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



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

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

Anders Aannestad
Morrison Foerster (San Diego, CA)

Sponsored by: American Conference Institute

Register online at at