Paragraph IV Notice – Delivered, Not Received
Nexus Files ANDA over Minocin®(minocycline)
Last year, Nexus filed an ANDA over Minocin and sent its PIV Notice to the patent holder Melinta Therapeutics. Nexus sent its Notice via FedEx to the Melinta corporate address. FedEx delivered it on December 8, 2020.
Due to Covid-19, the Melinta office was closed on December 8, 2020. In fact, it had been closed since March 2020. Melinta had a few people going to the office to collect mail and distribute it. According to a petition Melinta filed in October (2021P-1123) , the system seemed to work pretty well. It noted that it received and sorted through all of its other mail but not the PIV Notice Letter.
General Counsel Finds the Notice Letter
During the Covid-19 closure, apparently the Melinta General Counsel did not visit the office. She returned to the office March 31, 2021 where she “first identified the Nexus Letter, unopened.” The petition does not state exactly where the Letter was found — her desk, the mail room, the reception area, propped up against the door, the building lobby — we are not told.
30-Month Stay at Issue
Melinta filed its PIV case against Nexus more than 45 days after December 8, 2020. In the PIV case, the 30-month stay has become an issue — Nexus wants to gain FDA approval as soon as possible. However, in its Petition, Melinta asks FDA to apply the 30 month stay and argues that it “received” the PIV Notice on March 31, 2001. It points out that the statute cites “receipt” of the PIV Notice to be the key event — not delivery.
PIV Notice Best Practices
From the perspective of Nexus, it seems to have followed the statute and regulations when sending its PIV Notice. Moreover, it is not Nexus’ fault that the corporate office was closed, and having a closed office does not provide a good reason for not “receiving” delivery. However, it is entirely possible that FDA, or the Judge in the PIV case, may side with Melinta in this situation.
However, this issue could have been easily avoided by the application of a couple of best practices.
- An ANDA filer can follow up on its PIV Notice either by letter or phone call. Their counsel can simply call up the brand’s general counsel or outside counsel, if known.
- Brand General Counsel ought to visit the office regularly, even during an extended closure and do mundane things like check the mail. This is true for other members of the executive team. Their absence here is a bit surprising. Many other important notices could go missing. Also, establishing a strong rapport with the building management and mail services can prove important.