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    题名: 逆向付款（Reverse Payment）之法律爭議與政策研究
    其它题名: The Research on Legal and Policy Issues Concerning Reverse Payment
    作者: 馮震宇
    贡献者: 國立政治大學法律學系
    行政院國家科學委員會
    关键词: 逆向付款;藥價競爭及專利權延長法案;學名藥;實驗免責
    Reverse Payment;Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act);Generic Drug;Experimental Use Exemption
    日期: 2011
    上传时间: 2012-11-26 09:38:45 (UTC+8)
    摘要: 隨著諸多專利藥品將在 2013 年開始面臨專利權屆滿的問題，再加上新的專利藥品沒有辦法立即通過美國食品藥物管理局（FDA）的審查，使得專利藥品產生一個巨大的斷層，這也給學名藥廠一個難得的機會。在此趨勢下，專利藥廠一方面藉由購併方式紛紛殺進學名藥領域，另一方面則採行各種方式以避免學名藥廠的挑戰，除了與學名藥廠進行專利權有效與否的訴訟之外，更有部分藥廠採行逆向付款或逆向和解（Reverse Payment or Reverse Settlement）的方式，與學名藥廠和解，以避免學名藥廠分食其專利藥之市場，但是這種模式也引發諸多的法律與政策爭議。有鑑於台灣學名藥業者已經逐步開始茁壯，並開始進入國際市場，再加上專利法修正草案中確立實驗免責之規定，凸顯政府鼓勵學名藥發展的政策目標，因此台灣業者實有必要了解美國在處理學名藥的法制與相關的訴訟經驗，以及美國為了保護學名藥的可取得性所進行的相關修法（例如「保護可負擔學名藥取得法案」）。更重要的，則是了解國際間學名藥廠如何透過美國Hatch-Waxman Act「簡化新藥申請規定」（ANDA）之規範爭取學名藥上市，特別是第四類專利證明（Paragraph IV Certificate）之相關專利爭議與其衍生的逆向付款與逆向和解的法律爭議與政策考量問題，並探討我國學名藥市場的相關因應與配合。本研究也將配合我國實務以及專利法修正案的變革提出全面性的建議，期望能提升我國學名藥產業的發展及其在全球市場的競爭力。
    Over the years, the development of the generic drugs were lagging far behind the development of the patented drugs. However, over the next few years, generic drugs are positioning themselves for a brand new environment for fast deployment. One of the reasons is because many patented drugs’ patent protection will be expired starting from 2013. The other reason is because there are fewer new drug candidates in the pipe line. As a result, many big pharmaceutical companies are trying to get involved with the generic drug market so as to maintain its market shares and market position. The approaches used by those pharmaceutical companies include file patent infringement law suit against the generic drug makers, the other alternative is adopting the so called "reverse payment” to settle with the generic drug maker so that both parties can share the market. Because such "pay-for-delay" settlements postpone the possibility of competitor’s entry, they have attracted the attention of antitrust enforcement authorities, courts, and commentators. With respect to this thorny issue, the U.S. appellate courts have been blessing these settlements. And as the Supreme Court has accepted the appeal, it is becoming ever more apparent that Supreme Court and Congress will play a crucial role in addressing this problem. In Taiwan, the TIPO has proposed "experimental use exception" in the latest revised version of patent law. If this version is passed by the Legislative Yuan without further amendment, this will create a sound environment for Taiwan`s generic drug industry. Meanwhile, since U.S. is the largest drug market in the world, Taiwan’s generic manufacturers must carefully consider issues arising from reverse settlement litigation and pay special attention to FTC’s outright-ban attitude. In our research project, we aim at analyzing the general trends of generic drugs issues in U.S., so that Taiwan`s generic drug manufacturers will be able to obtain strategic advice regarding reverse settlement risks and eventually withstand global competition. The research will also aim at to explore and analysis the related legal and policy issues regarding reverse payment so as to clarify the dispute surrounding the generic drugs.
    關聯: 基礎研究
    學術補助
    研究期間:10008~ 10107
    研究經費:375仟元
    行政院國家科學委員會
    計畫編號NSC100-2410-H004-021
    数据类型: report
    显示于类别:[法律學系] 國科會研究計畫

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