| 英文摘要 |
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. |
