Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics

September 19, 2014 1:14pm

  • Overview of Title VII of the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148), i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
  • Biosimilar pathway vs. 505(b)(2) and BLAs
  • Defining “biological” and “biosimilars” under BPCIA
  • Exploring interchangeability requirements
  • Understanding the significance of the methods of making claims in this legislation
  • Examining the effect of this abbreviated approval pathway on innovation
  • A look at FDA Rule making and guidance relative to biosimilars
  • How will biosimilars fit in with life cycle strategies?
    • targeting R&D efforts
    • re-examining prosecution efforts
    • anticipating vulnerable patents and litigation
  • Small molecule patent strategies and their application to biologics
  • Active ingredient claims
  • “Purity” claims (impurity profiles, polymorphs
  • Formulation claims and the Exception Excipient Rule
  • Analytical method claims and the Supreme Court’s Momenta decision
  • Pharmacokinetic / bioequivalence claims
  • Extra hurdles for patenting biologics
  • Enablement
  • Written Description
  • Subject Matter Eligibility
  • Bioequivalence v. biosimilarity
    • What ANDA filers need to show for bioequivalence
    • Exploring bioequivalence in a BCPIA pathway
    • Patent opportunities
    • Relation to doctrine of equivalents and more broadly infringement
      • Role of “copying”
  • What lessons can be applied to biologics from FDA’s rating precedent for 505(b)(2) products?
  • What lessons can be applied to biologics from FDA’s same labeling precedent for small molecules?

There are a number of different modes and methods of exclusivity (non-patent). This session will outline what they are and what challenges, opportunities, and current controversies arise in relation to them, including the role that the FDA plays in regulating these modes of exclusivity. Modes and methods of exclusivity to be discussed include:

  • Orphan Drug Exclusivity (7 years)
  • New Chemical Entity Exclusivity (5 years)
  • New Clinical Study Exclusivity (3 years)
  • Pediatric Exclusivity (6 months)
  • First Generic Applicant Exclusivity (180 days)
  • New Antibiotic Exclusivity