Emerging Weapons Against Generics


Health Law 360 article written by Terry Mahn, April 12, 2007

“Emerging Weapons Against Generics”
by Terry Mahn
Health Law 360
April 12, 2007

Since enactment of the Hatch-Waxman Act in 1984, the U.S. Food and Drug Administration has been at the vortex of pharmaceutical patent enforcement.

As overseer of the so-called Orange Book, where pioneer patents are listed to provide notice to generics as well as to potentially block their market entry, the FDA has been pulled into patent disputes, both small and large, for over two decades.

Ill-equipped to mediate such disputes and reluctant to take sides, the FDA was forced nonetheless to adopt reforms in 2003 to eliminate various Orange Book “strategies” which generics had claimed were stifling drug competition.

Since then, pioneer manufacturers have responded with new and increasingly clever ways of asserting their drug patents against generics manufacturers.