Court Opinion

ID: 185538
Source: CourtListenerOpinion
Date Created: 2011-02-05 02:33:12+00
Date Added: 2024-06-11T17:26:16.611560
License: Public Domain

269 F.3d 1077 (D.C. Cir. 2001)
American Bioscience, Inc., Appellantv.Tommy G. Thompson, Secretary of Health and Human Services, et al., Appellees
No. 01-5125
United States Court of Appeals  FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued September 17, 2001Decided November 6, 2001

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.
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:

1
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.

2
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 ANDAs for generic versions of Taxol, intervened as defendants.

3
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.

4
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 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.

5
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. § 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

6
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 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.

7
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

8
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.

9
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  AmericanBioscience 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.

10
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  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.

11
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.

12
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 regulation was not plainly erroneous or inconsistent with the  regulation, which was itself valid.

13
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.

14
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;  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.

15
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.

16
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.

17
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.

18
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.

19
As we have repeatedly recognized, however, when a party  seeks review of agency action under the APA, the district 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.

20
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  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

21
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.

22
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 '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."

23
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:

24
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

25
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.

26
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.

27
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.

28
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, 88788 (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.

29
* * * *

30
Accordingly, the district court is directed to vacate the  FDA's order and remand to the agency.

31
So ordered.

Notes:

*
  Senior Judge Williams was in regular active service at the time  of oral argument.

1
 The Drug Price Competition and Patent Term Restoration Act  of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984).

2
 BNP argues that the statute does not allow for consecutive 30month stays, even if there are subsequent Paragraph IV certifications.  The FDA did not adopt this reading.

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.

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.

5
 Between August 14, 2000 and September 14, 2000, the FDA had  at least seven telephone conversations with BNP.

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.

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).

8
 Since under 28 U.S.C. § 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.

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