藥品專利納入藥品標準後的禁令救濟問題

Issues Relating to Injunctive Relief for Drug Patents after Their Incorporation into Standards

在最高人民法院發佈的2018年中國法院50件典型知識産權案例中,齊魯製藥有限公司與北京四環製藥有限公司侵害發明專利權糾紛案~1(以下簡稱"四環訴齊魯案")頗爲值得關注,因爲該案涉及藥品專利與藥品標準相結合所産生的禁令救濟問題。不過,藥品專利與藥品標準的結合已非新鮮事,與四環訴齊魯案同批發佈的胡小泉與山東省惠諾藥業有限公司侵害發明專利權糾紛案(以下簡稱"胡小泉訴惠諾案")~2,以及十餘年前的廣西南寧邕江藥業有限公司與河南省天工藥業有限公司侵犯發明專利權糾紛案(以下簡稱“邕江訴天工案”)3均有涉及。所不同的是,被告在後兩案中主要是以其使用涉案專利屬於執行國家藥品標準的合法行爲爲由,作不侵權抗辯。

Among the 50 typical intellectual property cases of 2018 announced by the Supreme People’s Court of China,the invention patent infringement case of Qilu Pharmaceutical Co.,Ltd.v.Beijing Sihuan Pharmaceutical Co.,Ltd.(hereinafter referred to as uSihuan v.Qilun)1 is worthy of our attention,because this case is related to the issue of injunctive relief arising from the coupling of drug patents and drug standards.It is not that the coupling of drug patents and drug standards is a novel thing,as the subject has been touched on in two former invention patent infringement cases,one being Hu Xiaoquan v.Shandong Huinuo Pharmaceutical Co.,Ltd.(uHu Xiaoquan v.Huinuon)2,which was announced together with Sihuan v.Qilu in the same batch of typical cases,and the other being Guangxi Nanning Yongjiang Pharmaceutical Co.,Ltd.v.Henan Tiangong Pharmaceutical Co.,Ltd.[“Yongjiang v.Tiangong”)3,a case of more than a decade ago.Sihuan v.Qilu was different in the sense that the defendants in the latter two cases primarily made non-infringement defense on the grounds that the exploitation of the patents in suit was a legal act of implementing national drug standards.