Hatch-Waxman Litigation

Integrated technical expertise

With profitability and corporate viability at stake, the pharmaceutical industry is waging complex battles at the intersection of antitrust and intellectual property law. The goal is to prevail in asserting IP rights in the face of Hatch-Waxman Act and Abbreviated New Drug Application (ANDA) applications and tackle any arising antitrust challenges, such as allegations of sham litigation or challenges to Hatch-Waxman case settlements by the U.S. Federal Trade Commission (FTC). 

Branded leaders of the global pharmaceutical industry rely on Dechert trial lawyers, appellate lawyers and Ph.D.-level subject matter experts to take on these challenges with them.

Our legal services are distinguished by a high degree of technical and scientific sophistication. Taking an interdisciplinary approach, we design strategies to protect and maximize the value of our clients’ pharmaceutical patents. Our deep bench of trial lawyers has prepared for and litigated many ANDA disputes – and because we have pursued and won cases involving as many as a dozen ANDA filers, we are not afraid to take these disputes to trial. Likewise, our seasoned antitrust lawyers, which include former FTC personnel, are highly skilled in patent-antitrust issues.

We have handled numerous ANDA matters for branded companies, including:

  • GlaxoSmithKline
  • Endo Pharmaceuticals
  • Penwest
  • Stiefel
  • Teikoku
  • Norgine
  • Elan Pharmaceuticals

Big picture business focus

Our lawyers see the ANDA picture from start to finish, which gives us a distinctive perspective on each Hatch-Waxman matter. We focus on our clients’ business needs from the day the Paragraph IV notice is received to the trial and appeal or FTC ANDA settlement review process. When necessary, our team is adept at handling follow-on antitrust litigation. 

Our firm’s frequent, high-profile success on behalf of life sciences companies means that our teams handle highly sensitive matters, including pre-litigation Orange Book reviews and product launch strategic assessments and, in one case, architecting what is likely the largest branded/generic settlement of all time and shepherding it through the FTC. 

Shaping Public Policy

Our lawyers have been invited by the FTC and the Department of Justice to participate in shaping public policy. This involvement has helped us establish credibility with policy makers and has kept us at the forefront of legal developments. We draw upon our experience in the public policy arena to provide definitive advice and practical guidance to our clients.