The Hatch-Waxman Act was intended to strike a balance of incentives for the first entrants of pioneer small-molecule drugs and the first entrants of generic drugmakers on the market. Fox Rothschild lawyers have significant experience navigating the Act’s complexities on behalf of our clients’ quest to bring worldwide generic pharmaceuticals to the U.S. market. Our lawyers' range of scientific experience involves biotechnology processes and products, chemical processes, synthesis and products, medical devices, formulations, experiments and polymorphic products to name a few.

We are experienced in clearance and Paragraph IV opinions in support of Abbreviated New Drug Applications (ANDAs). Fox attorneys frequently represent clients in litigation related to ANDAs filed under the Hatch-Waxman law, as well as generation of non-infringement, invalidity and freedom-to-operate opinions with respect to Orange Book-listed patents.

Representative Cases:

  • Warner Chilcott Company, LLC v. Lupin, Ltd. et al.
    Court ruled in favor of our client that the evidence of prima facie obviousness was strong and invalidated the chewable oral contraceptives patent number 6,667,050.
  • Tyco Healthcare Group LP et al v. Pharmaceutical Holdings Corporation et al.
    Court granted summary judgment in favor of our client’s claim of prima facie obviousness. The case was appealed to the Federal Circuit.
  • Teva Women's Health, Inc. v. Lupin, Ltd.
    Court held in favor of our client that the evidence of prima facie obviousness was strong and invalidated the patent. The case was appealed to the Federal Circuit.
  • Astrazeneca Pharmaceuticals LP et al v. Lupin Ltd. et al.
    Settled case on terms favorable for our client.
  • Astrazeneca AB et al v. Dr. Reddy's Laboratories Inc. et al.
    Settled case on terms favorable for our client.
  • Gilead Sciences, Inc. v. Sigmapharm Laboratories, LLC
    Settled case on terms favorable for our client.
  • The Medicines Company v. Teva Parenteral Medicines, Inc. 
    Served as Special Master to the Court.
  • Novartis Pharmaceuticals Corporation v. Actavis LLC
  • Horizon Pharma AG et al v. Watson Laboratories, Inc.- Florida et al.
  • Novartis Pharmaceuticals Corporation et al v. Wockhardt USA LLC et al.