Thursday, April 15, 2010

Integrilin®: Be Careful What You Wish For, Come November 2011, New Merck

Nominally a win for Merck, as successor to Schering-Plough patent positions, here -- the very able Judge J. Curtis Joyner, in the federal District Court of Delaware ruled, overnight, that Teva would not be granted a court-ordered stay of the lapse of its potential 180 day exclusive selling period, should it prevail in this Integrilin® (Eptifibatide) patent litigation, and win the right to bring a generic version to market. The "at risk launch window" on this compound opens in November of 2011. It is still a $300 million a year drug, for New Merck.

Got all that? Good. Well, what that means is that if (or when) Teva does ultimately win the right to bring the generic to market, several other generics are likely to launch on the same day -- so, instead of a gradual six-month decline in Merck's branded sales, there will be a very sharp cliff-fall-off, in Merck's Integrilin sales.

Be careful what you wish for, here, Whitehouse Station:

. . . .Although it would be permissible to grant a stay at this stage of the proceedings, given the balancing of the other factors discussed above, we do not believe that it would be appropriate to exercise our discretion to do so at this time. Granting a stay would cause a hardship to Plaintiffs [Merck] and any hardship caused to Defendants [Teva] was the foreseeable result of Defendants’ choice to file their ANDAs when they did. As granting a stay would also not be likely to simplify the issues for trial, Defendants’ request shall be denied. . . .


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