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Apotex Inc. v. Food and Drug Administration

February 13, 2006


The opinion of the court was delivered by: John D. Bates United States District Judge


Plaintiff Apotex, Inc. ("Apotex") brings this action against the Food and Drug Administration ("FDA"), Secretary of Health and Human Services Michael O. Leavitt, and Acting FDA Commissioner Lester M. Crawford, challenging FDA's decision to deny immediate approval to Apotex for a generic version of the drug omeprazole as arbitrary and capricious under the Administrative Procedure Act ("APA"), 5 U.S.C. § 706(2). In essence, the parties disagree regarding the proper interpretation of 21 U.S.C. § 355(j)(5)(B)(iv) (2000),*fn1 the same statutory provision at issue in Teva Pharms. USA, Inc. v. FDA, 398 F. Supp. 2d 176 (D.D.C. 2005), and several other recent cases in this district and the D.C. Circuit.


1. Statutory and Regulatory Framework

In order to market an original pharmaceutical product, a company must file a New Drug Application ("NDA") with the FDA, providing technical information regarding the pharmaceutical's composition, clinical trial results as to safety and effectiveness, the method of manufacture, and proposed labeling for the pharmaceutical's use. See 21 U.S.C. § 355(b)(1). The FDA must approve the NDA, and the applicant must also submit information concerning patents that "claim[] the drug . . . or which claim[] a method of using such drug . . . ." 21 U.S.C. §§ 355(b)(1), (c)(2). The FDA then "lists" this information, once approved, in a publication called "Approved Drug Products With Therapeutic Equivalence Evaluations" (also known as "the Orange Book"). See 21 U.S.C. § 355(c)(2); 21 C.F.R. § 314.53(a).

The Drug Price Competition and Patent Term Restoration Act of 1984, codified at 21 U.S.C. § 355 and 35 U.S.C. §§ 156, 271, 282, governs the marketing of generic versions of pharmaceuticals that are covered by pre-existing NDAs. See 21 U.S.C. § 355(j). The generic pharmaceutical company must submit an Abbreviated New Drug Application ("ANDA"), which is a truncated version of the original NDA, enabling the generic applicant to avoid the considerable expense of repeating the detailed clinical studies originally conducted in connection with the NDA. See Dr. Reddy's Labs., Inc. v. Thompson, 302 F. Supp. 2d 340, 343 (D. N.J. 2003). The ANDA-applicant must establish that its generic product is bioequivalent to the NDA-product, and must ordinarily show that the ANDA-product has the same active ingredient, dosage form and strength, method of administration, and labeling as the NDA-product. 21 U.S.C. § 355(j)(2)(A). In addition, the ANDA must include one of four certifications as to each patent that is listed in the Orange Book in connection with the NDA-product. See 21 U.S.C. § 355(j)(2)(A)(vii). The four available certifications state that: (1) there is no patent information; (2) the listed patent has expired; (3) the ANDA-applicant will not market its generic drug until the listed patent expires ("paragraph III certification"); or (4) the listed patent is invalid and/or will not be infringed by the ANDA-drug ("paragraph IV certification"). See 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV).

An ANDA-applicant seeking to market its drug before the NDA-drug's patent has expired must make a paragraph IV certification with respect to the "listed patents" (i.e., the patents that are listed in the Orange Book when the ANDA is filed), as well as those that are placed in the Orange Book subsequently (i.e., "later-listed patents"), and must further advise the NDA-holder of the legal and factual grounds for the certifications. See 21 U.S.C. § 355(j)(2)(B). Under the law, as soon as an ANDA-applicant makes a paragraph IV certification as to a patent that claims the NDA-drug, the ANDA-applicant has infringed that patent, and the NDA-holder may immediately sue the ANDA-applicant for infringement. See 35 U.S.C. § 271(e)(2)(A). If the NDA-holder files the infringement suit within forty-five days of the date on which it received notice of the paragraph IV certification, then any approval of the ANDA is automatically stayed for thirty months thereafter. 21 U.S.C. § 355(j)(5)(B)(iii). The thirty-month stay will not apply, however, if a final court decision is rendered earlier in the patent case, or if the presiding court orders otherwise. 21 U.S.C. § 355(j)(5)(B)(iii).

As an incentive for generic pharmaceutical companies to further the statutory purpose of helping the public gain access to lower-cost drug products more expeditiously, Hatch-Waxman grants a 180-day period of generic marketing exclusivity to a "previous" ANDA-applicant that has filed a paragraph IV certification. See 21 U.S.C. § 355 (j)(5)(B)(iv). Each strength and dosage form of a particular generic drug is a separate drug product for which an ANDA applicant can potentially qualify for generic exclusivity. During this 180-day exclusivity period, no other generic competition is permitted. Id. The 180-day period is triggered by the earlier of either: (1) "the date on which the Secretary receives notice from the applicant under the previous application of the first commercial marketing of the drug under the previous application"; or (2) "the date of a decision of a court in an action described in clause (iii) holding the patent which is the subject of the certification to be invalid or not infringed." See 21 U.S.C. § 355(j)(5)(B)(iv). The latter triggering-event is referred to as the "court-decision trigger."

The present litigation concerns whether a 180-day exclusivity period is awarded to each ANDA-applicant who is the first to make a paragraph IV certification as to a listed patent ("patent-based" exclusivity), or rather only to the single ANDA-applicant who is the first to make a paragraph IV certification as to any listed patent on the drug ("drug-product based" exclusivity).*fn2 The patent-based interpretation allows for multiple exclusivity periods that may be conferred in connection with a single drug product. The drug-product based interpretation, on the other hand, permits only one exclusivity period to arise in relation to a particular drug product. Hence, the FDA (which has adopted the patent-based approach) submits that an exclusivity period attaches to each individual patent, but Apotex (as a proponent of the drug-product based approach) contends that a single exclusivity period attaches to the drug product as a whole.

2. Factual Background

Apotex, formerly known as TorPharm, Inc., is a generic pharmaceutical manufacturer organized under the corporate laws of Canada. Pl.'s Statement of Undisputed Material Facts at 1 ¶ 1 ("Pl.'s Stmt."). AstraZeneca LP ("AstraZeneca") initially held seven patents in connection with its approved NDA for Prilosec(r), the branded version of the generic drug omeprazole, which is most commonly prescribed to treat gastroesophageal reflux disease. Compl. at 8 ¶¶ 25-26; see Pl.'s Stmt. at 2 ¶ 6. Six of the seven originally-listed Prilosec(r) patents are relevant to this litigation: Nos. 4,636,499 ("'499 patent"); 4,786,505 ("'505 patent"); 4,853,230 ("'230 patent"); 5,093,342 ("'342 patent"); 5,629,305 ("'305 patent"); and 5,599,794 ("'794 patent"). Pl.'s Stmt. at 2-3 ¶ 8. AstraZeneca's approved NDA covers 10 mg, 20 mg, and 40 mg capsule dosages. Compl. at 8 ¶ 25. The present litigation concerns the 40 mg dosage.

On March 17, 1998, Andrx Pharmaceuticals, Inc. ("Andrx"), submitted an ANDA seeking to market 10 mg and 20 mg generic dosages. Compl. at 9 ¶ 27. More than six months later, on September 28, 1998, Andrx amended its ANDA to include the 40 mg dosage. Id. When Andrx amended its ANDA, it also submitted paragraph IV certifications as to AstraZeneca's six listed patents. Id. Andrx was the first to file an ANDA containing paragraph IV certifications regarding the 40 mg product. Id. at ¶ 28. In connection with the September 28, 1998 paragraph IV certifications for the 40 mg product, FDA granted Andrx a 180-day exclusivity period under Hatch-Waxman. See id.

Following Andrx's September 28, 1998 amendment to its ANDA, AstraZeneca listed four additional patents in connection with Prilosec(r): U.S. Patent Nos. 6,147,103 ('"103 patent"); 6,150,380 ('"380 patent"); 6,166,213 ('"213 patent"); and 6,191,148 ('"148 patent"). Compl. at 12 ¶ 37. In the spring of 2001, Andrx amended its ANDA a second time, so as to include paragraph IV certifications with respect to the later-listed '103, '380, '213 and '148 patents. Id.; Admin. Rec. Exh. 51; see also Admin. Rec. Exh. 50 at 2; Admin. Rec. Exh. 62 at 1. FDA then granted Andrx a 180-day period of generic exclusivity in connection with the paragraph IV certifications as to these later-listed patents. Compl. at 12 ¶ 37. On or about December 23, 1998, Andrx withdrew its paragraph IV certifications as to the '342, '305 and '794 patents (three of the relevant group of six originally-listed patents). Id. at ¶ 29. Once withdrawn, those patents could no longer serve as the basis for exclusivity, see Dr. Reddy's Labs., 302 F. Supp. 2d at 360-66, and exclusivity could only be predicated upon the remaining paragraph IV certifications as to the '499, '505, and '230 patents (from the originally-listed group).

In February of 1999, another generic pharmaceutical company, Dr. Reddy's Laboratories, Inc. ("DRL"), filed an ANDA seeking to market the 40 mg dosage, simultaneously making paragraph IV certifications as to all of AstraZeneca's listed patents. See Pl.'s Mot. Summ. J. Exh. 3 at ¶¶ 23-25; Pl.'s Mot. Summ. J. Exh. 4 at ¶¶ 23-25; see also Admin. Rec. Tab 68 at 1. AstraZeneca then sued Andrx, DRL,*fn3 and a third ANDA-applicant by the name of Genpharm in the United States District Court for the Southern District of New York for infringement of the '499, '505 and '230 patents. That court ultimately granted summary judgment in favor of Genpharm and DRL as to the '499 patent, holding it not infringed. See Admin. Rec. Tab 34 at Exh. F, Exh. G. Final judgment of infringement against Andrx with respect to several claims of the '505 and '230 patents was entered on October 30, 2002. See Admin Rec. Tab 34 at Exh. F; see also In re Omeprazole Patent Litig., 222 F. Supp. 2d 423, 433, 541-47 (S.D.N.Y. 2002); Compl. at 10 ¶ 31. The court also enjoined Andrx from selling generic omeprazole capsules in any strength until the expiration of the '505 and '230 patents -- and the subsequent pediatric exclusivity period held by AstraZeneca*fn4 -- on October 20, 2007. See Admin. Rec. Tab 34 at Exh. F. Furthermore, the effective date of approval for Andrx's ANDA was delayed at least until that date. See id. The judgment of infringement against Andrx was affirmed on December 11, 2003. See In re Omeprazole Patent Litig., 84 Fed. Appx. 76, 83, 2003 U.S. App. LEXIS 24899, at *17 (Fed. Cir. Dec. 11, 2003).

On December 5, 2000, Apotex submitted an ANDA for omeprazole products in 10 mg, 20 mg and 40 mg strengths. Compl. at 11 ¶ 35. The ANDA contained paragraph IV certifications as to the '505 and '230 patents. Id. AstraZeneca then sued Apotex for infringement as to those patents, and that litigation currently remains pending without a court decision. Id. The FDA granted tentative approval to Apotex for its 40 mg product on October 6, 2003, but delayed final approval on the grounds that Andrx's 180-day exclusivity period had not yet expired. Id. at ¶ 36. Apotex's ability to obtain final approval from the FDA and to market its 40 mg product, then, is blocked by the FDA's decision to grant a second 180-day exclusivity period to Andrx, which was conferred in connection with Andrx's ANDA for AstraZeneca's later-listed patents. See id. at ¶¶ 37-41. As a result, the ...

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