In addition, each real-life situation will have its own sets of factual issues to factor into the analysis. For example, in certain circumstances it might make financial and risk-management sense to frontload costs and spend more on the product right after it receives a patent challenge. Nonetheless, by using timing probabilities set as a backdrop, any product under Paragraph IV challenge can create financial analysis decision points so that the company can weigh decisions by using timing probabilities and clear delineation of risk and reward.

Without a doubt, generics companies will continue to use the Paragraph IV patent challenge as gateway into the marketplace. Brand teams can no longer effectively manage their products by using guesswork, supposition, and the hope that "legal will handle this." Armed with the appropriate data, brands and companies can, at the very least, understand the financial implications of their product management decisions. When factoring in its own risk profile, a company can then make more informed choices and manage the risk to its satisfaction.

Gregory Glass, MBA, is the principal of Gregory Glass Associates in Downingtown, PA, and the editor of the Paragraph Four Report. He can be reached at comments@gregoryglass.com.