Transcript ANDA Slides – PR 3-8

EDTX Patent Rule 3-8
DEADLINE
DISCLOSURE REQUIREMENT
Case Management
Conference (CMC)
Defendant(s) produce ANDA
14 days after CMC
Defendant(s) must disclose:
1. Invalidity contentions as per P.R. 3-3 and 3-4;
2. Non-infringement contentions, including
element-by-element claim charts and all
documents relied upon in defense any
infringement allegation.
45 days later
Plaintiff must disclose its asserted claims and
infringement contentions as per P.R. 3-1 and 3-2.
EDTX Patent Rule 3-8 (cont.)
DEADLINE
3 days of filing
ADDITIONAL NOTIFICATION AND DISCLOSURE
REQUIREMENTS
Defendant must notify the FDA of any and all
motions for injunctive relief;
7 days from date sent Defendant must produce a copy of all
or received
correspondence with the FDA pertaining to the
ANDA or set for the basis of any claim of privilege