In a major judgment handed down on 30 January 2020 in Generics (UK) and Others, [1] the EU Court of Justice (the Court) – the EU’s highest court – clarified for the first time the analytical framework for assessing when patent settlement agreements that restrict a generic pharmaceutical company’s ability to enter the market infringe the EU antitrust rules. While the ruling addresses specific questions raised by a UK court in the context of an individual antitrust case relating to the anti-depressant drug paroxetine, manufactured by GlaxoSmithKline (GSK), the ruling also carries wider significance. The judgment provides detailed guidance that will assist pharmaceutical companies in self-assessing whether any patent settlement agreements they contemplate are in line with EU antitrust rules.
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The EU Court of Justice clarifies for the first time when patent settlement agreements restricting a generic pharmaceutical company’s ability to enter the market infringes the EU antitrust rules (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
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