United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued January 18, 2001 Decided March 30, 2001

No. 00-5350

American Bioscience, Inc.,
Appellant

v.

Tommy G. Thompson, Secretary of Health
and Human Services, et al.,
Appellees

Appeal from the United States District Court
for the District of Columbia
(00cv02247)

Joseph F. Coyne, Jr. argued the cause for appellant. With
him on the briefs were Carlton A. Varner, Robert F. Green,
Arthur Y. Tsien, David F. Weeda and Jacqueline H. Eagle.
David L. Durkin entered an appearance.

Howard S. Scher, Attorney, U.S. Department of Justice,
argued the cause for federal appellees. With him on the brief


were David W. Ogden, Assistant Attorney General, Douglas
N. Letter, Attorney, Wilma A. Lewis, U.S. Attorney, and
Annamarie Kempic, Counsel, Food and Drug Administration.

Philip A. Sechler argued the cause for appellees Baker
Norton Pharmaceuticals, Inc. and Zenith Goldline Pharma-
ceuticals, Inc. With him on the brief was Richard M. Cooper.

Before: Edwards, Chief Judge, Sentelle and Randolph,
Circuit Judges.

Opinion for the Court filed by Circuit Judge Randolph.

Randolph, Circuit Judge: This appeal from the district
court's judgment denying a preliminary injunction against the
Food and Drug Administration requires us to consider once
again the Supreme Court's opinion in Citizens to Preserve
Overton Park v. Volpe, 401 U.S. 402 (1971). Although the
procedural background of the appeal is complex, our reasons
for vacating and remanding are simple: the administrative
record was never filed in court and we cannot tell on what
basis the Food and Drug Administration took the agency
action the plaintiff seeks to enjoin.

The statutory framework is as follows. A company wishing
to market a drug must seek FDA approval usually by com-
pleting a "New Drug Application" (NDA) containing data
from tests showing the drug's safety and effectiveness. See
Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 1060, 1063
(D.C. Cir. 1998). The Hatch-Waxman Amendments to the
Food, Drug and Cosmetic Act in 1984 made it easier for drug
manufacturers to obtain approval of generic drugs. See Drug
Price Competition and Patent Term Restoration Act, Pub. L.
No. 98-417, 98 Stat. 1585 (1984) (codified in scattered sections
of 21, 35 & 42 U.S.C.). Under these amendments, a generic
drug producer need not undertake the complicated and time-
consuming testing process associated with an NDA and can
instead file an "Abbreviated New Drug Application" (ANDA),
relying on the NDA filed by the original manufacturer. See
21 U.S.C. s 355(j); Mova Pharmaceutical Corp., 140 F.3d at
1063.


While making it easier to bring generic drugs to market,
Congress also wanted to protect patent holders whose rights
might be infringed by the generic drugs. The law, therefore,
requires that NDAs contain a list of any patents "which
claim[ ] the drug ... or which claim[ ] 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."
21 U.S.C. s 355(b)(1). If new patents claiming the drug or a
method of using the drug are filed after the drug has been
approved, the approved applicant must inform the Food and
Drug Administration within 30 days. See 21 U.S.C.
s 355(c)(2). The FDA keeps all of this information in a
publication officially titled Approved Drug Products with
Therapeutic Equivalence, commonly called the Orange Book.
See 21 U.S.C. s 355(j)(7)(A).

The statute also includes patent protections when an Ab-
breviated New Drug Application is filed. For "each patent
which claims" the drug the applicant would like to distribute
in a generic version, the applicant must certify (1) that no
patent has been filed with the FDA; or (2) that the patent
has expired; or (3) that the patent has not expired, but will
expire on a particular date; or (4) that the patent is either
invalid or the generic drug will not infringe it. See 21 U.S.C.
s 355(j)(2)(A)(vii).

The fourth of these options, known as a Paragraph IV
certification, is central to the case as the parties have framed
it. When a generic drug applicant certifies that a patent is
invalid or that its proposed generic drug will not infringe
upon it, it must also certify that it will give notice to the
patent holder that it has entered the Paragraph IV certifica-
tion. See 21 U.S.C. s 355(j)(2)(B). If the patent holder has
not filed a patent infringement action within 45 days of
receiving this notice, the FDA may immediately approve the
ANDA. See 21 U.S.C. s 355(j)(5)(B)(iii). However, if a
patent infringement action is filed within 45 days, the FDA
may not approve the ANDA for 30 months, or until the patent
dispute has been resolved, whichever is sooner. See 21
U.S.C. s 355(j)(5)(B)(iii).


Bristol Meyers-Squibb has FDA approval to manufacture
and distribute Taxol, an anti-cancer drug with the active
ingredient paclitaxel. American Bioscience allegedly devel-
oped a new process that permits a patient to receive higher
doses of Taxol with fewer side effects. American Bioscience
received U.S. Patent Number 6,906,331 (the '331 patent) for
this process on August 1, 2000. Bristol Meyers refused to
inform the FDA of this new patent. See 21 U.S.C.
s 355(c)(2). American Bioscience then sued Bristol Meyers
in the Central District of California, asking the court to
compel Bristol Meyers to submit the patent for listing in the
FDA's Orange Book. On August 11, the court entered a
temporary restraining order requiring Bristol Meyers to list
the drug with the FDA immediately. The restraining order
also included a provision requiring Bristol Meyers to "take all
steps under its control to cause the de-listing of the Taxol
Patent from the FDA's Orange Book" should it ultimately
lose the case.

Bristol Meyers sent a letter to the FDA indicating that it
was submitting information on the '331 patent for listing
"pursuant to an order of the United States District Court."
On September 7, 2000, the District Court for the Central
District of California dissolved the temporary restraining
order on the ground that under the Federal Food, Drug and
Cosmetic Act, American Bioscience had no private right of
action to compel Bristol Meyers to list the patent. The court
ordered Bristol Meyers to make its best efforts to remove the
patent listing from the Orange Book.

Enter Baker Norton Pharmaceuticals. Baker Norton filed
an Abbreviated New Drug Application for a generic form of
Taxol in 1997. That application was postponed because of
other infringement actions. After the '331 patent was listed,
Baker Norton amended its application and included a Para-
graph IV certification that its generic drug either did not
infringe on the '331 patent or that the '331 patent was not
valid. It did not give notice either to Bristol Meyers or to
American Bioscience that it had included this certification in
its ANDA. American Bioscience discovered Baker Norton's
Paragraph IV certification when Baker Norton intervened in


the action in California. American Bioscience then sued
Baker Norton for infringing the '331 patent.

Meanwhile, approval of Baker Norton's ANDA was pro-
ceeding. On September 8 and September 14, 2000, Baker
Norton sent the FDA two letters amending its ANDA and
informing the FDA of the proceedings in California. Because
the '331 patent was to be "de-listed" pursuant to the Califor-
nia court's order dissolving the temporary restraining order,
Baker Norton wished to amend its application, certifying that
there were no additional patents listed that it was required to
account for and removing its Paragraph IV certification re-
garding the '331 patent. On September 15, 2000, the Food
and Drug Administration sent Baker Norton a letter approv-
ing its ANDA. The FDA's letter referred to Baker Norton's
September 8 and 14 letters amending the application but
included no other discussion of the '331 patent.

American Bioscience brought this action against Baker
Norton and the FDA in the United States District Court for
the District of Columbia Circuit, seeking an injunction to
prevent the FDA from approving Baker Norton's application.
Foremost among American Bioscience's many legal argu-
ments was its claim that its patent had never been "de-listed"
because Bristol Meyers never intended to have it removed
from the Orange Book. If the FDA had approved Baker
Norton's ANDA on this basis, reasoned American Bioscience,
it had done so contrary to fact. Moreover, American Biosci-
ence contended before the district court and contends here
that the Hatch-Waxman Act merely directs the FDA to "list"
patents as they are received. Because its role is ministerial,
it is not authorized to remove patents from the listing once
they are received.

American Bioscience also contends that the FDA could not
have approved the application under the "late listing" regula-
tion, which only requires an ANDA applicant to amend its
application to include a late-listed patent if the patent was
listed before the application was submitted. See 21 C.F.R.
s 314.94(a)(12)(vi) (2000). If the FDA could rely on the


regulation to approve the ANDA, American Bioscience ar-
gues, the regulation itself is invalid.

The district court denied American Bioscience's motion for
a preliminary injunction, in part on the ground that it had not
shown a probability of success on the merits. In reaching
this conclusion the court determined that the patent had been
"de-listed" by Bristol Meyers, that Baker Norton's ANDA
was protected by the FDA's late listing regulation, and that
the late listing regulation is valid.

As to "de-listing," there is not adequate support for the
district court's conclusion that the FDA approved Baker
Norton's ANDA on that basis. The court referred to the
"FDA's determination that [Bristol Myers] had not listed
[American Bioscience's] patent within thirty days of the pat-
ent's issuance" and the FDA's "finding that [Bristol Myers]
did not list the '331 patent within thirty days...." American
Bioscience v. Shalala, No. 00-2247, slip op. at 10, 13 (D.D.C.
Oct. 3, 2000). But the FDA's approval letter contains no such
"determination" and no such "finding."

The district court also concluded "that the FDA's interpre-
tation and application of the 'late listing' regulation are not
'plainly erroneous or inconsistent with the regulation.' "
American Bioscience, slip op. at 19 (citation omitted). But
there is nothing in the FDA's approval letter to indicate how
it interpreted this regulation; in fact, the letter does not even
say whether the FDA was relying on the regulation.

The short of the matter is that we do not know whether the
FDA approved the application because it considered the '331
patent to have been "de-listed"; whether it considered the
court-ordered listing ineffective for purposes of the Hatch-
Waxman Act; whether it treated the application as one
covered by the late-listing regulation; or whether, if it did,
why it thought the regulation applied. For all we know, the
FDA made a clerical error in approving the application even
though it thought that the '331 patent had been continually
listed.


These problems and others stem partly from the fact that
in an "informal adjudication" such as this, the Administrative
Procedure Act, see 5 U.S.C. s 554, requires neither agency
findings of fact nor conclusions of law. As Overton Park tells
us, judicial review nevertheless must proceed, but not by trial
de novo. The review must "be based on the full administra-
tive record that was before the [FDA] at the time [it] made
its decision." 401 U.S. at 420. Overton Park arose on a
motion for a preliminary injunction (to halt construction of a
highway); this case too comes to us upon the denial of a
preliminary injunction. Here, as in Overton Park, the admin-
istrative record was never filed, despite APA s 706's direction
that judicial review shall be performed by "review[ing] the
whole record or those parts of it cited by a party...." 5
U.S.C. s 706; see Overton Park, 401 U.S. at 419. Rather
than calling for the administrative record, the district court
appears to have relied on the parties' written or oral repre-
sentations to discern the basis on which the FDA acted.
Surely that was not sufficient. For all we know, the attor-
neys were merely speculating. In any event, the Supreme
Court in Overton Park held that even sworn affidavits filed
during the litigation would not suffice to explain the action of
the Secretary of Transportation. Id. at 419.

As in Overton Park, we leave to the district court the
determination of how best to proceed on remand in light of
what the administrative record reveals. See 401 U.S. at 420-
21; Camp v. Pitts, 411 U.S. 138 (1973) (per curiam); Nation-
al Nutritional Foods Ass'n v. FDA, 491 F.2d 1141 (2d Cir.
1974) (Friendly, J.). We hold only that the court, before
assessing American Bioscience's probability of success on the
merits, should have required the FDA to file the administra-
tive record and should have determined the grounds on which
the FDA granted Baker Norton's application. Cf. Gordon G.
Young, Judicial Review of Informal Agency Action on the
Fiftieth Anniversary of the APA: The Alleged Demise and
Actual Status of Overton Park's Requirement of Judicial
Review "On the Record," 10 Admin. L.J. Am. U. 179, 226
(1996).


The judgment of the district court is vacated and the case
is remanded for further proceedings consistent with this
opinion.

So ordered.