Tuesday, January 31, 2017

Back To Merck Drug Postings: Additional Generic Entrants To Compete Against Nasonex® In the US

None of this is financially material (any longer) to Kenilworth, since the branded product has faced generic competitors (including -- as we noted -- Apotex, and Teva) for quite a while now. [I think Law360 put something out on this yesterday, but I didn't get a chance to look at it.] What this means is that Amneal need not wait until August 2017 to enter the US markets with its generic. But Merck only sold about $94 million of the drug last quarter, due to other generic competition, so this is of scant moment.

That's my take on it all, with backgrounders, and the relevant 2015 memorandum order in full -- and an excerpt of it, below. Merck has lost two prior rounds in these battles -- just to be clear, here. And a bit -- of what likely did the claim in, here -- allowing Amneal to prevail:

. . . .The crux of Dr. Cockcroft's testimony in the Delaware cases will be (as it was in New Jersey I): Did Dr. Cockcroft find monohydrate in the accused formulations? He did not in New Jersey I; we can assume that he will find it in the Delaware cases, albeit using different technology. . . .

Given the nature of patent litigation today (the "no stone left unturned" mentality), common sense also dictates that Apotex's competitors (Teva and Amneal) will attempt to use the discovery process at bar to impeach Dr. Cockcroft with his past work for Apotex, where his expertise was used to demonstrate non-infringement of the '353 patent. Indeed, Amneal has specifically indicated that it intends to seek "full discovery of all information relating to [Dr. Cockcroft's] prior testimony." (D.I. 131 at 109) As a point of fact, in response to requests for production of such information, Merck has explained that it "[could not] produce it because it contains Apotex's confidential information. . . .

Onward, and as travel looms from Friday, through a good chunk of next week -- new postings may become rather scarce over that weekend -- even if 45 continues to make ill-starred moves -- ones that are unbecoming of our 240 plus year experiment in ordered liberty. Now you know. Smile. . .

[I should also mention (almost as a footnote) that 45 has renewed his vow to lower US drug prices (by ending EU "free-loading", in his words), and allow Medicaid/Medicare to negotiate directly with drug companies on pricing -- as he meets with Merck Chairman Kenneth Frazier and Pfizer's Ian C. Read in DC this morning. That according to CNN's anonymous sources who were present in the private meeting.]


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