As part of the FDA's hearing on "The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access," I offer testimony that does two things.First, it shows how the balance has tilted away from generic access, pointing as examples to settlements, product hopping, REMS patents, and...

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,...

Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management...

This roundtable explores issues presented by "reverse payment" settlements by which brand-name drug companies pay generic firms to delay entering the market. Kent Bernard, Karen Bokat, Michael Carrier, Howard Morse, and Eric Stock explore the history of the settlements, potential legislation,...

In this comment to ITC Investigation 337-TA-745 (Certain Wireless Communication Devices, Motorola v. Apple) we, as teachers and scholars of economics, antitrust and intellectual property, remedies, administrative, and international intellectual property law, former Department of Justice lawyers...

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...