Background - Practices (Details)

Pharmaceutical & Biologics Litigation

Crowell & Moring is home to a team of patent litigators representing and advising clients in cases arising under the "Hatch-Waxman Act" and the Biologics Price Competition and Innovation Act (“BPCIA”). Our life sciences patent litigation group currently consists of nearly 20 intellectual property litigators who bring experience, dedication, and skill to life sciences patent litigation.

Our group includes first-chair life sciences patent trial litigators (both non-jury and jury), lawyers with technical degrees, including advanced degrees in the relevant disciplines, and lawyers experienced in working with experts to develop the relevant testing and opinion testimony that in many cases is critical to success. Our life sciences patent litigation team has been victorious in courts throughout the country, including Delaware, New Jersey, and Maryland.

Our lawyers also have experience in the specific regulatory framework in which these cases are fought and use their knowledge to advance our clients' interests. Our lawyers address matters in nearly every aspect of the Hatch-Waxman and BPCIA arena. In addition to patent litigation, we also are experienced with citizen petitions filed with the Food and Drug Administration (FDA) on various regulatory issues under the Hatch-Waxman Act that may concern approval, exclusivity, forfeiture, or other issues critical to the successful commercialization of a product and also have expertise with patent term extensions under 35 U.S.C. §156 for both drug and medical device products.

With offices in many international jurisdictions, Crowell has the capability and experience to coordinate and handle international litigations on specific products, thereby ensuring clients are able to leverage the knowledge gained in each jurisdiction and disseminate it to other jurisdictions litigating the same product. This not only provides key consistency in arguments made across jurisdictions, but also helps client reduce costs of international litigation by using the same counsel in multiple jurisdictions world-wide.