Assessing Adverse Events

Analysis Group was retained to assess patent claims involving the differences in side effects and comparable efficacy between a complex pharmaceutical and competing generics. The plaintiff filed suit against two competitors for allegedly infringing upon its patent claims. The defendants pointed to a recent study demonstrating the lack of difference between the drugs, thereby rendering the patent claims invalid. Our team, led by President Pierre Cremieux and including Vice Presidents Lisa Pinheiro and Jimmy Royer, evaluated statements made in the newer study and analyzed the clinical trial data to assess the relative levels of the adverse event at issue for comparable levels of efficacy, and to confirm the patent claim of a lower side effect for a given efficacy level for the patented drug.