Sets December 5, 2008, Compliance Date for Submission of Patent Information  

As described in an earlier Pharmaceutical and Biotechnology Update,1 last October President Bush signed into law the Qualifying Individual Program Supplemental Funding Act of 2008 (the “QI Act”). Section 4 of the law made the patent and marketing exclusivity provisions of the Hatch-Waxman Act applicable for the first time to many older antibiotic drugs.2 As we discussed at that time, the law also required sponsors to submit to the FDA, “not later than 60 days after the date of enactment” of the QI Act, any patent information required to be filed on an approved antibiotic drug.  

Last Friday, the FDA issued its first guidance regarding the law, containing the FDA’s “current thinking” on implementation.3 According to the FDA, the relevant compliance date for submitting the required patent information is December 5, 2008. The FDA determined that, although 60 days after enactment falls on Sunday, December 7, the law requires submission of the patent information no later than that date, which effectively makes the deadline this Friday, December 5.  

By its terms, the guidance “does not address FDA’s interpretation of the scope of, and procedural requirements associated with,” the other requirements of the QI Act. For example, the guidance does not address the complex labeling carve-out or 180-day marketing exclusivity issues raised in our earlier update. Those subjects may be dealt with in later guidance.