Background - Practices (Details)

Pharmaceutical & Biologics Litigation

Since its enactment in 1984, the Hatch-Waxman Act has saved consumers, insurers, and government payers over $1 trillion by enabling generic pharmaceutical companies to bring to market less expensive alternatives to branded drug products more expeditiously via the ANDA, or Abbreviated New Drug Application, process. Crowell & Moring is committed to representing generic pharmaceutical clients in ANDA litigation arising under the Hatch-Waxman Act. Our experience and know-how make us uniquely qualified to handle all stages of ANDA litigation for first filers and subsequent filers alike, from initial pre-suit investigation, counseling through trial and appeal, "at-risk" launch, and settlement. Moreover, our understanding of the regulatory framework surrounding ANDA litigation and the interplay between district courts and FDA proceedings allows us to implement successful and creative legal and regulatory strategies on behalf of our clients.

Crowell & Moring's Intellectual Property Group includes first-chair trial lawyers with years of experience litigating ANDA cases on behalf of generic pharmaceutical clients, and numerous other attorneys with significant trial experience in ANDA litigation. The ANDA litigation team includes attorneys and non-attorney professionals with technical backgrounds in biology, biotechnology, chemistry, biochemistry, organic chemistry, inorganic chemistry, and chemical engineering, as well as other related disciplines, including individuals with advanced technical degrees and Ph.D.'s in these disciplines. This depth equips Crowell & Moring with the ability to understand the complicated technical issues that often arise in these cases, as well as to translate these concepts to litigation strategies and successfully try complex ANDA litigation cases. 

Crowell & Moring's lawyers are also experienced in handling appeals of these cases before the Federal Circuit and have won many Paragraph IV litigations at the district court and appellate court levels.

Crowell & Moring's ANDA litigation attorneys include thought leaders in the biosimilars (generic biologics) field who have written and spoken extensively regarding the 2009 Biosimilar Price Competition and Innovation Act (BPCIA) and trial lawyers who have litigated biotechnology cases. With this experience, and the knowledge we have gained litigating and counseling generic pharmaceutical clients under the Hatch-Waxman Act, we are poised to guide clients through the new regulatory and emerging litigation processes under the BPCIA to successfully launch and market lower-cost biologic products.