An issue that may arise for both the plaintiff and defendant in a patent dispute involving pharmaceutical technology concerns the risks associated with selling an allegedly infringing product prior to the dispute being resolved. The plaintiff has the option to seek a preliminary injunction. Deciding whether to grant an injunction involves fact specific analysis. The economic components in such an analysis, which are addressed in this report, are: assessing whether the plaintiff will suffer irreparable harm without an injunction, measuring the balance of harms to the plaintiff and defendant, and evaluating whether the public interest will be served by an injunction.

This report identifies the risk and regulatory factors that influence location decisions by research-based pharmaceutical/biotechnology companies. The primary data are from interviews with 34 senior executives representing 14 research-based pharmaceutical/biotechnology companies. These interviews provided qualitative information on the particular factors that matter and their relative importance in selecting a host country for an investment. The specific factors that influence the general willingness of companies to invest in a particular country are: industry history, the incremental nature of investments, stability, structure of the pharmaceutical marketplace, access to leading scientists and physicians, adequate supply of skilled workers, sufficient patient population for clinical trials, tax policy, and transport links both within the region served and to global headquarters.

In U.S. patent cases, a factor for demonstrating that an invention is non–obvious is the commercial success of the product embodying that invention. There must also be a nexus or connection between the patented characteristics of the claimed product and its commercial success. One may presume that a nexus exists if the characteristics of a product that is shown to have commercial success are covered by the patent claims at issue. In Europe, “commercial success alone is not to be regarded as indicative of inventive step. The following requirements must first be met: a long–felt need must have been fulfilled, and the commercial success must derive from the technical features of the invention and not fro mother influences (e.g. selling techniques or advertising).” Based on my understanding of U.S. and European patent law relevant to the issue of commercial success, this paper addresses some of the economic issues and associated data to consider in assessing whether a patented pharmaceutical product is a commercial success.