安杰视点｜欧盟法院就CMA处罚葛兰素史克等公司迟延支付案做出法律适用判决

2020年1月30日，欧盟法院（Court of Justice of the European Union）就英国竞争与市场监管局（Competition and Markets Authority，以下简称“CMA”）处罚葛兰素史克（GlaxoSmithKline，以下简称“GSK”）与其他仿制药生产企业达成迟延支付协议（pay-for-delay）一案的欧盟法适用做出判决。欧盟法院分别针对原研药与仿制药的潜在竞争替代、目的限制及效果限制的认定、药品市场界定等争议问题给出了普遍适用于欧盟各成员国法院处理类似案件的分析思路及意见。

2016年2月12日，CMA做出决定，认定GSK与抗抑郁药帕罗西汀（paroxetine）的仿制药生产企业达成了金额总计超过5000万英镑（约人民币4.55亿元）的协议，要求这些生产企业延迟进入英国市场，这一行为属于违法协议及协同行为，并且GSK滥用了其市场支配地位。最终CMA对GSK及涉案的5家仿制药企业处以共计4499万英镑（约人民币4.01亿元）的罚款。之后，GSK等公司就该决定向英国竞争上诉法庭（Competition Appeal Tribunal，以下简称“CAT”）提出上诉，CAT在其诉讼过程中认为，由于该案涉及欧盟运行条例（TFEU）中第101、102条认定垄断行为的解释，因此中止了诉讼程序并将案件移送至欧盟法院。

在欧盟法院做出判决的当日，CMA及欧盟委员会竞争专员维斯塔格女士对欧盟法院的这一判决表示支持。CMA负责人Andrea Coscell表示：“该案展示了，我们一直在努力采取行动，打击损害英国国家医疗服务体系的竞争的制药公司所做出的非法行为。该案经历了一个漫长的过程，我们期待CAT做出最终判决。打击诸如迟延支付协议等损害竞争的行为，对于保护英国国家医疗服务体系（即为其支付税款的纳税人）避免为重要药物支付超出其应有的水平至关重要” 。维斯塔格女士表示在阅读判决后“感到鼓舞”。

（1）虽然本判决仅针对迟延支付协议的法律适用问题做出解释、而非处理本案的实体问题，但是判决意见仍表明欧盟法院倾向于认定迟延支付协议构成目的限制的垄断协议。该意见将直接影响已经上诉至欧盟法院的灵北制药案及施维雅案的相关判决；

（2）该判决是欧盟法院首次针对反向支付是否可能构成滥用市场支配地位给出的分析，但目前尚不能明确欧盟法院的司法倾向；

（3）中国竞争执法机构可能会根据中国特定的制度背景（如药品专利链接制度等）及市场竞争状况就类似行为进行相关的执法调查，在中国开展业务的相关制药企业也应紧密关注国内外的执法动态。

本案的实体判决将由英国竞争上诉法庭做出，预计案件仍将持续数年之久。

附：欧盟法院发布新闻稿全文：

The Court of Justiceclarifies the criteria governing whether a settlement agreement with respect toa dispute between the holder of a pharmaceutical patent and a manufacturer ofgeneric medicines is contrary to EU competition law 

In the judgment Generics (UK) and Others (C-307/18), delivered on 30 January2020, the Court has clarified the criteria applicable to the characterisationof settlement agreements with respect to disputes between the holder ofpharmaceutical patents and manufacturers of generic medicines having regard tothe prohibition on practices or agreements that have as their object or effectthe restriction of competition (Article 101 TFEU) and the prohibition on abuseof a dominant position (Article 102 TFEU). 

The Competition Appeal Tribunal (UK) sent to the Court a request for apreliminary ruling for the purposes of its examination of the lawfulness of adecision imposed by the Competition and Markets Authority (UK) on variousmanufacturers of generic medicines and the pharmaceutical group GlaxoSmithKline('GSK') concerning settlement agreements with respect to patent disputes ('thecontested decision'). GSK was the holder of a patent for the activepharmaceutical ingredient of the anti-depressant medicine paroxetine and ofsecondary patents protecting some processes for the manufacture of that ingredient.When GSK's principal patent expired in 1999, a number of manufacturers ofgeneric medicines contemplated introducing generic paroxetine on the UK market.Against that background, GSK brought infringement proceedings against thosemanufacturers of generic medicines, and the latter challenged the validity ofone of GSK's secondary patents. GSK and the manufacturers of generic medicinesthereafter concluded settlement agreements with respect to those disputes,whereby the latter chose to refrain, for an agreed period, from entering themarket with their own generic medicines, in return for payments made by GSK('the agreements at issue'). By the contested decision, the Competition andMarkets Authority held that the agreements at issue infringed the prohibitionon concluding agreements that restrict competition and constituted, on the partof GSK, an abuse of its dominant position in the relevant market. Consequently,the CMA imposed financial penalties on the parties to those agreements. 

The Court stated, first, that an agreement between undertakings is subject tothe prohibition laid down by Article 101(1) TFEU only if it has a negative andappreciable effect on competition within the internal market, which presupposesthat those undertakings are at least in a relationship of potentialcompetition. With respect to manufacturers of generic medicines who had not yetentered the market at the time when such agreements were concluded, the Courtstated that the required relationship of potential competition presupposes thatit is demonstrated that there are real and concrete possibilities of access tothe market. To that end, the Court held that it is necessary to assess, foreach manufacturer of generic medicines concerned, whether the manufacturer of genericmedicines concerned has a firm intention and an inherent ability to enter themarket, having regard to the preparatory steps it has taken, and that there areno insurmountable barriers to entry. Any patent rights do not constitute, inthemselves, such barriers, according to the Court, since their validity can becontested. 

As regards the concept of a 'restriction of competition by object', the Courtrecalled that if the agreements at issue are to be so characterised, thatpresupposes a finding that those agreements reveal a sufficient degree of harmto competition, having regard to the content of their provisions, theirobjectives, and their economic and legal context. According to the Court,taking into consideration the appreciable fall in the sale price of themedicines concerned following the market entry of their generic version, thatdegree of harm may be identified where the transfers of value provided for byan agreement such agreements at issue cannot, because of their scale, have anyexplanation other than the commercial interest of the parties to the agreementnot to engage in competition on the merits and, accordingly, act as anincentive to the manufacturers of generic medicines to refrain from enteringthe market concerned. For the purposes of characterisation as a 'restriction ofcompetition by object', the Court also required that any pro-competitiveeffects arising from agreements at issue be taken into consideration, providedthat those effects are demonstrated. The Court made clear however that takinginto consideration such effects is merely a part of the analysis of whether theagreement under examination causes a sufficient degree of harm. The Courtconcluded that it is for the national court to assess, with respect to eachagreement under examination, whether the demonstrated pro-competitive effectsare sufficient to permit a reasonable doubt as to whether it causes asufficient degree of harm to competition. 

As regards whether a settlement agreement such as those at issue may be characterisedas a 'restriction of competition by effect', the Court states that, in order toassess the existence of potential or real effects of such an agreement oncompetition, it is necessary to determine how the market will probably operateand be structured in the absence of the concerted practice, but it is notnecessary to establish the probability of the manufacturer of generic medicinesconcerned being successful in the patent proceedings or of a settlementagreement being concluded that is less restrictive of competition. 

In response to the questions in relation to the concept of an 'abuse of adominant position', the Court held, first, that the product market must bedetermined taking into account also the generic versions of the medicine whosemanufacturing process remains protected by a patent, provided that it can beestablished that their manufacturers are in a position to enter the market withsufficient strength to constitute a serious counterbalance to the manufacturerof originator medicines already on that market. Second, the Court stated thatthe finding of an abuse of a dominant position presupposes an adverse effect onthe competitive structure of the market that exceeds the specific effects ofeach of the agreements concerned with respect to which penalties were imposedunder Article 101 TFEU. More particularly, the Court observes that, taking intoconsideration the possible cumulative effects that are restrictive ofcompetition of the various agreements, the conclusion of those agreements, inso far as it is part of an overall contractoriented strategy, has a significantforeclosure effect on the market, depriving the consumer of the benefits ofentry into that market of potential competitors manufacturing their ownmedicine and, therefore, reserving that market directly or indirectly to themanufacturer of the originator medicine concerned. The Court recalled, last,that such conduct can be justified if the party engaged in it proves that itsanti-competitive effects may be counterbalanced, or outweighed, by advantagesin terms of efficiency that also benefit consumers. For the purposes of thatweighing of effects, the Court states that the favourable effects oncompetition of the conduct concerned must be taken into consideration regardlessof the objectives pursued by the party engaged in that conduct. 

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