As a public service, I thought it might be useful to set out -- side-by-side, the 
relevant back-and-forth, sentence, by sentence, in the Clarinex RediTab patent dispute -- a fight with the potential to quickly allow Orchid to introduce a generic version of Clarinex RediTabs into the US markets by the back half of this year -- yes, that was the same Schering product that generated about $800 million of 2007 sales worldwide. This one will certainly bear continued monitoring of the federal court docket, by this website. So, I promise we will keep you right up-to-date on developments in this important case.
Do take a look for yourself -- but this is no knock-out punch, here, from Schering [the blue text is from Orchid's Counterclaims, as to the alleged invalidity of Schering's patent claims]:
| Orchid Counterclaim | Schering-Plough Response | |
| 18. Defendant Orchid filed an ANDA for desloratadine orally disintegrating tablets (No. 78-356), which referenced Plaintiff Schering’s CLARINEX RediTabs NDA, and included a paragraph IV certification for the ’274 patent listed in the Orange Book. Orchid provided notice to Schering of the certification, Schering sued within the required 45-days, and now FDA presumptively is prevented from approving Orchid’s ANDA for 30-months, or until about March 2009, absent prior action by this Court. . . . | 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 hereby 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 improperly caused the FDA to list the ’274 patent with regard to NDA No. 021-312 because the ’274 patent does not cover Clarinex® RediTabs. . . . The ’274 patent discloses and claims desloratadine compositions containing a basic salt. . . . 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. | 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 descarbonylet-hoxyloratadine 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. Orchid is in a position to enter the market for generic deslora-tadine orally disintegrating tablets but for the presumptive 30-month stay associated with Schering’s filing of the instant lawsuit relating to Orchid ANDA No. 78-356. . . . Thus, as Schering is aware, Orchid has fully and finally resolved a separate lawsuit with another pharmaceutical company involving another patent listed in the Orange Book for NDA No. 21-312 and another listed patent has expired. . . .
In short, the 30-month stay is the only remaining barrier to the availability of generic desloratadine orally disintegrating tablets to the public. . . . | 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. Concerned that pharmaceutical companies might improperly list patents in the Orange Book to thwart potential generic entry, Congress has specifically authorized courts to issue an order that the NDA holder “correct or delete the patent information submitted by the holder . . . on the ground that the patent does not claim either — (aa) the drug for which the application was approved; or (bb) the approved method of using the drug.” 21 U.S.C. § 355(j)(5)(C)(ii). . . . 22. Orchid is entitled to an order that Schering be ordered to delete the ’274 patent from the Orange Book with respect to NDA No. 21-312 on the grounds that the ’274 patent neither claims the drug for which NDA No. 21-312 was approved nor an approved method of using the drug. . . . | 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. . . . |
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