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ALPHAPHARM PTY LIMITED v. THOMPSON

August 13, 2004.

ALPHAPHARM PTY LIMITED, Plaintiff,
v.
TOMMY G. THOMPSON, Secretary of Health and Human Services, et al., Defendants.



The opinion of the court was delivered by: JAMES ROBERTSON, District Judge

MEMORANDUM

Plaintiff Alphapharm Pty Limited challenges the Food and Drug Administration's ("FDA") refusal to list the `884 patent for citalopram (brand name Celexa®) in its Orange Book and FDA's related refusal to receive Alphapharm's abbreviated new drug application ("ANDA") for review. Before the Court are the parties' cross-motions for summary judgment. For the reasons stated below, defendant's motion must be granted, plaintiff's cross-motion denied, and the case dismissed.

Background

  The Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., prohibits the introduction into interstate commerce of any new drug unless FDA approves a New Drug Application ("NDA") for that drug. See 21 U.S.C. § 355(a). An NDA must include "the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug." Id. § 355(b)(1); see also id. § 355(c)(2) (addressing patent information that could not be submitted before NDA approval). An applicant must amend an NDA application "[i]f . . . a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application." Id. § 355(b)(1). If FDA approves the application, it must publish this information in the "`Orange Book,' an FDA publication that includes all patent information that companies have submitted to the agency." Purepac Pharm. Co. v. Thompson, 354 F.3d 877, 880 (D.C. Cir. 2004); see also 21 U.S.C. § 355(j)(7)(A)(ii) (requiring FDA to update patent information in the Orange Book every 30 days).

  In 1984, Congress enacted the "Hatch-Waxman" amendments to the FDCA in order to expedite the process by which drug manufacturers can obtain FDA approval of generic versions of already-approved brand-name drugs, see Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585 (1984); Purepac, 354 F.3d at 879. "[T]he amendments allow companies seeking such approval to submit Abbreviated New Drug Applications, known as ANDAs, that `piggyback' on the safety-and-effectiveness information that the brand-name manufacturers submitted in their NDAs." Purepac, 354 F.3d at 879 (citing 21 U.S.C. § 355(j)(2)(A); 21 C.F.R. § 314.94(a)(3)).

  Lest drug innovation be discouraged, the Hatch-Waxman amendments provide that NDA applicants may obtain exclusivity periods for innovative drugs. During those exclusivity periods, FDA may not accept or approve ANDAs for generic versions that rely for approval on the innovative drug. See 21 U.S.C. § 355(c)(3)(E)(ii)-(iv); id. §§ 355(j)(5)(F)(ii)-(iv). A five-year exclusivity period is granted to an NDA holder "for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under [§ 355(b)]," although an ANDA applicant may submit an application referencing a listed drug after four years if the NDA holder of the drug has submitted patent listing information for the drug pursuant to 21 U.S.C. § 355(b)(1) or (c)(2). 21 U.S.C. § 355(j)(5)(F)(ii); see also 21 C.F.R. § 314.101(b), (e); 21 C.F.R. § 314.108(b)(2). A six-month extension of a marketing exclusivity period may be granted for the submission, at FDA's request, of studies about whether pediatric use of the new drug will produce health benefits in that population. See 21 U.S.C. § 355a.

  The Hatch-Waxman amendments also "create[d] a strong incentive for a generic competitor to be the first to file an ANDA and receive FDA approval: a 180-day period of marketing exclusivity vis-à-vis other generic competitors." Valley Drug Co. v. Geneva Pharms., Inc., 350 F.3d 1181, 1185 n. 10 (11th Cir. 2003). "In other words, the first filer to receive FDA approval is entitled to market the generic versions of the drug for 180 days without competition from any other generic drug manufacturers." Id.; see also 21 U.S.C. § 355(j)(5)(B)(iv). However, "[l]ike NDAs, ANDAs must address patents that cover or might cover the relevant drugs." Purepac, 354 F.3d at 879. For each patent, ANDA applicants must file one of four "certifications" explaining why the ANDA should be approved despite a patent's claim on the drug: "[A] certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the listed drug . . . (I) that such patent information has not been filed, (II) that such patent has expired, (III) of the date on which such patent will expire, or (IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted." Id.; 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV). (The last certification is known as a "paragraph IV" certification).

  The facts presented by the instant case are these: FDA approved Forest Laboratories, Inc.'s NDA application for citalopram (under the brand name of Celexa®) on July 17, 1998. Forest was awarded a five-year period of marketing exclusivity for an innovative drug under 21 U.S.C. § 355(j)(5)(F)(ii), and a six-month pediatric exclusivity under 21 U.S.C. § 355a. In its NDA application, Forest included patent information on three patents. See Defs.' Mem., at 11. Before its application was approved, however, Forest sent a letter to FDA discussing the three patents and amending its application to declare that "there are no patents which claim the drug or the drug product or which claim a method of using the drug product and with respect to which a claim of patent infringement could reasonably be asserted. . . ." Admin. R., tab 1, at 2.

  After the NDA was approved, Forest sent another letter to FDA, again referencing the three patents mentioned in its application, but also adding a reference to a fourth — the `884 patent. Id., tab 2, at 2. This letter concluded with a declaration that "none of these patents are relevant to [its] approved NDA," and, as stated in the previous letter, that "there are no patents which claim the drug or the drug product or which claim a method of using the drug product and with respect to which a claim of patent infringement could reasonably be asserted. . . ." Id.

  The `884 patent had been issued and assigned to H. Lundbeck A/S on March 17, 1987. As with NDAs, patents may be extended up to five years if the patented item was subject to regulatory review by FDA before the item was marketed. See 67 Fed. Reg. 8,546, 8,546 (Feb. 25, 2002); see also Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. 98-417; Generic Animal Drug and Patent Term Restoration Act, Pub. L. 100-670. In September 1998, Lundbeck filed an application with the Patent and Trademark Office ("PTO") for a patent term extension. In response to a request for additional information from the PTO, Lundbeck stated:
Applicant has demonstrated that the preparation of the citalopram intermediate . . .; the citalopram intermediate itself . . .; and the process or converting the citalopram intermediate to citalopram, are used in the manufacture of the approved product.
Compl., Ex. C, at 2. The PTO then requested FDA's assistance in determining the `884 patent's eligibility for an extension. See 67 Fed. Reg. at 8,547. Thereafter, FDA advised the PTO that the human drug product patented at `884 "had undergone a regulatory review period and that the approval of Celexa represented the first permitted commercial marketing or use of the product." Id. The PTO then requested that FDA determine the product's regulatory review period, and FDA responded that the applicable regulatory review period for Celexa is 5,498 days. Id.; Compl., Ex. D, at 1. FDA published notice of its findings and, receiving no objection, informed the PTO that its determination was final. See Compl., Ex. E.
  On December 6, 2002, Alphapharm sent a letter to FDA requesting that the `884 patent be listed in the Orange Book. See Admin. R., tab 3, at 1. Alphapharm argued that the FDCA requires an NDA holder to submit to FDA for listing in the Orange Book "any patent which claims the drug for which the applicant submitted the application . . . and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use or sale of the drug," id. (quoting 21 U.S.C. § 355(b)(1)), and that patent `884 claims the drug citalopram. Alphapharm stated:
The `884 patent was assigned by the inventor . . . [to] H. Lundbeck A/S, which in turn has licensed the rights to make, use and sell the drug citalopram under this patent in the United States to the U.S. pharmaceutical manufacturer Forest Laboratories, Inc.
. . .
[Lundbeck's] application for an extension of the term of the `884 patent: (a) constitutes a representation by the patent owner to the PTO that the `884 patent claims the drug citalopram; and (b) demonstrates the patent owner's reliance on this interpretation. . . .
Id., at 2 (emphasis omitted). Alphapharm also attached a letter from Forest, and said of it that it "constitutes evidence that Forest, the NDA holder and licensee under the `884 patent, believes that the `884 patent (a) claims the drug citalopram and (b) could reasonably be asserted against an unauthorized person or entity engaged in the manufacture, use or sale of citalopram." Id. (emphasis omitted). Alphapharm concluded its letter by stating that "Forest Laboratories should have submitted statutorily required patent information to FDA for the `884 patent, and has failed to do so." Id. On December 16, 2002, FDA sent a letter to Forest, attaching Alphapharm's letter and requesting that Forest provide it with "written confirmation that the challenged data is correct or not correct pertaining to [its] Celexa NDA," and with "any corrections that need to be made to the patent and exclusivity information" relating to listing in the Orange Book. Id., tab 4. Forest responded on January 14, 2002, stating in a letter to FDA that
 
the submission of patent information for Celexa™ is accurate, and complies with the requirements of U.S.C. § 355(b)(1) and 21 C.F.R. § 314.50(h) and § 314.53(b). In addition, all of the information in the Request for Patent Term Extension for U.S. Patent No. [`884] is accurate.
U.S. Patent No. [`884] is eligible for Patent Term Extension pursuant to 35 U.S.C. § 156, but is not eligible for Orange Book listing (because it claims an intermediate of citalopram hydrobromide and a method of its manufacture).
Id., tab 5. FDA forwarded this response to Alphapharm. FDA did not (and continues not to) list the `884 patent in the Orange Book.

  Four and a half years after approval of Forest's NDA, (on January 17, 2003), Alphapharm submitted an ANDA application for generic citalopram. The application included a paragraph IV certification of invalidity and noninfringement of the `884 patent. On March 20, 2003, FDA informed Alphapharm that the

 
ANDA would not be received for substantive review pursuant to 21 C.F.R. § 314.101(b)(1), because (a) the application contained a paragraph IV certification against the `884 patent which the agency had declined to include in the Orange Book; and (b) only an ANDA with a paragraph IV certification against a listed patent could be received during the [five and a half] year combined [innovative drug and pediatric] exclusivity period awarded to this particular reference listed drug.
Compl., Ex. I, at 3. Thereafter, Alphapharm sent FDA four letters requesting reconsideration of its decision not to list the `884 patent and not to accept Alphapharm's ANDA. FDA responded on September 16, 2003, again declining to list the `884 patent or to receive Alphapharm's ANDA, and stating that, "[u]nless a patent is listed for Celexa, no applicant may submit an ...

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