In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Eight years after the conclusion of the 2008 pharmaceutical sector inquiry, it is clear that the Commission has largely been true to its stated enforcement priorities. However, the recent announcement of an…
We have recently celebrated the 25th anniversary of the EU Merger Regulation, which came into force on 21 September 1990. Since that date, we have seen an exponential growth in merger control notifications at the European level – at least up until the financial crisis that began in 2008. The good news is that, to…
Opening a new front in litigation over so-called reverse payment pharmaceutical patent infringement settlements, the California Supreme Court recently held that private parties can challenge these settlements under its state antitrust law, the Cartwright Act.[1] The court relied heavily on the U.S. Supreme Court’s decision interpreting federal antitrust law in F.T.C. v. Actavis, Inc.,[2] importing…
The U.S. Supreme Court recently issued a decision that provides generic pharmaceutical manufacturers with the ability to challenge the “use codes” listed by brand name manufacturers in filings made with the U.S. Food and Drug Administration (“FDA”). The decision in Caraco v. Novo Nordisk illustrates the impact that these “use codes” can have on the…
