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  • The Orange Book blog team are a group of attorneys with McAndrews, Held and Malloy, which is a full-service IP firm representing both brands and generics in various aspects of IP law. This blog does not provide legal advice. If you are seeking legal advice, please contact the author directly.

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May 22, 2014

ACI "Biosimilars" Conference, New York, June 5-6

American Conference Institute is holding their 5th annual "Biosimilars" conference in New York on June 5-6.  Speakers include in-house counsel from Eli Lilly, Mylan, Sandoz, Amgen, AbbVie, Momenta, J&J, and Actavis.  Also speaking will be representatives of the Federal Trade Commission, GPhA, and PhRMA.

The agenda includes the following presentations:

  • Minimizing the Uncertainty Surrounding the Untested Pathway: Insight Into FDA's Current Position and Initiatives Regarding Biosimilars
  • Predicting Follow-On Entry and Evaluating the Risk and Commercial Opportunity in the Emerging Biosimilar Landscape
  • New Kid No More: Evolution in Biosimilars Science and Regulations
  • The Holy Grail for Biosimilars: Meeting FDA's Requirements for Biosimilarity and the Heightened Standard of Interchangeability
  • FTC Keynote: Revisiting Competition Issues in the Follow-On Biologics Arena: Substitution and Naming Conventions
  • The Importance of Biologic Manufacturer Accountability: Key Policies for Biologic Substitution and Nonproprietary Names
  • Industry Round Table: Weighing in on the Emerging Controversy on Biosimilars Naming and State Substitution Laws
  • The EU Experience: Regulatory and IP Lessons Learned So Far from the First Biosimilar Antibody Approval in Europe
  • Analyzing the Arguments in the First BPCIA Case, Sandoz v. Amgen: Immediate Action Plans for Innovators and Biosimilars to Prepare Before the First Application is Public
  • The Most Powerful Tool in Your Arsenal: Using Inter-Partes Reveiw at the PTO to Revamp Branded and Biosimilar Litigation Strategies
  • Going Beyond the Hatch-Waxman Comparisons: Delving into Pre-Suit Due Diligence and Pre-Litigation Tactics for Evaluating Patent Strength and Assertion Strategies
  • Platform Patents and Antibodies: Specific Action Plans to Protect or Defend Patents Most Ripe for a Biosimilars First Wave Challenge
  • Key IP Case Law Through the Biosimilars Lens: Top 5 Patent Battles to Consider When Updating Your Biosimilars Prosecution and Litigation Strategies
  • Case Spotlight: Momenta v. Amphastar and Bioequivalence: Understanding the Implications for the Future of Biosimilars
  • Timing is Everything: Managing the Logistics of the BPCIA Exchange Process and Preparing for "Early" and "Late" Phase Litigation
  • Ethics in the Biosimilars Realm: Avoiding Conflicts and Maintaining Confidentiality in the Brave New World

ACI is also offering a pre-conference primer on June 4 that includes two sessions:  "Biosimilars 101: Comprehensive Deep Dive Into the Relevant Legal, Regulatory, and Scientific Factors Companies Must Now" in the morning and "Biosimilars Around the World: A Regulatory and Patent Cheat Sheet to Maximize Global Biosimilars Market Share and Minimize Risk" in the afternoon.

For more information or to register, please visit the conference website.

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