Sunday, February 28, 2010

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:]


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.]


Anonymous said...

Wait, I'm confused. Didn't Millennium previously share/license to S/P Eptifibatide?

If so, when Millennium let it go 'completely' about 3 years ago, where there any strings attached?

condor said...

As you can see, I was completely wrong on this -- you are completely right. I have rewritten the entire post. Forgive me my lack of caffiene, yesterday.

I imbibed a full cup this morning, and rewrote the piece, top to bottom.

Sincerely, THANK YOU for noticing my manifold errors.


Robcarl said...

This is a little off topic but...whenever a drug goes off patent, the first thing the brand manufacturer does is cancel all the patient assistance programs (PAPs).

Somehow they equate that if say, half the market goes to the generic manufacturer, patients at the lower end of the economic scale and without insurance can suddenly absorb the full cost of the drug.

According to Merck's 10K, Integrilin sales dropped from $266M in 2010 to $230M in 2011. They also dropped their PAP. So much for charity.

condor said...

I agree with you.

In some cases, the cost of the generic is quite affordable -- in others, it is only 20 percent less that the previously-patented, branded drug.

And then even the generics are out of reach for people of average, or below average incomes.

What to can be done about it? I am unsure. I do know that Mr. Obama's2014 measures will ameliorate some of this -- but not all of it.

That is, if he is re-elected, and helath care reform is not dismantled, in 2013.

Namaste, and do stop back!