiwan has no regulation for the management of wild plants and micro-organism, so there is no regulation to confine the access to wild plants and microorganism. To enlarge the scope of management in terms of the access to Taiwan's biological resources, the government authority has authorize the related scholars to prepare the draft of Genetic Resources Act.
The aim of the Genetic Resources Act is to establish the guidance of the access of genetic resources and the sharing of interests in order to preserve the genetic resources. The draft regulates that the bio-prospecting activity should be classified into business and academic, with the premise of not interfering the traditional usages.
After classification, application of the permit should be conducted via either general or express process. During the permit application, the prospector, the management authority, and the owner of the prospected land should conclude an agreement jointly. In the event that the prospector wishes to apply for intellectual property rights, the prospector should disclose the origin of the genetic resources and provide the legally effective documents of obtaining these resources. In addition, a Biodiversity Fund should be established to manage the profits derived from genetic resources. The import/export of genetic resources should also be regulated. Violators should be fined.
Over the past twenty years, the Government has sought to cultivate the biopharmaceutical industry as one of the future major industry in Taiwan. Back in 1982, the Government has begun to regard biotechnology as a key technology in Technology Development Program, demonstrated that biotechnology is a vital technology in pursuit of future economic growth. Subsequently, the Government initiated national programs that incorporated biotechnology as a blueprint for future industrial development. In order to enhance our competitiveness and building an initial framework for the industry, The Executive Yuan has passed the Biotechnology Industry Promotion Plan. As the Government seeks to create future engines of growth by building an environment conducive for enterprise development, the Plan has been amended four times, and implemented measures focused on the following six areas: related law and regulations, R&D and applications, technology transfer and commercialization, personnel training, investment promotion and coordination, marketing information and marketing service. In 2002, the Executive Yuan approved the Challenge 2008, a six-year national development plan, pointing out biotechnology industry as one of the Two Trillion, Twin Stars industries. The Government planned for future economic growth by benefiting through the attributes of the biotechnology: high-tech, high-reward and less pollution. Thus, since 1997 the Strategic Review Board (SRB) under the Executive Yuan Science and Technology Advisory Panel has taken action in coordinating government policies with industry comments to form a sound policy for the biotechnology industry. Additionally, a well-established legal system for sufficient protection of intellectual property rights is the perquisite for building the industry, as the Government recognized the significance through amending and executing related laws and regulations. By stipulating data exclusivity and experimental use exception in the Pharmaceutical Affair Act, tax benefits provided in Statute for Upgrading Industries , Incentives for Production and R&D of Rare Disease Medicine, Incentives for Medical Technology Research and Development, provide funding measures in the Guidance of Reviewing Programs for Promoting Biotechnology Investment. Clearly, the government has great expectation for the industry through establishing a favorable environment by carrying out these policies and revising outdated regulations. Thus, the Legislative Yuan has passed the “Act for The Development of Biotechnology and New Pharmaceuticals Industry” in June, 2007, and immediately took effect in July. The relevant laws and regulations became effective as well, driving the industry in conducting researches on new drugs and manufacturing new products, increasing sales and expanding the industry to meet an international level. For a biopharmaceutical industry that requires long-term investment and costly R&D, incentive measures is vital to the industry’s survival before the product launches the market. Accordingly, this article will be introducing the recent important regulation that supports the biopharmaceutical industry in Taiwan, and analyzing the government’s policies. Biotechnology is increasingly gaining global attention for its potential in building future economic growth and generating significant profits. In an effort to support the biotechnology industry in Taiwan, the Government has made a step forward by enacting the “Act for the Development of Biotech and New Pharmaceutical Industry”. The biopharmaceutical industry is characterized as high-risk and high-reward, strong government support and a well-developed legal system plays a vital role from its establishment throughout the long term development. Therefore, the Act was enacted tailor to the Biotech and New Pharmaceutical Industry, primarily focuses on tax benefits, R&D activities, personnel recruitment and investment funding, in support of start-up companies and attracting a strong flow of funding worldwide. To pave the way for promoting the biopharmaceutical industry and the Biotech and New Pharmaceutical Company, here the article will be introducing the incentive measures provided in the Act, and supporting development of the industry, demonstrating the efforts made by the Government to build a “Bio-tech Island”. Reference “Act for Development of Biotech and New Pharmaceutical Industry”, webpage of Law and Regulations Database of the Republic of China. 4 July, 2007. Ministry of Justice, Taiwan. 5 Nov. 2008 http://law.moj.gov.tw/Eng/Fnews/FnewsContent.asp?msgid=3180&msgType=en&keyword=undefined
A Before and After Impact Comparison of Applying Statute for Industrial Innovation Article 23-1 Draft on Venture Capital Limited PartnershipsA Before and After Impact Comparison of Applying Statute for Industrial Innovation Article 23-1 Draft on Venture Capital Limited Partnerships I. Background Because the business models adopted by Industries, such as venture capital, film, stage performance and others, are intended to be temporary entities, and the existing business laws are not applicable for such industries,[1] the Legislature Yuan passed the “Limited Partnership Act” in June 2015,[2] for the purpose of encouraging capital injection into these industries. However, since the Act was passed, there are currently only nine limited partnerships listed on the Ministry of Economic Affairs' limited partnership information website. Among them, “Da-Zuo Limited Partnership (Germany) Taiwan Branch” and “Stober Antriebstechnik Limited Partnership (Germany) Taiwan Branch”, are branch companies established by foreign businesses, the remaining seven companies are audio video production and information service businesses. It is a pity that no venture capital company is adopting this format.[3] In fact, several foreign countries have set up supporting measures for their taxation systems targeting those business structures, such as limited partnerships. For example, the pass-through taxation method (or referred to as single entity taxation) is adopted by the United States, while Transparenzprinzip is used by Germany. These two taxation methods may have different names, but their core ideas are to pass the profits of a limited partnership to the earnings of partners.[4] However, following the adoption of the Limited Partnership Act in Taiwan, the Ministry of Finance issued an interpretation letter stating that because the current legal system confers an independent legal entity status to the business structure of a limited partnership, it should be treated as a profit-seeking business and taxed with Profit-Seeking Enterprise Income Tax.[5] Therefore, to actualize the legislative objective of encouraging innovative businesses organized under tenets of the Limited Partnership Act, the Executive Yuan presented a draft amendment for Article 23-1 of the Statute for Industrial Innovation (hereinafter referred to as the Draft), introducing the "Pass Through Taxation Principle" as adopted by several foreign countries. That is, a Limited Partnership will not be levied with the Profit-Seeking Enterprise Income Tax, but each partner will file income tax reports based on after-profit-gains from the partnership that are passed through to each partner. It is expected that the venture capital industry will now be encouraged to adopt the limited partnership structure, and thus increase investment capital in new ventures. II. The Pass Through Taxation Method is Applicable to Newly Established Venture Capital Limited Partnerships 1. The Requirements and Effects (1) The Requirements According to the provisions of Article 23-1 Paragraph 3 of the Draft, to be eligible for Pass Through Taxation, newly established venture capital limited partnerships must meet the following requirements: 1. The venture capital limited partnerships are established between January 1, 2017 and December 31, 2019. 2. Investment threshold of the total agreed capital contribution, total received capital contribution, and accumulated total capital contribution, within five years of the establishment of venture capital limited partnerships: Total Agreed Capital Contribution in the Limited Partnership Agreement Total Received Capital Contribution Accumulated Investment Amount for Start-up Companies The Year of Establishment 3 hundred million ✕ ✕ The Second Year ✕ ✕ The Third Year 1 hundred million ✕ The Fourth Year 2 hundred million Reaching 30 percent of the total received capital contribution of the year or 3 hundred million NT dollars. The Fifth Year 3 hundred million 3. The total amount, that an overseas company applies in capital and investments in actual business operations in Taiwan, reaches 50% of its total received capital contribution of that year. 4. In compliance with government policies. 5. Reviewed and approved by the central competent authority each year. (2) The Effects The effects of applying the provisions of Article 23-1 Paragraph 3 of the Draft are as follows: 1. Venture capital limited partnerships are exempt from the Profit-Seeking Enterprise Income Tax. 2. Taxation method for partners in a limited partnership after obtaining profit gains: (1) Pursuant to the Income Tax Act, Individual partners and for-profit business partners are taxed on their proportionally-calculated, distributed earnings. (2) Individual partners and foreign for-profit business partners are exempt from income tax on the stock earnings distributed by a limited partnership. 2. Benefit Analysis Before and After Applying Pass Through Taxation Method A domestic individual A, a domestic profit-making business B, and a foreign profit-making business C jointly form a venture capital limited partnership, One. The earnings distribution of the company One is 10%, 80% and 10% for A, B, and C partners, respectively. The calculated earnings of company One are one million (where eight hundred thousand are stock earnings, and two hundred thousand are non-stock earnings). How much income tax should be paid by the company One, and partners A, B, and C? (1) Pursuant to the Income Tax Act, before the amended draft: 1. One Venture Capital Limited Partnership Should pay Profit-Seeking Enterprise Income Tax = (NT$1,000,000 (earning) - NT$500,000[6])x12% (tax rate[7])=NT$60,000 2. Domestic Individual A Should file a comprehensive income report with business profit income =(NT$1,000,000-NT$60,000) x 10% (company One draft a voucher for net amount for A) + NT$60,000÷2×10% (deductible tax rate)= NT$97,000 Tax payable on profit earnings＝NT$91,500×5%(tax rate)＝NT$4,850 Actual income tax paid＝NT$4,850 - NT$60,000÷2×10% (deductible tax rate) ＝NT$1,485 3. Domestic For-Profit Business B Pursuant to the provisions of Article 42 of the Income Tax Act, the net dividend or net income received by a profit-seeking company is not included in the income tax calculation. 4. Foreign For-Profit Business C Tax paid at its earning source＝(NT$1,000,000 - NT$60,000) ×10% (earning distribution rate) ×20% (tax rate at earning source)＝NT$18,800 (2) Applying Pass Through Taxation Method After Enacting the Amendment 1. One Venture Capital Limited Partnership No income tax. 2. Domestic Individual A Should pay tax＝NT$800,000 (non-stock distributed earnings)×10% (earning distribution rate)×5% (comprehensive income tax rate)＝NT$1,000 3. Domestic For-Profit Business B Pursuant to the provisions of Article 42 of the Income Tax Act, the net dividend or net income received by a profit-seeking company is not included in the income tax calculation. 4. Foreign For-Profit Business C Tax paid at its earning source＝NT$800,000 (non-stock distributed earnings)×10%(earning distribution rate)×20% (tax rate at earning source)＝NT$4,000 The aforementioned example shows that under the situation, where the earning distribution is the same and tax rate for the same taxation subject is the same, the newly-established venture capital limited partnerships and their shareholders enjoy a more favorable tax benefit with the adoption of pass through taxation method: Before the Amendment After the Amendment Venture Capital Limited Partnership NT$60,000 Excluded in calculation Shareholders Domestic Individual NT$1,850 NT$1,000 Domestic For-Profit Business Excluded in calculation Excluded in calculation Foreign For-Profit Business NT$18,800 NT$4,000 Sub-total NT$80,650 NT$5,000 III. Conclusion Compared to the corporate taxation, the application of the pass through taxation method allows for a significant reduction in tax burden. While developing Taiwan’s pass through tax scheme, the government referenced corporate taxation under the U.S. Internal Revenue Code (IRC), where companies that meet the conditions of Chapter S can adopt the “pass through” method, that is, pass the earnings to the owner, with the income of shareholders being the objects of taxation;[8] and studied the "Transparenzprinzip" adopted by the German taxation board for partnership style for-profit businesses. Following these legislative examples, where profits are identified as belonging to organization members,[9] the government legislation includes the adoption of the pass through taxation scheme for venture capital limited partnerships in the amended draft of Article 23-1 of the Statute for Industrial Innovation, so that the legislation is up to international standards and norms, while making an important breakthrough in the current income tax system. This is truly worthy of praise. [1] The Legislative Yuan Gazette, Vol. 104, No. 51, page 325. URL:http://misq.ly.gov.tw/MISQ//IQuery/misq5000Action.action [2] A View on the Limited Partnership in Taiwan, Cross-Strait Law Review, No. 54, Liao, Da-Ying, Page 42. [3] Ministry of Economic Affairs - Limited Partnership Registration Information URL: http://gcis.nat.gov.tw/lmpub/lms/dir.jsp?showgcislocation=true&agencycode=allbf [4] Same as annotate 2, pages 51-52. [5] Reference Letter of Interpretation dated December 18, 2015, Tai-Cai-Shui Zi No. 10400636640, the Ministry of Finance [6] First half of Paragraph 1 of Article 8 of the Income Basic Tax Act [7] Second half of Paragraph 1 of Article 8 of the Income Basic Tax Act [8] A Study on the Limited Partnership Act, Master’s degree thesis, College of Law, Soochow University, Wu, Tsung-Yeh, pages 95-96. [9] Reference annotate 2, pages 52.
Experiences about opening data in private sectorExperiences about opening data in private sector Ⅰ. Introduction Open data is the idea that data should be available freely for everyone to use and republish without restrictions from copyright, patents or other mechanisms of control. The concept of open data is not new; but a formalized definition is relatively new, and The Open Definition gives full details on the requirements for open data and content as follows: Availability and access: the data must be available as a whole with no more than a reasonable reproduction cost, preferably by downloading over the internet. The data must also be available in a convenient and modifiable form. Reuse and redistribution: the data must be provided under terms that permit reuse and redistribution including the intermixing with other datasets. The data shall be machine-readable. Universal participation: everyone must be able to use, reuse and redistribute the data— which by means there should be no discrimination against fields of endeavor or against persons or groups. For example, “non-commercial” restrictions that would prevent “commercial” use, or restrictions of use for certain purposes are not allowed. In order to be in tune with international developmental trends, Taiwan passed an executive resolution in favor of promoting Open Government Data in November 2012. Through the release of government data, open data has grown significantly in Taiwan and Taiwan has come out on top among 122 countries and areas in the 2015 and 2016 Global Open Data Index[1]. The result represented a major leap for Taiwan, however, progress is still to be made as most of the data are from the Government, and data from other territories, especially from private sector can rarely be seen. It is a pity that data from private sector has not being properly utilized and true value of such data still need to be revealed. The following research will place emphasis to enhance the value of private data and the strategies of boosting private sector to open their own data. Ⅱ. Why open private data With the trend of Open Government Data recent years, countries are now starting to realize that Open Government Data is improving transparency, creating opportunities for social and commercial innovation, and opening the door to better engagement with citizens. But open data is not limited to Open Government Data. In fact, the private sector not only interacts with government data, but also produces a massive amount of data, much of which in need of utilized. According to the G20 open data policy agenda made in 2014, the potential economic value of open data for Australia is up to AUD 64 billion per annum, and the potential value of open data from private sector is around AUD 34 billion per annum. Figure 1 Value of open data for Australia (AUD billion per annum) Source: McKinsey Global Institute The purpose for opening data held by private entities and corporations is rooted in a broad recognition that private data has the potential to foster much public good. Openness of data for companies can translate into more efficient internal governance frameworks, enhanced feedback from workers and employees, improved traceability of supply chains, accountability to end consumers, and with better service and product delivery. Open Private Data is thus a true win-win for all with benefiting not only the governance but environmental and social gains. At the same time, a variety of constraints, notably privacy and security, but also proprietary interests and data protectionism on the part of some companies—hold back this potential. Ⅲ. The cases of Open Private Data Syngenta AG, a global Swiss agribusiness that produces agrochemicals and seeds, has established a solid foundation for reporting on progress that relies on independent data collection and validation, assurance by 3rd party assurance providers, and endorsement from its implementing partners. Through the website, Syngenta AG has shared their datasets for agricultural with efficiency indicators for 3600 farms for selected agro-ecological zones and market segments in 42 countries in Europe, Africa, Latin America, North America and Asia. Such datasets are precious but Syngenta AG share them for free only with a Non-Commercial license which means users may copy and redistribute the material in any medium or format freely but may not use the material for commercial purposes. Figure 2 Description and License for Open data of Syngenta AG Source: http://www.syngenta.com Tokyo Metro is a rapid transit system in Tokyo, Japan has released information such as train location and delay times for all lines as open data. The company held an Open Data Utilization Competition from 12 September to 17 November, 2014 to promote development of an app using this data and continues to provide the data even after the competition ended. However, many restrictions such as non-commercial use, or app can only be used for Tokyo Metro lines has weakened the efficiency of open data, it is still valued as an initial step of open private data. Figure 3 DM of Tokyo Metro Open data Contest Source: https://developer.tokyometroapp.jp/ Ⅳ. How to enhance Open Private Data Open Private Data is totally different from Open Government Data since “motivation” is vital for private institutions to release their own data. Unlike the government data can be disclosed and free to use via administrative order or legislation, all of the data controlled by private institutions can only be opened under their own will. The initiative for open data therefore shall focus on how to motivate private sectors releasing their own data-by ensuring profit and minimizing risks. Originally, open data shall be available freely for everyone to use without any restrictions, and data owners may profit indirectly as users utilizing their data creating apps, etc. but not profit from open data itself. The income is unsteady and data owners therefore lose their interest to open data. As a countermeasure, it is suggested to make data chargeable though this may contradict to the definition of open data. When data owners can charge by usage or by time, the motivation of open data would arise when open data is directly profitable. Data owners may also worry about many legal issues when releasing their own data. They may not care about whether profitable or not but afraid of being involved into litigation disputes such as intellectual property infringement, unfair competition, etc. It is very important for data owners to have a well protected authorization agreement when releasing data, but not all of them is able to afford the cost of making agreement for each data sharing. Therefore, a standard sample of contract that can be widely adopted plays a very important role for open private data. A data sharing platform would be a solution to help data owners sharing their own data. It can not only provide a convenient way to collect profit from data sharing but help data owners avoiding legal risks with the platform’s standard agreement. All the data owners have to do is just to transfer their own data to the platform without concern since the platform would handle other affairs. Ⅴ. Conclusion Actively engaging the private sector in the open data value-chain is considered an innovation imperative as it is highly related to the development of information economy. Although many works still need to be done such as identifying mechanisms for catalyzing private sector engagement, these works can be done by organizations such as the World Bank and the Centre for Open Data Enterprise. Private-public collaboration is also important when it comes to strengthening the global data infrastructure, and the benefits of open data are diverse and range from improved efficiency of public administrations to economic growth in the private sector. However, open private data is not the goal but merely a start for open data revolution. It is to add variation for other organizations and individuals to analyze to create innovations while individuals, private sectors, or government will benefit from that innovation and being encouraged to release much more data to strengthen this data circulation. [1] Global Open Data Index, https://index.okfn.org/place/（Last visited: May 15, 2017）
Observing Recent Foreign Developments upon Bio-medicine、 Marketing Medical Devices、Technology Development Project and the Newest Litigation Trend Concerning the Joint Infringement of Method/Process Patents1、Chinese REACH has put into shape, how about Taiwan REACH? - A Perspective of Chinese Measures on Environmental Management of New Chemical Substances Taiwan food industry has been struck by the government agency's disclosure that certain unfaithful manufacturers have mixed toxic chemicals into the food additives for the past 30 years, and the chemicals may seriously threaten public health. This event has not only shocked the confidence of the customers to the industry, but also drew public attention on the well-management and the safe use of chemicals. In order to manage the fast advancing and widely applicable chemical substance appropriately, the laws and regulations among the international jurisprudences in recent years tend to regulate unfamiliar chemicals as “new chemical substances” and leverage registration systems to follow their use and import. REACH is one the most successful models which has been implemented by European Union since 2006. China, one of our most important business partners, has also learned from the EU experience and implemented its amended " Measures on Environmental Management of New Chemical Substances" (also known as "Chinese REACH") last year. It is not only a necessity for our industry which has invested or is running a business in China to realize how this new regulation may influence their business as differently , but also for our authority concerned to observe how can our domestic law and regulation may connect to this international trend. Therefore, except for briefing the content of Chinese REACH, this article may also review those existing law and regulations in Taiwan and observe the law making movement taken by our authority. We expect that the comparison and observation in this article may be a reference for our authorities concerned to map out a better environment for new chemical management. 2、The study on Taiwanese businessmen Join the Bid Invitation and Bidding of Science and Technology Project China government invests great funds in their Science and Technology Project management system, containing most of innovated technology. It also creates the great business opportunity for domestic industry. China government builds up a Bid Invitation and Bidding Procedure in the original Science and Technology Project Regime recent years, in order to make the regime become more open and full of transparency. It also improves Regime to become more fairness and efficiency. Taiwan industry may try to apply for those Science and Technology Project, due to this attractive opportunity, but they should understand china's legal system before they really do that. This Article will introduce the "Bid Invitation and Bidding Law of the Peoples Republic of China", and the "Provisional Regulation on Bid Invitation and Bidding of Science and Technology Project", then clarify applied relationship between the "Bid Invitation and Bidding Law of the Peoples Republic of China", and "Government Procurement Law of the Peoples Republic of China". It also analyzes "Bid Invitation and Bidding Procedure", "Administration of Contract Performance Procedure", "Inspection and Acceptance Procedure", and "Protest and Complaint Procedure, providing complete legal observation and opinion for Taiwan industry finally. Keyword Bid Invitation and Bidding Law of the Peoples Republic of China; Government Procurement Law of the Peoples Republic of China; Provisional Regulation on Bid Invitation and Bidding of Science and Technology Project; Applying for Science and Technology Project Regime; Bid Invitation and Bidding Procedure; Administration of Contract Performance Procedure; Inspection and Acceptance Procedure; Protest and Complaint Procedure. 3、Comparing the Decisions of the United States Supreme Court regarding Preempting Marketing Medical Devices and Drugs from State Tort Litigations with the Decision of a Hypothetical Case in Taiwan The investment costs of complying with pertinent laws and regulations for manufacturing, marketing, and profiting from drugs and medical devices (abbreviated as MD) are far higher than the costs necessary for securing a market permit. The usage of MD products contains the risk of harming their users or the patients, who might sue the manufacturer for damages in the court based on tort law. To help reduce the risk of such litigation, the industry should be aware of the laws governing the state tort litigations and the preemption doctrine of the federal laws of the United States. This article collected four critical decisions by the United States Supreme Court to analyze the requirements of federal preemption from the state tort litigations in these cases. The article also analyzed the issues of preemption in our law system in a hypothetical case. These issues include the competing regulatory requirements of the laws and regulations on the drugs and MDs and the Drug Injury Relief Act versus the Civil Code and the Consumer Protection Law. The article concluded: 1. The pre-market-approval of MD in the United States is exempted from the state tort litigations; 2. Brand-name-drug manufacturers must proactively update the drug label regarding severe risks evidenced by the latest findings; 3. Generic-drug manufacturers are exempted from the product liability litigations and not required to comply with the aforementioned brand-name-drug manufacturers' obligation; 4. No preemption issues are involved in these kinds of product liability litigations in our country; 5. The judge of general court is not bound by the approval of marketing of drug and MD; 6. The judge of general court is not bound by the determination and verdict of the Drug Injury Relief Act. 4、Through Computer-Aided Detection Software, Comparing by Discussing and Analyzing the Regulatory Requirements for Marketing Medical Devices in the United States and in Taiwan Computer-Aided Detection (CADe) software systematically assists medical doctors to detect suspicious diseased site(s) inside patients' bodies, and it would help patients receive proper medical treatments as soon as possible. Only few of this type of medical device (MD) have been legally marketed either in the United States of America (USA) or in Taiwan. This is a novel MD, and the rules regulating it are still under development. Thus, it is valuable to investigate and discuss its regulations. To clarify the requirements of legally marketing the MD, this article not only collects and summarizes the latest draft guidance announced by the USA, but also compares and analyzes the similarities and differences between USA and Taiwan, and further explains the logics that USA applies to clarify and qualify CADe for marketing, so that the Department of Health (DOH) in Taiwan could use them as references. Meanwhile, the article collects the related requirements by the Administrative Procedure Act and by the Freedom of Government Information Law of our nation, and makes the following suggestions on MD regulations to the DOH: creating product code in the system of categorization, providing clearer definition of classification, and actively announcing the (abbreviated) marketing route that secures legal permission for each individual product. 5、A Discussion on the Recent Cases Concerning the Joint Infringement of Method/Process Patents in the U.S. and Japan In the era of internet and mobile communication, practices of a method patent concerning innovative service might often involve several entities, and sometimes the method patent can only be infringed jointly. Joint infringement of method/process patents is an issue needed to be addressed by patent law, since it is assumed that a method patent can only be directly infringed by one entity to perform all the steps disclosed in the patent. In the U.S., CAFC has established the "control or direction" standard to address the issue, but the standard has been criticized and it is under revision now. In Japan, there is no clearly-established standard to address the issue of joint infringement, but it seems that the entity that controls and benefits from the joint infringement might be held liable. Based on its discussion about the recent development in the U.S. and Japan, this article attempts to provide some suggestions for inventors of innovative service models to use patents to protect their inventions properly: they should try to avoid describing their inventions in the way of being practiced by multi-entities, they should try to claim both method and system/apparatus inventions, and they should try to predict the potential infringement of their patents in order to address the problem of how to prove the infringement.
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