Follow-up on the Proposed Rule on ANDA and 505(b)(2) Applications

We are slogging through the 371 page document and, as promised, here are a few more tidbits regarding changes that are being proposed in the new revised regulations.

Sending PIV Notice

The existing regulations require that when an ANDA holder or 505(b)(2) applicant makes a paragraph IV certification challenging a patent, that the applicant send the required notice to the patent holder and the NDA applicant by US Postal Service via registered or certified return receipt requested mail.  If you wanted to use an overnight delivery service like FedEx or UPS, you had to get express approval from the Office of Generic Drugs (OGD), prior to sending the notice.  This involved a telephone call to the OGD to get permission (which, by the way, was always given, unless you tried to use the pony express).  This took up valuable time for the applicant getting the notice to the proper parties and caused OGD to have to document the call and note the permission in the application.   Since 1984, with the increased use and reliability of overnight delivery services, the need for obtaining such permission to use an alternate method of delivery is no longer an issue.  FDA defines the general requirements for a designated delivery service and agrees to update the definition as may be necessary in the future.

Serial Patent Certifications and Premature Notification

Once a patent is granted or issued by the Patent and Trademark Office (PTO), in order for the patent to be considered to be a timely listed patent, the NDA holder that plans to list the patent must do so within 30 days.  However, the patent may not be published in the Orange Book immediately upon receipt of the information by the NDA holder.  This caused ANDA and 505(b)(2) applicants to make serial patent certifications for the 30-day period after issuance of the patent to assure that they would be in the group of first-to-file applicants.   The Proposed Rule would define a date, which “is the first working day after the day the patent is published in the Orange Book, before which an ANDA applicant cannot send a valid notice of a PIV certification to a newly listed patent.”

This new provision is designed to provide equity among applicants and eliminate the need for the serial submissions.  FDA will also impose an administrative consequence for sending notice to the NDA or patent holder prematurely.  The date of the ANDA submission will be delayed by the number of days that the notice does not comply with the Medicare Modernization Act (MMA) period of permissible notice and, thus, an applicant may, therefore, lose eligibility for 180-day exclusivity.

These two important topics are designed to save both the applicant and the Agency time and money (if time is money) and place all applicants on the same footing.  Keep tuned for more on the Proposed Rule.