Anticompetitive Patent Settlements – Where Are We Ten Years After the European Commission’s Pharmaceutical Inquiry?

• Authors: Anna Laszczyk

Abstracts

FR

En 2009, la Commission européenne a publié un rapport final sur son enquête de marché concernant le secteur pharmaceutique. Le rapport a révélé les préoccupations de la Commission concernant les pratiques de marché des laboratoires pharmaceutiques visant à retarder l’entrée sur le marché de produits pharmaceutiques génériques moins chers. L’une des pratiques retardatrices identifies par la Commission européenne était les règlements de brevet entre un laboratoire et un fabricant de produits génériques, notamment : (i) un transfert de valeur du laboratoire de vers un fabricant de génériques, et (ii) l’obligation pour un fabricant de génériques de ne pas entrer sur le marché. Ces accords de brevet étaient qualifies d’accords de paiement pour retard, puisque le paiement était apparemment effectué en échange de l’obligation de ne pas entrer sur le marché. La Commission européenne a poursuivi l’enquête sur les accords de brevet en exerçant une surveillance continue. Elle a également lancé des procédures antitrust qui se sont terminées par l’imposition d’amendes considérables aux sociétés pharmaceutiques. Les recours sont maintenant en cours devant les tribunaux de l’UE. Dix ans après la publication du rapport final sur l’enquête de marché, cet article vise à résumer l’évolution de la jurisprudence et à fournir une analyse critique. L’article se concentre sur l’analyse des accords de paiement des retards en tant qu’infractions à l’article 101 du TFUE uniquement et ne considère pas la conclusion de ces accords comme un abus de position dominante.

EN

In 2009, the European Commission published a final report on its market inquiry into the pharmaceutical sector. The report revealed the authority’s concerns regarding market practices of pharmaceutical originator companies aimed at delaying the market entry of cheaper generic pharmaceutical products. One of the delaying practices identified by the European Commission were patent settlements between an originator and a generic company including: (i) a value transfer from the originator to a generic company, and (ii) an obligation of a generic company not to enter the market. These patent settlements were called pay-for-delay agreements since the payment was allegedly made in exchange for the non-mark-entry obligation. The European Commission continued the investigation of patent settlements by its continuous monitoring. It also initiated antitrust proceedings that terminated with huge fines imposed on pharmaceutical companies. The appeals are now pending before the EU courts. Ten years after the publication of the final report on the market inquiry, this article aims to summarize the development of the case law and provide its critical analysis. The article focuses on the analysis of pay-for-delay agreements as infringements of Article 101 TFEU only and does not consider the conclusion of these agreements as an abuse of a dominant position.

Keywords

EN

antitrust law; anticompetitive agreements; patent settlements; pay-fordelay; agreements; pharmaceutical sector

• Publisher: Uniwersytet Warszawski. Wydawnictwo Naukowe Wydziału Zarządzania
• Journal: Yearbook of Antitrust and Regulatory Studies
• Year: 2019
• Volume: 13
• Issue: 21
• Pages: 129-160

Dates

published

2020

Contributors

author

Anna Laszczyk

• https://orcid.org/0000000349587773

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Identifiers

DOI

10.7172/1689-9024.YARS.2020.13.21.5

Biblioteka Nauki

2158992