Paragraph IV Disputes West

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.