與藥物雜質相關的專利問題
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摘要
<正>一、"微創新"概念的再審視毋庸置疑,傳統小分子化學藥物對人類健康做出了巨大的貢獻。然而,在經週上世紀的飛速發展後,受成熟靶點少、成功率低等原因的局限,有觀點認爲化學藥物逐漸進入一個平臺期,也有樂觀者稱之爲穩定期。從專利的角度看,似乎更多數量的申請轉向關注對已有結構的進一步修飾優化,以及對新晶
引文
1田艷、陸景坤、董志强等:“桂呱齊特致血液系統不良反應的實驗研究”,《毒理學雜誌》,2011年第25卷第4期,第273-275頁。
2《中國藥典》(2015年版)第四部:“藥品雜質分析指導原則”,第377-378頁。
3白東魯、沈競康主編:《新藥研發案例研究——明星藥物如何從實驗室走向市場》,化學工業出版社,2014年版,第3章,第40-53頁。
4《最高人民法院關於審理侵犯專利權糾紛案件應用法律若干問題的解釋(二)》(法釋[2016]1號)第七條:“封閉式組合物權利要求保護範圍被訴侵權技術方案在包含封閉式組合物權利要求全部技術特徵的基礎上增加其他技術特徵的,人民法院應當認定被訴侵櫂技術方案未落人專利權的保護範圍,但該增加的技術特徵屬於不可避免的常規數量雜質的除外”。
5汪泉:“藥物雜質化合物如何獲得專利保護”,“知産力”,2018年9月25日。
6陳哲鋒、陳申軍:“藥物'雜質'的可專利性分析”,“知産力”,2018年9月20日。
7孟八一:”藥物能通過雜質專利獲得保護嗎?(上、下)”,“同寫意”,2018年04月9日、10日。
8 Chris Tang:“訴訟新套路—從齊魯製藥和四環製藥的專利言訴訟大戰説起”,“醫律專利”,2017年2月28日。
9趙昊:“聊聊藥品雜質專利那些事—從馬來酸桂哌齊特説起”,“知産力”,2018年1月2日。
1 Tian Yan,Lu Jingkun,Dong Zhiqiang et al.(2011).Experimental study on adverse reactions of blood system caused by cinepazide.Journal of Toxicology,Vol.25,No.4,273-275.
2 Pharmacopoeia of the People's Republic of China(2015),Vol.4:Guidelines for Drug Impurity Analysis(pp.377-378).
3 Bai Donglu and Shen Jingkang(editors in chief)(2014).New Drug R&D Case Study-How Innovative Drugs Go from the Laboratory to the Market(Chapter 3,pp.40-53).Chemical Industry Press.
4 Interpretation(Ⅱ)of the Supreme People's Court on Several Issues Concerning the Application of Law in the Trial of Dispute over Patent Infringement[No.Fashi 1/2016],wherein Article 7 reads“where any alleged infringing technical solution is supplemented with other technical features on the basis of including all technical features of the claims for any enclosed composition,the people's court shall determine the alleged infringing technical solution does not fall within the scope of protection of the patent right,except when the added technical features do not fall within the scope of the conventional quantity of inevitable impurities.”
5 Wang Quan.How to obtain patent protection for impurity compound in drug.Zhichanli.(25 September,2018).
6 Chen Zhefeng and Chen Shenjun.Analysis of patentability of"impurities"in drug.Zhichanli.(20 September,2018).
7 Meng Bayi.Can drugs be protected through impurity patents?(ⅠandⅡ).Tongxieyi.(9-10 April,2018).
8 Chris Tang.New strategy in litigation-Based on Qilu Co.v.Beijing Sihuan.Yilvzhuanli.(28 February,2017).
9 Zhao Hao.Drug impurity patents—Starting from cinepazide maleate.Zhichanli.(2 January,2018).
2《中國藥典》(2015年版)第四部:“藥品雜質分析指導原則”,第377-378頁。
3白東魯、沈競康主編:《新藥研發案例研究——明星藥物如何從實驗室走向市場》,化學工業出版社,2014年版,第3章,第40-53頁。
4《最高人民法院關於審理侵犯專利權糾紛案件應用法律若干問題的解釋(二)》(法釋[2016]1號)第七條:“封閉式組合物權利要求保護範圍被訴侵權技術方案在包含封閉式組合物權利要求全部技術特徵的基礎上增加其他技術特徵的,人民法院應當認定被訴侵櫂技術方案未落人專利權的保護範圍,但該增加的技術特徵屬於不可避免的常規數量雜質的除外”。
5汪泉:“藥物雜質化合物如何獲得專利保護”,“知産力”,2018年9月25日。
6陳哲鋒、陳申軍:“藥物'雜質'的可專利性分析”,“知産力”,2018年9月20日。
7孟八一:”藥物能通過雜質專利獲得保護嗎?(上、下)”,“同寫意”,2018年04月9日、10日。
8 Chris Tang:“訴訟新套路—從齊魯製藥和四環製藥的專利言訴訟大戰説起”,“醫律專利”,2017年2月28日。
9趙昊:“聊聊藥品雜質專利那些事—從馬來酸桂哌齊特説起”,“知産力”,2018年1月2日。
1 Tian Yan,Lu Jingkun,Dong Zhiqiang et al.(2011).Experimental study on adverse reactions of blood system caused by cinepazide.Journal of Toxicology,Vol.25,No.4,273-275.
2 Pharmacopoeia of the People's Republic of China(2015),Vol.4:Guidelines for Drug Impurity Analysis(pp.377-378).
3 Bai Donglu and Shen Jingkang(editors in chief)(2014).New Drug R&D Case Study-How Innovative Drugs Go from the Laboratory to the Market(Chapter 3,pp.40-53).Chemical Industry Press.
4 Interpretation(Ⅱ)of the Supreme People's Court on Several Issues Concerning the Application of Law in the Trial of Dispute over Patent Infringement[No.Fashi 1/2016],wherein Article 7 reads“where any alleged infringing technical solution is supplemented with other technical features on the basis of including all technical features of the claims for any enclosed composition,the people's court shall determine the alleged infringing technical solution does not fall within the scope of protection of the patent right,except when the added technical features do not fall within the scope of the conventional quantity of inevitable impurities.”
5 Wang Quan.How to obtain patent protection for impurity compound in drug.Zhichanli.(25 September,2018).
6 Chen Zhefeng and Chen Shenjun.Analysis of patentability of"impurities"in drug.Zhichanli.(20 September,2018).
7 Meng Bayi.Can drugs be protected through impurity patents?(ⅠandⅡ).Tongxieyi.(9-10 April,2018).
8 Chris Tang.New strategy in litigation-Based on Qilu Co.v.Beijing Sihuan.Yilvzhuanli.(28 February,2017).
9 Zhao Hao.Drug impurity patents—Starting from cinepazide maleate.Zhichanli.(2 January,2018).