The opinion of the court was delivered by: Sullivan, District Judge.
MEMORANDUM OPINION AND ORDER
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.
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
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 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
(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
(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 ...