One of the most difficult legal issues today involves settlements by which brand-name drug companies pay generic firms to delay entering the market. Such conduct requires courts to consider not only patent and antitrust law, but also the Hatch-Waxman Act, the complex regime governing behavior in...

Two principles collide in the pharmaceutical industry. On the one hand, the U.S. Food and Drug Administration (“FDA”) approves potentially dangerous drugs under Risk Evaluation and Mitigation Strategies (“REMS”) programs when a drug's benefits outweigh its risks. But on the other hand,...

A lot changed between 2008 and 2015. Lindsay McSweeney's stewardship cemented the importance of CPI Antitrust Chronicle. Standard-essential patents, the smartphone patent wars, and patent trolls thrust themselves onto the IP/antitrust scene. But perhaps the most significant change is the...

In GSK v. Teva, the Federal Circuit (in a 2-1 ruling) found that Teva induced infringement of GSK's patent. While much of the opinion addresses issues of causation as applied to the facts at issue in the case, one aspect of the opinion raises significant general concern.In settings in which a...

The Supreme Court's decision in FTC v. Actavis has justly received widespread attention for its antitrust analysis of settlements by which brand-name drug companies pay generics to delay entering the market. Much of the attention has focused on the application of the Court's standard and the...

This short article summarizes FTC v. Actavis, the first case in which the Supreme Court analyzed the antitrust legality of agreements by which brand-name drug companies pay generics to settle patent litigation and delay entering the market. It concludes that the ruling must be counted as a win...

Whether behavior relating to a patent thicket presents an antitrust issue is a nuanced question. But a recent ruling involving the biologic Humira shows how not to decide these issues. This short piece discusses the court’s opinion and highlights its errors analyzing sham behavior, patent...

The essay develops a new approach for antitrust analysis of pay-for-delay settlements in pharmaceutical patent infringement cases, an approach that shows them to be presumptively prohibited agreements in restraint of competition. The issue is timely in light of the Watson v FTC case now pending...

The paper studies the Lundbeck patent settlement antitrust case of the European Commission from an economic perspective. The Commission concludes that the agreements in Lundbeck involving reverse payments from the originator to generics have violated competition law. The paper shows that this...

Patent settlements between originator and generic firms in the pharmaceutical industry are a controversial topic, both in EU competition policy and U.S. antitrust law. The main concern is that patent settlements, which involve large payments from the originator to generic firms (reverse...