臺灣創新藥與學名藥專利之平衡與發展──以美國、臺灣學名藥之豁免為例

全球多數國家藥品的價格昂貴，其原因由於專利成本較高所致。各國政府為全民健康之福祉考量，鼓勵在創新藥之專利保護期到期之後，價格低廉的學名藥能夠及時上市，以減少醫療費用之巨額開支。為此WTO在杜哈宣言後，將「與貿易有關的智慧財產權協議」（ Agreement On Trade-related Aspects of Intellectual Property Right,TRIPs）中涉及相關藥品專利仿製試驗免責（下稱「試驗豁免」）之條款修改為，「生產企業、進口國、進口貿易商在急難環境，非營利公共目的的前提下不侵犯專利人之權利，且該強制授權不以僅供進口國內國使用，而是可以將該藥品再次出口至有需求（regional trade agreement）之發達和發展中國家」。在此前，Bolar例外和Hatch-Waxman法案是美國最早提供學名藥更快進入市場的兩項規則，其中試驗豁免條款是引用國家最多且影響最大的內容之一。而臺灣則在Bolar例外和Hatch-Waxman法案後，結合了杜哈協議，在專利實務和法規中進行試驗豁免的相關規定。本文討論之核心，基於討論美國學名藥的專利豁免制度，從其立法沿革入手，探討從Bolar例外到Hatch-Waxman法案的制度發生之緣由和制度之內容；同時通過分析臺灣關於藥品專利豁免之相關規定，進而探討臺灣專利豁免制度與美國相關法之異同。進而立足於臺灣之本土藥品市場，探尋藥品專利中權利人之私有壟斷利益和學名藥公共利益之平衡點1，供臺灣立法及處理實務之參酌。

In most countries, the price of medicines is high, due to the high costof patents. In consideration of the welfare of the whole people, governmentsencourage the low-cost generic drugs to be listed in time after theexpiration of the patented drugs, so as to reduce the huge expenses ofmedical expenses. To this end, the WTO revised TRIPs as “production enterprises,importing countries, and import traders do not infringe the rightsof patent holders under the premise of non-profit public purposes, and thecompulsory authorization is not for use only by importing domestic countries.”Instead, the drug can be re-exported to developed and developingcountries with regional trade agreements. The Bolar Exception and Hatch-Waxman Act are the first two rules in the United States to provide genericdrugs enter the market faster, and experimental exception is one of themostly cited and most influential clause in the world. Taiwan is subject tothe Bolar Exception and the Hatch-Waxman Act, combined with the Doha Agreement to test exemptions in patent practice and regulations. The coreof this paper is based on the discussion of the patent exemption system ofgeneric drugs in the United States, starting from its legislative development,discussing the reasons and institutional contents of the system fromBolar exception to Hatch-Waxman Act. Meanwhile, Taiwan patent exemptioncase is analyzed to further explore the similarities and differences betweenTaiwan’s patent exemption system and US relevant laws. Basedon the local pharmaceutical market in Taiwan, the balance between theprivate monopoly interests of the drug patents right holders and the publicbenefits of generic drugs is explored, which could be a discretion for Taiwanlegislation and handling of practices.