Intellectual Property

Hatch-Waxman Disputes

J.S. Held’s Inaugural Global Risk Report Examines Potential Business Risks & Opportunities in 2024

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Our team has been retained on behalf of branded and generic pharmaceutical firms to provide economic and financial analyses and expert opinions in Hatch-Waxman disputes.

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With regard to the issue of Commercial Success, we offer expertise in evaluating the economic and business factors as well as drug product features that influence physician prescription practices. With regard to Motions for Preliminary Injunctions, we evaluate claims of irreparable harm by branded pharmaceutical firms and assess the measures and amounts of damages that may result from the introduction of generic drugs in the United States.

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Hatch-Waxman Engagements – Commercial Success

Commercial success is 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.

Hatch-Waxman Engagements – Irreparable Harm

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 IQVIA Inc. (formerly, 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.

Hatch-Waxman Engagements – Economic Damages

After a generic 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” analyses may involve a market-expansion evaluation and consider the impact of other generic entrants, including 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.

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