The opinion of the court was delivered by: PAUL FRIEDMAN, District Judge
This matter initially came before the Court on plaintiffs' motion for
a preliminary injunction. At filing, plaintiffs Ranbaxy Laboratories
Limited, Ranbaxy Inc. and Ranbaxy Pharmaceuticals, Inc. (collectively,
"plaintiffs" or "Ranbaxy") also moved for summary judgment and to
consolidate the preliminary injunction hearing with a hearing on the
merits. The federal defendants, the United States Food and Drug
Administration; Mark B. McClellan, M.D., Ph.D., Commissioner of the Food
and Drug Administration; and Tommy G. Thompson, Secretary, United States
Department of Health and Human Services (collectively, the "Federal
Defendants" or "FDA") filed an opposition to the motion for a preliminary
injunction and a cross-motion for summary judgment. Defendant-intervenor
Pfizer Inc. ("Pfizer") also filed a cross-motion for summary judgment and
an opposition to both of plaintiffs' motions.
Oral argument on the motions took place on March 4, 2004. All the
parties requested that the Court expedite its decision so that an appeal
may be taken promptly in light of the time-sensitive nature of the
Broadly, this matter concerns the process by which the FDA approves
generic drugs, which is delineated in a 1984 amendment to the Federal
Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et
seq., commonly referred to as the "Hatch-Waxman Amendments."
See 21 U.S.C. § 355(j). This matter also concerns a second
amendment to the FDCA that provides for an additional exclusivity period
for patents held by brand-name drug manufacturers that participate in
pediatric studies of those patented drugs. See 21 U.S.C. § 355a. Both
these statutory schemes are explained in great detail in Mova
Pharmaceutical Corp. v. Shalala, 140 F.3d 1060, 1063-65 (D.C. Cir.
1998), and Barr Laboratories, Inc. v. Thompson, 238 F. Supp.2d 236,
239-241 (D.D.C. 2002). There is no need to recite their background again
B. Administrative History of this Action
On January 29, 1990, the FDA approved Pfizer's new drug application
("NDA") for fluconazole (brand name Diflucan), which is indicated for the
treatment of various fungal infections, including vaginal yeast
infections, oral yeast infections and cryptococcal meningitis.
See Complaint ("Compl."), Ex. 1, Physicians' Desk
Reference 2592 (58th ed. 2004) at 3. Pfizer filed patents that claim
Pfizer's approved drug product and uses, and the FDA listed these patents
in the "Approved Drug Products With Therapeutic Equivalence Evaluations"
Book"). U.S. Patent No. 4, 404, 216 (`"216 Patent"), the last of the
Pfizer patents at issue in this matter, expired on January 29, 2004.
See Compl., Ex. 2, Orange Book Excerpt at 3.
Ranbaxy, a generic drug manufacturer, submitted to the FDA an
abbreviated new drug application ("ANDA") for fluconazole (oral
suspension) on December 26, 2001, and an ANDA for fluconazole (tablet) on
March 27, 2002. See Compl., Ex. 3, July 11, 2003, Letter from
Gary Buehler, Director, Office of Generic Drugs to Abha Pant, U.S. Agent
for Ranbaxy Laboratories, Ltd. (oral suspension) ("July 11, 2003 FDA
Letter"); Compl., Ex. 4, May 1, 2003, Letter from Gary Buehler, Director,
Office of Generic Drugs to Abha Pant, U.S. Agent for Ranbaxy
Laboratories, Ltd. (tablet) ("May 2, 2003 FDA Letter").*fn1 Each ANDA
contained a Paragraph IV certification to the `216 Patent. Ranbaxy
provided notice of the certifications to Pfizer in accordance with
Section 505(j)(2)(B), and in response Pfizer filed a patent infringement
suit on each ANDA within the 45-day period provided for in the statute in
the United States District Court for the District of New Jersey. These
filings triggered a 30-month statutory stay. The district court
subsequently consolidated the two suits. During the course of the
litigation the FDA tentatively approved both of Ranbaxy's AND As.
See July 11, 2003 FDA Letter; May 2, 2003 FDA Letter.
Also during the course of the patent infringement litigation, the
district court denied Pfizer's motion for summary judgment. See
Administrative Record ("AR"), Ex. 30, December 26, 2003 Letter from Abha
Pant to Gary J. Buehler ("December 26, 2003 FDA Letter") at 1 and
attached court docket. After the summary judgment decision, however, the
court indicated to Ranbaxy and Pfizer that the court's schedule would not
allow for a trial until after the January 29, 2004, expiration of the
`216 Patent. See December 26, 2003 FDA Letter at 2. In
response, the parties entered into a stipulation of dismissal on November
14, 2003. See Compl., Ex. 9, Pfizer Inc. v. Ranbaxy
Pharmaceuticals, Inc., Consolidated Civil Action No. 02-2493 (GEB),
Stipulation of Dismissal (D.N.J. Nov. 14, 2003). The Stipulation provided
that in light of the fact that the `216 Patent was set to expire prior to
the time that the court's schedule could accommodate a trial, the
consolidated actions would be "dismissed as moot upon the January 29,
2004 expiration of the `216 patent with no further action of the parties,
with each party to bear its own costs and attorneys' fees."
Id. at 1.
Meanwhile, on December 31, 2001, the FDA had issued a written request
to Pfizer for pediatric studies on fluconazole, and Pfizer submitted the
requisite studies in response. On January 21, 2004, the FDA determined
that Pfizer's pediatric studies adequately responded to the written
request, and concluded that Pfizer was entitled to pediatric exclusivity
for fluconazole under Section 505a. See AR, Ex. 32, Pediatric
Exclusivity Determination Checklist (granting pediatric exclusivity). In
response to the threat of a pediatric exclusivity grant to Pfizer that
would preclude the final approval of Ranbaxy's ANDAs, Ranbaxy sought
confirmation with the FDA by letters of June 6, 2003, August 21, 2003,
and January 16, 2004, that its fluconazole ANDAs would be approved upon
expiration of the `216 Patent on January 29, 2004. In each
letter Ranbaxy asserted that the preconditions for delaying an ANDA
on the basis of pediatric exclusivity provided for in Section
505a(c)(2)(B) (governing Paragraph IV certifications) could not be
satisfied unless Pfizer obtained a ruling that the `216 Patent was valid
and would be infringed, which it was unlikely to do in view of the
district court's schedule. See AR, Ex. 26, June 6, 2003 Letter
from Abha Pant to Gary J. Buehler; AR, Ex. 28, August 21, 2003 Letter
from David G. Adams, Esq. to Daniel E. Troy, Chief Counsel Food and Drug
Administration; AR, Ex. 31, January 16, 2004 Letter from Richard M.
Cooper, Esq. to Daniel E. Troy.
By letter of January 28, 2004, the FDA issued an administrative
decision indicating that Ranbaxy's ANDAs would not be approved until
after the expiration of Pfizer's pediatric exclusivity on July 29, 2004.
In the decision, the FDA concluded that "an ANDA applicant will be
subject to any pediatric exclusivity that attaches to a patent where the
ANDA applicant has filed a paragraph IV certification, was sued by the
NDA holder or patent owner within 45 days, and the litigation is
unresolved on the merits and the 30-month stay has not run when the
patent expires." AR, Ex. 34, January 28, 2004 Letter from Gary J. Buehler
to Richard M. Cooper ("FDA Ranbaxy Decision"). In so concluding, the FDA
first determined that Ranbaxy had relied on the wrong subsection of the
pediatric exclusivity statute because the generic manufacturer wrongly
had assumed that its Paragraph IV certification remained in effect past
the expiration of the patent. See id. at 4. Instead,
the FDA decided that upon patent expiry, the Paragraph IV certification
became a Paragraph II certification (irrespective of Ranbaxy's failure to
amend its certification to reflect the change in each patent's status
under 21 C.F.R.
§ 314.94(a)(12)(viii)(C)(1)) and that under a Paragraph II
certification, the statute provides for a delayed ANDA approval for six
months beyond expiration of the patent. See id. at 4-5.*fn2
The FDA then opined that even if Section 505a(c)(2)(B) were the
applicable subsection for the purpose of determining Pfizer's pediatric
exclusivity, the subsection does not address expressly a situation in
which the patent litigation is unresolved at the time of patent expiry.
Assuming its duty to fill gaps left in the statute by Congress, the FDA
concluded that the absence of a provision addressing unresolved patent
litigations in the Paragraph IV certification context did not mean that
Congress intended to exclude such circumstances from the pediatric
exclusivity provision. See FDA Ranbaxy Decision at 5-6. ...