學名藥上市審查之專利連結制度：從美國經驗檢證其存立基礎與制度設計

Patent Linkage in Generic Pharmaceutical Marketing Approval System: A Critical Assessment of Experiences in the United States

王立達(Richard Li-Dar Wang) ； 陳蔚奇(Wei-Chi Chen)

《臺大法學論叢》 39卷4期 (2010/12) Pp. 349-406

https://doi.org/10.6199/NTULJ.2010.39.04.07

摘要

作為世界上最具影響力之國家，美國不斷透過貿易協商與制裁之手段，希望延伸其制度理念至他國，藉以降低貿易障礙並保護本土產業。近年來該國亟欲引介「專利連結」制度進入台灣，即為一顯例。所謂專利連結制度，係指學名藥上市審查或政府之藥品定價與保險給付決定，與其是否侵害原廠藥品專利連結在一起。本文擬針對此一主題，探討美國專利連結制度所包含的多重複雜環節，依其至今實際施行狀況，是否具有充分的正當化基礎，可以解決現實問題並導引國內產業蓬勃發展。本文擬透過文獻研究，就美國專利連結之制度結構與配套措施，進行通盤檢討並評估其立法缺陷，同時援引世界貿易組織與美國實務案例加以印證，藉以釐清專利連結制度之真正核心要素，並且指出美國現制下包含過多保護原廠專利之週邊措施，所造成的可觀負面影響。

關鍵字

學名藥 ； 專利連結 ； Hatch-Waxman Act ； 藥品專利 ； 上市審查

並列摘要

As one of the most powerful countries in the world, the United States has been constantly promoting its legislations to countries around the world through trade negotiation and threat to sanction, for the purposes of abating trade barriers and pursuing its own interest. In recent years, for instance, the United States has been trying zealously to introduce the ”patent linkage” system into Taiwan. ”Patent linkage” means that the marketing approval of generic drugs or the payment of medical insurance are ”linked” to the judgment of whether the generics infringe a valid patent held by a brand-name pharmaceutical company on the same type of drugs or not. Focusing on this issue, the authors firstly makes further discussion into the complexity of the patent linkage system in order to examine whether the system is fully justifiable, and try to evaluate whether it in reality resolves the problems it was set to settle and facilitates the development of domestic pharmaceutical industry. Secondly, this article evaluates thoroughly the pros and cons of the existing patent linkage system in the U.S. by means of literature review and case study. The authors find that most of the negative effects that the system now brings about result from its pro-brandname measures, which not only stifle generics competition and accessibility in the pharmaceutical market but also are not essential for the system to fulfill its mandate. Even if Taiwanese government finally chooses to adopt patent linkage, these injurious side measures should not be introduced altogether.

並列關鍵字

generic drugs ； brand-name drugs ； Hatch-Waxman Act ； pharmaceutical patents ； marketing approval

參考文獻

《各國學名藥狀況》。載於中華民國學名藥協會網站http://www.tgpa.org.tw/Disc_2.html（最後瀏覽日：11/02/2010）。（The circumstances of Generic Drugs Industries development in different countries. [n.d.] Retrieved from http://www.tgpa.org.tw/Disc_2.html）

台北市美國商會（2008）。《美國商會2008 年台灣白皮書產業議題與回應》，載於行政院經濟建設委員會網站http://www.cepd.gov.tw/m1.aspx?sNo=0010599（最後瀏覽日：01/02/2010）。（American Chamber of Commerce In Taipei [2008]. The 2008 Taiwan white paper concerned industrial issues and responses. Retrieved from http://www.cepd.gov.tw/m1.aspx?sNo=0010599）

台北市美國商會（2009）。《美國商會2009 年台灣白皮書產業議題與回應》，載於行政院經濟建設委員會網站：http://www.cepd.gov.tw/m1.aspx?sNo=0012121（最後瀏覽日：01/02/2010）。（American Chamber of Commerce In Taipei [2009]. The 2009 Taiwan white paper concerned industrial issues and responses. Retrieved from http://www.cepd.gov.tw/m1.aspx?sNo=0012121）

王立達(2008)。限制競爭之專利侵害和解：尋求合適分析架構。全國律師。12(1)，51-62。

王立達(2009)。TRIPS 協定之例外條款：以概括型例外條款為中心。政大法學評論。107，83-127。