Antitrust and Patent Settlement Investigations

Tue May 01 16:24:38 EDT 2007
By David Monk with former NERA Vice President Dr. Joseph Cook

NERA contributed this chapter to Healthy IPRs: A Forward Look at Pharmaceutical Intellectual Property (edited by Meir Pugatch and Anne Jensen), a new book from the Stockholm Network examining central issues in the field of US pharmaceutical intellectual property rights (IPRs).

The chapter addresses the implications of settlement agreements for alleged infringement of pharmaceutical patents. Although most civil litigation settles, the settlement agreements reached by branded and generic pharmaceutical companies over the last several years have contributed to a high profile policy debate. The authors examine a number of factors that have made the relationship between antitrust and intellectual property a contentious issue in the pharmaceutical industry -- including the 1984 Hatch-Waxman Act, the institutional and regulatory structures of pharmaceutical markets, and recent decisions by the Supreme Court and the 11th Circuit Court of Appeals.