Ongoing Nasonex® Patent Spats — Suing Three Generics At Once — Leads To A Disqualification Of A Former Apotex Expert Witness Hired By Merck

I think the Lexis/Nexis practice compendiums may be running an item on this development today, but here is my take on it, with backgrounders, and the relevant memorandum order in full — and an excerpt of it, below. Merck has lost two prior rounds in these battles — just to be clear, here.

None of this is financially material (any longer) to Kenilworth, since the branded product has faced generic competitors (including — as we noted — Apotex) for quite a while now, but it does mark a “too clever, by half” attempt to rope in a formerly opposing science expert witness (in the Apotex NJ I case), and use him as a weapon in these later cases. Cheeky — but the very able Judge Sue Robinson (in Delaware federal District Court) isn’t biting. And so, a chunk of the order from last week, then:

. . . .Despite the knowledge of both Merck and Dr. Cockcroft that he had rendered expert assistance to Apotex in prior litigation involving the ‘353 patent, Merck engaged the services of Dr. Cockcroft in the above captioned litigation, again in connection with Merck’s patent rights that cover Nasonex nasal spray. In this regard, Dr. Cockcroft failed to give notice to Apotex of his engagement by adverse party Merck because he believed that his engagement by Apotex “ended when that case ended,” and that the agreement did not limit his “ability to act as a freelance consultant on a permanent basis. . . .”

Moreover, Apotex’s confidential information is at a substantial risk of disclosure and/or adverse use, by virtue of the fact that Merck has chosen to pursue simultaneous cases against all three generic manufacturers — Teva, Amneal, and Apotex — regarding the ‘353 patent. In this regard, common sense dictates that generic products (even pharmaceutical generic products) cannot be so dissimilar as to completely alleviate the natural instinct to draw upon past knowledge to solve even new problems, leading to inadvertent adverse use if not disclosure. Here, where Amneal and Apotex share the same “API” (active pharmaceutical ingredient) (D. I. 131 at 108), and where the three cases initiated by Merck all involve “an anhydrate-based formulation [of mometasone furoate] that is bioequivalent to the brand” (id. at 108-109), the risk of inadvertent use should not be minimized. . . .

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. . . .”

Of course, since Merck essentially “manufactured” the potential for a violation of confidentiality, by hiring Apotex’s former expert, that cannot be a basis to resist lawful discovery motions — or subsequent orders, in patent litigation. So Merck loses this one. And rightly so. Onward — in a sweet hot wet rain here, now!

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