Analyzing Invalidity & Non-Infringement Assertions In Light of the ANDA Applicant’s Pre-Litigation Obligations and Assertions

December 4, 2012 | 9:15-10:15 a.m. PT | San Francisco

MBHB partner Paul Tully is a featured presenter at a two-day conference entitled, “Paragraph IV Disputes” set to take place Dec. 4-5, 2012 in San Francisco. Sponsored by American Conference Institute, the event is described as a “must-attend event for litigators from brand name and generic companies to share insights into increasingly high-stakes and complicated Hatch-Waxman litigation.” Mr. Tully’s presentation is as follows:

Analyzing Invalidity & Non-Infringement Assertions In Light of the ANDA Applicant’s Pre-Litigation Obligations and Assertions

• Reexamining the initial obligations
  
• NDA applicant under Paragraph IV in light of the Supreme Court’s ruling in Microsoft v. i4i
  
  
  
  • when is there “clear and convincing” evidence that patent is invalid and therefore not infringed
    
  • assessing the consequences of not meeting this burden of proof
  
  
• Weighing your options in light of the burden: should you file a Paragraph IV certification or choose another ANDA route?
  
• Choosing which Orange Book patents to challenge
  
  
  
  • compounds; formulations
    
  • reformulations
    
    
    
    • The Research Foundation of State University of New York v. Mylan Pharmaceuticals, Inc.
      
    • AstraZeneca AB et al v. Hanmi USA, Inc.
    
    
  • process; methods of use
    
  • polymorphs
    
  • extended release
    
    
    
    • In re Cyclobenzaprine
      
    • Cyntora
      
    • AstraZeneca Pharmaceuticals LP v. Torrent Pharmaceuticals Ltd.
    
    
  • enantiomers
    
    
    
    • Sunovian Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.
    
    
  • factoring “forfeiture” into your Orange Book strategy
    
  • skinny labeling and carve-out considerations via Caraco
    
  • obviousness assessments
  
  
• How Patent Reform may impact Orange Book patent challenges
  
  
  
  • elimination of Best Mode defense
    
  • prior user rights
    
  • exploring new Post Grant Review and Inter Partes Review as another mechanism for invalidating an Orange Book patent
  
  
• Understanding the role of non-Orange Book patents in your PIV ANDA strategies
  
  
  
  • innovator / non-innovator
    
  • API
  
  
• Procuring legal opinions on invalidity and non-infringement-
  
  
  
  • performing cost effective due diligence and freedom to operate analysis before filing an ANDA
    
  • assessing when opinions are needed
    
  • opinion of in-house v. outside counsel
    
  • questions of privilege
    
    
    
    • Rule 26 (b) (4) revisions regarding expert opinions
  
  
• Filing the ANDA
  
  
  
  • fulfilling requirements for FDA approval:
    
    
    
    • pharmaceutically equivalent; bioequivalent
    
    
  • identifying triggers which may necessitate new bioequivalence studies
  
  
• Contents of the Paragraph IV certification

Presenters:

Paul Tully
Partner
McDonnell Boehnen Hulbert & Bergoff LLP (Chicago, IL)

Rochelle Dede
Patent Attorney
Sandoz Inc. (Princeton, NJ)

Anders Aannestad
Partner
Morrison Foerster (San Diego, CA)

Sponsored by: American Conference Institute

Register online at at http://americanconference.com/paragraphIVSNF/overview.