Tag Archives: Integrilin Eptifibatide Patent Suit against generic manufacturers Millennium Teva anticompetitive February 27 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. . . .

Fascinating.

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Merck Claims Additional Patent Infringements — Via Teva’s Generic Eptifibatide Formulations [Nee Integrilin®!]


Or, more potential “pay for delay” underway, now at New Merck?

[This item has been completely rewritten, thanks to an overnight (astute and observant) anonymous commenter, below. . . . Editor’s Note: lack of caffiene is my sole (and completely feeble) excuse. Schering-Plough has not sued Millennium, in any capacity — the two are co-licensed to the IP contained in the patents in suit, here. . . .]

You’ll likely recall that last Spring, Teva said it was going to sell a generic version of Integrilin® (Eptifibatide) — and legacy Schering-Plough (now New Merck) responded with a patent infringement suit — that suit covered the ‘825, ‘902 and ‘447 patents, as applied to a 2 mg/mL, 10 mL vial formulation of Integrilin. That suit is wending its way toward a trial date, late this year.

In a suit just filed last week, New Merck is suing Teva, again, because on January 5, 2010, Teva formally notified New Merck that it had filed an additional ANDA with the FDA — cementing plans to sell a generic version of the 0.75 mg/mL, 100 mL vial formulation of Integrilin. The new suit also covers the ‘825, the ‘902 and ‘447 patents — each of which is now held by (or through) New Merck (as successor to legacy Schering-Plough). Thus:

. . . .[From Teva’s Answer to the 2009 Complaint in the 2 mg/mL, 10 mL vial infringement suit:]

AFFIRMATIVE DEFENSES

Further responding to Plaintiffs’ Complaint. . . Teva. . . asserts the following affirmative defenses and reserves the right to amend their Answer and Affirmative Defenses as additional information becomes available:

1. TPM and Teva USA do not infringe, and have not infringed, any valid and enforceable claim of the ‘825 patent, either literally or under the doctrine of equivalents.

2. The claims of the ‘825 patent are invalid and void for failure to comply with the requirements of Title 35, United States Code, including, but not limited to, one or more of Sections 101, 102, 103, 112, and/or obviousness-type double patenting. . . .

Yeh — these twin suits should prove interesting. Will they go all the way to the mat? Or will they each settle early, in return for payments to Teva, and extended exclusivity (beyond the November 2011 end of the 30 month stay date — the date for Teva’s “at-risk” launch, of a generic covered in the 2009 suit)? We’ll see. I bet the DoJ and FTC are both popping popcorn, and watching these unfolding flicks, very closely. This is still a $300 million a year franchise — but likely declining, over time, as competitors’ branded offerings enter the market, well ahead of the nominal 2015 patent expiry. Chief among these, in the next generation of clot-reduction drugs, is the Sanofi-Aventis candidate, otamixaban.

[And. . . Yes — this is the answer to my earlier (Tuesday) trivia question.]