Terry G. Mahn | Fish & Richardson P.C.
Hatch-Waxman turns 30 this year. One measure of its success has been the phenomenal growth and universal acceptance of generic drugs, which now account for over 80% of all prescriptions filled in the U.S. While much of the industry’s success was designed to come at the expense of pioneer drug developers, some clearly was unintended. One example how Hatch-Waxman has unexpectedly titled the balance in favor of generics is the evolution of FDA policies toward method of use patents.