Brown Rudnick Berlack Israels LLP, One Financial Center, Boston, MA 02111, USA, Tel: +1 617 856 8284, Fax: +1 617 856 8201, Email: saunders@brbilaw.com

Revised 3 September 2003.

Abstract

Settlement is almost always preferable to last-man-standing litigation. While litigation posturing is a necessity, all but the largest pharmaceutical houses must avoid suing to a conclusion. The objective is to make a reasonable deal. Having a non-lawyer corporate representative fully engaged in direct settlement efforts, with the assistance of counsel, throughout the process is one way to foster settlement. Also, be sure to propose a Scheduling Order with as many points of decision as possible. In particular, separate Markman claim construction briefings and rulings from summary judgment briefings and rulings. Preparing for the 95 per cent probability of settlement is prudent, cost effective and substantially less bloody. Abbreviated new drug application (ANDA) Paragraph IV litigation is a unique litigation exercise. Address ANDA Paragraph IV litigation and settlement separately in terms of how the 'other side' will react and how the Federal Trade Commission (FTC) will react. The objective is not to sustain or defeat a patent. These are merely aspects of potentially profitable constructions of a settlement agreement.