專利連結(Patent Linkage)-藥品研發與競爭之阻力或助力？談藥品查驗登記程式與專利權利狀態連結之發展（下）

"Patent Linkage"-Impediment or Stimulant to Pharmaceutical R&D and Competition? An Overview on the Development of the Interaction between Patents and Pharmaceutical Regulatory Approval

黃慧嫺

《科技法律透析》 21卷3期 (2009/03) Pp. 32-48

https://doi.org/10.7062/STLR.200903.0032

摘要

一般而言，藥物主管機關在考量是否准許新藥上市時，皆以藥品之品質、安全性輿療效爲審查標准，至於申請人申請上市之藥品有無侵害他人專利，並不在考量之列，這除了是基於主管機關之權限使然，更是由於專利侵權輿否屬於私權爭議，理應由主張權利受到侵害者，依一般訴訟程式訴請法院救濟輿保護。然而，近來製藥産業界卻出現應否將藥品審查程式輿專利效力加以連結（以下簡稱：「專利連結」）之爭議，其後續發展如何頗值關注。
「專利連結」(patent linkage)概念上係指將學名藥(generic drug)的上市審查程式，輿其參考的原開發藥廠藥品(the originator reference product)的專利權利狀態連結(patent-registration linkage)在一起；進一步言，一旦首個新藥通過藥物主管機關的審查上市後，只要在該新藥相關的專利有效期間，主管機關不應核准該新藥之仿製藥品上市。在藥品上市審查之過程中連結到專利權利狀態之目的，係爲確保學名藥不得在原開發藥廠之專利到期前上市，同時藉此降低學名藥一旦於上市後被控侵權敗訴，因藥品回收銷除且不得繼續販賣製造的結果，反而造成藥品供給面的問題，影響病患用藥之權益。
鑑於專利連結乃是美國法制下特有之産物，故本文從美國專利連結制度之概念、制度建立考量及遊戲規則切入，其次探討專利連結制度推及於美國以外國家的緣由，進而就美國以外已實施專利連結國家的法制面之具體實踐情形加以介紹，最後深入研析我國若實施此一機制將可能對我國藥廠産生何等影響，以及政府及業界可以思考的因應方式，供各界參考。

關鍵字

專利連結 ； 專利扣合 ； 學名藥 ； 仿製藥 ； 類新藥 ； 藥品價格競爭及專利回復法 ； 橘皮書

並列摘要

Basically, a national drug authority approves or registers a new drug only when it meets the standards of safety, efficacy and quality required by laws. Whether an applicant infringes others' patent rights will not be considered during drug examination procedure. The rational behind this is that the patent rights belong to private right, hence, the applicant shall implement his/her right himself/herself through court actions. The drug authority does not have such a duty to ensure his/her patent rights been protected within the regulatory review process. However, there is a tendency that the R&D-based pharmaceutical industry is eager to asking the drug authority not to approval a drug (usually a generic drug) before the not-infringement-status of the drug related patents being cleared. Such an appeal to the drug authority is named ”patent linkage” or ”patent-registration linkage”, which was first regulated in the US Hatch-Waxman Law of 1984.
Although ”patent linkage” or ”patent-registration linkage” is not a TRIPS obligation, the US trade representative however, has, the tendency to ask its foreign trade partners to modify their national drug laws to include such kind of provisions. This has been showed in many of the Free Trade Agreements (FTAs) the US signed with its foreign trade partners. Since on one hand it is Taiwan Government's endeavour to have a FTA signed with the USA; on the other hand, however, FTA provisions including a commitment to implement the ”patent linkage” regime will bring enormous impact on Taiwan's generic-based pharmaceutical industry, the government should therefore take special attention to the issues surrounding with ”patent linkage”. This article begins with examining the ”patent linkage” regime under Hatch-Waxman Law, its abusing practices and recent rectification. Then it is followed by introducing how other countries implemented ”patent linkage” regime react in their laws. It is not the intent of this article to provide detailed suggestions on how Taiwan should introduce this regime, but to identify special concerns in Taiwan while considering whether or not to introduce this regime.

並列關鍵字

patent linkage ； patent-registration linkage ； generic drug ； HWA ； Hatch-Waxman Act ； Orange Book ； paragraph IV ； ANDA

參考文獻

SOR/93-133, available at http://laws.justice.gc.ca/en/p-4/sor-93-133/161377.html (last visited on 13 November 2006).

Valiquet, Dominique(2006).The Patented Medicines (Notice of Compliance) Regilations.Report for the Parliamentary Information and Research Service.(Report for the Parliamentary Information and Research Service).,未出版.

Canada Gazette II, Vol. 132, No. 7, 1998, p.1501

Canada Gazette II, Vol. 133, No. 21, 1999, p.2355

Section 4 (6), Section 3 (4), Section 7, Section 6 (5), Section 6 (1), Section 5 (1)(b), Section 3, Section 4 of the NOC Regulations (1993)