On October 8, 2008, President Bush signed into law S. 3560, the QI Program Supplemental Funding Act of 2008 (Public Law Number 110-379), which, among other things, amends the Federal Food, Drug, and Cosmetic Act (FDCA) to create new exclusivity opportunities for drug products containing "old" antibiotic ingredients.¹ S. 3560 reverses certain provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA) that exempted products containing "old" antibiotics from the Hatch-Waxman provisions regarding marketing exclusivity and the patent listing and certification process. The new law accomplishes this in different ways for different categories of "old" antibiotics.

First, for products that contain an antibiotic ingredient that originally was approved under section 507 of the FDCA before November 21, 1997, the new law authorizes FDA to grant the sponsor 3-year marketing exclusivity under the existing Hatch-Waxman provisions. This exclusivity, however, is subject to important limitations. In particular, a drug product is eligible for 3-year exclusivity only if (a) its marketing application is submitted to FDA after October 8, 2008 (the enactment date of the new law), and (b) the approval involves a new condition of use (i.e., one for which the antibiotic had not been approved prior to October 8, 2008).

Second, for products that contain an antibiotic ingredient that was submitted to FDA for review under Section 507, but was not approved, before November 21, 1997, a sponsor may elect to be eligible for either: (a) non-patent exclusivity (both 3-year exclusivity and 5-year exclusivity), or (b) a patent term extension under 35 U.S.C. § 156. Sponsors can take advantage of this election only if (a) the marketing application for the drug product containing the "old" antibiotic is submitted to FDA after October 8, 2008; and (b) for non-patent exclusivity, the approval involves a new condition of use (as defined above).

The statute further provides that the Hatch-Waxman Amendments are applicable to any drug that takes advantage of the exclusivity or patent term restoration provisions of the new law, subject to certain limitations specified in the statute (such as the requirement discussed above regarding new conditions of use). One such limitation provides that the new law shall not be construed to entitle an antibiotic drug product to "any market exclusivities or patent extensions" other than those specified in the statute. While this provision clearly places limits on how the new law can be interpreted, it is unclear whether it is also intended to limit the availability of exclusivity under other statutory provisions, such as pediatric or orphan drug exclusivity. These exclusivity periods are awarded under Sections 505A and 527 of the FDCA, respectively, rather than under Section 505(v), the provision added by the new law.

Finally, the new statutory provisions appear to subject drugs containing an "old" antibiotic to the Hatch-Waxman patent listing and certification provisions, including, arguably, the 30-month stay provisions. Indeed, the statute includes three "transitional rules" intended to apply the patent certification process to certain drugs containing "old" antibiotics. First, by December 7, 2008 (i.e., 60 days after enactment), sponsors must submit to FDA for Orange Book listing information on patents issued on or before October 8, 2008, where such patents cover "old" antibiotics approved before November 21, 1997. Second, FDA is required to list such patents in the Orange Book as soon as the information is received, but in no event later than January 6, 2009. Finally, with respect to the newly listed patents covered by the above transitional rules, the new law grants "first filer" status to each applicant that amends a pending Abbreviated New Drug Application to contain a Paragraph IV certification by February 5, 2009. Multiple Paragraph IV filers that submit by that deadline would share first filer status and potential 180-day exclusivity.

The new law contains several ambiguities that will need to be addressed during FDA's implementation. These include, among others:

• the availability of pediatric exclusivity to new products containing "old" antibiotics; and
• whether and how the patent listing and certification provisions apply to drug products that contain an antibiotic ingredient that was submitted to FDA for approval prior to November 21, 1997, under Section 507 of the FDCA but was not approved until after November 21, 1997, under Section 505.

Companies should carefully review their product portfolios to determine whether these new exclusivity provisions apply and ensure that any required actions, such as patent listing, are accomplished within the applicable deadline.

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1 An "old" antibiotic is one for which an application under Section 507 of the FDCA was submitted to the Food and Drug Administration (FDA) prior to November 21, 1997, the date of enactment of the Food and Drug Administration Modernization Act (FDAMA). Section 507 was the approval pathway for antibiotic drug products. It was repealed by FDAMA in 1997.