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Hatch-Waxman Litigation

Generic pharmaceutical companies turn to Goodwin Procter. We have a team of experienced lawyers who specialize in guiding pharmaceutical companies through the rocky terrain of Hatch-Waxman litigation.

Our Hatch-Waxman team includes attorneys and scientists who collectively hold more than 50 advanced degrees in pharmacology, biotechnology and chemistry. Because we understand the science behind drug patents, we’re in a better position to advise clients accordingly. We analyze and evaluate validity and infringement issues associated with complex pharmaceutical patents and develop effective strategies based on the specifics of each case.

As part of the firm’s commitment to working in cross-disciplinary teams, attorneys in our FDA practice collaborate on Hatch-Waxman litigation matters. Our FDA lawyers have extensive experience handling the complex issues surrounding Abbreviate New Drug Applications (ANDAs), including whether a patent can be listed in the FDA’s Orange Book, the specific certification requirements and the scope of market exclusivity periods. With two former FDA Associate Chief Counsels on staff, we have a keen understanding of how the agency works and can also assist clients with responding to all inquiries, including untitled and warning letters, investigations and enforcement actions.