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Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: 

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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

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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 Pharmaceuticals, 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 completing 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 timeconsuming 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.

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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 Abbreviated 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 certification. 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).

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Bristol Meyers-Squibb has FDA approval to manufacture

and distribute Taxol, an anti-cancer drug with the active

ingredient paclitaxel. American Bioscience allegedly developed 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 Paragraph 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

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the action in California. American Bioscience then sued

Baker Norton for infringing the '331 patent.

Meanwhile, approval of Baker Norton's ANDA was proceeding. 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 California 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 regarding the '331 patent. On September 15, 2000, the Food

and Drug Administration sent Baker Norton a letter approving 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 arguments 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 Bioscience 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" regulation, 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

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regulation to approve the ANDA, American Bioscience argues, 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 patent'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 interpretation 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 HatchWaxman 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.

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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 administrative 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 administrative 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 representations to discern the basis on which the FDA acted.

Surely that was not sufficient. For all we know, the attorneys 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); National 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 administrative 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).

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The judgment of the district court is vacated and the case

is remanded for further proceedings consistent with this

opinion.

So ordered.

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