Or, "Why didn't Schering deliver a Knock-out Punch, in its Clarinex Patent Suit Response to Orchid's Counterclaims?"
. . . .Last night (and earlier yesterday), in the comments to this post, an "Ashley" posted two answers.
It is only now -- with the benefit of hind-sight -- that we see, rather astoundingly, how closely those comments, by "Ashley" of yesterday, and last night, pre-echo, the actual filed-Response of McCarter & English, LLP, Schering-Plough's lawyers on the Clarinex patent case. Here is the relevant portion of the McCarter & English Response, filed this very afternoon. The paragraph numbers below correspond to the paragraph numbers in Orchid's filing -- they answer, one for one:
18. . . . Upon information and belief, Schering admits that Orchid filed ANDA 78-356 for desloratadine orally disintegrating tablets. Upon information and belief, Schering further admits that ANDA 78-356 stated that "This ANDA is based on the listed drug, CLARINEX® Reditabs® (Desloratadine Orally-Disintegrating) Tablets, 2.5 mg and 5 mg (NDA # 021312) which is distributed by Schering Corporation, USA the holder of the approved application and which is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (known as Orange Book)." Upon information and belief, Schering further admits that ANDA 78-356 states that "Orchid Healthcare herby certifies that the patent US 6,100,274 is invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of Desloratadine Orally Disintegrating Tablets, 2.5 mg and 5 mg for which this Abbreviated New Drug Application is submitted. This certification is made in accordance with Section 505(j)(2)(A)(vii) of the FD&C Act and pursuant to 21 C.F.R. 314.94(a)(12)(i)(A)(4)." Upon information and belief, Schering further admits that it received notice of Orchid's Paragraph IV Certification on August 30, 2006. Schering further admits that it filed a Complaint against Orchid on September 29, 2006 and an Amended Complaint against Orchid on December 18, 2006 for infringement of the '274 Patent. Schering further admits that pursuant to applicable provisions of the United States Code and Code of Federal Regulations, ANDA 78-356 may not be approved by the FDA until December 21, 2009, in the absence of prior action by the court. See 21 U.S.C. § 355(j)(5)(F)(ii); 21 U.S.C. § 355a(b)(1)(A)(i)(I); 21 C.F.R. § 314.107(b)(3)(i)(B); 21 C.F.R. § 314.108(b)(2). To the extent that Counterclaim Paragraph 18 contains any other or different averments, Schering denies them. . . .
19. Schering denies the averments in the first sentence of Counterclaim Paragraph 19. Schering admits that the '274 Patent discloses and claims, among other things, "A pharmaceutical composition for oral administration comprising an anti-allergic effective amount of descarbonylethoxy-loratadine in a pharmaceutically acceptable carrier medium comprising a DCL-protective amount of a pharmaceutically acceptable basic salt and at least one pharmaceutically acceptable disintegrant." Schering further admits that the '274 patent discloses and claims, among other things, "A pharmaceutical composition comprising an anti-allergic effective amount of descarbonylethoxyloratadine in a pharmaceutically acceptable carrier medium wherein said composition contains less than about 1% by weight of N-formylDCL." Schering further admits that it submitted patent information regarding the '274 patent for its Clarinex® RediTabs® orally disintegrating tablet products to the FDA on March 14, 2005.
Schering further admits that the March 2005 labeling information it submitted to the FDA for its Clarinex® RediTabs® orally disintegrating tablet products stated that they contain: desloratadine, mannitol USP, microcrystalline cellulose NF, pregelatinized starch, NF, sodium starch glycolate, USP, magnesium stearate NF, butylated methacrylate copolymer, crospovidone, NF, aspartame NF, citric acid USP, sodium bicarbonate USP, colloidal silicon dioxide, NF, ferric oxide red NF and tutti frutti flavoring. Schering further admits that the current product information for Clarinex® RediTabs® orally disintegrating tablet products states that "[e]ach
RediTabs Tablet contains either 5 mg or 2.5 mg of desloratadine. It also contains the following inactive ingredients: mannitol USP, microcrystalline cellulose NF, pregelatinized starch, NF, sodium starch glycolate, NF, magnesium stearate NF, butylated methacrylate copolymer, crospovidone, NF, aspartame NF, citric acid USP, sodium bicarbonate USP, colloidal silicon dioxide, NF, ferric oxide red NF and tutti frutti flavoring." To the extent that Counterclaim Paragraph 19 contains any other or different averments, Schering denies them. . . .
20. . . .Schering denies the averments in the first sentence of Counterclaim Paragraph 20. With respect to the second sentence of Counterclaim Paragraph 20, Schering admits that U.S. Patent No. 4,659,716, which was listed in the Orange Book for NDA 021312, has expired. Schering further admits that it is aware that a dismissal was entered in the action Cima Labs, Inc. v. Orchid Chemicals & Pharmaceuticals, Ltd., Civil Action No. 06-04809-KSH-PS (D.N.J) on December 12, 2007. Schering further admits that it is aware that the dismissed action involved U.S. Patent No. 5,607,697, which is listed in the Orange Book for NDA 021312. With respect to the third sentence of Counterclaim Paragraph 20, Schering admits that ANDA 78-356 has not obtained, and may never obtain, tentative or final approval from the U.S. FDA. Schering is without knowledge or information sufficient to form a belief as to the truth of the remaining averments in this sentence and denies them on that basis. Schering denies the averments in the last sentence of Counterclaim Paragraph 20. To the extent that Counterclaim Paragraph 20 contains any other or different averments, Schering denies them. . . .
21. Schering admits that 21 U.S.C. § 355(j) (5)(C)(ii) states that: "If an owner of the patent or the holder of the approved application under subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the patent brings a patent infringement action against the applicant, the applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted by the holder under subsection (b) or (c) on the ground that the patent does not claim either - (aa) the drug for which the application was approved; or (bb) an approved method of using the drug." To the extent that Counterclaim Paragraph 21 contains any other or different averments, Schering denies them. . . .
22. Denied. . . .
Wow. Now, here are the comments from "Ashley", from yesterday:
That patent you're referring to, 6100274, is for the formulation which contains a salt. Namely, dibasic calcium phosphate dihydrate USP. You can see this on the label for Clarinex Redi-tabs.
The patent states, "Stable pharmaceutical compositions containing 8-chloro-6,11-dihydro-11-(4-piperidylidene)-5H-benzo[5,6]cycloheptic[1,2-b ]pyridine("DCL") and a DCL protective amount of a pharmaceutically acceptable basic salt such as calcium dibasic phosphate and an amount of at least one disintegrant, preferably two disintegrates such as microcrystalline cellulose and starch sufficient to provide dissolution of at least about 80% by weight of the pharmaceutical composition in about 45 minutes and suitable for oral administration to treat allergic reactions in mammals such as man are disclosed."
April 29, 2008 8:37 PM
Actually, I made a mistake above. Dibasic calcium phosphate dihydrate USP is an excipient in the tablet. The basic salt excipient used in the reditab appears to be sodium bicarbonate USP. See the label below that I copied from the FDA's website (approved on 12/14/2006).
"The CLARINEX RediTabs® brand of desloratadine orally-disintegrating
tablets are light red, flat-faced, round, speckled tablets with an “A” debossed on
one side for the 5 mg tablets and a “K” debossed on one side for the 2.5 mg tablets.
Each RediTabs Tablet contains either 5 mg or 2.5 mg of desloratadine. It also
contains the following inactive ingredients: mannitol USP, microcrystalline cellulose
NF, pregelatinized starch, NF, sodium starch glycolate, USP, magnesium stearate
NF, butylated methacrylate copolymer, crospovidone, NF, aspartame NF, citric acid
USP, sodium bicarbonate USP, colloidal silicon dioxide, NF, ferric oxide red NF and
tutti frutti flavoring."
April 30, 2008 5:39 PM. . . .
As to the substance -- I remain unconvinced, even by McCarter & English's as-filed Response. Does all that legalese above actually say the Schering Patent No. '274, or some other Schering patent, claims/covers non-salt-based -- read: RediTab versions of -- Clarinex? I don't see it.
McCarter & English is a very fine firm of lawyers. If it had a knockout punch, here -- a clearly disclosed in the Orange Book submission of an applicable Schering patent, on a formulation of desloratadine that was made from other than a basic salt, it likely would have said so, and in plain English, to be sure that the judge saw, and understood, the knock-out.
It seems McCarter & English did no such thing, at all, here -- it merely carefully recited what the '274 patent claims, and what the label copy for the RediTab describes. Now, to be fair, one school of thought holds that it is unwise to disclose too much in pleading practice, and that saving the real firepower for live hearings before the court is good case management strategy. "Don't give the opponent too many (or any) angles to prepare, and shoot from."
A competing theory holds that judges read motions and pleadings very carefully, and because so much is often going on, at once, in the courtroom, live, the judge's full attention may be lost -- at just that critical moment when one presents one's winning argument, orally. So, this theory holds that submitting one's very best argument, in advance, in writing, really gets the judge leaning one's way. "Judges don't like surprises", this theory holds.
On balance, I think most lawyers adhere to this latter-theory, in high-stakes litigation (like this one), because the potential costs of being mis-understood, by the judge, orally, in that likely-fleeting moment, are so very steep.
So now, where, exactly, is the plain English "salt or no salt" Schering patent language? It is not set forth above. Not in plain English. Maybe -- just maybe -- McCarter & English will tell the judge that one of those chemical-compounds in the above laundry-lists irrefutably and unambiguously tells a trained scientist that yet another way to make the desloratadine dissolve more readily, is without the use of any basic salt, and that patent '274 claims that way, as well. But I doubt it. If they had it, it would be the headline. There is, effectively, no such headline here.
As I wrote last night to "Ashley":
The mere fact that an FDA-filed-label-copy document recites and/or suggests that a basic salt is present in the RediTab formulation is NOT the same thing as actually showing me that either (1) that all RediTabs ARE, in fact, made with a basic salt, or, in the alternative, (2) a patent-filing (in which the filing claims, and is granted, a patent on the active ingredient, the metabolite of desloratadine, WITHOUT any basic salt present, in the actual final football formulation.
That -- the second branch, above -- is, as I understand it, Latham & Watkin's contention -- that the RediTab version actually contains NO basic salt -- viz, from Orchid's filing:
". . . .However, as the FDA-approved label for Clarinex® RediTabs confirms, Schering’s orally disintegrating formulation does not contain a basic salt. June 26, 2002 Final Draft Labeling at 1. . . ."
Thus, that formulation would not be covered by any existing Schering patent, at all.
And so, all the suggestions of an "at risk" launch by Orchid are floating about. Again [Ashley, or anyone (else!) from McCarter & English, LLC], do stop back and correct my errors. I am sure I've made some.
Finally, remember, here, that patents -- as restraints on free-trade -- are very narrowly, and strictly, construed. Typically, if one did not expressly claim the exact method for composition, it is not covered. But I will be back