Frequently asked questions (FAQ) about ANDA litigation

1) When ANDA filer need to send notice Letter (PIV) to brand company? 

After submitting ANDA to FDA, An ANDA applicant must notify both patent owner and NDA holder by sending notice Letter, In notice Letter applicant need describe invalidation or non-infringement arguments. 

Timeline: After filing ANDA, FDA will give acknowledgment that the ANDA has been received and is ready for substantive review.  After receiving FDA acknowledgment letter applicant has 20 days time to send notice Letter.

2) To whome all ANDA applicant need to send notice Letter? 

ANDA need to send both patent owner and NDA holder, if product having multiple NDA holders and patent owners then ANDA applicant has to send notice Letter to all of them.

3) When 30 months stay trigger and which date need to consider?

30 months stay trigger from the date of receiving notice Letter to NDA holder and patent owner. 

4) If product having multiple NDA holder and patent owners in different locations and Notice Letter received in different dates to them in this case which date has to consider for 30 month stay?

If product having multiple NDA holders and patent owners in different locations, in this case 30 month stay trigger from last recipient of notice Letter date.

5) Does ANDA filer need to certify late listed OB patent against RLD? 

Yes, ANDA filer need to give certification according to his IP strategy and ANDA filer need not to litigate separately and there is no separate stay for late listed OB patent.