The Hatch-Waxman Act was intended to strike a balance of incentives for the first entrants of pioneer small-molecule drugs and the first entrants of generic drugmakers on the market. Fox Rothschild lawyers have significant experience navigating the Act’s complexities on behalf of our clients’ quest to bring worldwide generic pharmaceuticals to the U.S. market. Our lawyers' range of scientific experience involves biotechnology processes and products, chemical processes, synthesis and products, medical devices, formulations, experiments and polymorphic products to name a few.
We are experienced in clearance and Paragraph IV opinions in support of Abbreviated New Drug Applications (ANDAs). Fox attorneys frequently represent clients in litigation related to ANDAs filed under the Hatch-Waxman law, as well as generation of non-infringement, invalidity and freedom-to-operate opinions with respect to Orange Book-listed patents.
Fox's intellectual property attorneys possess an intimate knowledge of the science and technology behind each client's ideas. All of the firm's patent lawyers and patent agents have science or engineering backgrounds, many possess advanced degrees, and most have deep industry experience.
When our patent attorneys enter a courtroom, they routinely explain complex technical issues in a straightforward manner, presenting our client's story to the judge and jurors in the most compelling way possible. We assertively advocate patent proceedings for large and small corporations as well as individual inventors and start-up enterprises.