Cornering the Market in a Post-9/11 World: The Future of Horizontal Restraints

Abstract

This article examines the legality of agreements between brand drug manufacturers and generic producers that delay generic drug entry into the relevant market. More specifically, this article explores the connection between patents, pharmaceuticals, and antitrust policy in a post 9/11-world facing an increased need for affordable pharmaceuticals to combat potential acts of bio-terrorism. The 9/11-aspect is crucial to understanding the evolutionary nature of antitrust because, in a dialectical sense, 9/11 changed the thesis of antitrust enforcement in the pharmaceutical market. This change is most clearly illustrated with respect to the antibiotic Ciprofloxacin (Cipro), the anti-anthrax drug that became a household name for unfortunate reasons following 9/11. The Cipro debate, detailed in Part III, which has taken on great importance since 9/11, provides a useful case study of the relationship between patent law, brand name drugs, generic counterparts, and antitrust enforcement in the general pharmaceutical market.

This article will survey all relevant phenomena bearing on the generic drug competition issue, including, but not limited to, the legislative, executive, political, historical, economic, and judicial factors that inform the question. The idea is to treat a question of antitrust policy as an historical phenomenon that cannot be assessed solely in terms of doctrine, but in view of the legal and social context the issue arises within. In assessing the legality of agreements that delay generic entry into the market, this article addresses two questions. The first question is whether patents on pharmaceuticals encourage or discourage competition in the relevant market or markets. The second question is whether courts will be more or less willing to find antitrust violations by brand drug manufacturers in the post-9/11 world.

Keywords: antitrust, Hatch-Waxman, brand drug, generic, Cipro, bioterrorism