探討因應醫藥品專利之合理措施

The Study on the Reasonable Measures Balancing Pharmaceutical Patents

陳文吟(Wen-Yin Chen)

《中正大學法學集刊》 8期 (2002/07) Pp. 67-112

https://doi.org/10.30094/NCCULJ.200207.0002

摘要

基於鼓勵保護發明及國民健康福祉，賦予醫藥品專利不失為正確的政策，然而，在賦予專利的同時，應一併考量其負面影響，並宜審慎處理。
美國藥廠與南非的醫藥專利爭議，凸顯高收入的已開發國家與低收入的開發中或低度開發國家間對醫藥品專利的對立立場。我國以已開發國家成為WTO的一員，已開發國家的立場固足供我國借鏡；然觀諸我國核准的醫藥品專利案件係以外國業者居多，開發中國家維護國民健康的經驗以及國際間對低度開發國家的建議，亦足以為我國面臨類似問題的參考。
真品平行輸入增加國內市場上的競爭，強制授權平緩供不應求的窘境，亦可增加市場上的競爭；二者均可達到平穩藥價的效果。惟，低收入開發中國家如何尋得低價來源俾進口藥品，恐為其能否順利採行真品平行輸入的首要關鍵。強制授權的先決條件為其本國業者有製藥能力，此為工業落後國家的另一難題。抑價措施雖為多國所採行，對低收入開發中國家（包括低度開發國）卻未必適宜，因其可能導致藥廠退出其市場；反之，價格區分制的合理優惠價格以及市場區隔，兼顧患者及藥廠權益。論者建議採行價格區分制輔以國際經濟援助，當可更有效地解決低收入開發中國家的醫藥問題。
以美國為首的已開發國家，亦有面臨藥價過高之虞。美國雖極力反對專利強制授權，惟，揆諸其立法暨司法實務，其廣泛運用強制授權俾達到公共利益的立場，可謂係主要工業國家之最，當則足以解決藥價過高及供應不足的問題。美國為確保專利權人之權益，禁止真品平行輸入，更為鼓勵藥廠的研發而未採行抑價措施。是以，美國僅得藉由強制授權暨市場的自由競爭，達到平穩藥價的目的。
我國採行抑價措施，處方藥價較為合理；倘藥品供不應求、或藥價在抑價措施下，仍超乎大多數民眾之經濟能力者，強制授權（特許實施）及國際耗盡原則當足以發揮其足量供應及平抑價格的功能。
無論任一國家決定採行增進藥品供應及平穩藥價的措施時，宜權衡其國內客觀環境暨前揭各制度之利弊，採行最適度的措施。

關鍵字

醫藥品專利 ； 強制授權 ； 特許實施 ； 真品平行輸入 ； 抑價措施 ； 價格區分制 ； 市場區隔 ； 專利權濫用 ； 耗盡原則

並列摘要

It has been well established that to provide patent protection for pharmaceuticals is the best way to promote innovations and public health & welfare. However, for the past decades, AIDS disease brought us to reconsider the potential problem (or we should say real problem) arose from pharmaceutical patents, especially the dispute between South Africa and the U.S. pharmaceutical industry.
It's not right to delete pharmaceuticals from the list of patentable subject matter, what we should do is to figure out the proper measures to solve the problems it brought (or will bring).
Compulsory licensing and parallel imports, price control and tiered pricing are considered to be reasonable measures to prevent patent misuse, and, to protect public welfare as well. But, not all of them are good to each country of the world.
For instance, to those less/least developed countries, compulsory licensing isn't fit for them due to their lacking of manufacturing capacity; parallel imports is not a good measure to them either, because there is no place to find where the drug price is lower than that in their own countries. So do the price control raise some problem. Tiered pricing and international financial assistance shall be the only and proper measure for less/least developed countries to solve their pharmaceutical problem.
To those developed countries and the top level of developing countries, including our own, the measures mentioned may be proper except tiered pricing which is deemed to be applied to the less/least developed countries.
In sum, when a country decides to take some measure to protect public health, it shall consider the advantage as well as disadvantage or risk so as to make a right decision.

並列關鍵字

Pharmaceutical Patents ； Compulsory Licensing ； Parallel Imports ； Price Control ； Tiered Pricing ； Market Segment ； Patent Misuse ； Exhaustion Doctrine