Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-01-05125/USCOURTS-caDC-01-05125-0/pdf.json

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

---

<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued September 17, 2001 Decided November 6, 2001

No. 01-5125

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)

Jacqueline H. Eagle argued the cause for appellant. With

her on the briefs were Joseph F. Coyne, Jr., Carlton A.

Varner, Arthur Y. Tsien, David F. Weeda, and Robert F.

Green.

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 1 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

Howard S. Scher, Attorney, United States Department of

Justice, argued the cause for appellee. With him on the brief

were Kenneth L. Wainstein, United States Attorney, Douglas

N. Letter, Litigation Counsel, Michael M. Landa, Acting

Chief Counsel, Food & Drug Administration, and AnnaMarie

Kempic, Associate Chief Counsel.

Richard M. Cooper argued the cause for appellees Baker

Norton Pharmaceuticals, Inc. and IVAX Pharmaceuticals,

Inc. With him on the brief was Philip A. Sechler.

Before: Tatel, Circuit Judge; Silberman and Williams,*

Senior Circuit Judges.

Opinion for the Court filed by Senior Circuit Judge

Silberman.

Silberman, Senior Circuit Judge: American Bioscience,

Inc., appeals from the district court's denial of its request for

preliminary injunctive relief. Appellant argues that the Food

and Drug Administration's decision to approve intervenordefendant Baker Norton Pharmaceutical's Abbreviated New

Drug Application (ANDA) for a generic version of the cancer

treatment Taxol was arbitrary and capricious. We agree and

vacate that approval.

I.

This case is here for the second time. See American

Bioscience, Inc. v. Thompson, 243 F.3d 579 (D.C. Cir. 2001).

American Bioscience is a pharmaceutical research firm that

has developed a patented process for delivering safer and

more effective dosage forms of Taxol. Bristol-Myers Squibb

Company holds the patent on and FDA approval of Taxol

itself, a drug that has generated billions of dollars in sales.

Bristol-Myers intervened in the district court proceeding for

the limited purpose of providing information. Appellees Baker Norton Pharmaceuticals, Inc. (BNP) and Zenith Goldline

Pharmaceuticals, Inc., who are corporate affiliates and hold

__________

* Senior Judge Williams was in regular active service at the time

of oral argument.

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 2 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

ANDAs for generic versions of Taxol, intervened as defendants.

This dispute arises out of the complex relationship between

the FDA's approval process for generic drugs and patent law.

A company wishing to market a new (or "pioneer") drug must

seek FDA approval, usually by completing a New Drug

Application. The NDA is expensive and time-consuming,

requiring data from tests showing the drug's safety and

effectiveness. Prior to 1984, a firm that wished to make a

generic version of an approved drug was required to file a

new NDA, complete with new safety and effectiveness studies. In 1984, Congress enacted the Hatch-Waxman Amendments,1 which introduced the Abbreviated NDA and allowed a

generic drug ANDA to rely on the pioneer NDA's safety and

effectiveness studies. These amendments also provide that a

competitor may use and manufacture an approved and patented drug, for the purpose of developing a generic version,

without infringing that patent.

The Hatch-Waxman Amendments also sought to afford an

NDA holder some patent protection, to lower the risk to

innovation posed by the simplified ANDA process. NDAs

are required to contain a list of any patents which claim the

drug or which claim a method of using such a drug and with

respect to which a claim of patent infringement could reasonably be asserted--but that includes patents held by those

other than the NDA holder. The FDA publishes all patent

listings in the Approved Drug Products With Therapeutic

Equivalence (the "Orange Book"). For "each patent which

claims" the pioneer drug, an ANDA must certify: (1) that no

patent has been filed with the FDA; (2) that the patent has

expired; (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 (a "Paragraph IV certification"). When an ANDA applicant files a Paragraph IV

certification, it must also certify to the FDA that it will give

notice to the patent holder. That notice must include a

__________

1 The Drug Price Competition and Patent Term Restoration Act

of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984).

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 3 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

detailed statement of the factual and legal basis of the

applicant's opinion that the patent is not valid or will not be

infringed and must be given at the same time the certification

is submitted to the FDA. Filing a Paragraph IV certification

can constitute patent infringement. Upon receipt of notice of

a Paragraph IV certification, the patent holder has 45 days in

which to file an infringement suit. If the patent holder does

not file within that time period, the FDA may immediately

approve an otherwise conforming ANDA. If, on the other

hand, the patent holder does sue within 45 days, the FDA

may not approve the ANDA for 30 months, or until the patent

dispute has been resolved, whichever is sooner. The first

ANDA filed and approved gets a 180-day period of market

exclusivity.

If a qualifying patent issues at a later date--after the NDA

is approved--the NDA holder must inform the FDA within 30

days of the patent's issuance. See 21 U.S.C. s 355(c)(2). But

if the NDA holder fails to so notify the FDA, an ANDA

applicant is excused, according to the FDA's late-listing regulation, from amending its patent certification to reflect the

new patent so long as the ANDA had an "appropriate" patent

certification on file. As shall be apparent, however, only the

NDA holder has the obligation (and the right) to list the new

patent--not the patent holder if it is another company. In

this case, if Bristol-Myers listed American Bioscience's patent within 30 days of its issuance, BNP was required to

certify to that patent, potentially leading to a patent infringement suit and 30-month stay.2

In the event a person disputes the accuracy or relevance of

patent information published by the FDA in the Orange

Book, he must first notify the agency, in writing, stating the

grounds for disagreement. The FDA will then request that

the applicable NDA holder confirm the correctness of the

patent information or omission of patent information. Unless

the NDA holder withdraws or amends its patent information

__________

2 BNP argues that the statute does not allow for consecutive 30-

month stays, even if there are subsequent Paragraph IV certifications. The FDA did not adopt this reading.

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 4 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

in response to the FDA's request, the agency will not change

the patent information in the list. And if the NDA holder

does not change the patent information, an ANDA must,

despite any disagreement as to the correctness of the patent

information, contain an appropriate certification for each listed patent. The FDA, pursuant to longstanding practice and

its own regulations, and based on its acknowledged lack of

expertise and resources, has refused to become involved in

patent listing disputes, accepting at face value the accuracy of

NDA holders' patent declarations and following their listing

instructions.

The FDA approved Bristol-Myers' NDA to manufacture

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

ingredient paclitaxel, in 1992. Five years later, BNP submitted an ANDA for a generic version of Taxol. Bristol-Myers

instituted patent infringement proceedings against BNP within the 45-day statutory window, triggering the 30-month

stay, which expired in June 2000. The record does not

reveal, and counsel for the FDA could not explain, why the

FDA did not approve BNP's ANDA promptly upon expiration

of the stay. But on August 1, 2000, American Bioscience

received U.S. Patent Number 6,906,331 for a new process that

purported to permit a patient to receive higher doses of Taxol

with fewer side effects. Bristol-Myers did not immediately

list the new patent.3 Ten days after the patent issued,

American Bioscience sued Bristol-Myers in the United States

District Court for the Central District of California requesting a TRO compelling Bristol-Myers to submit the '331

patent for listing in the Orange Book, which the court granted, ordering Bristol-Myers to "immediately take all steps

under its control to cause the FDA to list in its 'Orange Book'

[American Bioscience's] Taxol Patent, subject to the proviso

that, unless Plaintiff carries its burden of proof on the [Order

to Show Cause], [Bristol-Myers] shall then take all steps

__________

3 We are told that correspondence between American Bioscience

and Bristol-Myers indicates that Bristol-Myers refused to list the

patent without a court order, but that is not part of the administrative record.

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 5 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

under its control to cause the de-listing of the Taxol Patent

from the FDA's Orange Book." That same day, BristolMyers sent a letter to the FDA, stating that it was submitting

the '331 patent for listing "pursuant to" the August 11 court

order and "in accordance with" the voluntary listing provision. Bristol-Myers also submitted a patent declaration with

the listing.

On August 14, 2000, BNP filed a Paragraph IV certification

for the '331 patent but contrary to the statute it did not notify

either Bristol-Myers or American Bioscience. One week

later, the California court held a hearing at which BristolMyers, American Bioscience and BNP (as a proposed intervenor) were present.4 American Bioscience then learned for

the first time of BNP's Paragraph IV certification. On

August 28, 2000, the FDA tentatively approved BNP's

ANDA, subject to resolution of the '331 patent issues. Meanwhile, after two hearings, the California court determined

that it lacked "jurisdiction" over American Bioscience's suit

because the Food Drug and Cosmetic Act did not provide

American Bioscience a private right of action. On September

7, 2000, the California court dissolved the TRO and ordered

Bristol-Myers "[p]ursuant to the condition in the TRO and in

order to restore the status quo ... [to] use its best efforts to

cause the delisting of [American Bioscience's] '331 Patent

from the Orange Book." It recommended to the FDA that it

toll the amount of time the TRO was in place and stayed its

order until September 13, 2000.

Also on September 7, 2000, American Bioscience sued BNP

for patent infringement and informed the FDA the next day

but the FDA did not grant a stay. On September 11, 2000,

Bristol-Myers wrote the FDA a letter stating that it was

listing the '331 patent "pursuant to" the voluntary listing

provision. Then three days later, on September 14, 2000,

Bristol-Myers wrote the FDA another letter, which stated

__________

4 BNP repeatedly refers to the transcript of this hearing in

support of its allegation that Bristol-Myers and American Bioscience colluded to obtain temporary injunctive relief. This transcript

is not a part of the administrative record.

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 6 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

that it was de-listing the '331 patent to the extent it was listed

pursuant to the California court's TRO, but that it did not

mean to affect the continued and continuous listing of the

patent. That same day, after receiving a phone call from the

FDA, BNP withdrew its Paragraph IV certification.5 And

the next day, the FDA approved BNP's ANDA. In its

approval letter, the FDA referenced BNP's September 8 and

September 14 amendments, but did not otherwise discuss

the '331 patent.

American Bioscience then brought this action, claiming that

the FDA's actions were contrary to the Administrative Procedure Act. Specifically, it asserted that the '331 patent was

timely and continuously listed from August 11, 2000, therefore the FDA's refusal to grant a stay and its approval of

BNP's ANDA were contrary to law; that the FDA's decision

not to toll the 30-day listing window was arbitrary and

capricious; that BNP could not benefit from the late-listing

regulation because a certification could not be "appropriate"

without the required notice; and that the FDA exceeded its

regulatory authority in promulgating the late-listing regulation. Appellant requested a declaration that approval be

stayed; injunctive relief ordering the FDA to rescind the

approval; attorney fees and costs; and any other just and

proper relief. The district court granted BNP's motion to

intervene and allowed Bristol-Myers to intervene to provide

additional information.

The FDA defended on the ground that Bristol-Myers had

not "timely" listed the '331 patent and therefore BNP did not

have to certify to it. The agency had not previously disclosed

the basis for its approval, nor did it provide a certified

administrative record. After oral argument, the district court

issued a written memorandum and opinion denying American

Bioscience's requested relief on the ground that it had failed

to show that it was likely to prevail on the merits because the

FDA's interpretation and application of the late-listing regu-

__________

5 Between August 14, 2000 and September 14, 2000, the FDA had

at least seven telephone conversations with BNP.

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 7 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

lation was not plainly erroneous or inconsistent with the

regulation, which was itself valid.

American Bioscience appealed and we vacated the district

court's decision and remanded because "there [was] nothing

in the FDA's approval letter to indicate how it interpreted

[the late-listing] regulation." American Bioscience, 243 F.3d

at 582. We did 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, if it did, why it thought the regulation applied,

observing that, for all we knew, the FDA made a "clerical

error" in approving the application even though it thought

that the '331 patent had been continually listed. We held that

the district 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 [BNP]'s

application." Id. We left to the district court the determination of how best to proceed on remand in light of what the

administrative record revealed.

On April 6, 2001, the FDA certified the administrative

record which included a declaration by Gary J. Buehler, the

acting director of the FDA's Office of Generic Drugs, Center

for Drug Evaluation and Research. Buehler focused on the

court orders in his explanation of the agency's rationale. In

his view, the September 7 order compelled Bristol-Myers to

de-list the '331 patent "to restore the status quo." He

concluded that because the court order directing BristolMyers to submit the patent to the FDA was dissolved, and

Bristol-Myers withdrew the original submission, the August

11 listing was "without effect." Accordingly, because BristolMyers had failed to timely list the patent, BNP was entitled

to the benefit of the late-listing regulation. The FDA did not

follow the court's recommendation that it toll the period in

which Bristol-Myers could timely list because the FDA was

not a party to the California litigation; he was not sure that

the FDA had the authority to toll the statutory time limit;

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 8 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

tolling would set an undesirable precedent; and he saw no

reason why Bristol-Myers could not have "voluntarily" listed

the '331 patent during the 30-day statutory period.

Buehler quoted the passage from the September 14 letter

in which Bristol-Myers stated that it was "[t]hereby withdrawing" the August 11 listing to the extent that listing was

compelled by the TRO, but did not address the significance of

Bristol-Myers' statement that it had not intended to affect

the continued and continuous listing of the patent. Buehler

also said that the FDA received letters pertaining to "this

issue" (presumably the issue of approving a generic version of

Taxol), and that he had been made aware of the concerns of

the Federal Trade Commission and some members of the

public about the potential for the aggressive use of patent

listings to delay generic competition.6 The administrative

record consists in large part of the tentative and final approval letters for BNP's ANDA; the August 11, 2000 TRO and

the September 7, 2000 order; the August 11, 2000, September

11, 2000, and September 14, 2000 letters from Bristol-Myers

to the FDA; correspondence from BNP to the FDA outlining

BNP's concerns about the '331 patent, certifying to the '331

patent, and withdrawing the certification to the '331 patent;

the Federal Trade Commission's amicus brief in the California case; records of telephone conversations between the

FDA and BNP; and letters from the National Organization

for Women Foundation, the Generic Pharmaceutical Association, and Senator Kennedy expressing their concerns about

delay in the availability of generic drugs. The administrative

record does not contain either the transcripts of the hearings

in the California court, or any correspondence between

Bristol-Myers and American Bioscience.

__________

6 After American Bioscience filed suit and before the FDA filed a

certified administrative record, the FDA approved a second potentially infringing ANDA for Zenith Goldline and granted "tentative"

approval to a third. BNP apparently waived its 180-day statutory

market exclusivity as to its corporate affiliate Zenith Goldline, but

not with respect to the third ANDA.

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 9 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

Shortly after the FDA certified the administrative record,

American Bioscience renewed its request for preliminary

injunctive relief, which the district court denied. The court

held that American Bioscience failed to show that it would

suffer irreparable harm and was not substantially likely to

prevail on the merits. It acknowledged that the administrative record did not include any "overt reference to the

decisions at issue," but concluded that the record implicitly

supported the FDA's version of events (as set forth by

counsel) and that the FDA's decision to approve BNP's

ANDA was supported by "inferences" that could be drawn

from the administrative record.

II.

Appellant makes two basic arguments. The FDA acted

contrary to law by approving BNP's application in light of

Bristol-Myers' listing of the '331 patent. It was arbitrary

and capricious for the agency to have concluded that BristolMyers' September 14 letter revoked the August 11 listing.

Secondly, American Bioscience argues that even if the September 11 listing were legitimately thought to be BristolMyers' first listing, BNP could not benefit by the late-listing

regulation since it did not have an "appropriate" patent

certification filed (as it had never given notice). We need not

reach appellant's second argument because we think it is

clearly correct on its first.

Before discussing the merits we must dispose of the government's argument as to appellant's asserted lack of irreparable injury. Normally when a party seeks a preliminary

injunction in district court the district judge properly balances the likelihood of the plaintiff prevailing on the merits

against the severity of the injury the plaintiff will suffer if

relief is denied. But that procedure assumes that the district

judge will be obliged to make a decision before the complete

case is presented--before all the evidence is submitted.

As we have repeatedly recognized, however, when a party

seeks review of agency action under the APA, the district

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 10 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

judge sits as an appellate tribunal.7 The "entire case" on

review is a question of law. See, e.g., Marshall County

Health Care Auth. v. Shalala, 988 F.2d 1221, 1226 (D.C. Cir.

1993) (holding that in agency review context there was no real

distinction between questions presented in Rule 12(b)(6) motion to dismiss and motion for summary judgment); University Medical Center of S. Nevada v. Shalala, 173 F.3d 438,

440 n.3 (D.C. Cir. 1999) (explaining that when reviewing

agency action the question of whether the agency acted in an

arbitrary and capricious manner is a legal one which the

district court can resolve on the agency record, regardless of

whether it is presented in the context of a motion for judgment on the pleadings or in a motion for summary judgment);

James Madison Ltd. v. Ludwig, 82 F.3d 1085, 1096 (D.C. Cir.

1996), cert. denied, 519 U.S. 1077 (1997) (holding that issues

that appellant argued were issues of fact precluding summary

judgment were issues of law in the context of agency review);

County of Los Angeles v. Shalala, 192 F.3d 1005, 1011 (D.C.

Cir. 1999), cert. denied, 530 U.S. 1204 (2000) (holding that rule

of finality does not apply to bar appellate review of the

district court's finding that the agency action was arbitrary

and capricious even though that court had not yet resolved

the issue of remedy). Absent very unusual circumstances the

district court does not take testimony. See, e.g., Citizens to

Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402 (1971);

James Madison, 82 F.3d at 1096.

If an appellant has standing--which is undeniable here--

and prevails on its APA claim, it is entitled to relief under

that statute, which normally will be a vacatur of the agency's

order. See, e.g., Association of Battery Recyclers, Inc. v.

EPA, 208 F.3d 1047, 1061 (D.C. Cir. 2000). Cf. Canadian

Pacific Railway Co. v. Surface Transp. Bd., 197 F.3d 1165

(D.C. Cir. 1999). To be sure, although appellant based its

cause of action on the APA, it introduced a good deal of

__________

7 Which is not to say that a motion for preliminary injunction

against an agency is never appropriate. See, e.g., CityFed Financial Corp. v. Office of Thrift Supervision, 58 F.3d 738 (D.C. Cir.

1995) (involving Office of Thrift Supervision's decision to issue a

temporary cease and desist order against appellant freezing virtually all of its assets).

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 11 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

confusion by seeking an injunction (as well as other appropriate relief). But, whether or not appellant has suffered irreparable injury, if it makes out its case under the APA it is

entitled to a remedy.8

We implicitly recognized this point before when we ordered

the remand of the case for the agency to produce a record

without consideration as to whether appellant's injury was

irreparable. See American Bioscience, 243 F.3d 579. The

challenged action is an "informal adjudication" which is the

administrative law term for agency action that is neither the

product of formal adjudication or a rulemaking. See, e.g., id.

at 582; United States v. Mead Corp., 121 S. Ct. 2164, 2178 n.1

(2001) (Scalia, J., dissenting). Ever since Overton Park and

Camp v. Pitts, 411 U.S. 138 (1973), government agencies

which issue orders subject to appeal under the APA typically

include some explanation--however short--that will provide a

record on appeal. After examining the Buehler declaration,

which purports to explain the FDA's action in this case, it is

perhaps not surprising that the agency took the action it did

originally without explanation. For assuming that that declaration satisfies our demand for the record before the agency,

we find it sadly inadequate to sustain the agency's action.

As we noted, and the parties agree, the FDA has a

longstanding policy not to get involved in patent disputes. It

administers the Hatch-Waxman Amendments in a ministerial

fashion simply following the intent of the parties that list

patents. In this case, however, Buehler appears to have

relied on his reading of the district court order-to which the

agency was not a party--to trump Bristol-Myers' stated

intention.9 His declaration notes that the district court on

September 7 "dissolved the TRO, dismissed [American Bioscience's] complaint and ordered [Bristol-Myers] to delist the

__________

8 Since under 28 U.S.C. s 1657(a) the granting or denying of a

preliminary injunction is the basis for an expedited appeal the

district courts should be careful--in such a case as this--not to do

so.

9 Paradoxically, in rejecting the district court's tolling recommendation Buehler emphasizes the California district court had no

jurisdiction and the FDA was not a party.

'331 patent from the Orange Book to restore the status quo."

And then "on September 14, 2000 [Bristol-Myers] submitted

a letter to FDA to comply with the court order to delist the

patent. The letter states '[Bristol-Myers] hereby withdraws

the Original Listing to the extent that listing was compelled

by the TRO.' " Because of that sequence, the "FDA considered [Bristol-Myers'] first submission of the patent on August 11, 2000 to be without effect."

But Buehler omits reference to much of the September 14

letter which clearly indicates that Bristol-Myers' original

filing of August 11 had a bifurcated purpose-to comply with

the court order and to voluntarily list the '331 patent and

accordingly it was abrogating the first but not the second.

Thus, Bristol-Myers' counsel stated:

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 12 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

Although that submission (the "Original Listing") (Attachment A) was made in accordance with a Temporary

Restraining Order ("TRO") entered on that date by the

United States District Court for the Central District of

California, it was also timely filed in full compliance with

all governing statutory and regulatory requirements for

voluntary patent listing. It contained all required listing

information, was presented in the format recommended

by the agency for voluntary listings, and was supported

by a declaration signed by Steven Reiter, counsel for the

patent owner, using the precise language required by

regulations set forth at 21 C.F.R. 314.53(c)(2).

And at the end of the letter, after the sentence Buehler

quoted, counsel states: "This action does not affect the

continued and continuous listing of the patent ...," which

unequivocally indicates what Bristol-Myers meant when it

limited its withdrawal of the listing only "to the extent that

listing was compelled by the TRO ..." As such Buehler,

speaking for the FDA, seems to wholly ignore Bristol-Myers'

stated intent. He gives no forthright justification for such a

blatantly artificial reading of its letters.10

__________

10 The government contends that Bristol-Myers' letter of September 11 again listing the '331 patent suggests that it realized the

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 13 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

He seems to implicitly suggest that Bristol-Myers' stated

intent is somehow inconsistent with the California district

court's order and on appeal the government boldly contends

that that intent--to continue its listing on a voluntary basis--

is "unacceptable" without explaining why that should be so.

But there is nothing in the California district court's original

order that prevented Bristol-Myers from changing its mind

and deciding to list voluntarily in addition to complying with

the court order. Nor is there anything in the order directing

the return to the status quo that would extend to requiring

Bristol-Myers to abrogate such voluntary action. We, of

course, owe no deference to an agency's reading of judicial

orders or decisions, see, e.g., United States Dep't of Justice v.

FLRA, No. 00-1433, 2001 WL 1180726, *2 (D.C. Cir. Oct. 9,

2001); New York v. Shalala, 119 F.3d 175, 180 (2d Cir. 1997),

but even if we did we would not accept the reading the

government urges upon us because it is unreasonable. Indeed, it is not at all clear to us that the FDA, under its

regulations, would be authorized to reject the obvious intent

of an NDA holder even if it acted directly contrary to a court

order. Certainly, the FDA points us to no authority upon

which it could rely to do so.

Intervenor BNP in its brief (and its letters to the FDA)

would have us believe that appellant and Bristol-Myers are in

cahoots, that the California lawsuit was a Kabuki play and

that they have a common objective to frustrate the introduction of generic versions of Taxol. The difficulty with these

assertions--besides being not proven--is that the FDA

(Buehler) did not rely on this rationale. Nor is it clear that

the FDA, as opposed to a district court in an antitrust or

patent infringement case, could adjudicate such a claim.

__________

district court order would result in the elimination of the August 11

listing. But the FDA (Buehler) did not offer that reasoning. In

any event, it seems obvious to us that Bristol-Myers' September 11

letter was simply an effort to add a belt to suspenders and is even a

greater indication that it never intended to completely de-list the

'331 patent.

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 14 of 15
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

To be sure, Buehler hints in his declaration that he has

dark suspicions by saying that he "was also made aware of

the concerns of the Federal Trade Commission and some

members of the public of the potential for the aggressive use

of patent listings to delay generic competition." But such

hints are hardly the stuff of reasoned decisionmaking. We

therefore do not see how we can give any weight to BNP's

allegations nor the letter from other members of the public

opposing appellant's position.

Which brings us to the remedy. We have already directed

the district court to remand this case once to compile a

record. See American Bioscience, 243 F.3d at 582-83. That

is consistent with our practice of remanding without vacating

when we are unsure of the grounds the agency asserts to

defend its action (and, perhaps, where we perceive that a

ground poorly articulated might be sufficient to sustain the

action). See, e.g., Checkosky v. SEC, 23 F.3d 452, 454 (D.C.

Cir. 1992); City of Los Angeles, 192 F.3d at 1023; RadioTelevision News Directors Assoc. v. FCC, 184 F.3d 872, 887-

88 (D.C. Cir. 1999). But at this point we think the only

appropriate course is to vacate the action appellant challenges--the FDA's approval of BNP's ANDA. We frankly do

not know what recourse is left to the FDA or other government agencies to take any steps that would affect the marketing of generic versions of Taxol. But we are convinced that

the FDA's order, in this case, was arbitrary and capricious

and must be vacated.

* * * *

Accordingly, the district court is directed to vacate the

FDA's order and remand to the agency.

So 

ordered.

USCA Case #01-5125 Document #636567 Filed: 11/06/2001 Page 15 of 15