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醫療糾紛之理論與實證研究 / An empirical study on the medical disputes劉惠芝, Liu, Hui Chih Unknown Date (has links)
近年來有關醫療法律糾紛案件有逐漸增加之趨勢,本文嘗試藉由實證分析,剖析目前實務與學理上之不同見解,簡要提出個人淺見。於實證分析前,本論文先就文獻理論作簡略之論述,首要說明醫療行為與醫療糾紛之相關概念,以界定醫師或醫療機構對其醫療行為應負之責任。並從實體法上論述醫療過失民事責任之基礎及其內涵,如醫療契約責任、醫療侵權責任、消保法與醫療法之適用,以及醫療過失之因果關係等。次就程序法上探討民事醫療訴訟舉證責任分配之基本原則,同時就美國法與德國法有關醫療過失舉證責任分配的調整於我國實務上之運用,作概略分析及探討。再者,鑑於法官於具體個案中判斷醫療糾紛之相關要件,往往需將訴訟資料送請醫療專業機構加以鑑定,因此,本文亦加以說明我國醫療鑑定制度運作之現況,並據此指出現行醫療糾紛鑑定問題之所在。
最後,本文就最高法院民事案件,分別從醫療糾紛判決背景資料之「年度」、「醫療機構層級」、「科別」、「上訴人」與「上訴結果」,以及醫療糾紛審判實務,如「醫療過失」、「因果關係的認定」、「民事責任請求權基礎及舉證責任之分配情況」、「告知義務」、「醫療鑑定在醫療糾紛應用」,進行實證分析,並依實證數據成果,提出「醫療科別屬性與醫療糾紛案件量多寡密切攸關」、「法院對於醫師在個案是否盡注意義務,應以理性醫師之注意標準綜合評價」、「針對醫療訴訟特性,適度分配醫病雙方之舉證責任」、「宜建立醫療傷害補償基金制度」、「醫事人員確切履行告知說明義務」、「健全現行病歷表之相關問題」、「關於醫療糾紛鑑定實務」暨「透過消保法填補醫療(院)組織疏失之責任」等八項結論及建議,以供實務與學術研究者未來對於醫療糾紛訴訟案件研析時之參考。 / Recently, legal cases concerning medical dispute have a tendency to increase gradually. This article tries to explore different viewpoints between practice and academic theory by empirical analysis and then briefly indicates some of my humble views. Before doing the empirical analysis, this article will briefly introduce the related literatures and theories. Firstly, explains related concepts between medical behavior and medical dispute to define the liability that doctor and medical institution should bear because of their medical behaviors. Then, discuss the basis and connotation of the civil liability for medical malpractice from the substantive law viewpoint, such as the liability for medical contract, medical tort liability, the implementation of the Consumer Protection Law and the Medical Care Act and the causality from the medical malpractice etc. Secondly, this article will discuss the basic principles of allocation of burden of proof for civil medical dispute from the procedural law viewpoint and in the same time, briefly analyze and research that whether it is appropriate to adopt the allocation of burden of proof for medical malpractice from American and German law in our own practice. Furthermore, respecting the fact that for judges to make their decisions in particular medical dispute cases, they always have to send action materials to professional medical institutes for identification, thus, this article also wants to explain the current situation of implementation of our medical identification system, and points out the problems of current medical dispute identification system accordingly.
Lastly, this article will proceed empirical analysis according to the Year, Levels of the medical institutions, Divisions, Appellant, Result of Appeal from the background of the verdicts of the civil medical dispute cases awarded by the Supreme Court and according to the medical malpractice, the determination of the causality, the condition of basis of civil title of claiming and allocation of burden of proof, obligation of informing, medical identification in the medical dispute from the medical dispute trial practice. Base upon these results, this article indicates eight conclusions and suggestions for reference for the active participants and academic researchers in future medical dispute lawsuits: the attribution of the medical care division and the number of the medical dispute cases are closely related, court should do omnibus assessment using the standard of due diligence as a rational doctor to determine whether a doctor fulfill his duty of care in a specific case, with the particularity of medical actions in mind, appropriately allocate the burden of proof between doctor and patient, it is better to establish the compensation foundation system for medical damage, medical personnel should literally perform their obligation of informing, to refine the problems of current medical record, things concerning medical dispute identification practice and using the Consumer Protection Act to fill the vacancy that caused by the negligence of the medical institutions.
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跨國專利侵權訴訟之管理陳郁婷, Chen,Yu-Ting Unknown Date (has links)
自1980年以來,台灣企業逐漸於國際商業競爭上嶄露頭角的同時,也開始面臨智慧財產保護課題。
2003年3月,聯發科為全球獲利最高的IC設計公司,美商DVD播放機控制晶片供應商ESS正向系統客戶送樣(預計4月開始出貨),以增加客戶採用之可能性的同時,在美國北加州聯邦法院向聯發科提起專利侵權訴訟,禁止聯發科使用DVDPlayer單晶片(SoC)播放機銷往美國;6月初,傳出ESS與聯發科達成和解,金額從數千萬美元到1億美元,消息傳出,聯發科股價一度下滑近10%,市場與法人同步傳出聯發科將面臨官司敗訴,需賠償1億美元,據悉聯發科高層對消息提前曝光相當震怒,傳出對消息外露人員處以解職。6月中,聯發科宣布與美商ESS簽訂技術授權合約,未來2年內,聯發科將支付9,000萬美元的權利金。
2004年3月,美商Zoran向美國國際貿易委員會(ITC)控告,聯發科侵犯CD/DVD控制器設計架構,以及直接連結IDE/ATA資料埠的主端界面控制器等相關三項專利權,隨後又向美國洛杉磯地方法院提起專利侵權訴訟,除請求賠償金以外,亦要求美國法院發出禁制令,命令聯發科之侵權相關產品不得輸往美國;聯發科則回應,因尚未收到任何正式文件,委由美國律師了解,俟收到正式文件後再對外說明;同年7月,聯發科也在美國德拉瓦聯邦地方法院對Zoran提起專利侵權訴訟,2005年9月ITC判定聯發科敗訴,市場傳聞聯發科已提列準備金8億元;2006年1月,雙方達成和解,聯發科支付8,500萬美元權利金給Zoran,侵蝕聯發科該年獲利約10%。
而跨國專利侵權訴訟有別於傳統訴訟的特殊性在於(1)跨國性:涉及於不同國家企業、不同國之涉訟地、不同國之市場與生產。因在跨國企業之布局運籌下,訴訟地必定尋求最有影響力之地點,通常為美國及中國,案例中由於ESS及Zoran均為美商,因此在美國提起對聯發科之訴訟;(2)計畫性:為達成商業目的而規劃之訴訟,案例中,ESS對聯發科基於競爭關係而提出訴訟,目的在於增加訂單、減少競爭;Zoran對聯發科則基於增加營收之目的,要求侵權損害賠償,作為過去一年之營運虧損。換言之,為自己或客戶增加營收及訂單、減少競爭,為其訴訟計畫之最終目的;(3)規模性:為了增加影響力與壓力,往往在許多國家同時提起,對象從侵權者擴及其下游客戶,攻擊點既廣且深;(4)繼續性:訴訟期間,影響客戶對其之信任及訴訟管理能力形象;案例中,聯發科雖有傲人之獲利能力,然而在與ESS一案中,卻顯出訴訟管理能力之薄弱,導致Zoran效而尤之,此形象一旦形成,勢必將為聯發科帶來更多不必要之侵權訴訟紛爭;(5)組織性:將訴訟工具與企業組織做連結,融入組織文化以全面改善,並由此發展一套標準作業流程,案例中Zoran習慣性地在提起訴訟前,先於市場發放消息,造成市場恐慌以形成其客戶之壓力,並使該壓力轉嫁至侵權對象,使其容易屈服;(6)資源性:跨國專利侵權訴訟必須具備以下基本要件,「錢多」因需支付龐大之訴訟費、律師費、專家費、賠償金及權利金、並有能力迴避設計及改變模具,並需有喪失市場及流失營收之心理準備。「人多」因訴訟之故,需具備詳盡之專利資料庫建立、調查產業/技術/產品/競爭者分析等資料為因應,並有訴訟規劃人員、應訴人員、支援人員等龐大後勤單位。「命長」因企業必須有能力支撐營運,不致在訴訟過程之謠言紛擾中倒下,案例中,均有市場傳言紛擾之問題,足以說明。
自1980年以來,台灣廠商歷經歐洲、美國、日本等大廠商之專利侵權訴訟逼迫下,付出了昂貴的代價,因此開始投入鉅額資金為研發、申請專利,近十年來台灣企業在美國、台灣、中國所申請的專利申請費用便高達了一千九百多億台幣,加上遭受了至少一百多件跨國專利訴訟的訴訟費用,便高達兩千億之多,尚不包括每年支付的權利金也高達台幣一千五百多億台幣,足以養活台積電兩萬名員工及影響四十七萬名股東生活長達兩年之久,足見台灣廠商在研發及專利申請方面之投入程度及所花費心血之鉅。
然而,審視台灣企業近十年在專利侵權訴訟方面之表現,發現:(1)每年均有影響台灣產業發展的專利侵權訴訟發生;(2)遍及每個產業;(3)以被告居多;(4)和解的以付出鉅額權利金居多;(5)打完訴訟的以敗訴居多。
由此可見,台灣企業付出昂貴的研發費用、專利申請費用之後,並沒有改善台灣企業年年被告、年年支付鉅額權利金、損害賠償金的宿命,在高度的付出之下,卻沒有改善在國際研發方面的地位,顯然付出與獲得顯不成比例。
智慧財產的創造、保護、管理,其中的費用包括研發費用、專利申請費用、訴訟費用、權利金及損害賠償等,美國企業是在研發、專利申請支出了龐大的費用,然而可以在訴訟費用、權利金及損害賠償中賺回來,亦即至少符合投資報酬率,然而,反觀台灣企業,不但在研發、專利申請時支出了龐大的費用,在訴訟費用及權利金、損害賠償方面,不但沒有賺回來,反而必需支付更多的金錢,顯然的,台灣企業在跨國專利侵權訴訟管理的方法論上出了極大的問題,而有立即改變之必要!
有別於過去文獻侷限於「文獻與法規的翻譯」、「片段案例的選擇討論」、「過多理論的探討」、更幾乎沒有人探討重要的「中國專利侵權訴訟」,以致於見樹不見林,徒有理論而不會操作,消耗過多精力與資源於繁瑣而不重要的法律細節,卻無法猜透國際企業專利侵權訴訟背後的策略運籌,導致不能真正打贏過一場戰爭。
因此,本文提出一套跨國專利侵權訴訟管理之機制,橫跨最重要的兩個世界市場—美國、中國為主,法律面提供詳盡完整的如警告信發送、起訴、審前會議、馬克曼聽證會、發現程序、審判程序、專利無效程序、訴前救濟、保全措施等訴訟程序、制度規定與流程架構;企業管理面提供包含研發、生產製造、市場行銷、財務、會計、租稅、外部律師、專家、公證人等全面性管理策略,以大量實證的方式分析整理、以豐富的跨國專利侵權訴訟實戰經驗寫成,期望能使台灣產業真正打贏一場戰爭。 / Since 1980, Taiwan companies had been sued by European, U.S.A., Japan companies for patent infringements and forced to pay out enormously. Therefore, they started to invest tremendous amount of money and resources in research & development (R&D), as well as in patent prosecution. Last decade, Taiwan companies had already spent up to 190 billions New Taiwan Dollar (NTD) in U.S.A., Taiwan, and China patent prosecution and maintenance fee. Yet, if added up the cost of hundreds of transnational patent litigations, the total amount was up to 200 billions NTD and it did not include Taiwan companies had to pay out 150 billons NTD royalty yearly. 190 billions NTD for example could provide for twenty thousand employees and influence 470 thousand shareholders in Taiwan Semiconductor Manufacturing Company (TSMC). This certainly exhibited that Taiwan companies had been invested magnificently in R&D and patent prosecution.
However, examining the outcome of patent infringement litigations of Taiwan companies in last decade, it shows: (1) every year there are critical patent infringement litigations which influence the development of Taiwan industry; (2) litigations are throughout all important Taiwan industries; (3) in most of time, Taiwan companies are defendant , not plaintiff; (4) Taiwan companies reach the settlement with paying a great sum of indemnification and royalty mostly; (5) most Taiwan companies lose in the litigation.
As the above described, although Taiwan companies have invested enormous resources in R&D and patent prosecution, it does not change the situation which every year Taiwan companies are sued for patent infringement, have to pay out a great sum of indemnification and royalty, and certainly still stand in indifferent position of the R&D value chains. After all, what Taiwan companies obtain is not what they expect from their investments.
The cost of creation, protection, management of intellectual property include R&D, patent prosecution, patent litigation, royalty, and indemnification. Although U.S.A. companies invest a lot in R&D and patent prosecution, they usually earn back from patent litigation, royalty, and indemnification. However, Taiwan companies not only invest tremendous money and resources in R&D and patent prosecution, but also pay out much for royalty or the outcome of patent litigation. Obviously, Taiwan companies have some serious problems in their methodology of management transnational patent infringement litigations, thus it is very crucial to change their methodology immediately!
Taiwan theses and studies usually fall into “translating foreign papers, laws and regulations ”, “discussing the choice of some parts of cases”, or “studying theories excessively”, also almost no inquires into patent litigations in China. Consequently, the discussions and studies of patent litigations in Taiwan have never brought out the whole picture and practical actions of strategic management of patent litigations. Obviously, most studies spend too much efforts and resources on legal details and ignore the most important matter which is how international companies control and manage transnational patent litigation. As a result, Taiwan companies never learn how to win a patent litigation war.
Therefore, this thesis is different from other Taiwan theses because this thesis provides a mechanism of managing transnational patent infringement litigations. Prominently, this thesis covers patent litigation procedures and management in the most significant markets in the world—U.S.A. and China.
In the legal aspect, this thesis provides information on the complete litigation procedure in U.S.A. and China which includes cease and desist letter , service, pre-trial conference, markman hearing, discovery, trial, patent validity procedure, pre-trial injunction, protective injunction; in the management aspect, this thesis provides complete management strategies which shall be carried out as the regular basis and during a patent litigation while managing R&D, manufacture, marketing, finance, accounting, taxing, law firm and lawyer, expert, judge performing notarization. Most importantly, this thesis analyzes enormous patent litigation cases and industrial information, therefore this thesis is able to provide the first and never-seen practical structure for Taiwan companies to win a patent litigation war.
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技術標準必要專利與禁制令救濟之研究 / A Study of Injunctive Relief and Standard Essential Patent Infringement王柏翔, Wang, Bo-Hsiang Unknown Date (has links)
技術標準化與相關智慧財產權保護,一直以來為智慧財產權法與競爭法的交集與爭議的話題。其中又以標準必要專利侵權糾紛為主。基於標準必要專利權人與前在被授權人雙方的立場,其中目前最具爭議的問題應該涉及禁制令救濟的適用性或以F/RAND授權原則為基礎的抗辯來排除侵權。
標準制訂組織(Standard Setting Organization, SSO)訂定F/RAND授權原則承諾(Fair, Reasonable And Non-Discriminatory)於其智慧財產權政策,要求標準專利權人應以公平、合理且無歧視的授權條件,向所有標準實施者提供授權。F/RAND授權原則承諾之發展,目前趨向於強調專利權人的契約義務,以第三方受益人的立場來平衡授權當事人的談判地位;如何「符合F/RAND授權原則之授權」,目前各國尚未有明文法律解釋,對於F/RAND授權原則承諾之清楚定義與規範,目前僅有法院及競爭法主管機關之見解。
在標準必要專利訴訟中,台灣廠商處於被告之身分的狀況居多。面對禁制令的威脅,如何更清楚地了解目前各管轄法院的看法以決定訴訟或談判策略更是重要。本文整理美國、歐洲及亞洲國家之管轄法院案例,加上對競爭法架構下的標準專利授權規範的分析,最後整理如何讓F/RAND授權原則承諾成為對抗禁制令有效抗辯。希望本文能為涉及標準專利訴訟之台灣廠商提供有價值的參考意見。 / Technology standardization and intellectual property protection has been an overlapping and controversial issue between Intellectual Property laws and Competition Law, particularly when it comes to infringement on F/RAND encumbered Standard Essential Patent, SEP. From both standard essential patent owner and potential licensee’ perspectives, the most questionable issue is whether injunctive relief should be available to the holder of F/RAND encumbered SEP who committed to license on fair, reasonable and non-discriminatory (F/RAND) terms, in order to prevent a third-party implementer from practicing a standard reading on that SEP, when such implementer is willing to take a license but the parties disagree on the terms of the license.
Furthermore, the definition of F/RAND has never been clearly defined by statutes or interpreted by any judiciary; interested parties could only refer to decisions or guidelines made by the judiciaries or competition authorities in different countries. It is rather common for Taiwanese companies to face F/RAND encumbered SEP law suits as the defendants. Given the even severer threat of injunctive relief, it becomes more important to understand the position each judiciary takes on this issue to have appropriate strategies on law suits and negotiation.
This thesis is accordingly written on the following perspectives: firstly, starting with discussion about F/RAND-encumbered SEP law suits in the United States, Europe and Asia; secondly, bringing in SEP encumbered disputes or investigations into framework of Competition Law from competition authorities among different countries and lastly trying to present possibilities that F/RAND commitment as a cause of action under Contract Law can be applied as defense to overcome injunctive relief sought by F/RAND-encumbered SEP licensors. Meanwhile, this thesis is expected to provide Taiwanese companies valuable strategies to law suits or disputes involving F/RAND-encumbered SEPs.
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由美國聯邦最高法院廣達案判決後最新發展探討專利權耗盡原則之演變 — 以台灣資訊代工產業為中心 / Exploring the Evolution of the Doctrine of Patent Exhaustion After Quanta Case of the U.S. Supreme Court — Centering on Taiwan’s Information OEM/ODM Industry闕河國, Chueh, Ho Kuo Unknown Date (has links)
美國聯邦最高法院廣達v.LG案的判決結果,再次確認「專利權耗盡原則」之適用原則及標準。被告廣達電腦乃為台灣資訊代工產業的龍頭,該判決除了限制專利權人對產業鏈的不當控制外,也將影響整個產業供應鏈對於專利風險的承擔及專利授權策略。廣達案除了建立「未完成品足以體現專利物之必要特徵,且唯一用途係該專利物」及「方法權利項」適用專利權耗盡的重要標準,但也留下「附條件銷售或授權」合法性的爭議。在廣達案後續判決,對「專利權耗盡原則」的詮釋及適用,更值得加以重視。台灣資訊產業在產業供應鏈多居於「製造或組裝」角色,卻受制於上游關鍵元件的強勢及品牌客戶的訂單壓力,而被迫必須承擔產品引發的所有專利侵權的風險。如何善用廣達案及後續各國相關判決,將有助於台灣資訊代工廠商處理國際專利爭訟、專利授權等議題,並做為專利侵權抗辯手段的參考。
本論文首先從經營策略及代工模式,探討台灣資訊代工產業發展與面臨的困境。其次,從專利權與專利侵害的法律規範,到專利權耗盡原則的法理基礎做一完整論述,加以美國先前相關案例的整理及類型分析,對「專利權耗盡原則」的理論與發展做一完整的探討。更進而整理廣達案判決後美國、中國大陸及台灣重要案例,探討「專利權耗盡原則」在其專利法制及實務案例的適用及影響。接著,探討在「契約自由原則」與「專利權耗盡原則」的衝突與調和下,其對於專利授權實務的操作及影響。最後,整理台灣資訊代工產業的代工類型化與廣達案前後美國、中國大陸及台灣權利耗盡重要判決之關聯性,並提出看法及建議。本文初步結論,美國法院案例可初步解析侵權風險及專利權耗盡的適用,並在專利授權談判可提出有效因應條款。廣達案後,美國各級法院均大致遵守此一判決先例,惟中國大陸及台灣法院實務判決仍未完全採取美國的判斷原則。對於後續的研究建議,新興3D列印科技發展及應用,其引發的複雜智慧財產權及「專利權耗盡原則」適用的爭議,確實值得重視。 / Quanta v. LG reaffirmed the applicable principles and standards of the "patent exhaustion principle". As the Quanta plays the lead role in Taiwan’s Information ODM/OEM industry, this US Supreme court’s decision not only limits the patent holder improper control of the industrial chain, but also affects the entire supply chain face the risks and patent license strategies. Quanta establishes the index that "unfinished finished enough to reflect the essential features of the patent and the sole purpose thereof " and "method claim" apply to patent exhaustion. However, "conditional sale or license" is still controversial. Therefore, the Post-Quanta interpretation is worthy of attention. Taiwan's IT Industries most account for the role of "manufacture or assembly" in the supply chain. Subject to the upstream suppliers of the key components or downstream brand customers, they bear all risks caused by infringement of patented products. The Quanta case and its post development will help Taiwan Information foundries to deal with international patent litigation, patent license and etc., and take it as a means to defend against patent infringement claim.
Firstly, this thesis explores the development of Taiwan's information ODM/OEM industry and the difficulties of its business strategies and ODM/OEM models. Secondly, it turns to discuss the development of the "patent exhaustion doctrine", and then reviews US critical cases of "patent exhaustion doctrine". In addition, it analyzes post-Quanta cases of the United State, China and Taiwan to discuss the application and impact of the "patent exhaustion doctrine". Furthermore it explores its operation and effect on patent license practice under the conflict and reconciliation of "freedom of contract" and "patent exhaustion doctrine". Then, it identifies Taiwan’s information OEM/OEM industry in a variety of models and associates the models with the important cases of the United States, China and Taiwan regarding patent exhaustion, and makes remarks and suggestions. Finally, this thesis preliminarily concludes that US court cases basically resolve the risk of infringement and patent exhaustion application, and patent license negotiation may be made to respond effectively to the situation. After Quanta, US courts are substantially in compliance with this precedent judgment, but not for China and Taiwan. For subsequent study suggestion, it is worth attention about dispute of the emerging 3D printing technology development and application, which link complex intellectual property rights and the application of "patent exhaustion doctrine".
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藥品的核准前專利爭端解決程序- 美國專利連結為借鏡 / Pre-Approval Patent Resolution Process of Drug Product- Lessons From U.S. Patent Linkage吳東哲, Wu, Tung-Che Unknown Date (has links)
美國作為醫藥技術的領導者,為了確保其利益,並維持其領導地位,不斷在各種貿易談判場合,向世界各國施加壓力,要求提供醫藥品更強力的智慧財產保護。台灣當然也不例外,在加入跨太平洋戰略經濟夥伴關係協議 (Trans-Pacific Partnership Agreement, TPP)、簽訂臺美貿易暨投資架構協定 (Trade and Investment Framework Agreement, TIFA) 的壓力下,我國政府從2014年開始積極推動專利連結,雖然獲得美國商會肯定,但卻在國內業界卻引起十分強力的反彈。
專利連結,本質上只是核准前專利爭端解決程序 (Pre-Approval Patent Resolution Process) 的其中一個類型而已。核准前專利爭端解決程序,就是在特定產品上市核准的准駁中,把專利侵權問題作為准駁的考量。國際上類似的制度主要出現在人用藥品、動物藥品中,通常是在允許引據他人安全性、有效性資料的藥品中 (類新藥、學名藥)。
我國目前對類似制度的了解並不深,尤其缺乏對制度原生國-美國的全面性研究。本研究選擇以發展最早的藥品專利連結作為研究標的,並全面、深入分析其中每個機制的目的、立法/修法歷史 (含行政法規)、法院判決,探求其爭議的發展過程。在這個基礎上,本研究就引進的必要性、各種立法手段的選擇與優劣,提出「修正版柔性專利連結」,主要特徵在排除了自動停止核准期、重定核准日條款,使藥品審查和專利爭端大致維持獨立,並符合TPP的要求。希望本研究能夠幫助台灣建立一套明確、合理,且符合我國國情的核准前專利爭端解決程序。 / As the phamaceutical industry’s market leader, the United States continues to call for strengthening patent protection for pharmaceutical products during every trade negotiation, to preserve its national profit and leadership. Taiwan, being highly interested in joining “Trans-Pacific Partnership Agreement” (TPP) and signing “Trade and Investment Framework Agreement” (TIFA) with the United States, Taiwan's government is actively promoting the “patent linkage” since 2014. Althougn the effort done by Taiwan's government is extremely welcomed by American Chamber of Commerce, the domestic industry, which is mainly organized with generic drug manufactors, has expressed their opposition resolutely.
Patent linkage, as a kind of “pre-approval patent resolution process”, considers the possibility of patent infringement as a factor when issuing market approval. Such process are normally found in those countries that are trade partners of the United States, and espetially during the approval prosses of human-use drug products, animal drug products, which permits persons to rely on evidence or information concerning the safety and efficacy of a product that was previously approved.
Our current knowledge of pre-approval patent resolution process is limited, especially on how it was oranginally created in the United States. This research will focus on the purpose, enactment, amendment, court decisions, development, and issues of patent linkage, the first-of-its-kind which is established in 1984. On this basis, the reseach will then look back to what Taiwan has faced now, and provides recommendations on whether there is necessity of introdution, how to adjust the prosses, and how to enforce it, without serious abuse. This research propose “revised soft patent linkage”, which excludes automatic stay and re-date remedy, generally keeps the independence between drug approval and patent infringement, and at the same time meets TPP requirement. The research hopes to help Taiwan establishing its own pre-approval patent resolution, fair, clear and meet the need of domestic and public the industry.
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民法上抗辯權之研究阮詠芳, Juan, Yung-Fang Unknown Date (has links)
我國學者關於民法上抗辯權之著述,偏重於個別類型中重點問題的探討;本論文則係從總論的角度檢視抗辯權制度的共通問題。由於在抗辯權理論下,係以其法律效力—「排除請求權之實現性」,與強調效力的發生以抗辯權人之主張為必要—「主張之必要性」,作為該制度之兩大特徵;而質疑抗辯權制度之獨立性與正當性的學說,亦以撼動此兩大支柱為要務。是故,本論文即以抗辯權之「法律效力」及「主張之必要性」為兩大主軸,對民法上各個抗辯權進行分析整理,首先澄清何謂「排除請求權之實現性」,此等抗辯權效力所造成之法律狀態,與請求權消滅乃至於權利本身之消滅有何不同,是否仍不變動原有的法律關係,因而與形成權有別;其次探求強調「主張之必要性」的理由何在、能否貫徹,各該抗辯權以此特徵在訴訟法上與權利障礙抗辯及權利消滅抗辯區隔,是否均切合制度設計的意旨,並檢討目前學說實務對於訴訟上抗辯權主張之處理方式,是否能落實立法原意,或者有背道而馳的疑慮。
抗辯權制度起源於羅馬法時代程式訴訟中的exceptio,本屬訴訟法領域之概念,發展至今日卻成為實體法上權利,惟仍不脫濃厚的訴訟法色彩。因此,在抗辯權制度之研究上,諸多重要問題若未能兼顧實體法及訴訟法層面從事討論,往往失之偏廢而欠缺全面性的考量。有鑑於此,本論文整合了實體法及訴訟法之觀點,對於涉及此二領域交錯之問題,重新予以檢討,尤其,時值近期我國與德國民事訴訟法就相關規定均有重大修正之際,關於抗辯權之闡明與當事人及法院應盡之訴訟促進義務,更是著力的重心之一。
第一章緒論,提出研究動機及所欲探討的問題,並說明研究主軸、研究方法及論文架構。第二章介紹抗辯權制度之發展及其基本理論。第三章民法上個別抗辯權之學說與實務分析,針對第二章所列舉出之民法上抗辯權,以「法律效力」及「主張之必要性」為兩大主軸,個別討論其對請求權實現性之影響,以及抗辯權效力之發生,是否均以抗辯權人之主張為必要。第四章抗辯權之效力及其實現,首先整合第三章之內容,重新組織抗辯權之效力,以呈現「排除請求權之實現性」的具體內容;其次討論兩大爭議問題:已行使之抗辯權之「拋棄」,以及抗辯權排除債務人給付遲延責任之效力;最後檢討抗辯權與形成權之界線,思考抗辯權在實體法上之定位,是否能與形成權截然劃分。第五章抗辯權在訴訟上之處理,首先討論抗辯權之行使是否限於訴訟上主張,始生效力,被告在訴訟外主張抗辯權者,法院得否斟酌;又,訴訟上如何認定被告有無抗辯權之主張;其次討論法院就抗辯權之闡明權與闡明義務,指出向來通說實務關於得否闡明抗辯權之標準的問題所在,並呼應新法精神予以再檢討;最後,當事人及法院之訴訟促進義務亦屬不可忽略之一環,認為被告應於適當時期為抗辯權之主張,並在賦予當事人充分程序保障、防止發生突襲的前提下,透過爭點整理程序解決拋棄或撤回抗辯權主張之問題,同時確立兩造應受拘束之規範;而在法院善用現行民事訴訟法進行計畫性審理、集中審理下,採用一造辯論判決是否會不當剝奪被告主張抗辯權之機會的疑慮,應能降到最低。第六章結論,分為「從法制史中獲得之啟示」、「關於現行法制下之解釋及適用」、「關於立法論上之建議」三部分,總結本論文對抗辯權之過去、現在、未來的看法。
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