Competition Law And Settlement Agreements

In Generics, the Court also explained the circumstances in which patent holders of medicinal products abuse a dominant position by concluding remuneration agreements under Article 102 TFEU (and Article 24 of the Dutch Competition Law). The Court stated that, in the Generics judgment of 30 January 2020, the Court defined the criteria for determining whether a settlement agreement in a patent dispute between an author and a generic medicine was contrary to the prohibition on cartels. The judgment was delivered on the basis of the uk Competition Appeal Tribunal`s request for a preliminary ruling on the decision of the English Competition Authority (CMA). The CMA`s fine decision in question targeted GlaxoSmithKline (“GSK”) and a number of generic drugs. AG Kokott also considered, as the ECJ had done in the Generics judgment (UK), that the procedural patents at issue did not constitute insurmountable barriers to entry for generic drug manufacturers. Although the patents were considered valid, it found that the presumption of validity of such patents could not be equated with a presumption of illegality of generic medicinal products which are placed on the market in force and that entry into the market was `threatened` as a real and concrete possibility of entering the market. This is particularly the case for procedural patents. However, according to the GA, procedural patents are part of the economic and legal context of a settlement agreement. Following an extensive investigation by the pharmaceutical sector into competition in 2008, the European Commission is increasingly focusing on patent arrangement agreements, with a particular focus on practices aimed at delaying the market entry of generic medicines. The Commission has made a series of formal “statements of opposition” to pharmaceutical companies, including Servier Laboratories and Lundbeck in two major cases concerning citalopram, an antidepressant, and perinopril, a cardiovascular medicine. This pressure field is clearly visible in the pharmaceutical sector, where particular attention is paid to the accessibility of medicines. The Court added a number of new perspectives in generics. This judgment shows that settlement agreements between drug manufacturers can pose problems from the point of view of competition law in the event of patent litigation.

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