Supplementary Protection Certificates (SPCs) were implemented in Europe in 1993 to compensate patentees in the pharmaceutical field for the loss of effective patent terms caused by the delay in obtaining regulatory approval for the sale of medicinal products. The legal framework is codified in Regulation (EC) No. 469/2009 of the European Parliament and of the Council, dated May 6, 20091 (in the following termed “SPC Regulation” or simply “Regulation”). As with any EU law, the authority for interpreting the law ultimately rests with the Court of Justice of the European Union (CJEU). Although SPCs generally are dealt with on the national level, as far as registration and enforcement of an SPC is concerned, the national courts may or, as the case may be, even must, request the CJEU to give advice when it comes to the interpretation of the Regulation. The CJEU has been called on numerous times in recent years to answer questions regarding the interpretation of the SPC Regulation arising during national proceedings throughout Europe. Many of these questions centered on the substantive requirements for gaining supplementary protection, as detailed in Article 3 of the Regulation, which states: A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application: (a) the product is protected by a basic patent in force; (b) a valid authorization to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate; (c) the product has not already been the subject of a certificate; (d) the authorization referred to in point (b) is the first authorization to place the product on the market as a medicinal product. (Emphases added.) The Regulation itself provides a definition of the term “product” in that the “product” is defined as “the active ingredient or combination of active ingredients of a medicinal product,” while the “medicinal product” is defined as “any substance or combination of substances presented for treating or preventing disease in human beings or animals.…”2 In particular, Articles 3(a) and 3(c) of the Regulation have been repeatedly interpreted by the CJEU in various rulings, yet some of these decisions have left us with more questions than answers. As early as 1999, the CJEU commented for the first time on the question of when a “product is protected by a basic patent in force” (Article 3(a) of the Regulation) in its Farmitalia decision (C-392/97). The case was referred by the German Federal Court of Justice (BGH) and concerned an SPC application for “idarubicin and salt thereof including idarubicin hydrochloride.” The basic patent in this case was German patent No. 25 25 633, whose claims were directed, inter alia, to idarubicin as such, but not to the salts of it. The Federal Court of Justice asked the CJEU whether, for the interpretation of Article 3(a) of the Regulation, it is necessary to consider the wording of the claims or the scope of protection of the claims. The CJEU decided that in the absence of patent law harmonization in the European Union, it is a question of the applicable national law whether a product is protected by a basic patent. In the following years, the different European courts developed divergent practices with regard to what constitutes a product that is protected by a basic patent. Essentially, two approaches were established: the “infringement test,” asking whether the product defined in the SPC application would, on manufacturing or selling, infringe the rights deriving from the basic patent, and the “disclosure test,” asking whether the product defined in the SPC application would be disclosed in the wording of the claims of the basic patent. Recognizing the divergent practice, which stood in stark contrast to the Regulation's objective of providing a “uniform solution” “under the same conditions” in each of the member states (recitals 7 and 8 of the Regulation), the Court of Appeal of England and Wales turned to the CJEU in the Medeva case (C-322/10) and asked how, in the absence of harmonization of national patent laws, Article 3(a) of the Regulation should be interpreted. Medeva BV had sought supplementary protection for different combination vaccines, each vaccine containing at least the antigens A and B in addition to further active ingredients. The SPC applications all referred to the same basic patent with claims directed to a method for preparing a vaccine comprising A and B. In its ruling, the CJEU stated that to be protected by a basic patent, the active ingredients according to the SPC request have to be “specified in the wording of the claims.” The court's decision has been largely understood as rejecting the “infringement test” that had been applied by numerous European national courts. Yet what the term “specified” means remained a mystery.3 No further light was shed on this matter by additional decisions of the CJEU that were handed down at the same time, e.g., Yeda (C-518/10), University of Queensland (C-630/10), and Daiichi-Sankyo (C-6/11), all of which essentially agreed with Medeva. As a result, practitioners and patent/SPC proprietors were left with some uncertainties as to the correct interpretation of Article 3(a) and worried that “specified in the wording of the claims” might actually mean literally disclosed in the claims, which would significantly limit an applicant's options on gaining supplementary protection—in particular, if the underlying patent claims are phrased broadly, e.g., if the claims are directed to a genus of compounds rather than to a particular species. Another major battleground has been the interpretation of Article 3(c) of the Regulation, which requires that the “product has not already been the subject of a certificate” and essentially serves the purpose of preventing the patent holder from obtaining an unwarranted extension of protection for a given medicinal product.4 Already in the 1990s, the CJEU held, in its Biogen decision (C-181/95), that Article 3(c) should not be interpreted to prevent the grant of multiple SPCs for the same product, where this product is protected by several basic patents belonging to different owners. The CJEU held that under Article 3(c), only one certificate may be granted for each basic patent. In Biogen, the Court was concerned exclusively with a single product (but multiple patents). Therefore, the Court's statement was generally understood to be limited to the individual product; and in the years following the Biogen decision, patent offices continued to allow multiple SPCs for different products based on the same underlying patent, effectively establishing a “one SPC per product per patent” practice throughout Europe. Yet recently, the CJEU's 2011 Medeva decision (C-322/10) was interpreted to prohibit the grant of more than one SPC per patent even if the SPCs were directed to different products, based on a statement that essentially reiterated verbatim what had been said in Biogen (“where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent” (compare Biogen, paragraph 28 and paragraph 41 of Medeva)) (emphasis added). This interpretation, which deviates from the established view, may be ascribed to the different facts underlying the Medeva case: whereas in Biogen, the entire case centered on one product covered by different patents, the case of Medeva centered on questions of whether different combination products may be eligible for multiple SPCs on the basis of one basic patent. As a result of the Medeva decision, some patent offices tightened the requirements to “one SPC per patent,” whereas others maintained the previous “one SPC per product per patent” practice. Given the ensuing divergent interpretation of Article 3(c), a question arose over what the correct approach would be. To seek clarification on the above matters, various national courts have referred additional questions to the CJEU regarding the interpretation of Article 3(a) and (c) of the Regulation, resulting in the three rulings that were handed down by the CJEU last year in the cases of Eli Lilly (C-493/12), Actavis (C-443/12), and Georgetown II (C-484/12). These cases are discussed in the following.

中文翻译：

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欧盟欧洲法院近期关于补充保护证书的裁决：几个答案——许多问题

补充保护证书 (SPC) 于 1993 年在欧洲实施，以补偿制药领域专利权人因延迟获得药品销售监管批准而失去有效专利条款的情况。20091 年 5 月 6 日欧洲议会和理事会第 469/2009 号法规（以下称为“SPC 法规”或简称“法规”）编纂了法律框架。与任何欧盟法律一样，解释法律的权力最终属于欧盟法院 (CJEU)。尽管 SPC 通常在国家层面处理，但就 SPC 的登记和执行而言，国家法院可以或视具体情况甚至必须要求欧盟法院在解释时提供建议条例的规定。近年来，CJEU 多次被要求回答在整个欧洲国家程序中出现的有关 SPC 法规解释的问题。其中许多问题都集中在获得补充保护的实质性要求上，如条例第 3 条所述，该条规定：如果在提交第 7 条所指申请的成员国且在该申请的日期： (a) 该产品受有效的基本专利保护；(b) 已根据指令 2001/83/EC 或指令 2001/82/EC 酌情授予将产品作为药品投放市场的有效授权；(c) 该产品尚未成为证书的对象；(d) (b) 点中提到的授权是将产品作为医药产品投放市场的第一个授权。（重点增加。）法规本身提供了术语“产品”的定义，因为“产品”被定义为“医药产品的活性成分或活性成分的组合”，而“医药产品”被定义为“用于治疗或预防人类或动物疾病的任何物质或物质组合。……”2 特别是，欧盟法院在各种裁决中反复解释了法规第 3(a) 和 3(c) 条，但其中一些决定给我们留下的问题多于答案。早在1999年，CJEU 在其 Farmitalia 决定 (C-392/97) 中首次就“产品何时受有效基本专利保护”（法规第 3(a) 条）的问题发表了意见。该案由德国联邦法院（BGH）转介，涉及“伊达比星及其盐，包括盐酸伊达比星”的最高人民法院申请。在这种情况下，基本专利是德国专利第 25 25 633 号，其权利要求特别针对伊达比星本身，但不针对其盐类。联邦法院询问欧洲法院，对于《条例》第 3(a)条的解释，是否需要考虑权利要求的措辞或权利要求的保护范围。CJEU 决定，在欧盟没有统一专利法的情况下，产品是否受基本专利保护是适用的国家法律的问题。在接下来的几年里，不同的欧洲法院就受基本专利保护的产品的构成制定了不同的做法。本质上，建立了两种方法：“侵权测试”，询问 SPC 申请中定义的产品在制造或销售时是否会侵犯源自基础专利的权利，以及“披露测试”，询问产品是否定义了在 SPC 申请中将在基础专利的权利要求的措辞中公开。认识到与条例形成鲜明对比的不同做法 为了在每个成员国“在相同条件下”提供“统一解决方案”（条例第 7 条和第 8 条），英格兰和威尔士上诉法院在 Medeva 案中求助于欧洲法院（C- 322/10)，并询问在没有统一国家专利法的情况下，应如何解释条例的第 3(a) 条。Medeva BV 曾为不同的组合疫苗寻求补充保护，每种疫苗除含有更多活性成分外，还至少含有抗原 A 和 B。SPC 申请均涉及同一基础专利，权利要求涉及制备包含 A 和 B 的疫苗的方法。 CJEU 在其裁决中表示，要受基础专利保护，根据 SPC 请求的活性成分具有“在权利要求的措辞中指定。” 法院的决定在很大程度上被理解为拒绝了许多欧洲国家法院采用的“侵权测试”。然而，“特定”一词的含义仍然是个谜。 3 同时颁布的欧洲法院的其他决定没有进一步阐明这个问题，例如 Yeda (C-518/10)，昆士兰大学(C-630/10) 和第一三共 (C-6/11)，所有这些基本上都同意 Medeva。因此，从业者和专利/SPC 所有人对第 3(a) 条的正确解释存在一些不确定性，并担心“在权利要求的措辞中指定”实际上可能意味着权利要求中的字面公开，这将显着限制申请人获得补充保护的选择——尤其是，如果基础专利权利要求措辞宽泛，例如，如果权利要求涉及化合物的一个属而不是特定的物种。另一个主要战场是对《条例》第 3(c) 条的解释，该条要求“产品尚未成为证书的主体”，本质上是为了防止专利权人获得无根据的保护延伸。 4 早在 1990 年代，CJEU 在其 Biogen 决定 (C-181/95) 中就认为第 3(c) 条不应被解释为阻止对同一产品授予多个 SPC，本产品受属于不同所有者的多项基本专利保护。欧洲法院认为，根据第 3(c) 条，每项基础专利只能授予一份证书。在百健，法院只关注单一产品（但多项专利）。因此，法院的声明通常被理解为仅限于个别产品；在 Biogen 决定之后的几年里，专利局继续允许基于相同基础专利的不同产品有多个 SPC，在整个欧洲有效地建立了“每个专利每个产品一个 SPC”的做法。然而最近，根据一项基本上一字不差地重申了上述内容的声明，欧盟法院 2011 年的 Medeva 决定 (C-322/10) 被解释为禁止每项专利授予一个以上的 SPC，即使 SPC 是针对不同产品的在 Biogen（“如果专利保护产品，根据第 469/2009 号条例第 3(c)条，该基本专利只能授予一个证书”（比较 Biogen，Medeva 的第 28 段和第 41 段））（强调）。这种偏离既定观点的解释可能归因于 Medeva 案背后的不同事实：而在 Biogen 中，整个案子集中在不同专利涵盖的一种产品上，而 Medeva 案则集中在不同组合产品是否存在问题上。基于一项基础专利可能有资格获得多项 SPC。由于 Medeva 的决定，一些专利局收紧了“每项专利一个 SPC”的要求，而其他专利局则保持以前的“每件产品每件 SPC”的做法。鉴于随后对第 3(c) 条的不同解释，出现了正确方法的问题。为寻求上述事项的澄清，各个国家法院已将有关法规第 3(a) 和 (c) 条解释的其他问题提交给欧盟法院，从而导致欧盟法院去年在礼来 (C- 493/12)、阿特维斯 (C-443/12) 和乔治城 II (C-484/12)。下面将讨论这些情况。