Reining in Patent Term Extensions for Related Pharmaceutical Products Post-Photocure and Ortho-McNeil

Kotze, Ann | July 1, 2012

The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch–Waxman Act, was enacted with the dual goals of fostering economic incentives for pioneer pharmaceutical research and development as well as making available more low-cost generic alternatives. While generally regarded as haaving successfully balanced both branded and generic interests, the Act’s provisions have also been circumvented and manipulated by pharmaceutical companies’ anticompetitive efforts, as illustrated by two recent decisions regarding its Patent Term Extension provision. In Ortho–McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc. and PhotoCure ASA v. Kappos, both decided in May 2010, the Federal Circuit affirmed term extensions on new compounds highly related to drugs already approved and in commercial use in order to compensate for time lost during lengthy Food and Drug Administration regulatory review. Such decisions signal a shift in the historically inconsistent Federal Circuit treatment of the statutory term “product” for purposes of patent-term-extension analysis by easing extension grants for new drug products highly related to those previously approved and marketed. This Comment argues that a reversal from the Federal Circuit’s recent treatment of highly related compounds is necessary to establish a more beneficial balance between innovation and consumer protection in the patent regime, and to prevent further manipulation of Hatch–Waxman provisions.