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ACI 2nd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA ACI 2nd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA

ACI 2nd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA

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.
Tuesday, October 25, 2022
1:00 PM

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