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我國土地登記審查有關切結問題之探討王文美 Unknown Date (has links)
為了加速土地登記案件之審查速度,地政機關針對若干審查事項,改以「切結」來簡化應附文件。但此種審查方式,一方面除了使我國土地登記究係採何種審查制度迄今仍無明確之見解外;另一方面,對於任何土地登記應附文件是否皆能以「切結書」替代,或其能運用之界限為何,本文即就此等問題進行審視。
經本文從行政法學之角度審視「切結」,其在不同的行政行為當中,具有不同之概念,而此等概念經實體運作於各種行政流程作業當中,則可分為六種性質,即(一)具有申請性質之切結。(二)具有同意性質之切結。(三)具有準負擔性質之切結。(四)具有行政契約性質之切結。(五)屬管制手段之切結。(六)屬真實性表示性質之切結。又再將其與土地登記制度進行探討後發現,地政機關除了就「真實性表示」性質之事件,得命申請人提出切結書外,其餘類型則不得以切結書予以替代。
又依行政程序法第36條:「行政機關應依職權調查證據,不受當事人主張之拘束,對當事人有利及不利事項一律注意。」及同法第43條:「行政機關為處分或其他行政行為,應斟酌全部陳述與調查事實及證據之結果,依論理及經驗法則判斷事實之真偽,並將其決定及理由告知當事人。」之規定,當事人於程序中所提出之相關證據,行政機關就仍負有調查義務,故縱使申請人已檢附「真實性表示」之切結書,該切結書之內容是否真實,依法仍屬地政機關之調查職責。
在個案實證方面,目前土地登記所使用之39項切結書,僅有9種情況因地政機關之相關作為已臻其依職權所能調查之界限,故此9項具有「真實性表示」之切結,其用於協力地政機關之調查並無不妥;而其他則不宜以切結之方式作為簡化土地登記應附文件,而應改以其他行政手段進行審查。
經由本文之研究,由於切結書之提出,原則上仍不構成主觀舉證責任或證據提出責任,同時客觀舉證責任仍由地政機關負擔,因此,未來地政機關應務實地考量,是否應完全停止使用「切結書」於土地登記審查制度當中,並針對地政機關「已盡其調查責任」亦無法完成審查之類型,從法律層面進行改善,將該等責任以法律明定為申請人負責事項,方能有效解決以切結取代土地登記應附文件所引發之相關問題。
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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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