資料專屬權與專利保護制度之競合：以美國藥品上市法制為中心

The Coopetition between Data Exclusivity System and Patent System-Focusing on American Law

夏禾(Ho Hsia) ； 陳鋕雄(Chih-Hsiung Chen)

《智慧財產評論》 12卷1期 (2014/06) Pp. 117-191

https://doi.org/10.30387/NCCUIPR.201406_12(1).0004

摘要

藥品的資料專屬權制度從誕生至今一直是個充滿爭議的制度，其中一個重要的爭議即為資料專屬權制度與專利制度間在實質功能上的競合關係。從製藥產業的發展歷史來看，專利制度在學名藥之簡易上市程序出現後，開始在製藥產業中扮演起舉足輕重的角色，發揮著提供藥品研發誘因的實質功能。而當製藥產業已經存在有此一強力的誘因機制時，何以制度上還需要資料專屬權來提供更多的誘因，誠為一值得進一步探究的問題。本文透過文獻分析與實證研究的結果，認為：考量到專利制度在製藥產業的實務運作模式，不同類型的專利以及不同類型的藥品技術，均會影響專利保護實質的範圍與效果；加以學名藥廠對專利連結機制下的paragraph IV挑戰制度之操作日益成熟，資料專屬權對於藥品研發所能提供之誘因及影響性，其實經常是被低估的。進一步言之，資料專屬權的存在，讓藥開發藥廠有更強大的誘因，去將具醫療價值的治療成分開發成消費者能夠近用的藥品。此外，在專利取得因KSR案後之實務趨勢而日益困難的非新成分新藥領域，資料專屬權的重要性更可能會超越專利，成為主要的誘因提供機制。爰此，本文以為資料專屬權實為一有效的政策工具，可望能填補專利制度運用到製藥產業的缺陷，有助於新藥上市法規體系之完整性，以及公益與私益間的平衡。

關鍵字

資料專屬權 ； 專利權 ； 專利要件 ； 非新成分新藥 ； 橘皮書

並列摘要

Pharmaceutical data exclusivity has been a controversial system since the day it was created, and one of the important controversies is the competitive relationship between the practical function of the data exclusivity system and that of patent system. If we trace back to the history of pharmaceutical industry, it can be noticed that after the ＂abbreviated new drug application＂ system was introduced in this area, patent system started to exert its function of supplying inducement to encourage the research and development of pharmaceutical products. However, since we already have this powerful system to supply inducement, is it necessary for us to have the data exclusivity system? In this article, we use documentary analysis and positive research to show that in practical operation of the pharmaceutical industry, different kinds of patents and pharmaceutical technologies may influence the protective effect of the patents; moreover, generic pharmacies are getting familiar with the paragraph IV challenge approach under patent linkage system, the possibility for patents to be revoked is way higher than before. Because of the practical situations stated above, we think the inducement and the effect of data exclusivity are always underestimated in fact. To be more specific, data exclusivity system can supply more sufficient inducement to research-based pharmacies, urging them to develop the valuable pharmaceutical ingredient to real pharmaceutical products which are available to the consumers. In addition, because of the practical trend of the post-KSR era that it's more difficult to get non-compound patents, data exclusivity may act as a protagonist supplying ample inducement to the invention and development of noncompound new drugs. In conclusion, data exclusivity can be an effective tool of policy which is possible to be used to make up the flaws of the real practice of patent system in pharmaceutical industry, helping to perfect the legal system related to new drug approval system and the balance between public interest and private interest.

並列關鍵字

data exclusivity ； patent right ； the requirements of patent ； non-compound new drug ； patent and exclusivity information addendum