Κατεύθυνση Άυλα Αγαθά και Ανταγωνισμός
Library of the School of Law

2023-01-30

2023

Lamprinoudi Vasiliki

Ευθυμία Κινινή, Επίκουρη Καθηγήτρια εμπορικού δικαίου, ΕΚΠΑ
Εμμανουήλ Μαστρομανώλης, Επίκουρος Καθηγητής εμπορικού δικαίου, ΕΚΠΑ
Αλεξάνδρα Μικρουλέα, Αναπληρώτρια Καθηγήτρια εμπορικού δικαίου, ΕΚΠΑ

Συμφωνίες φιλικού διακανονισμού που συνέχονται με τα διπλώματα ευρεσιτεχνίας και το δίκαιο του ελεύθερου ανταγωνισμού στον φαρμακευτικό τομέα

Greek

Patent settlement agreements in the pharmaceutical industry and their effects on competition law

Patent Settlement Agreements that are concluded between generic producers and originator companies can affect in many ways the competition in a pharmaceutical market. Those agreements raise issues relating to both competition and industrial property law, two areas of commercial law which are interdependent and together they provide the necessary legal tools for the integration of the pharmaceutical sector itself.
This thesis examines the broad problematic of the legality of such agreements from a competition-law perspective, first through the studying and understanding of the general context in which such agreements are concluded, and, then, through the analysis of the European Commission’s and EU Courts’ approach on this matter. In the context of assessing patent settlement agreements in light of Article 101 TFEU, what is of particular concern to the Commission and the EU Courts is whether such agreements do introduce a restriction ex object or ex effect. A brief comparative overview of the issue is attempted, in conjunction with US law and US court practice, with the latter already resorting to the implementation of the so-called ‘rule of reason’.
However, as far as the EU practice is concerned, the new economic and social reality require a more comprehensive assessment of the situation, by taking into account and balancing all kinds of effects, without being bound by ‘standards and templates’. This is why in recent years a general shift in case-law has been noticed, pointing towards an effects-based approach when investigating possible infringements of Articles 101 and 102 TFEU. In any event, the effective enforcement of EU competition rules in the pharmaceutical sector remains an issue of high priority within the EU, while patent settlement agreements have been, and will probably continue to be, in the very centre of the EU Courts’ attention.

Law and Legislation

Commercial Law

patent settlement agreements, pay-for-delay, restriction on competition, pharmaceutical industry, generics

No

0

No

45

84

https://pergamos.lib.uoa.gr/uoa/dl/object/3259943/file.pdf

https://pergamos.lib.uoa.gr/uoa/dl/object/3259943