The Doctrine of Equivalents: Fairness and Uncertainty in an Era of Biologic Pharmaceuticals

Research in the rapidly developing area of biologic pharmaceuticals promises to improve the lives of millions of patients suffering from disorders that were, until very recently, untreatable. The staggering potential market for such treatments has attracted enormous investment from the pharmaceutical industry, with a concomitant increase in related patent disputes. This investment, coupled with proposed legislation that would pave the way for the creation of ¿follow-on¿ biologic treatments via a statutory pathway similar to the one created for generic pharmaceuticals by the Hatch¿Waxman legislation of the early 1980s, should ensure that the number of patent disputes involving biologic pharmaceuticals will continue to rise dramatically in the coming years.