This short comment applauds the FDA's proposed Guidances on shared REMS (Risk Evaluation and Mitigation Strategies). The FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used REMS, intended to bring drugs to the market, to block generic...

Brand-name drug firms sometimes switch from one version of a drug to another to delay generic entry. In a case involving the acne-treating antibiotic Doryx, the Third Circuit failed to sufficiently appreciate the anticompetitive concerns with such “product hopping.” The court misapplied the...

In Mylan v. Warner Chilcott, a Third Circuit panel offered a highly questionable decision on “product hopping,” by which a pharmaceutical company switches from one version of a drug to another.Mylan offered a simple and compelling anticompetitive story: (1) defendants were the exclusive...

Since the Supreme Court's decision in FTC v. Actavis, the question that has received the most attention is whether “payment” is limited to cash or encompasses non-cash forms of consideration. The courts, including the Third Circuit in the “King Drug” case, have consistently held that...

In my testimony to the Senate Judiciary Committee, I explained the benefits of legislation addressing anticompetitive conduct that brand-name drug companies have employed: sample denials, pay-for-delay settlements, citizen petitions, product hopping, and patent thickets. By increasing generic...

Using the sleep-disorder drug Provigil as a case study, this short symposium piece explores the anticompetitive harm presented by the combination of two distinct activities. First, brand-name drug firms such as Cephalon, the developer of Provigil, have settled patent litigation by paying generic...

Intellectual property (“IP”) is often credited with providing an incentive for inventors to develop their creativity. Through IP protection, inventors can recoup their investment and make a profit. That idea, which has inspired legislators worldwide, is currently challenged in the European...

In FTC v. Actavis, the Supreme Court held that a payment from a brand firm to a generic firm, in exchange for the generic’s agreement to delay entering the market, could violate the antitrust laws. In In re Wellbutrin XL Antitrust Litigation, defendants claim that the Court’s antitrust...

This short piece responds to Alan Morrison’s post on SCOTUSblog that the Supreme Court’s Actavis decision is unclear because of its emphasis on “large and unjustified” payments. The piece first explains that the payments at issue in "reverse payment" cases are, by definition, likely to...

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...