Hatch-Waxman Litigation

Overcoming Legal and Regulatory Barriers
We offer the legal, business, regulatory, and scientific counsel clients need for managing Abbreviated New Drug Application 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 resources to counsel clients on all aspects of pharmaceutical drug development. That includes providing patent and FDA counseling prior to ANDA filing, and Hatch-Waxman litigation after ANDA filing. The Arent Fox team has represented multiple generic pharmaceutical companies in cases involving dozens of drugs.

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) a team of experienced patent trial lawyers, b) cost-effective solutions, c) cutting-edge technology, and d) active client participation.

Who We Counsel

  • US and foreign 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

Over the past two decades, Arent Fox has litigated dozens of Hatch-Waxman cases in courts across the country. That includes both first-to-file and trailer ANDA litigation.

The group is led by Rich Berman, Janine Carlan, and Jay Deshmukh. Rich has represented pharmaceutical companies in dozens of Hatch-Waxman lawsuits, and advises chemical, pharmaceutical, and medical device companies on the acquisition, sale, in-licensing, and out-licensing of intellectual property. Janine represents clients in bench and jury trials throughout the US. She has been the first chair in numerous federal district court cases, and has led teams on behalf of first-to-file generic drug manufacturers. Jay is an experienced Hatch-Waxman litigator with significant experience counseling and litigating on behalf of many of the leading global generics companies. Prior to his work in private practice, Jay was the head in-house lawyer for Ranbaxy during its most active period of Hatch-Waxman litigation (including first-to-file litigations regarding atorvastatin and esomeprazole).

Key Contacts