Antitrust issues in the settlement of pharmaceutical patent disputes, Part II.

The settlement of patent disputes in the pharmaceutical industry, and the possible antitrust issues arising therefrom, are of notable concern to the Federal Trade Commission. In this Comment, based on his second speech on the subject, Commissioner Leary re-examines some of this earlier positions under the light of the Commission's further experience with these matters, and provides the industry with some additional objective standards under which it may legally operate. With the Hatch-Waxman Act as a backdrop for patent settlements between manufacturers of patented drugs and potential generic entrants to the market, the Commissioner reviews a variety of scenarios that may or may not be permissible. After initially noting the circumstances of presumptively valid settlements, Commissioner Leary reviews the often complex settlement structures that will be deemed unlawful when and if the finding of reverse payments is evidenced. Finally, the Commissioner concludes with a brief examination of other settlement structures and offers his general views as to their likely legality.