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Business Articles Awards > Intellectual Property

It’s Possible; Settling Pharma Patent Infringement Claims in Compliance with EU Competition Law

Matthew Hall, International Antitrust Bulletin, 2017, Vol. 2

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Competition law regulators in the European Union (EU) continue to focus on issues arising out of pharmaceutical patent settlement agreements between originator and generic companies. The main concern is so-called “Category B.II” cases, under which, where there is a dispute about the validity of or whether there would be an infringement of the originator’s patents, the generic company agrees to a limitation on its entry with a competing generic (unbranded and unpatented) product and there is a value transfer from the originator to the generic (often referred to as “pay-for-delay” settlements).

It remains the case that there is no certainty in this area for companies and their advisers and no coherent counselling standard. Nevertheless, the possibility of agreeing to a legal Category B.II settlement should not be dismissed. These are extremely fact intensive cases and Category B.II settlements can be compatible with EU and EU Member State competition law. The European Commission has made it clear that a case-by-case analysis is required and there is no presumption of illegality, even for Category B.II settlements.

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