Last Call! FDA Issues Draft Guidance on Submission of Patent Information for Certain Old Antibiotics

December 1, 2008

By Kurt R. Karst –      

Late last week while those of us in the U.S. were still digesting our turkey dinners, FDA issued a draft guidance document describing the Agency’s current thinking on the implementation of § 4(b)(1) of the Q1 Program Supplemental Funding Act (Pub. Law No. 110-379) (“the Q1 Act”).  Specifically, FDA’s draft guidance addresses when sponsors of NDAs for “old” antibiotics must submit patent information to FDA for Orange Book listing under the transition rules of the Q1 Act.  The draft guidance does not address FDA’s interpretation of the scope of, and procedural requirements associated with FDC Act § 505(v). 

As we previously reported (here and here), the Q1 Act, which was enacted on October 8, 2008, amended the FDC Act to add new § 505(v) – “Antibiotic Drugs Submitted Before November 21, 1997” – to create Hatch-Waxman benefits for “old” antibiotics.  The Q1 Act includes three “transition provisions.”  Those provisions: (1) require antibiotic drug NDA sponsors to submit to FDA for Orange Book listing information on applicable patents within 60 days of enactment of the Q1 Act; (2) require FDA to list those patents in the Orange Book not later than 90 days after the enactment of the Q1 Act; and (3) create “fist applicant” status (for 180-day exclusivity purposes) for each ANDA applicant that not later than 120 dates after enactment of the Q1 Act amends a pending application to contain a Paragraph IV certification to a newly listed antibiotic drug patent. 

To date, few patents have been submitted to FDA for Orange Book listing.  The first “old” antibiotic patents were listed on October 24, 2008 for MOXATAG (amoxicillin).  Since then, other patents have been listed for ZMAX (azithromycin), and NEORAL (cyslosporine).  We understand that other patents covering “old” antibiotic drug products will soon be added to the Orange Book before the 60-day deadline for Orange Book patent listing expires later this week.

FDA’s draft guidance reminds NDA sponsors of the fast-approaching deadline:

Section 4(b)(1) of the Q1 Act requires the submission of patent information to FDA “not later than sixty days after enactment of [the Q1 Act].”  Sixty days after enactment falls on Sunday, December 7, 2008.  Therefore, to be in compliance with this provision, sponsors must submit the patent information on or before the weekday preceding December 7, 2008, that is, on or before December 5, 2008.  [(emphasis added)]

FDA’s draft guidance also clarifies who must submit the patent information to FDA under §  4(b)(1) of the Q1 Act:

The sponsor of an NDA approved on or before October 7, 2008, for a drug (including a combination drug) containing an antibiotic drug that was the subject of an application approved under section 507 of the FD&C Act (as in effect before November 21, 1997) must submit this patent information.  [(emphasis added)]

One of the reasons so few patents covering “old” antibiotics have been submitted to FDA for Orange Book listing might be due to a misunderstanding of the applicability of the transition provisions.  Some have speculated that the transition provisions might apply only to NDAs for “old” antibiotics approved after October 8, 2008 when the Q1 Act was enacted.  According to FDA, this is not the case:

The application of section 4(b)(1) of the Q1 Act set forth in this guidance gives meaning to both section 505(v) of the FD&C Act, as added by section 4(a) of the Q1 Act, and the legislation’s transitional rules at section 4(b).  Section 4(b)(3) of the Q1 Act contemplates submission of patent certifications by applicants of pending ANDAs that reference drugs for which patent information must be listed under section 4(b)(1).  By statute, ANDAs may reference only already approved drugs.  See 21 U.S.C. 355(j)(2)(A). Therefore, the drugs referenced by these pending ANDAs (that is, drugs for which patent information was submitted under section 4(b)(1) of the Q1 Act) must be drugs that were approved on or before October 7, 2008.  This approach is further supported by the requirement that FDA must, upon receipt of the patent information required to be submitted under 4(b)(1) of the Q1 Act, publish the information in the electronic version of FDA’s Approved Drug Products with Therapeutic Equivalents (the Orange Book).  Per section 505(j)(7) of the FD&C Act, the Orange Book includes only information about approved drugs.  See section (4)(b)(2) of the Q1 Act. 

Categories: Hatch-Waxman