The FTC says pay for delay deals are rapidly on the rise -- up from 19 to 31from 2009 to 2010 -- and costing consumers big bucks -- $3.5 billion annually -- in inflated drug prices. It calls for the courts or the Congress to step in and block these deals.
The Patent Doc blog points out that pay-for-delay is an outgrowth of the Waxman-Hatch Act - where first ANDA filers can earn up to 180-day exclusivity for a successful application. However, if unsuccessful, the ANDA filer needs to wait until after patent expiration before reaching the market. Under many pay-for-delay deals (or patent settlements), the generic challenger does wait to get to market but does so in exchange for reaching the market prior to the patent expiration date or earlier than would be the case under an unsuccessful ANDA challenge -- this is particularly true of ANDA filers who are not the first filer.
Patent Doc also says to look at the FTC's own data under a different light. The number of potential pay-for delay deals (deals that involved compensation for the generic producer and an agreement to not to market for a longer term than provided under a successful ANDA) did increase but so did the number of settlements. As a percentage of the total though, the frequency of pay for delay deals is trending down since 2006. It's the same story for potential pay for delay deals among first filers too since 2007. See data here.
ANDA settlements are trending downward in their liklihood to result in an agreement that provides monetary compensation to generic drugmakers in exchange for delayed market entry. It would seem there is a recognition of the wastefulness associated with ANDA litigation among innovators and generic producers alike.
Look at both sides arguments and make up your own mind.
Posted by Bruce Lehr May 10th 2011.