“延迟付费”协议Following the European Commission’s Pharmaceutical Sector Inquiry, ‘pay-for-delay’ agreements (when a generic company delays independent entry onto the market in return for a transfer of value from the originator company) have continued to be heavily scrutinised by the competition authorities.

虽然CJEU尚未提供决定Lundbeck.或者服务器(both appeals from Commission decisions and subsequently from General Court judgments），on 30 January 2020 the CJEU did hand down its judgment in Case C-307/18,Generics (UK) Limited and Others v Competition and Markets Authority（这 '判断’)。The Judgment, which responded to a preliminary reference from the UK’s Competition Appeal Tribunal, ‘猫'，特别重要，因为这是欧洲最高法院第一次为竞争法评估对“延误的薪酬拨款”协议第一次提供指导。

鉴于CJEU所考虑的问题，本文重点关注CJEU关于第101条TFEU的调查结果，并寻求突出一些关于这一问题判决的一些最有趣的方面。帕罗西汀诉讼简要介绍与GSK的帕罗西汀产品（以品牌名称Seroxat®销售）有关的情况，并关注Glaxosmithkline（'）之间的一系列协议（'GSK.’) and a number of generic companies (namely, IVAX; Generics (UK) (‘gu’); and Alpharma). Before the expiry of the basic compound patent in January 1999 and of data exclusivity in December 2000, GSK had obtained a number of other patents relating to paroxetine including the Anhydrate patent (which claimed four paroxetine polymorphs and the process for making them). By mid-2000, GSK became aware that a number of generic companies were contemplating entry onto the UK market. GSK entered into agreements with IVAX, GUK and Alpharma. For the purpose of this article it is sufficient to note that these agreements sought to settle disputes relating to,除其他外，无水化专利，并广泛地说，提供：

• 一般的制造商将恋爱补给品ed with a limited volume of paroxetine manufactured by GSK but were otherwise prevented from making, importing or supplying generic paroxetine; and
• GSK.would make a number of ‘value transfers’ to the generic companies including, for example, contributions towards their legal costs, provision of a ‘promotional allowance’ or ‘marketing allowance’ and/or a payment in respect of the ‘production and preparation cost of launch in the UK market’ (see paragraphs 10 to 14 of the Judgment for more detail).

尽管在GSK，IVAX，GUK和Alpharma之间签订了协议，但干水化专利也是GSK和GSK和GSK之间诉讼的主题其他仿制公司。例如，在2002年7月，巴斯夫带来的诉讼程序中，残余物专利被部分失效（仅留下两项工艺索赔）。2003年12月，另一个普通公司（APOTEX）成功地捍卫了GSK带来的侵权索赔，并进入了市场。Ivax，Guk和Alpharma然后终止了与GSK相应的协议，独立进入市场，没有克制。

比赛和市场权威（'CMA.’) found that GSK, GUK and Alpharma had infringed the prohibition in Chapter I of the Competition Act 1998 by entering into the GSK/GUK and GSK/Alpharma agreements and that, by entering into a series of agreements, GSK had also abused its dominant position in the market for paroxetine, infringing Chapter II of the Competition Act 1998. The CMA imposed penalties of more than £44 million. This decision was appealed to the CAT which made a preliminary reference to the CJEU asking ten questions about the correct interpretation of both Articles 101 and 102 TFEU. This article focuses on the Article 101 TFEU aspects of the judgment.

CJEU的判断 - 第101条TFEU的关键点

CJEU提到的前两个问题转到了潜在的竞争问题，实际上，在他们之间存在真正专利纠纷的情况下，询问者和通用是否可以被视为潜在的竞争对手。CJEU回答说，一般公司将成为一个发起人的“潜在竞争对手”，因为通用进入市场并与发起者竞争的“真实和具体的可能性”。根据CJEU（见Ruling 1），在进行评估时，有必要考虑：

1. whether the generic has a ‘firm intention’ and an ‘inherent ability’ to enter the market and has taken ‘sufficient preparatory steps’ (including obtaining an MA, having an adequate stock of the generic product, taking legal steps to challenge the process patents held by the originator and adopting a range of marketing initiatives); and
2. whether there are any ‘insurmountable barriers’ to market entry

CJEU对专利存在非常重量。例如，虽然CJEU指出，专利可以构成一项协议的经济和法律背景，但它没有考虑取决于专利有效性，有效性争议的不确定结果，或者临时禁令的存在将阻止或者iginator and a generic from being ‘potential competitors’. Moreover, the CJEU expressly concluded that the existence of a process patent for an active ingredient that is already in the public domain is not an ‘insurmountable barrier’ to market entry. In this regard, it is worth noting that the Judgment addresses the issue of potential competition with express reference to the existence of process patents. It is not yet clear whether the same analysis could be applied to a patent of a different type.

猫提到的第三个，第四和第五个问题要求CJEU澄清结算协议将构成竞争的竞争的情况。通过提醒方式，要对“对象”的竞争的限制，协议必须揭示“本身”对竞争的“充分危害”。在这种情况下，CJEU认为，结算协议是对“对象”竞争的限制（见Ruling 2）：

1. a generic manufacturer undertakes not to enter the market and not to continue an invalidity challenge in exchange for a transfer (or transfers) of value from an originator company; and
2. 值得清楚的是，价值转移的净收益只能通过缔约方的商业利益来解释协议的商业利益，以避免竞争优点;除非
3. the settlement agreement is accompanied by ‘sufficiently significant’ pro-competitive effects that are ‘specifically related to the agreements in issue’ and are capable of giving rise to a reasonable doubt that the agreement causes a sufficient degree of harm to competition – ‘minimal’ and ‘uncertain’ benefits (such as a slight reduction in price) will be insufficient to escape a ‘by object’ categorisation.

鉴于判决响应初步参考，CJEU并未明确考虑在潜在的帕罗西汀诉讼程序中发出的每个价值转移。然而，CJEU澄清说，所有价值转移（金钱和非金钱;直接和间接）应考虑到。The CJEU has also made clear that a transfer of value may be justified, and not lead to the conclusion that there is a ‘by object’ restriction of competition, if it is appropriate and strictly necessary in the light of the legitimate objectives of the agreement. The size of the value transfer is relevant and the net gain to the generic manufacturer must be ‘sufficiently large’ or ‘sufficiently beneficial’ to induce the generic manufacturer to delay entry. It will be interesting to see how the CAT applies this guidance to the agreements in issue.

The sixth question referred to the CJEU asks specifically about the relevance of two factors (namely the likelihood of success in patent proceedings and the likelihood of the parties having entered into a less restrictive agreement) to the assessment of a ‘by effect’ infringement (which will be relevant in circumstances where the pro-competitive aspects of the agreement are sufficient to raise a reasonable degree of doubt that the agreement will cause a sufficient degree of harm to competition to be regarded as an infringement ‘by object’). In answering this question, the CJEU has confirmed that it is not necessary for the referring court to establish that (in the absence of the agreement) the generic manufacturer可能是在专利诉讼或政党方面取得了成功可能是已结束限制性的解决方案协议（见Ruling 3）。

接下来是什么？

While the Judgment provides some helpful insight about the approach the CJEU is likely to adopt when analysing so-called ‘pay-for-delay’ agreements, it is inevitably focussed on the questions referred by the CAT. Accordingly, the Judgment does not address all of the competition law issues that arise in relation to ‘pay-for-delay’ agreements. For example, although the Judgment is fairly expansive in relation to ‘by object’ restrictions, comparatively little is said on the subject of ‘by effect’ restrictions (arguably due to the narrow nature of the question referred by the CAT). In addition, given that the Judgment has been given in the context of a preliminary reference, it will be for the CAT to apply the guidance given by the CJEU to the facts of the case. The conclusions reached by the CJEU in the context of theLundbeck.和服务器appeals from the General Court will be particularly interesting to the extent that they explore outstanding questions in more detail.

* Pat Treacy是繁荣的竞争实践和奥利维亚亨利的伙伴，是繁荣的LLP专利诉讼实践。本文中表达的观点是作者的个人观点，而不是繁荣的LLP或其任何客户。

Pat Treacy，Partner，Bristows LLP。		Olivia Henry，Associate，Bristows LLP。
Pat has specialised in EU law and competition law since the 1980s, handling landmark cases at EU and national level and helping clients from all over the world with their competition law needs.在竞争法和知识产权方面相交的竞争法和知识产权法相交的复杂法律和政策问题方面，她有特别优势，因为它在该领域的领导者中增加了一个世纪或更多的重要性。因此，许多客户都在高科技部门，包括生命科学和技术。帕特是竞争法协会的成员;英国欧洲律师协会;和律师协会的竞争部分。她是在知识产权法和实践与竞争法洞察中的编辑委员会。帕特讲座和写作局部问题。她还教导了牛津大学的竞争法模块在知识产权法和练习课程中的牛津研究生文凭。		奥利维亚是IP诉讼部门的员工。 在她的生物化学背景下，奥利维亚在生命科学部门的一系列问题上工作，包括专利侵权和无效程序和围绕补充保护证书（SPC）的问题。奥利维亚在高等法院前，上诉法院和欧洲联盟司法法院有经验。 Olivia于2016年纳入IP诉讼部门，在2014年加入德国作为实习律师。在她的培训合同期间，奥利维亚在全球计算机娱乐公司的法律部门花了三个月，用于一般商业和知识产权事务。Olivia也是每月EPO报告的贡献者，繁荣为CIPA Journy生产。