Ocean Tomo’s Expert Testimony group is regularly retained on behalf of generic pharmaceutical firms to provide economic and financial analyses and expert opinions relating to Hatch-Waxman disputes. Through our work, Ocean Tomo has developed expertise in evaluating, for example, the economic and business factors as well as the drug product features that influence physician prescription practices.
We are regularly asked to evaluate claims by branded drug companies of irreparable harm (in response to PI Motions) as well as economic damages resulting from the introduction of generic drug products in the United States. In connection with our work, we have analyzed and evaluated the cost structures and profitability of numerous multinational branded drug companies. In addition, we have extensively analyzed market, prescription, sales, and other financial data compiled by third-party research firms such as IMS Health.
Our Hatch-Waxman-related assignments generally concern addressing one or more of the following issues:
A secondary consideration of non-obviousness which requires a finding of significant sales in the context of the relevant market with a nexus to the asserted claims of the patent(s)-in-suit. Our evaluation of a relevant market typically considers physician prescribing practices, FDA approved indications for U.S. drug products, and the competitive product landscapes often reflected in the management reports and market studies of the plaintiffs/ branded drug companies. Our work also involves evaluating the economic factors and product features (including APIs disclosed in patents that may be prior art) that influence physician prescribing practices in order to address the nexus issue. In addition, we have researched and identified blocking patents that act as disincentives for third-parties to invest in R&D around the subject matters of the patents-in-suit.
The quantification of damages in pharmaceutical patent infringement cases can be relatively straight forward given the high level of detailed financial data and market research compiled and published by pharmaceutical industry research firms such as IMS Health. This does not however deter branded drug companies from asserting claims of irreparable harm in support of Motions for Preliminary Injunctions. In response to these Motions, we evaluate the significance of the sales and profits of patented products to the plaintiffs/branded drug company’s business, and evaluate the impact of the potential loss of exclusivity. In addition, we are sometimes asked to quantify the bond amount that should be posted by patentees in order to protect in the economic interests of the defendant/generic drug companies.
After a drug product has been introduced in the United States, we may be asked to quantify the measure and amount of damages resulting from the alleged patent infringement. Our “but-for” analysis includes a market-expansion evaluation and considers the impact of other generic entrants, as well as any generic product that has been authorized by the branded drug company. When the measure of damages is a reasonable royalty, we consider the significance, if any, of the patented technology on the demand for the patented drug product, and otherwise evaluate the factors set forth in the case of Georgia-Pacific.