New Developments in Market Access and Exclusivities

April 30, 2019 9:15am

What is it about?


Patents and Profit Centers: Brand and Generic Insights into the Relationship between Pricing and Patents in the New Hatch-Waxman Landscape

  • Analyzing how pricing and patents are connected, and how this link impacts Paragraph IV litigation
  • Understanding how the proposed Hatch- Waxman Integrity Act of 2018 could impact pricing, patents and litigation
  • Assessing what the Trump Administration is proposing in the Hatch-Waxman arena relative to pricing and patents



Determining 180-Day Exclusivity: Deciphering the FDA’s First Applicant Interpretation

  • Examining the FDA’s first applicant interpretation
  • »» First Submitted Interpretation Approach
  • »» MMA amendments of 2004
  • Understanding the significance of the FDA’s finding of 180-day exclusivity forfeiture in Suboxone
  • Exploring how the Suboxone letter decision was the impetus for Teva’s challenge to the FDA’s first applicant interpretation in seeking first filer status for generic Restasis
  • Considering the relief sought, including Teva’s contention that “FDA’s Letter Decision in Suboxone conflicts with the plain text, broader incentive structure, and legislative intent of the FDCA and therefore is “arbitrary,
    capricious, an abuse of discretion of otherwise not in accordance with law”
  • Understanding the broader implications of the Teva case for future ANDA applicants seeking first filer status



Clarifying the Breadth of Orphan Drug Exclusivity

  • Analyzing the implications of the GAO’s report on orphan drug designations
  • Exploring what has changed since FDARA 2017/PDUFA VI
  • Examining when orphan exclusivity for the “same drug” that is not clinically superior to the approved product is granted
  • Balancing the need for rare disease treatment against the perception of profit motivation