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...

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 conventional legal analysis of technical standard setting derives primarily from antitrust law. But antitrust remedies, taken alone, may not be broad enough to address recent abuses of the standardization process. The principal example of this shortcoming is the well-known case of Rambus,...

In recent years, reverse patent settlement agreements — whereby a patent holder pays or gives other forms of value to an infringer in order to avoid or to settle patent litigation — have raised considerable debate in the pharmaceutical field in both the United States and the European Union,...

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,...

Patent licensing contracts commonly prohibit licensees from challenging the validity of the patents at the basis of the contract or penalize such challenges. A considerable debate has emerged as to whether courts should enforce these challenge clauses. We argue that this debate has not gone far...

Patent settlements between rivals restrain competition in many different ways. Antitrust requires them to be "proportional" in that their anti-competitive effects are commensurate with the firms' expectations about (counterfactual) patent litigation. Because these expectations are private and...

The Patent Trial and Appeal Board (PTAB) is a recently-formed division of the Patent Office in which patents can be challenged as invalid, and which differs from federal courts in a number of respects. We investigate whether monopolist-patentees and their prospective rivals are using the PTAB...

This article examines a number of cases which have arisen in the EU and which raise the question of whether a holder of a standard-essential patent (SEP) which has given a commitment to license that SEP to any third party on fair, reasonable and non-discriminatory (FRAND) terms, should be able...

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...