Monday, July 2, 2012
Posted by D. Daniel Sokol
Anne Layne-Farrar (Compass Lexecon) has written on Cervantes' Sequel: The FTC's Quest to End Pay-for-Delay Pharma Settlements.
ABSTRACT: We are drawing close to the thirtieth anniversary of the Drug Price Competition and Patent Term Restoration Act, better known as Hatch-Waxman, enacted in 1984. Among other things, the Act grants generic manufacturers the ability to challenge the validity of a patent covering a brand name drug without incurring the cost of actually entering that drug market or having to risk the enormous damages that would flow from a finding of infringement. In other words, Hatch-Waxman made it a lot easier for generic drug companies to take on big pharma patents. Not surprisingly, the generic drug sector blossomed in the wake of the Act. In 1984, generics comprised only 19 percent prescription drug volume and 36 percent of brand drugs had a generic competitor; by 2002, 47 percent of prescription volume was generic and nearly 100 percent of brand drugs faced generic competition.