Abstract
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-market 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 summarise 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.
Highlights
In 2009, the European Commission published the final report on its market inquiry into the pharmaceutical sector, in which it identified practices of originator companies aimed at delaying the market entry of generic companies
Patent settlements are agreements aimed at terminating a patent dispute stemming either from invalidation claims raised by a generic company against the patents held by the originator company, or from an alleged patent infringement by a generic company
The Commission used the same test as applied in the Lundbeck and Fentanyl cases, consisting of the following conditions: (i) the existence of potential competition between a generic and the originator company, (ii) whether a generic company abandoned its independent efforts to enter the market, 38 An angiotensin converting enzyme inhibitor used for treatment of cardiovascular diseases, primary intended for treatment of hypertension and heart failure
Summary
The General Court’s judgments in the Perindopril case 3.4. Summary of the Commission’s Test for the Assessment of PFD. PFD Agreements as a by Object Restriction – Critical Review 5.3. PFD Agreements as an Effects Restriction – Critical Review 5.4. PFD Agreements – Enforcement by National Competition
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