解析生技製藥研發成果涉及智慧財產保護之新課題

Emerging Issues Related to the Intellectual Property Protection of Biopharmaceuticals

黃慧嫺

《科技法律透析》 20卷12期 (2008/12) Pp. 19-43

https://doi.org/10.7062/STLR.200812.0019

摘要

在美歐先進國家，製藥產業研發創新所涉及的智慧財產保護，脫離不了競爭角度的觀察與公益目的的調和，因此其製藥領域智慧財產保護法制的設計，往往是在第一位取得新藥上市許可的研發型藥廠與同類藥品的後續上市申請者（主要爲學名藥廠）之間，尋求利益的平衡點，1984年美國藥品價格競爭及專利回復法（Drug Price Competition and Patent Restoration Act，又名Hatch-Waxman Act, HWA）的制定，正是最好的寫照。
值得注意的是，美歐當前對於製藥產業所建立起來的智慧財產保護機制，乃是在化學藥品主導醫療照顧體系的時空背景所發展出來的，其藥物管理法規乃是針對化學藥品的管理與競爭遊戲規則規範。這些「傳統的」保護機制適用在「未來的」將由生技藥品獨領風騷的醫療環境，是否可以發揮如同其鼓勵化學合成新藥研發的效果，深受先進國家所關注。
2007年，美國國會先後提出「拯救生命藥品取得法案」(Access to Life-Saving Medicine Act, ALSMA, H. R. 1038, S. 623)、「生物藥品價格競爭與創新法案」(Biologics Price Competition and Innovation Act of 2007, BPCIA, S. 1695)兩個相關法案，其中對於生技藥品與生物仿製藥的遊戲規則的設計，展現出美國國會意識到生技藥品與傳統化學藥品的本質差異，因而提出了有別於HWA的設計。
生技藥品爲我國藥事法的適用對象，故藥事法中有關鼓勵創新研發與智慧財產保護的規定，自應適用於生技藥品，藥事法並未區分化學藥品與生技藥品而分別訂定其保護規定，然而，生技藥品有其特殊性，比起化學藥品，研發者的產業利益被不當侵蝕的可能性更高，因此乃有加強其智慧財產保護之呼聲。本文嘗試從生技藥品與化學藥品的差異性切入，鎖定生技製藥研發創新涉及的研發成果保護（即智慧財產保護）議題，探討在製藥領域智慧財產之「既有」保護法域，對於生技藥品研發的適用性。

關鍵字

生技藥品 ； 市場專屬保護 ； 資料專屬保護 ； 研發成果保護

並列摘要

In developed countries, government's IP policy design to stir R&D investment by pharmaceutical industries implies the merits of benefit-balancing between incentives to innovative, industry competition and public welfare. The US Drug Price Competition and Patent Restoration Act of 1984 is such an example.
While the current IP protection regime for the pharmaceutical industries is established during a timeframe when the chemical drugs dominated the healthcare system, whether such ”traditional” IP protection regime is suitable to apply on ”future” biopharmaceutical products is still not clear. Moreover, whether applying existing IP protection regime results in the same incentive effects on biotech industry is becoming a critical issue. Legislative movements focus on addressing this issue have been initiated constantly, such as the ”Access to Life-Saving Medicine Act” (S. 623 IS & H.R. 1038 IH), ”Biologics Price Competition and Innovation Act of 2007” (S. 1695 RS), ”Pathway for Biosimilars Act” (H.R.5629 IH), ”Patient Protection and Innovative Biologic Medicines Act of 2007” (I.H. 1956 IH) etc. in the 110th US Congress.
The 21st century heralds the ”biotechnology revolution”. Biotechnology with its highly potential is regarded as ”star” industry by Taiwan government. In the past two decades, the Government has demonstrated its commitment to infrastructure buildup, biotechnology R&D and its applications, among other, government funding on the biopharmaceutical related and gene-based R&D prevail over other biotech field.
Under the Taiwan drug law, Biopharmaceutical products fall in the scope of this law. Theoretically, the IP protection regime in drug law, especially data exclusivity, applies also for biopharmaceutical products. However existing Taiwan drug law is designed and developed to apply for chemical drug. Hence, further study on this issue is need. This article examines the IP protection regime in Taiwan, taking special attention on that in drug law; and analyses its adequateness in the context of biopharmaceutical products.

並列關鍵字

biopharmaceuticals ； biologics ； biopharmaceuticals ； biological products ； biological drug ； biotech drug ； biological medicinal product ； market exclusivity ； data exclusivity