FDA Data Exclusivity Guidance: Emerging Patent Challenges and Opportunities

Description

On Feb. 21, 2014, the FDA issued new draft guidelines going forth prospectively to grant five years of NCE data exclusivity to combination drug products with at least one new active moiety. Paradoxically, at the same time, the FDA denied the petitions that led to the new draft guidelines.

Counsel to companies with new NDAs and possibly those with new supplemental NDAs must understand the implications of these guidelines now, particularly with respect to combination therapy drug products (combo drug products).

For any combo drug product in which at least one active moiety is new, the NDA filer can get five-year data exclusivity, even if the drug product also contains an active moiety previously approved. If the combo drug product contains no new active moiety, but only at least one moiety that has previously been approved, the NDA filer gets three years' data exclusivity.

The data exclusivity periods of five- and three-years run irrespective of, but concurrent with, any applicable patent term, and stops approval of any ANDAs before certain time periods. But the five-year data exclusivity, advantageously to the NDA holder, sets a time bar on the filing of any ANDA after approval, whereas the three-year data exclusivity sets only a time bar on ANDA approval but no time bar on the filing of an ANDA.

Listen as our authoritative panel of patent attorneys reviews the momentous draft guidelines and recent citizen’s petition decisions, all taken in context with data exclusivity and its relation to ANDA filings and Hatch-Waxman litigation. The panel will also suggest patent and business strategies to maximize data exclusivity in light of the new landscape.