Abstract
摘要:本計畫擬從智慧財產法與競爭法之觀點,探討醫療、製藥產業於其研發、產銷階段所面臨之相關法律問題,思考如何一方面賦予適當誘因、維持醫療、製藥產業繼續的研發、創新與有效率的生產,另一方面則從維護該等市場自由且公平競爭之觀點,確保市場競爭機制之發揮不會受到不當阻礙,導致醫療、製藥產業中有限制競爭情事發生,阻礙研發、創新之進展。於此認識下,本計畫預定利用三年時間,探討下列各項議題。
首先,於第一年之計畫執行期間中,研究下列課題:
一、 基因專利、醫療方法專利等新型態的專利客體對於專利法制之衝擊
二、 競爭法對於專利權等智慧財產的權利行使之介入可行性與界限
三、 新藥資料專屬權之保護意義與功能,其阻礙學名藥上市可能引發之競爭法課題
其次,於第二年之計畫執行期間中,研究下列課題:
一、 基因專利、醫療方法專利等新型態專利對競爭法所帶來之挑戰,特別是以獨占地位或優勢地位濫用為中心,進行檢討
二、 ESTs(Expressed Sequence Tags)、蛋白質的立體結構資料、篩選檢方法、試劑、遺傳工程鼠、低分子化合物等「研究工具」(Research Tool),其專利取得可能性與可行性
三、 Research Tool拒絕授權、訂定Reach-Through授權契約時可能引發之競爭法問題,以及專利法、競爭法就此之強制授權可行性分析
四、 製藥產業之行銷手法與競爭法之規範問題
最後,在第三年的計畫執行期間中,則以前二年所提出之各該問題為基礎,嘗試從調和智慧財產法與競爭法之規範,提出可能的解決作法:
一、 醫療製藥產業中之強制授權與關鍵設施理論二者之特殊性
二、 專利法上研究、實驗之例外規定解釋的應有方向
三、 於促進生命科學領域之研發自由目標下,美國1999年「Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomaterial Research Resources」、OECD 2006年「Guidelines for the Licensing of Genetic Invention」、日本2007年「生命領域之Research Tool利用順暢化指針」等之規範內容
四、 借鏡Free Licensing、Creative Commons、Collective Licensing Organization、Patent Pool等作法或制度,思考我國醫療製藥產業未來有關基因專利、Research Tool專利應有之授權作為
Abstract: This research project tries to explore the interface between competition laws and intellectual property laws in medical and pharmaceutical industries. As recent developments have witnessed the prosperity of patents in these two industries, some commentators have showed their worries about these developments. The reasons lie on the facts that many medical or pharmaceutical patents have been abused and wielded against public interests. However, competition laws in Taiwan up to now did not interfere with the enforcement of intellectual property rights by right-owners. That situation contrasts with its foreign jurisdictions’ counterparts.
Being concerned with the recent development mentioned above and witnessing the inaction of Taiwan’s competition authority, this research aspires to provide some theoretical basis to curb the possible abuse of medical and pharmaceutical patent holders. Basically, it aims to provide appropriate incentives for medical and pharmaceutical industries to continue their R/D on one hand, and to curb their possible abusive behavior via competition law on the other.
This project designs a 3-year research program and the subjects it expects to study include the followings: (a)genome patents’ patentability and its impacts on patent law; (b)competition laws’ interference with the enforcement of IP right-owners; (c)data exclusivity and its competition with generic drugs; (d)competition laws’ regulation toward genome patents; (e)research tools’ patentability; (f)competition law regulations concerning refusal to deal of research tool owners and its relations to reach-through licensing contracts; (g)marketing and competition law regulations in pharmaceutical industry; (h)compulsory licensing and essential facilities in medical and pharmaceutical industries; (i)the fair use regarding research and experiment in patent law; (j) the regulations of U.S.”Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomaterial Research Resources” of 1999, OECD “Guidelines for the Licensing of Genetic Invention” of 2006; (k)what Free Licensing、Creative Commons、Collective Licensing Organization、Patent Pool can teach on research tool patents.
Keyword(s)
競爭法
智慧財產法
醫藥產業
研究工具
強制授權
competition law
compulsory licensing
intellectual property law
pharmaceutical and medical industry
research tool