The Ever Shifting Boundaries of the Safe Harbor: Determining the Scope of 271 (e)(1) Protections Relative to Paragraph IV Litigation Post Classen and Momenta

2:15-3:00 p.m. CT | Oct. 1, 2014 | Chicago

MBHB partner Paul Tully, Ph.D. is a featured co-presenter for a program entitled, “The Ever Shifting Boundaries of the Safe Harbor: Determining the Scope of 271 (e)(1) Protections Relative to Paragraph IV Litigation Post Classen and Momenta.” This program is held as part of the American Conference Institute’s Paragraph IV Disputes Master Symposium held September 29-October 1, 2014 in Chicago.

• Exploring recent applications of Classen and Momenta in the district courts
  
  
  
  • In Classen Immunotherapies, Inc. v. Shionogi, Inc., __ F. Supp. 2d __, 2014 WL 323941 (D. Md. 2014)
  
  
• Understanding how the present state of the law concerning safe harbor exceptions and expansion will impact ANDA filings
  
  
  
  • when and to what activities does the safe harbor exception apply?
    
    
    
    • pre-market vs. post-market activity
    
    
  • infringing vs. non-infringing activity
    
  • position of brands vs. that of generics relative to Paragraph IV challenges
    
  • how may this jurisprudence impact the relationship between brands and generics as established by the Hatch-Waxman Act
  
  
• Examining the possibility of further Supreme Court review of Classen v. Biogen (Fed. Cir. 2011)
  
  
  
  • dismissal without prejudice as premature
    
  • review of the Solicitor General’s findings
  
  
• Devising strategies for Hatch-Waxman litigation relative to the boundaries of 271(e)(1) in view of the law’s present state
  
  
  
  • brand name and generic perspectives

Sponsored by: American Conference Institute