Category Archives: Clarinex Descloratadine Patent Litigation (MDL No. 1851

Monday, July 21, 2008 will be a busy day for various developments at Schering-Plough — including Clarinex®

I’ll be out-of-pocket — in Northern California, for a quick in-and-out, on various meetings — but (owing to the time differences), I intend to live-blog highlights of the Merck, and the Schering Q2 calls, on Monday morning, from my hotel. We should learn quite a bit more from Merck’s call, as Merck will likely need to update its projection of $700 million in lost 2008 profits, solely from the Vytorin Joint Venture with Schering, due to these latest Schering-provided, IMS-generated, monthly scrips disclosures.

Will Merck CEO Dick Clark simply ante-up, and re-set it at a nice, round $1 billion? We’ll know a lot more — on Monday.

[An aside — today Citigroup initiated coverage on Schering. And, before you ask — the answer is “Yes“. Yes, yes, yes — Citi-controlled entities had over $860 million at stake in the August and September 2007 Schering public offerings it helped co-lead — offerings priced at $27.50 — Hmmmmm. . . just how independent is that coverage? I wonder. You should, too. But I digress. . . .] UPDATING, here: I just noticed that Citi initiated at “Hold” — that is a very-ominous sign — it would suggest that Citi sees almost no upside from here. It would suggest Citi thinks Schering is now fully- to over-, valued. Wow. And this, from a bank already showing a $5.50 per share (albeit unrealized) loss on its clients’ earlier purchases in the Schering public offerings, in Q3 2007.

I’ll have much more on what it will all mean for Schering, proper, on Monday, but now the real reason I foresee a log-jam of events:

I have been (quietly) watching the numerous pieces of Descloratadine (marketed as Clarinex® tablets) patent litigation (particularly Case No. 06-04715 against Zydus) that Schering brought against various would-be generic manufacturers of Clarinex®-equivalent tablets — back in 2007, and in some cases, back as far as 2006. These have now progressed to an important series of deadlines — many of which also fall on this Monday morning. Odd convergence, eh?

On Monday, the Briefs in Opposition — to Watson Laboratories, Inc.’s and Watson Pharmaceuticals, Inc.’s Motions to Dismiss chunks of Schering’s patent infringement suit — are due, from Schering’s Counsel, McCarter and English. Also on Monday, responsive pleadings and motions — as to other defendants in these Schering-intitiated lawsuits (now consolidated with the suits against Orchid, Sun, Barr, Sandoz, Watson and other would-be generic manufacturers — in the face of Schering’s claims about the broad coverage, and applicability of its so-called “Patent No. ‘274”), will be filed.

[Oh, and fascinatingly, Winston and Strawn has beefed up its defense team, adding lawyers from its Chicago office (on behalf of Sun, one of the other generic companies sued by Schering) to its roster, last night — which often suggests an imminent, and large, filing — authored by one (or more) of those newly-added lawyers. We’ll see.]

Finally, the decision of the federal District Court, in Newark, New Jersey — from United States Magistrate Judge Tonianne J. Bongiovanni, on Schering’s attempt to hide from public inspection most of its substantive papers in these consolidated actions — actions Schering, itself, brought — was earlier-scheduled for Monday, as well, but will now be held over until September 2, 2008, thus:

. . . .Motion to Seal certain materials submitted in Opposition to Defendants Watson Laboratories, Inc.’s and Watson Pharmaceuticals, Inc.’s Motion to Dismiss for Lack of Subject Matter Jurisdiction.

Motion Hearing set for September 2, 2008 before Magistrate Judge Tonianne J. Bongiovanni. . . .

We may decide to file some sort of amici materials, on this issue — these are public documents [the federal courts are presumtively open to all, regardless of some usually-remote potential for business advantage, or dis-advantage — the Clarinex® (descloratadine) patents at issue, here, are likewise entirely public documents — as are the formulae by under which Schering (and the generic companies) make the tablets] and, except for the relatively-few paragraphs that might contain core Clarinex® trade secrets, there is little legal basis for Schering-Plough to seal papers in a suit it made a conscious-choice to bring.

I may not get to a lot of this until I return, on Tuesday-evening, July 22, 2008.

But I can confidently predict there will be a lot of new information on whether Orchid Pharmaceuticals (based in India) will be in a position to attempt an “at-risk“, late-2008, launch of its generic version of Clarinex® tablets. If nothing else, it should all be rather droll — entertaining fare — assuming the court orders at least the non-trade-secret portions of these presumptively-public documents to appear in the electronic court files — and soon.

At the moment, one of Schering’s heftiest briefs is visible only as a summary — the actual brief (or statements of, and arguments on, the laws — entirely public laws) is now sealed, temporarily, from the public’s prying eyes (and iPhone®-G3’s). Heh.