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June 16, 1999


The opinion of the court was delivered by: Sullivan, District Judge.



Plaintiff Apotex, Inc., through its TorPharm division (hereinafter "TorPharm"), commenced this lawsuit to enjoin the Food and Drug Administration ("FDA") from granting a 180-day period of exclusivity to Novopharm Limited ("Novopharm") to market generic over-the-counter ("OTC") strength ranitidine hydrochloride. Plaintiff claims that the FDA has ignored a key provision of the Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 355, and frustrated Congressional intent by creating an unwarranted delay for open competition in the billion dollar ranitidine hydrochloride market.


I. Parties

Plaintiff TorPharm is a generic drug manufacturer that challenges the FDA's grant of a period of market exclusivity for 75 mg OTC ranitidine hydrochloride to intervenor defendant Novopharm. Defendants are Donna Shalala, Secretary of Health and Human Services; Jane Henney, Commissioner of the FDA; and the FDA. Intervenor defendant Novopharm is a generic drug manufacturer that received a 180-day exclusive period to market 75 mg OTC strength ranitidine hydrochloride.

II. The FDA's Statutory Scheme

A. New Drug Approval

The FDA has administrative jurisdiction of applications to market new drugs under the FDCA. Pharmaceutical companies that wish to market innovator or "listed" drugs must first obtain FDA approval through the filing of a new drug application ("NDA"). See 21 U.S.C. § 355(a), (b). The FDCA requires an NDA applicant to submit data to the FDA that demonstrates the safety and effectiveness of the drug. In addition, the NDA applicant must submit information on any patent that claims the drug or a method of using such drug for which a claim of patent infringement could reasonably be asserted against an unauthorized party. See 21 U.S.C. § 355(b)(1), (c)(2). The patent information must include the patent number and the date of expiration. See 21 U.S.C. § 344(b)(1). The FDCA requires the FDA to publish this information, and the FDA does so in a publication entitled "Approved Drug Products with Therapeutic Equivalence Evaluations" (commonly referred to as the "Orange Book"). See 21 C.F.R. § 314.53(e).

B. Abbreviated New Drug Approval

In 1984 Congress passed the Drug Price Competition and Patent Term Restoration Act, generally known as the Hatch-Waxman Amendments.*fn1 The Act provided generic drug manufacturers with greater access to the market for drugs and granted greater market protection to innovator drug manufacturers through special patent extensions and periods of exclusive marketing. The Act also established an abbreviated process by which the FDA could approve generic versions of listed drugs without requiring the submission of full safety and efficacy data. The Act also allows a generic drug manufacturer to seek approval of its drug product by submitting an abbreviated new drug application ("ANDA") that demonstrates, among other things, that the generic version of the drug is "bioequivalent"*fn2 to the innovator drug.

The FDCA requires an ANDA applicant who seeks approval of a generic drug to reference the particular listed drug that it intends to duplicate. See 21 U.S.C. § 355(j)(2)(A). "Listed drugs" are new drug products that have been approved under the FDCA for safety and effectiveness and that have not been withdrawn from sale for reasons of safety or effectiveness. See 21 C.F.R. § 314.3(b). A "drug product" is a finished dosage form (e.g., tablet, capsule, or solution) that contains a drug substance generally in association with one or more ingredients. See id. A "drug substance" is an "active ingredient that is intended to furnish pharmacological activity or other direct effect . . . but does not include intermediates used in the synthesis of such ingredient." Id.

The ANDA applicant must also submit information to show that the "route of administration, the dosage form, and the strength of the new drug are the same as those of the listed drug." See 21 U.S.C. § 355(j)(2)(iii) (emphasis added). Based on this and other statutory language, the FDA has concluded that each strength of drug product is a separately listed drug. See FDA Response to TorPharm Citizen Petition, at 3 (attached to plaintiff's complaint as Exh. H).*fn3

The statute also requires that an ANDA contain a certification with respect to each patent that claims the pioneer drug or the method of the drug's use. See 21 U.S.C. § 355(j)(2)(A)(vii). The certification must state one of the following:

  (I)   that the required patent information
        relating to such patent has not been filed;
(II)  that such patent has expired;
  (III) that the patent will expire on a particular
        date; or,
  (IV)  that such patent is invalid or will not be
        infringed upon by the drug for which
        approval is being sought.

See id. Plaintiff and intervenor made certifications under paragraph IV, which requires the ANDA applicant to give notice of the filing of the ANDA to the patent owner and the NDA holder for the pioneer drug. See 21 U.S.C. § 355(j)(2)(B)(i). The required notice must include a detailed statement of the factual and legal basis for the ANDA applicant's opinion that the listed patent is either not valid or will not be infringed upon by the marketing of the generic drug. See 21 U.S.C. § 355(j)(2)(B)(ii). Certifications pursuant to paragraph IV are specific to the listed drug and to the ANDA for which approval is being sought.

The FDA may give final approval to an ANDA with a paragraph IV certification that may become effective immediately despite the unexpired patent, unless the patent owner or NDA holder brings an action for infringement against the ANDA applicant within forty-five days of the date the patent owner and NDA holder receive notice of the paragraph IV certification. See 21 U.S.C. § 355(j)(5)(B)(iii); 21 C.F.R. § 314.107(f)(2). When a patent owner brings a patent action, the statute prohibits the ANDA from being approved until thirty months from the date that the patent owner and NDA holder received notice of the filing of the ANDA, unless a final decision is reached earlier in the patent case or the court orders a different time period. See 21 U.S.C. § 355(j)(5)(B)(iii).

When two or more ANDA applicants file paragraph IV certifications, as in the instant case, the statute provides an important benefit to the earliest applicant to have submitted a paragraph IV certified ANDA. Specifically, the statute requires that ...

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