M. Howard Morse will be speaking at the American Conference Institute's program entitled Paragraph IV Disputes: Expert Insights on Hatch-Waxman Litigation: Strategies for Brand Names and Generics in New York. 

The Hatch-Waxman reforms under Title XI of the MMA mandated that pharmaceutical companies provide the FTC with advance notice of proposed settlements of patent disputes. The FTC and state attorneys general have challenged a number of settlements on antitrust grounds and settled several cases. Private litigation raising similar claims has followed. The FTC v. Schering case is a prime example of the uncertainties in the debate which looms in this area like an ancient specter and begs the question as to whether a Paragraph IV case can ever be settled. This session will examine recent developments and discuss their implications for the future of settlements. Some of the questions to be explored include:

  • What types of settlements have been found invalid or unenforceable?
  • What are the options for parties who want to settle?
  • How do authorized generics fit into settlement schemes?
  • How the new congressional leadership may affect patent settlements