New Proposed Regulations – Some More Facts

Like the old joke – How do you eat an elephant?  One bite at a time!  We are serving up some additional bites at the massive ANDA and 505(b)(2) Proposed Rule.  I hope you enjoy your meal!

Where to Send Patent Information and When is it Received?

A very important factoid for NDA holders is where the patent information must be sent.  FDA admonishes not to send patent listing information on FDA Form 3542a to the Office of Generic Drugs or the Orange Book staff but to the CDER Central Document Room at the address on the FDA web site.  On the other hand – after approval, FDA form 3542 (the post-approval documentation of patents that cover the drug, drug product or method of use) should only be sent to the Office of Generic Drugs, Document Room, attn. Orange Book staff.  This is to assure that the patent information is published in the Orange Book.

“Patent information will be considered submitted to FDA for purposes of § 314.53(d)(3) as of the earlier of the date the information submitted on Form FDA 3542 is date-stamped by the Office of Generic Drugs, Document Room, or officially received electronically by FDA through the Electronic Submissions Gateway.”

Patent Certifications for Supplements to NDAs

FDA “is proposing to revise the requirements for submission of patent information for NDA supplements to reduce duplicative submissions of patent information and enhance efficiency.  Section 314.53(c) requires submission of patent information for certain types of supplements that relate to the drug product or a method of using the drug product, namely those supplements that seek approval to change the formulation, add a new indication or other condition of use, change the strength, or make any other patented change regarding the drug, drug product, or any method of use.”  Basically, when the patent information does not change from that submitted on the original 3542a,and 3542 based on a particular supplemental application, then resubmission of a new form is not necessary.  However, if there will be a new listing in the Orange Book (new patent, or new use claim, or other such item requiring a new listing) then additional patent information must be submitted on forms 3542a (when the supplement is submitted)  and 3542 (when it is approved).  In addition, if the new change to the product results in the previously filed and listed patent to be no longer relevant, the applicant must take action to “correct or delist the patent”.

Untimely Filed Patents

In accordance with section 505(C)(2) of the Act, applicants are required to submit patent information after approval of an NDA or relevant supplement within 30 days of the issuance of a patent by the Patent and Trademark Office.  Failure to do so makes the patent information “untimely filed”.  Based on longstanding practice, iIf the applicant fails to submit that required patent information within the 30 day period , any previously submitted ANDA or 505(b)(2) applicant does not have to certify to this patent, as it would be considered an untimely filed patent.  While FDA will permit an ANDA or 505(b)(2) applicant to certify to such patents in order to avail itself of a possible 180-day exclusivity period, failure to do so will not preclude the Agency from issuing an immediate effective approval as long as all other scientific and regulatory requirements are met for approval, despite any such patent listing, if the applicant does not make a certification to the untimely filed patent.   FDA is codifying this process.

We will be back with more on this expansive Proposed Rule.  I assume you have all had a chance to read the entire Proposed Rule.  But, be warned- if you read it close to bedtime, it is more effective for sleep than any FDA-approved product.  But be careful- reading such long documents can be habit forming!