Ice Miller partner Fabian Koenigbauer will be presenting at ACI's 2nd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA for day one of module five. ACI’s highly anticipated Proficiency Series provides true immersion in Hatch-Waxman and BPCIA Essentials with the objective of becoming proficient in three weeks.

1:00pm | Co-Chairs’ Opening Remarks

1:15pm | In-Depth Drill-Down on Bioequivalence, “Same Active Ingredient”, and Interchangeability

• 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)

2:15pm | Break

2:30pm | An In-Depth Look at 180- Day Exclusivity

• Understanding 180-day generic market exclusivity under the Hatch-Waxman Act
  • What are the qualifying criteria for exclusivity?
• How can an ANDA applicant really determine who is "first-to-file" and win 180 –day exclusivity?
• Identifying triggers for the running of the 180-day exclusivity period
• Deciphering the FDA’s new interpretation of pre- and post- MMA 180 day exclusivity
  • What are the implications of this interpretation for products having ANDA’s filed prior to the enactment of the MMA?
• Exploring the interplay between the 30-month stay and 180-day exclusivity
• Forfeiture provisions: identifying circumstances under which exclusivity is forfeited
  • Other circumstances that may trigger the loss of 180-day exclusivity
• When can the 180-day exclusivity period be transferred to another ANDA applicant?
• Evaluating when the 180-day exclusivity period can be relinquished, and exploring the consequences defining "shared exclusivity"

3:30pm | Comprehending the Intricacies of Non-Patent/ Regulatory Exclusivity

• Understanding which drug products are eligible for regulatory exclusivity
  • Small biologics v. biologics
• The different modes and methods of regulatory exclusivity (non-patent)
  • NCE (new chemical entity): 5 years marketing exclusivity/5 years data exclusivity
  • Indication (new indication or use): 3 years marketing exclusivity
  • NDF (new dosage formulation)
  • ODE (orphan drug exclusivity)
  • PED (pediatric exclusivity)
• FD&C 505b2 (alternate pathway to ANDA) a/k/a paper NDA
• What role does the FDA play in regulating these modes of exclusivity?
• When are each of these methods sought?
• Using trade dress as means of exclusivity

4:30pm | Questions and Answers

5:00pm | Day One Adjourns

Click here to see the full agenda.