中國新修正專利法涉及生技製藥產業之重要規定及其影響觀察

隨著兩岸搭橋、ECFA開啟兩岸新局，國人對於開啟中國市場躍躍欲試，尤其是兩岸智慧財產權協議似乎對台商承諾了更爲安全的研發創新保護環境，可以預見未來兩岸產學研界的互動交流將越來越密切，且兩岸之間的互補將不僅止於製造面，也將往前推進到技術研發與合作。在後ECFA的環境中，我國產學研界取用對岸資源、跨大市場佈局的機會增加，因應此股搶進中國的趨勢，意謂未來中國法律風險的管理不容忽視。本文將以中國新修正專利法爲例，除介紹這些新修正規定中涉及生技製藥產業之重要規定外，並作出其影響之初步觀察，以供國內生技製藥業者在規劃於中國大陸投資，或與中國大陸進行技術交流合作時之參考。

關鍵字

中國專利法；遺傳資源；強制授權；強制許可；試驗免責；兩岸經濟合作架構協議

並列摘要

With the execution of the ”Cross-Strait Bridging Plan” beginning in late 2008 and the taking into effect of ECFA this year, Taiwan's high technical industries are more and more interested in investing in or cooperated with China. In particular, the Cross-Strait Agreement on Intellectual Property Right Protection and Cooperation seems to promise a more secure legal environment for R & D and innovation activities in mainland China. It is undoubted that the cross-strait interactions between Taiwan and China will be even more vigorous in the future. In the post-ECFA era, Taiwan's high technical industries and research communities are preparing to take advantage of China's huge market and its human resources. Therefore, the management of the legal risks arising from investing China can not be ignored. Taking the resent amendment of the Chinese Patent Law as an example, this article introduces the most important provisions related to the biopharmaceutical industry and makes preliminary observations of the influence of those new amended provisions, with the intention to remind Taiwan's biopharmaceutical industry to take those regulatory changes into the consideration in planning of investing in or cooperation with China.