Conferences and Speeches

Paragraph IV Disputes West

December 07, 2010 {ml-event-to} December 09, 2010
01:00 AM ET

Morgan Lewis partner Robin M. Silva will present "Bioequivalence and the 'Same Active Ingredient' vis-à-vis Patentability" at a Paragraph IV Disputes West conference pre-conference workshop.

This hands-on workshop provides an in-depth review of the Hatch-Waxman schematic and other IP and regulatory basics relative to small molecules and biologics, as well as critical insights into the commercialization and the pre-approval processes for these products. The workshop leaders discuss the dynamics of the IP and regulatory backdrop underlying each Paragraph IV dispute and the complexities of the Hatch-Waxman litigation challenges presented during the main conference.

Her speech will cover:

  • Defining bioequivalence in drugs and biologics
    • drugs v. biologics
  • What an ANDA-filer must demonstrate for bioequivalence?
    • bioequivalence and dosage form - oral tablet/capsule, injection, -nasal sprays, topical, nasal sprays
  • How does bioequivalence relate to patents?
    • patenting of bioequivalence characteristics - extended-release -drug products
    • bioequivalence v. Doctrine of Equivalents - what is the difference?
    • arguments about bioequivalence raised in Paragraph IV -patent litigation
    • infringement, copying (non-obviousness)

More information about the conference can be found at http://www.americanconference.com/PIVdisputes/workshop.htm.