Part I: A Matter of Exclusivity and Offset Losses

June 27, 2023 10:45am

Natasha E. Daughtrey
Goodwin Procter LLP

James T. Evans, Ph.D.
Senior Director | Assistant General Counsel, Dispute Resolution
Regeneron Pharmaceuticals

  • What lessons were learned from the Humira biosimilars about the exclusivities afforded under the BPCIA – and now the IRA?
  • Assessing the possibility – or impossibility – of circumventing a patent thicket in view of the Humira District Court and Federal Circuit rulings
    • Extending exclusivity beyond the initial patent
    • Devising strategies for obtaining the longest exclusivity period for your biosimilar
  • Negotiating the best settlement agreement for sharing exclusivity period
    • Determining entry dates in the U.S. and abroad