The opinion of the court was delivered by: Kollar-kotelly, District Judge.
Plaintiff American Bioscience, Inc. ("ABI"), which holds a patent
related to the anti-cancer drug paclitaxel, claims that Defendant Food
and Drug Administration ("FDA") improperly approved the application
of Intervenor Baker Norton Pharmaceuticals ("BNP")*fn1 to market the
drug generically. Intervenor Bristoll-Myers Squibb Company ("BMY")
currently sells the drug under the brand name Taxol. In its Complaint,
ABI asks the Court to direct FDA to rescind its approval of BNP's generic
Before the Court is ABI's Motion for a Temporary Restraining Order or,
in the Alternative, for a Preliminary Injunction. As the parties have
agreed, the Court addresses the proposed temporary restraining order and
preliminary injunction simultaneously. Upon consideration of the motion,
Defendants' opposition, ABI's reply, and the Intervenors' submissions, as
well as supplemental pleadings ordered by the Court, the Court concludes
that neither a temporary restraining order nor a preliminary injunction
This case revolves around the interpretation of the statutory framework
that governs the marketing of generic drugs. A generic drug contains the
same active ingredients, but not necessarily the same inactive
ingredients, as a brand-name prescription drug. United States v. Generix
Drug Corp., 460 U.S. 453, 455, 103 S.Ct. 1298, 75 L.Ed.2d 198 (1983).
Ready availability of generic drugs is believed to benefit consumers by
increasing competition and reducing prices. All drugs, including generic
drugs, must receive FDA approval before they can be marketed. Typically,
a drug manufacturer wishing to market a new drug (so-called "pioneer
manufacturers") must complete a New Drug Application ("NDA") in order to
obtain FDA approval. The applicant must submit "data from studies showing
the drug's safety and effectiveness," which renders the NDA process both
time-consuming and expensive. Mova Pharm. Corp. v. Shalala, 140 F.3d 1060,
1063 (D.C.Cir. 1998).
Under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et
seq. ("FFDCA"), the holder of an approved NDA (the entity with the right
to sell a brand-name drug) must inform the FDA of any patents that could
reasonably be asserted to cover the drug in question. This is known as
"listing" the patents with the FDA. See 21 U.S.C. § 355 (b)(1);
21 C.F.R. § 314.53. If a relevant patent is issued after the NDA is
approved, the NDA holder has thirty days from the date the patent was
issued to "list" the patent. See 21 U.S.C. § 355 (c)(2);
21 C.F.R. § 314.53 (d)(3).
The procedure for obtaining approval of generic drugs is less onerous
than that faced by pioneer manufacturers. In 1984, in an effort to
facilitate the entry of generic drugs into the market, Congress passed
the Hatch-Waxman Amendments to the FFDCA, which significantly revised the
generic drug approval process. Instead of preparing an NDA, the generic
drug proponent can submit an Abbreviated New Drug Application ("ANDA").
See 21 U.S.C. § 355 (j). Section 355 sets forth various requirements
for the information that must be included in the ANDA. Unlike the pioneer
manufacturer, who bears the burden of proving to the FDA that the active
ingredient is safe and effective, the generic manufacturer bears the
lesser burden of providing enough information to show that its product
has the same active ingredient, labeling requirements, dosage form, and
other essentials as a drug that
has already been approved. See id. § 355(j)(2)(i)-(v). In other
words, the generic manufacturer is allowed to rely on the safety and
effectiveness data submitted in the pioneer's NDA.
To avoid the obvious patent infringement problems inherent in such a
statutory scheme, § 355 also contains some protection for the holders
of patents related to the approved brand-name drug. In addition to
showing that the active ingredient in its drug is the same as the active
ingredient in the brand-name drug, the ANDA applicant must also certify
to the FDA that the generic version will not interfere with any patents
that the NDA holder was required to "list." This can be accomplished by
(I) that such patent information has not been filed,
(II) that such patent has expired,
(III) . . . the date on which such patent will
(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. § 355(j)(2)(vii). The last of these, the so-called "Paragraph
IV" certification, is the only certification at issue in this
In addition to the requisite certification to the FDA, the Paragraph IV
ANDA applicant must also provide notice to the patent holder and to the
NDA holder explaining why the generic version does not infringe the
patent or why the patent is invalid. See id. § 355(j)(2)(B). If the
patent holder does not bring a patent infringement action within
forty-five days of receipt of that notice, the FDA may approve the ANDA
effective immediately. See id. § 355(j)(5)(B)(iii). If the patent
holder brings suit within forty-five days, the effective date of any FDA
approval is delayed, either for thirty months or until the court concludes
that the patent is invalid or has not been infringed, whichever is
shorter. See id.
B. The Factual Scenario of this Case
In 1992, the FDA approved BMY's New Drug Application for the
anti-cancer drug paclitaxel, which BMY has subsequently marketed under
the brand name Taxol. See Compl. ¶ 17. On July 30, 1997, BNP
submitted an ANDA for a generic version of the drug. See Mem. of P. & A.
in Supp. of the Mot. of Pl. [ABI] for a T.R.O. or, in the Alternative,
for a Prelim. Inj. [hereinafter "Pl.'s Mot."] Ex. 5 (Aug 28, 2000, FDA
letter to BNP). Following that submission, BMY listed two patents with
the FDA, and BNP certified as to them under Paragraph IV. BMY thereupon
initiated a patent infringement suit which delayed any FDA approval for
thirty months. That thirty month period ended in June 2000. See Fed.
Defs.' Mem. in Opp'n to Pl.'s Mot. for a T.R.O. or Prelim. Inj. at 9
[hereinafter "FDA's Opp'n Mem."]; Mem. of Defs. Intervenors [BNP] in
Opp'n to Pl.'s Mot. for a T.R.O. or, in the Alternative, for Prelim. Inj.
at 2, 4-5 [hereinafter "BNP's Opp'n Mem."].
On August 1, 2000, ABI received a patent for a novel dosage form of
Taxol ("'331 patent"). See Pl.'s Mot. Ex 3(A)(b) (printout from U.S.
Patent and Trademark Office website). Ten days later, ABI sued BMY in
U.S. District Court in California to compel BMY to list the '331 patent.
That same day, the California court issued a Temporary Restraining Order
("TRO") directing BMY to list the '331 patent "subject to the proviso
that, unless [ABI] carries its burden of proof [regarding a preliminary
injunction], BMY shall then take all steps under its control to cause the
de-listing" of the '331 patent. See Compl. Ex. 1(B) at 2 (TRO). BMY,
which had requested the TRO's narrow language and
proviso, complied with the requirements the same day, August 11, 2000.
See BNP's Opp'n Mem. Ex. 4 at 16-17 (Tr. of 9/16/00 hearing before Judge
Byrne) (describing BMY's desire for limitation on scope and requirements
of the TRO); Compl. Ex. 3 (BNP's August 11, 2000, submission to the
FDA). At that time, only ten of the thirty days allotted for listing had
On August 14, 2000, BNP submitted a Paragraph IV certification in which
it acknowledged the recently listed '331 patent, but stated that its ANDA
would not result in infringement. See Pl.'s Mot. Ex. 5 (Aug. 28, 2000 FDA
letter to BNP); FDA's Opp'n Mem. at 14. Two weeks later, the FDA informed
BNP that it had completed its substantive review of BNP's ANDA, but that
it could not issue final approval until the questions about the '331
patent had been resolved. See Pl.'s Mot. Ex. 5.
Simultaneously, in the California lawsuit between ABI and BMY, BNP
moved to intervene and argued for dismissal on the ground, inter alia,
that there is no private right of action under the FFDCA. See BNP's Opp'n
Mem. Ex. 8 at 3 (BNP's August 18, 2000, Mem. in Opp'n to Pl.'s Mot. for
Prelim. Inj. & in Supp. of BNP's Mot. to Dismiss and for Enforcement of
the Contingent Provision of the T.R.O.). Over the course of three
hearings on the record held in August and September, the California court
reviewed the circuitous history of the litigation, probed the parties in
an effort to understand their motivations and affiliations, and
questioned its own authority to render judgment in the matter. See BNP's
Opp'n Mem. Exs. 3 (Tr. of 8/21/2000 hearing), 4 (Tr. of 9/6/2000
hearing), 17 (Tr. of 9/7/2000 hearing).
During the August 21 hearing, BMY, ABI and BNP discussed the schedule
for resolving the outstanding motion for a preliminary injunction. While
none of the three informed the judge that the thirty-day listing window
would close on August 31, BNP pushed the court to hold a hearing on the
preliminary injunction (and the possible dissolution of the TRO) prior to
that date. Oddly, both BMY and ABI, the parties with the greatest
interest in ensuring proper and timely listing of the '331 patent,
opposed holding the hearing so early and urged the court to extend the TRO
as long as the Federal Rules would allow. See BNP's Opp'n Mem. Ex. 3 at
At the September 6 hearing, BMY made clear that it was unwilling to
list the '331 patent without a court order requiring it to do so. See
BNP's Opp'n Mem. Ex. 4 at 41-43. At the same hearing, the court ruminated
on its power to enforce compliance with the FFDCA and determined that it
lacked jurisdiction to do so. See id. Ex. 4 at 107 ("I find that the
court did not have jurisdiction over this matter at the time that Judge
Rea was presented with the T.R.O. that he issued requiring listing of the
On September 7, 2000, the California court dismissed the case, which
included the FFDCA claim and state law claims, under Rule 12(b)(6). In
the order announcing the dismissal, the court noted that ABI did not have
a private right of action under the FFDCA. Accordingly, the court
dissolved the TRO and commanded that "[p]ursuant to the condition in the
TRO and in order to restore the status quo, BMY shall use its best
efforts to cause the de-listing of [ABI's] Patent. . . . ABI shall
cooperate with BMY in its efforts to delist the '331 Patent pursuant to
the TRO." Compl. Ex. 5 ¶¶ 1-4 (September 7, 2000, dismissal order).
The effective date of the dissolution was stayed until September 13 in
order to give the parties an opportunity to appeal. See id. ¶ 11.
The court also noted that, at the time the TRO was issued, BMY had
twenty more days within which to file its listing of the '331 patent.
Since those twenty days had expired by the time the TRO was dissolved,
the court "recommend[ed] to the FDA that the time that the TRO was in
effect should toll the period in which BMY may timely cause such
listing." Id. ¶ 5.
Also on September 7, 2000, ABI brought a patent infringement suit
against BNP in the Central District of California. See Pl.'s Mot. Ex. 3
(H). ABI informed the FDA of this litigation on September 8, 2000, and
asserted that the lawsuit barred the FDA from approving BNP's ANDA for
thirty months. See Pl.s' Mot. Ex. 7.
On September 11, 2000,*fn2 BMY sent another letter to the FDA listing
the '331 patent. In that letter, BMY did not reference its August 11
listing pursuant to the TRO, and it did not indicate that it believed
that the patent was already listed in some manner. See Pl.'s Mot. Ex. 9.
According to the FDA, the September 11 letter amounted to a "late
listing" of the '331 patent. See Tr. of 9/29/00 Hearing Before Judge
Kollar-Kotelly at 47 [hereinafter "9/29/00 Tr."]. In the view of BNP, the
September 11 letter is a nullity because BMY had already listed the '331
patent via its August 11 letter. See BNP's Opp'n Mem. at 18.
On September 14, 2000, after the California court's dismissal order
took effect, BMY withdrew its August 11 listing of the '331 patent "to
the extent that listing was compelled by the TRO." Pl.'s Mot. Ex. 10 (BMY
letter to FDA, 9/14/2000). BMY also expressly stated that the withdrawal
did "not affect the continued and continuous listing of the patent." Id.
Ex. 10. The FDA and BNP agree that this letter completely removed the
August 11 listing. The FDA maintains that BMY's voluntary, but tardy,
listing on September 11 is still on the books. See 9/29/00 Tr. at 47. BNP
argues that the ...