BPCIA Guidance from the Federal Circuit and the Supreme Court

To access a recording of this webinar or receive a copy of the slides, please contact [email protected].

Recent and Upcoming BPCIA Guidance from the Federal Circuit and the Supreme Court

The Federal Circuit and the Supreme Court are poised to issue new guidance on the BPCIA governing the abbreviated pathways for biosimilars. In thiswebinar, John Adkisson, Tasha Francis and Jenny Shmuel provided an overview of the pending issues and the potential ramifications for the biologic and biosimilar industries.

Speakers discussedthe issues pending before these courts, including:

• Updates in the ongoing dispute as to whether the "patent dance" is optional
• The contours of the "Notice of Commercial Marketing" requirement
• The scope of discovery in a BPCIA litigation
• The weight accorded to materials exchanged in the "patent dance" in an infringement determination