PAY-FOR-DELAY AGREEMENTS UNDER EU COMPETITION LAW – A COMMENT ON PAROXETINE

João Pateira Ferreira
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Abstract

Summary The Court of Justice of the European Union (“Court of Justice”) issued its first ruling on pay-for-delay agreements, in reply to a reference for a preliminary ruling from the UK’s Competition Appeal Tribunal (“CAT”) during its review of the appeal of a Competition and Markets Authority (“CMA”) decision applying a fine to GlaxoSmithKline (“GSK”) and five generic manufacturers for having entered into agreements settling patent disputes relating to GSK’s antidepressant paroxetine, on the basis that such agreements infringed competition rules. In its Paroxetine ruling of 30 January 2020[1], the Court of Justice found that patent settlements are not, by their very nature, anticompetitive; however, generic manufacturers can be regarded as potential competitors to the originator manufacturers when they have announced their intention to compete in the same market as the originator and, as such, patent settlement agreements are to be reviewed as horizontal agreements between competitors. Finally, a payment from the originator to the generic manufacturer in a patent settlement agreement is not enough to qualify such an agreement as a restriction of competition by object (the agreement is not anticompetitive by its very nature), unless there is no other justification for the payment other than to compensate the generic manufacturer for accepting to delay its entry in the market. In those circumstances, the Court finds that such an agreement will constitute a restriction of competition by object[2]. In this comment, we review the Court’s findings in relation to the issue of potential competition between the originator and the generics manufacturers and the qualification of this agreement as a restriction of competition by object. Keywords: pay-for-delay; restriction; competition; agreement; settlement; patent
欧盟竞争法下的延迟付款协议——对帕罗西汀的评论
欧盟法院(“法院”)针对英国竞争上诉法庭(“CAT”)在对英国竞争和市场管理局(“CMA”)就葛兰素史克(“GSK”)和五家仿制药制造商达成协议解决与GSK抗抑郁药帕罗西汀相关的专利纠纷的上诉进行复审期间提出的一项初步裁决的参考,发布了其对延迟付款协议的第一项裁决。理由是这些协议违反了竞争规则。在2020年1月30日对帕罗西汀案的裁决中,美国法院发现,专利和解就其本质而言并非反竞争;然而,当仿制药制造商宣布他们打算与原创制造商在同一市场上竞争时,他们可以被视为原创制造商的潜在竞争对手,因此,专利和解协议应被视为竞争对手之间的横向协议。最后,专利发起人在专利和解协议中向仿制药制造商支付的款项不足以使该协议成为限制竞争的对象(该协议就其本质而言并不反竞争),除非除了补偿仿制药制造商接受延迟进入市场之外,没有其他理由支付这笔款项。在这种情况下,本院认为这种协议将构成对竞争的限制。在这篇评论中,我们回顾了法院关于发起人和仿制药制造商之间潜在竞争问题的调查结果,以及该协议作为客体限制竞争的资格。关键词:整治延迟;限制;竞争;协议;结算;专利
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