Post Exclusivity Issues For Biologics

Investments in research resulting in new drug inventions have long taken advantage of patent protection, but such investments may also benefit from market exclusivities granted by the Food and Drug Administration (the "FDA"). Both patent and market exclusivities encourage and protect the significant innovation and investments required to bring a new drug to market.¹

For typical small molecule pharmaceuticals, the Hatch-Waxman Act established a "regulatory framework that sought to balance incentives for continued innovation by research-based pharmaceutical companies and opportunities for market entry by generic drug manufacturers."² Since generic versions of small molecule drugs may be chemically identical to the brand name version of the drug, a generic manufacturer can rely on FDA testing already performed on the brand name drug to support an application for approval of the generic version. This greatly increases the likelihood of entry of generic small molecule