This patent challenge is somewhat unusual insofar as AGN already prevailed against Teva in a similar challenge that was decided in Sep 2011 (#msg-66939879). Teva is the best in the business at challenging patents, so WPI presumably has a novel argument to make to the Court.
AGN has two formulations of Lumigan at concentrations of 0.03% (approved in 2001) and 0.01% (approved in 2010); AGN’s goal is to switch patients from the former to the latter, which purportedly has equivalent efficacy with better tolerability. The entire franchise—consisting of Latisse and the two formulations of Lumigan—is generating about $500M in annual US sales, of which about 80% comes from Lumigan. (However, Latisse has considerable upside as a potential treatment for androgenetic alopecia—i.e. male/female pattern baldness.)
Lumigan (but not Latisse) has an Orange-Book CoM patent (5688819) expiring in Aug 2014; both products have a CoM patent (6403649) expiring in Sep 2012 and several “use” patents expiring much later. The AGN-Teva litigation decided in AGN’s favor included both the ‘649 and ‘819 patents.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”