Patents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologics can and should be treated like pharmaceuticals with regard to generics. In contrast with pharmaceuticals, which are manufactured through chemical...

The 1984 Drug Price Competition and Patent Term Restoration Act (the Waxman-Hatch Act) is unique in many ways. This Law was the first change in U.S. patent terms since 1861. It simultaneously lowered the barrier to entry for generic drug firms and increased patent terms for new drugs delayed by...