Federal Circuit Clarifies Patent Term Extension Law

September 2, 2004 Advisory

The Hatch-Waxman's patent term extension provision, part of the Hatch-Waxman Act's carefully negotiated set of compromises, increased the patent protection available to certain pharmaceutical products. The general legislative goal was to preserve incentives for innovation by restoring a portion of the patent term lost through a lengthy pre-market regulatory approval process. Accordingly, depending on the length of the regulatory approval process, the Hatch-Waxman Act may extend patent protection for a "product" if FDA approval provided "the first permitted commercial marketing or use of the product."