Dr Malcolm AbelPresented at Allied Academies Las Vegas 2009
The first drug manufacturer approved for a generic version of a branded drug has statutory exclusivity to market that generic drug for 180 days. The purpose of the exclusivity period is to make cheaper drugs available to the consumer. However, the Food and Drug Administration (FDA) has a policy requiring the generic drug manufacturer to sue the branded drug manufacturer to retain that market exclusivity when the branded drug patent holder has the patent(s) removed from the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations,” also known as the Orange book. This paper discusses the effects of delisting a drug patent, and whether the FDA’s policy is a valid one or contrary to the intent of statutory language.
|