Hatch-Waxman, Biologics and Biosimilars Litigation

Litigation in the pharmaceutical and biotechnology industry can be particularly complex, requiring counsel that is as well versed across scientific disciplines as it is in the law. Goodwin has made servicing the needs of the pharmaceutical and biotechnology industries a strategic priority for more than two decades, and we have one of the largest and most active life sciences practices in the United States. Our IP litigation team is among the most experienced in the country, successfully representing both brand and generic companies in Hatch-Waxman litigation. Our portfolio of clients includes some of the largest innovator and generic companies in the world, and we have represented our clients in patent cases involving some of the world’s biggest blockbuster drugs.

Our firm is also a leader in the emerging field of biologics and biosimilars litigation. Our lawyers were involved in the legislative process that resulted in the Biologics Price Competition and Innovation Act (BPCIA), and our work counseling clients as they advance their biologic and biosimilar development programs has been a natural outgrowth of our extensive work on behalf of the pharmaceutical industry. Clients consistently praise our blog, BigMoleculeWatch.com, for its timely and relevant posts on biosimilar-related litigation, legislation and regulatory developments. In addition, our team authored Guide to Biosimilars Litigation and Regulation in the U.S., 2019-2020 ed., a first of its kind publication that explores the BPCIA.