Hatch-Waxman Litigation

We offer the legal, business, regulatory, and scientific counsel clients need for managing Hatch-Waxman litigation.

Our Approach

A large measure of our success stems from a commitment to understand our clients’ business and how patent litigation impacts their bottom line. As one of the leading full-service intellectual property firms in the country, our team has the experience and resources to counsel clients on all aspects of pharmaceutical drug development including patents, Hatch-Waxman litigation, and FDA regulatory matters  before and after the filing of an Abbreviated New Drug Application (ANDA), 505(b)(2) application, or NDA. For more than two decades, the ArentFox Schiff team has represented many pharmaceutical companies in cases involving over 150 drug products in virtually every drug product category.

Our litigation strategies are designed with a simple goal: get our pharmaceutical clients to the market as quickly as possible. We do that with a team of experienced patent trial lawyers, who work closely with our clients, keeping them informed and involved throughout the process.

Who We Counsel

  • Pharmaceutical companies
  • Medical device manufacturers
  • Healthcare and life science companies

What We Do

  • ANDA and 505(b)(2) litigation
  • IPR/PGR proceedings
  • Pre-litigation counseling
  • Patent validity and infringement analyses
  • FDA and healthcare regulatory counseling

Our Work

Our lawyers were some of the first to represent generic pharmaceutical companies seeking to make medicine affordable to consumers in Hatch-Waxman matters. We continue to represent the world’s leading generic companies in ongoing major Hatch-Waxman litigation. This includes inter partes review, trials and appeals, as well as precedent-setting cases for some of the largest first-to-file (FTF) matters. We have litigated numerous Hatch-Waxman cases appearing before federal district courts over much of the country.

Our experience spans the full range of Hatch-Waxman issues, from product screening and selection through trial and appeal. Our team has the requisite technology skills to cover the spectrum of patent challenges, including compounds, polymorphs, formulations, compositions, drug delivery devices and methods of use. In every case, we work with our client to assemble the right team, knowing we have the bench strength and depth of experience to not only address any need, but to also do so cost-effectively.