July 13, 2017
Brussels antitrust partner Matthew Hall wrote an article titled “It’s Possible; Settling Pharma Patent Infringement Claims in Compliance with EU Competition Law” for the July 2017 issue of International Antitrust Bulletin, published by the American Bar Association’s Section of Antitrust Law.
In the article, Hall discussed the EU’s continuing focus on pharmaceutical patent settlement agreements between originators and generic companies. In particular, he analyzed a number of “Category B.II” cases, where, to settle the dispute, the generic company agrees to a limitation on its entry with a competing, unbranded and unpatented generic product, and there is a value transfer — or “pay for delay” — from the originator to the generic company. The article also discussed categories of restrictions and value transfers, and how to craft a legal category B.II settlement.
Hall noted in the article, however, that “[i]t remains the case that there is no certainty in this area for companies and their advisers and no coherent counselling standard.… 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.”