Services | Pharmaceuticals
The pharmaceutical industry has become one of the cutting edges of intellectual property litigation and policy-making today. Accurate and complete analysis of patent claims and potential damage exposure is essential to the adjudication or settlement of claims, as well as to the development of sound public policy for the future.
Development, approval and sales processes for prescription drugs are unlike those for any other industry. The data sources that capture these phenomena are equally unique. OnPoint's pharmaceutical specialty enables us to identify the most relevant data sources for any issue and to interpret them through the lens of industry practices.
OnPoint is thoroughly familiar with FDA approval processes, patent validity considerations, and the procedural and substantive implications of the Hatch-Waxman Act. Our analyses are founded on sound empirical data and proven economic models, and each report is informed by a deep understanding of marketing trends, techniques and returns.
Analysis performed includes:
Market definition and market power evaluation
Infringement and misappropriation damages calculation
Impact of generic entry on branded pharmaceuticals, including
calculation of potential losses from “at risk” generic entry
Running royalty and lost profit calculation
Commercial success and other secondary indicia of
patent validity
Systematic pricing issues
Identification and evaluation of non-infringing alternatives
Evaluation of contractual licensing arrangements