Bates White analysis of drug development efforts informs favorable opinion in contract dispute

In Himawan et al. v. Cephalon et al., supported FDA regulatory expert Dr. Brian Harvey in evaluating allegations that Cephalon failed to fulfill its contractual obligations to exercise commercially reasonable efforts to develop a novel biologic medication. Dr. Harvey's report described a challenging regulatory pathway to approval and provided novel analyses of clinical trial results based on data extracted from study exhibits in order to compare the at-issue drug’s probability of success and commercial viability to that of other pipeline products. His report and subsequent trial testimony defended the commercial reasonableness of Cephalon’s decision to cease development and criticized plaintiffs’ assertion that companies with comparable resources and expertise as Cephalon are developing similar products.

The judge stated that the testimony was instrumental and put him in a better position to decide the case and ruled in favor of defendants after a five-day trial. Counsel described retaining the Bates White team as “one of our best strategic decisions.”