再聊欧洲药品专利SPC（案例解析）

问题1：

EC No 469/2009中article 1对“产品”的定义为active ingredient or combination of active ingredientsof a medicinal product，那么对于active ingredient来说，其不同的药物形式（如盐、酯、新剂型、新载体形式等）算是独立的不同产品还是跟active ingredient属于同一产品呢？

在Directive 2001/83/EC中，其实是有明确的立法规定的：不同的盐、酯、醚、异构体、异构体混合物、络合物或衍生物应被视为同一活性物质，除非它们在安全性或有效性方面有显著差异。

The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy.

其次，SPC Regulation的立法说明（Explanatory Memorandum），也可说是SPC Regulation的起点文件，它里面有一段这样的话：

The proposal for a Regulation therefore concerns only new medicinal products. It does not involve granting a certificate for medicinal products that are authorised to be placed on the market. Only one certificate may be granted for any one product. a product being understood to mean an active substance in the strict sense. Minor changes to the medicinal product such as a new dose, the use of a different salt or ester or even of a different pharmaceutical form will not lead to the issue of a new certificate.

这段话在Case C-431/04 MIT (2006)一案中也被引用，以说明SPC 仅适用于新药物，不适用于剂型、盐型、酯型等微小变化。该案作为一个里程碑案件，也明确了 “活性成分”必须本身具有治疗作用，排除了仅起辅助、载体或剂型作用的物质。

关于active ingredient的解释，我在上一篇小文中还列举了C-443/17 Abraxis Bioscience（2019）和C-673/18 Santen（2020）这两个案例，有兴趣的可以自己检索看看。

问题2：

EC No 469/2009中article 3 只强调了该产品之前未获得过SPC，并未像中我国和美国的制度一样要求该专利之前未获得过SPC，也就是说同一件专利，可以为不同的产品申请SPC？

问题3：

2) 由于article 1中对“产品”的定义包含combination of active ingredients，那么包含同样ingredient的单药和组合产品能够算是不同的产品都获得SPC吗？

问题2和3，我们用In Joined Cases C‑119/22 and C‑149/22这一个案例来探讨。

案件背景：

本案是欧盟法院于2024年对来自芬兰市场法院（Case C-119/22）和爱尔兰高法院（Case C-149/22）的两个初步裁决请求的合并审理。

Case C‑119/22（芬兰）

原告：Teva BV 和 Teva Finland Oy

被告：Merck Sharp & Dohme LLC（默克）

争议SPC：Janumet（西他列汀+二甲双胍组合）

背景：Merck持有欧洲专利EP1412357，覆盖DPP-IV抑制剂（如西他列汀/sitagliptin）及其与二甲双胍/metformin（已知活性成分）的组合。Merck就西他列汀单独获得一个SPC，后又基于同一专利和Janumet的MA，Merck获得了第二个SPC（针对组合物）。Teva主张组合产品不应再获SPC。

Case C‑149/22（爱尔兰）

原告：默克

被告：Clonmel Healthcare Limited

争议SPC：Inegy（依折麦布+辛伐他汀组合）

背景：Merck 持有欧洲专利EP0720599，覆盖依折麦布/ezetimibe及其与他汀类药物（如辛伐他汀/simvastatin，已知活性成分）的组合。Merck已就依折麦布单独获得SPC，后又基于同一专利和Inegy的MA获得了第二个SPC。Clonmel主张组合产品不应再获SPC。

核心争议点：

1. 如何解释第3(c)中“the product has not already been the subject of a certificate”的条件？特别是，当一种活性成分（A）已单独获得SPC后，是否还能为该活性成分与另一种已知活性成分（B）的组合（A+B）授予SPC？

2. 如何解释第3(a)中“the product is protected by a basic patent in force”的条件？产品在专利权利要求中的明确提及是否足以满足该条件？

法院判决要点：

1. 关于3(c)的解释-组合产品与单一成分产品是不同的“产品”。

whether two products are identical or different, in the framework of Regulation No 469/2009, depends only on the comparison of the active ingredient or ingredients which they contain, irrespective of their therapeutic applications. In particular, where, as in the cases in the main proceedings, one of the products to be compared is a combination of active ingredients (A+B), it must be regarded as being a different product from the product consisting of only one of the active ingredients comprising the aforementioned product (A or B).

因此，即使其中一种活性成分（A）已单独成为过先前SPC的主题，也不能阻止包含两种活性成分的产品（A+B）被授予SPC。

Article 3(c) of Regulation No 469/2009 must be interpreted as not precluding the grant of an SPC for a product consisting of two active ingredients even if one of those two active ingredients has already been, alone, the subject of an earlier SPCand it is the only one to have been disclosed by the basic patent, whereas the other active ingredient was known at the filing date or priority date of that patent.

2. 关于3(a)的解释-仅在权利要求中明确提及产品还不够，还必须满足，从本领域技术人员角度，结合专利说明书和附图，该产品在申请日或优先权日必然落入该专利所覆盖的发明。

Article 3(a) of Regulation No 469/2009 must be interpreted as meaning that it does not suffice that a product is expressly mentioned in the claims of the basic patent in order for that product to be regarded as being protected by that patent, within the meaning of that provision. It is also necessary, in order to satisfy the condition laid down in that provision, that that product necessarily fall, from the point of view of a person skilled in the art, and in the light of the description and drawings of that patent, under the invention covered by that patent at the filing date or priority date.

由于欧盟法院在初步裁决程序中不负责对案件事实作出终裁决，而是为提出问题的国内法院提供法律解释的标准，本案中的芬兰市场法院和爱尔兰高法院则负责将欧盟法院提供的法律标准应用于案件的具体事实中。

不过根据欧盟法院确立的标准，起码C-149/22案的SPC有点悬了，因为判决书中明确指明，该专利虽然在权利要求中有明确提及这个组合，但说明书中并未披露该活性成分（依折麦布）与辛伐他汀的组合具有不同于二者效果简单相加的协同效应。

in Case C‑149/22 that the combination of ezetimibe and simvastatin is expressly mentioned in the claims of the basic patent at issue in that case, in particular in claim 17thereof. Similarly, it is not in dispute that simvastatin was in the public domain at the priority date of that patent and it is apparent from the request for a preliminary ruling that that patent does not disclose a combined effect of that active ingredient with ezetimibe that would differ from the sum of the effects of each of those active ingredients taken separately.

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