Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-08-05141/USCOURTS-caDC-08-05141-0/pdf.json

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 September 12, 2008 Decided November 7, 2008 

No. 08-5141 

TEVA PHARMACEUTICALS, USA, INC., 

APPELLEE

v. 

MICHAEL O. LEAVITT, IN HIS OFFICIAL CAPACITY AS 

SECRETARY OF HEALTH AND HUMAN SERVICES, ET AL., 

APPELLANTS

Appeal from the United States District Court 

for the District of Columbia 

(No. 1:08cv00395) 

Gerald F. Masoudi, Associate General Counsel, U.S. 

Department of Health and Human Services, argued the cause for 

appellants. With him on the briefs were Gregory G. Katsas, 

Acting Assistant Attorney General, U.S. Department of Justice, 

C. Frederick Beckner III, Deputy Assistant Attorney General, 

Eugene M. Thirolf, Director, Drake Cutini, Attorney, and Eric 

M. Blumberg, Deputy Chief Counsel, U.S. Department of 

Health and Human Services. 

USCA Case #08-5141 Document #1148171 Filed: 11/07/2008 Page 1 of 14
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Jay P. Lefkowitz argued the cause for appellee. With 

him on the brief were Michael D. Shumsky and Gregory L. 

Skidmore. 

Before: BROWN and KAVANAUGH, Circuit Judges, and 

WILLIAMS, Senior Circuit Judge. 

Opinion for the Court filed by Circuit Judge BROWN, in 

which Circuit Judge KAVANAUGH joins. 

Opinion concurring in the judgment filed by Senior Circuit 

Judge WILLIAMS. 

BROWN, Circuit Judge: The Hatch-Waxman Amendments 

help to expedite the marketing of generic drugs. Drug Price 

Competition and Patent Term Restoration Act of 1984, Pub. L. 

No. 98-417, § 101, 98 Stat. 1585, 1585 (1984). Getting a new 

“branded” drug to market is a time-consuming process. The 

manufacturer must file a New Drug Application (NDA) with the 

Food and Drug Administration (FDA), showing the new drug is 

safe and effective and identifying the number and expiration 

date of any patent or patents applicable to the drug. 21 U.S.C. 

§§ 355(a), (b). FDA has to publish this information. Id.

§ 355(b)(1). It meets this obligation by publishing a directory of 

Approved Drug Products with Therapeutic Equivalence 

Evaluations (also known as the Orange Book), a printed 

cumulative supplement to the Orange Book, and an electronic 

version of the Orange Book. 

A manufacturer preparing to market a generic bioequivalent 

of a branded drug can take a short-cut: filing an Abbreviated 

New Drug Application (ANDA) that piggybacks on the original 

manufacturer’s evidence of safety and efficacy. Id. § 355(j). To 

start the process, the ANDA applicant must certify—for each 

patent claiming a drug for which the applicant is seeking 

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approval—under one of four paragraphs that (I) patent 

information has not been filed; (II) the patent has expired; 

(III) the patent will expire on a specified date; or (IV) the 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)(A)(vii). The first drug manufacturer to file an 

approved ANDA, containing a paragraph IV certification, is 

rewarded with a 180-day period of marketing exclusivity for the 

manufacturer’s generic version of the drug. Id. 

§ 355(j)(5)(B)(iv). Marketing exclusivity is valuable, designed 

to compensate manufacturers for research and development 

costs as well as the risk of litigation from patent holders. See 35 

U.S.C. § 271(e)(2)(A) (stating a generic drug company 

certifying under paragraph IV commits an act of infringement 

for which the brand-name drug’s patent holder can sue). In this 

case, we referee an unusual dispute between FDA and an 

ANDA applicant about the effect of a paragraph IV certification 

submitted after the patent had been withdrawn by the NDA 

holder but before FDA deleted the patent information from the 

hardcopy version of the Orange Book. 

FDA insists reality matters. The point of paragraph IV, the 

Agency argues, is to reward risk when an applicant challenges a 

patent that would otherwise preclude price competition. Teva 

Pharmaceuticals counters that FDA’s obligations to keep the 

industry reliably informed is enforced—at least in part—by 

punishing the Agency’s inadvertence when the Orange Book 

does not reflect the Agency’s most current information. 

I 

Janssen Pharmaceuticals got FDA approval to market 

Risperdal in 1993 and submitted information for two patents, 

the ‘663 patent and the ‘952 patent. See Letter from Janet 

Woodcock, M.D., Acting Director, CDER, FDA to D. Jaskot, 

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M.S., R.A.C., Teva Pharmaceuticals USA, regarding Docket 

No. 2007P-0316/CP1 and CR1 (February 26, 2008) (“FDA 

Letter”) at 4. FDA listed both patents in the Orange Book. On 

April 4, 2001, Janssen withdrew the ‘952 patent for several 

different strengths of the drug, and on June 11, 2001 sent FDA a 

clarification requesting the withdrawal of remaining strengths. 

Id. FDA modified its patent listing database on June 11, 2001 

and updated the electronic Orange Book to reflect the delisting 

sometime between June 29, 2001 and July 20, 2001. Id. FDA 

conceded in its brief that neither the printed Orange Book nor its 

printed cumulative supplement reflected the delisting until 2002. 

Meanwhile, on August 28, 2001, Teva submitted an ANDA 

for a generic version of Risperdal, containing a paragraph IV 

certification to the ‘952 patent. Id. at 5. FDA promptly 

informed Teva that the ‘952 patent had been delisted and asked 

Teva to submit a revised ANDA. Id. Teva acquiesced. Id. 

Approximately six years later, Teva filed a citizen petition 

contesting FDA’s actions. Id. at 1. Teva asked FDA to relist 

the ‘952 patent and confirm Teva’s eligibility for the 180-day 

marketing exclusivity based on their original ANDA. Id. FDA 

refused. Id. 

Teva challenged the decision in district court and sought an 

expedited preliminary injunction. The district court 

consolidated the motion for preliminary injunction with the 

merits case and granted judgment in favor of Teva. On 

September 12, 2008, we issued an expedited mandate reversing 

the decision of the district court granting judgment in favor of 

Teva, and vacating the district court’s injunction. 

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II 

At the outset, we reject Teva’s claim that FDA raises 

arguments on appeal not presented to the district court. Teva’s 

confusion is partially explained by its misreading of FDA’s 

decision letter and its tendency to construe the statute’s 

independent publication mandate as if it modified the 

certification requirement. As explained more fully below, these 

requirements remain separate. And that is the position 

consistently asserted by FDA. FDA’s effort to refine and clarify 

its analysis in light of the district court’s ruling cannot be 

transmuted into a waiver of its arguments on appeal. See Yee v. 

City of Escondido, 503 U.S. 519, 534 (1992) (“Once a federal 

claim is properly presented, a party can make any argument in 

support of that claim; parties are not limited to the precise 

arguments they made below.”). 

A 

Turning to the merits, we review FDA’s interpretation of 

the Act it administers under step one of the two-step analysis in 

Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837, 842–43 (1984) 

(“[T]he court, as well as the agency, must give effect to the 

unambiguously expressed intent of Congress.”). The statute 

provides that, in order to qualify for the 180-day marketing 

exclusivity under paragraph IV, an ANDA must contain, inter 

alia: 

[A] certification . . . with respect to each patent which 

claims the listed drug . . . or which claims a use for such 

listed drug for which the applicant is seeking approval . . . 

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. 

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21 U.S.C. § 355(j)(2)(A)(vii) (emphasis added). The same 

requirement appears, with slight variation, in the FDA 

regulation. See 21 C.F.R. § 314.94(a)(12). How a manufacturer 

triggers the 180-day marketing exclusivity is clear under the text 

of the statute: no ANDA applicant can obtain exclusivity 

without a proper paragraph IV certification. 21 U.S.C. 

§ 355(j)(5)(B)(iv). A successful paragraph IV certification must 

identify a patent that “claims the listed drug” or that “claims a 

use for such listed drug for which the applicant is seeking 

approval.” Id. § 355(j)(2)(A)(vii). In the absence of such a 

patent, there can be no paragraph IV exclusivity. 

 Teva’s ANDA did not meet the clear and unambiguous 

requirements of the statute because it did not and could not 

include a certification to a patent that claimed Risperdal.1

 

According to Black’s Law Dictionary, a patent claim is “[a] 

formal statement describing the novel features of an invention 

and defining the scope of the patent’s protection.” BLACK’S 

LAW DICTIONARY 1160 (8th ed. 2004). The statute requires 

NDA holders to ascertain if, under substantive patent law, any 

patents claim the drugs for which the NDA holder submitted an 

application and then provide FDA with patent information for 

any drug which falls within the scope of a patent’s protection. 

21 U.S.C. § 355(b). The legislative purpose underlying 

paragraph IV is to enhance competition by encouraging generic 

drug manufacturers to challenge the patent information provided 

by NDA holders in order to bring generic drugs to market 

earlier. Thus, for paragraph IV purposes, a “claim” is simply a 

description of the subject a patent purports to cover as 

established by the NDA holder. See Engine Mfrs. Ass’n v. EPA, 

 

1 Even if the meaning of “claims” were ambiguous, FDA adopted a 

reasonable interpretation of the statute’s certification requirements 

under Chevron step two. Therefore, employing either analysis, Teva 

failed to meet the statutory prerequisites for marketing exclusivity. 

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88 F.3d 1075, 1088 (D.C. Cir. 1996) (recognizing if a statute 

“clearly requires a particular outcome, then the mere fact that it 

does so implicitly rather than expressly does not mean that it is 

‘silent’ in the Chevron sense”). All patent claim information is 

provided by the NDA holder. Therefore, as a practical matter, a 

patent claims a drug when the NDA holder says it does. 

When it comes to the veracity of the patent information 

supplied by NDA holders, FDA operates in a purely ministerial 

role, relying on the NDA holders to provide the Agency with 

accurate patent information. See Am. Bioscience, Inc. v. 

Thompson, 269 F.3d 1077, 1080 (D.C. Cir. 2001). This 

approach is consistent with the statute, which requires FDA to 

publish submitted patent information, but does not require FDA 

to review the merits of the patent information provided. 21 

U.S.C. § 355(b)(1). Several courts have affirmed this commonsense policy choice. See, e.g., Am. Bioscience, 269 F.3d at 

1080; Apotex, Inc. v. Thompson, 347 F.3d 1335, 1348–49 (Fed. 

Cir. 2003); aaiPharma Inc. v. Thompson, 296 F.3d 227, 242–43 

(4th Cir. 2002). Consequently, in determining what drugs a 

patent claims or covers for purposes of a paragraph IV 

certification, the patent’s actual scope is irrelevant. See, e.g.,

Purepac Pharm. Co. v. TorPharm, Inc., 354 F.3d 877, 883 

(D.C. Cir. 2004). Rather, FDA must base its decision on what 

the NDA holder asserts a patent claims. Id. 

 Here, the facts are undisputed. On August 28, 2001, when 

Teva submitted its ANDA for a generic version of Risperdal, no 

patent claimed Risperdal because Janssen had withdrawn the 

‘952 patent. Moreover, FDA had removed the listing from the 

electronic version of the Orange Book. FDA informed Teva of 

the discrepancy and Teva withdrew its paragraph IV 

certification. When Teva filed its citizen petition on August 3, 

2007, asking FDA to confirm its eligibility for 180-day 

exclusivity, the Agency refused. Its decision letter rejecting 

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Teva’s citizen petition accurately reiterated the sequence of 

events. The letter noted FDA’s staff, conducting routine filing 

reviews, always checks to see if “patent certifications contained 

in the ANDA correspond to the patents actually listed for the 

reference listed drug, as assessed by the most current patent 

information the Agency has received.” See FDA Letter at 8. 

B 

 Teva nevertheless claims its ANDA certification was valid 

because one version of the Orange Book still listed the patent. 

Neither this Court nor FDA has ever confronted the peculiar 

factual circumstances present in this case. We have, however, 

considered the vexed question of marketing exclusivity in other 

contexts and held that FDA may not delist a patent once a valid 

paragraph IV certification has been submitted, Ranbaxy Labs. 

Ltd. v. Leavitt, 469 F.3d 120, 126 (D.C. Cir. 2006)(holding 

“unlawful the FDA’s policy requiring that the first filer of a 

paragraph IV certification be sued in order to preserve its 

statutory exclusivity when the NDA holder seeks to delist the 

patent rather than to litigate”), and that 21 U.S.C. § 

355(j)(5)(B)(iv) precludes FDA from conditioning marketing 

exclusivity upon an ANDA applicant prevailing in patent 

litigation, Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 

1060, 1069 (D.C. Cir. 1998); see also Purepac Pharm. Co. v. 

Friedman, 162 F.3d 1201, 1204–05 (D.C. Cir. 1998). 

 Unfortunately for Teva, an ANDA applicant’s right to a 

period of marketing exclusivity does not vest merely because a 

paragraph IV certification is filed. Only compliance with 

paragraph IV triggers exclusivity, and compliance presupposes 

the existence of a claiming patent. The claim is a prerequisite; 

without it, there can be no valid certification. Inadvertent 

failure by the agency to meet its separate publication 

requirement cannot defeat facts. Indeed, for this Court to accept 

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Teva’s position, we would have to accept the proposition that 

even partial inadvertence is sufficient. The electronic version of 

the Orange Book reflected the withdrawal of the ‘952 patent at 

least a month before Teva submitted its certification. Teva’s 

argument goes beyond punishing Agency inadvertence; it would 

reward willful blindness on the part of manufacturers—a 

position clearly at odds with Hatch-Waxman’s focus on 

fostering competition and lowering drug prices. 

 Teva argues the instructions prefacing the Orange Book and 

its Cumulative Supplement constitute binding directives that 

restrict both applicants and FDA from considering other sources 

regarding listed patents. FDA counters that statements in the 

Orange Book are not the law and cannot change the law 

regarding whether a patent “claims” a drug. FDA is correct; 

both the statute and the Agency’s policies compel FDA to rely 

on the actual status of a patent (as indicated by the NDA holder) 

and not on the varying contents of a published reference guide. 

As FDA’s counsel conceded at oral argument, the Agency’s 

failure to list a patent after the NDA holder provided the 

information would not deprive the branded drug manufacturer 

of its rights under paragraph IV. Furthermore, the Agency has 

consistently required ANDA applicants to certify to patents 

recently submitted to FDA, even if FDA had not yet published 

the patent in any version of the Orange Book. FDA Letter at 8 

n.14. In the end, none of Teva’s arguments can overcome one 

critical lacuna: the lack of any patent claiming the drug. 

III 

The NDA holder asked FDA to remove the ‘952 patent 

from the Orange Book listing in April and June of 2001—

months before Teva attempted to submit a paragraph IV 

certification. Under the statutory and regulatory structure 

governing marketing exclusivity, the company’s notification 

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was sufficient for FDA to consider the patent withdrawn. 

Accordingly, under step one of Chevron, Teva did not submit a 

valid paragraph IV certification and neither the Orange Book 

nor any of its instructions—however faulty—trump the clear 

requirements of the statute. 

Therefore, in conformity with our mandate issued on 

September 12, 2008, we reverse the decision of the district court 

granting judgment in favor of Teva, vacate the district court’s 

injunction, and direct the entry of judgment for FDA. 

So ordered.

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WILLIAMS, Senior Circuit Judge, concurring: I write 

separately to clarify an ambiguity in the majority opinion. 

The Hatch-Waxman Amendments refer in a number of places 

to the obligation of a firm filing a “New Drug Application” 

(“NDA”) to include certain information with regard to “any 

patent which claims the drug” in question. 21 U.S.C. 

§§ 355(b)(1), 355(c)(2) (emphasis added); see

§ 355(j)(2)(A)(vii). This case relates to the obligations of the 

FDA in relation to that filing, and the opinion seems to me 

ambiguous in its reading of the statute. The panel opinion 

says on the one hand that “a ‘claim’ is simply a description of 

the subject a patent purports to cover as established by the 

NDA holder.” Maj. Op. at 6 (emphasis added). This seems to 

imply that the statute requires the FDA to accept the NDA 

holder’s listing and delisting decisions, imposing on it the 

ministerial role that it has chosen for itself. On the other 

hand, the majority opinion describes the FDA’s choice to 

adopt a ministerial role as a “common-sense policy choice” 

that is merely “consistent with the statute.” Id. at 7. I have 

seen no reasoning either in this opinion or in those of other 

courts that would support the idea that the statute mandates a 

ministerial role; for this case, all that is needed is a conclusion 

that the FDA’s adoption of that role is reasonable. 

 A Fourth Circuit decision, aaiPharma Inc. v. Thompson, 

296 F.3d 227 (4th Cir. 2002), discusses the matter quite 

comprehensively. There an NDA holder had refused to 

include the plaintiff’s patent in the list of patents claiming the 

drug. The plaintiff patent holder wanted the FDA to order the 

NDA holder to list the patent. At stake was the plaintiff’s 

right under Hatch-Waxman to delay FDA approval of an 

“Abbreviated New Drug Application” (“ANDA”) by up to 30 

months, by suing the ANDA applicant for patent 

infringement. Id. at 236, 242; see 21 U.S.C. 

§ 355(j)(5)(B)(iii). 

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The FDA’s position was that its role in the process was 

purely ministerial, while the plaintiff insisted that in case of a 

dispute the FDA had to make its own determination about a 

patent’s eligibility for listing. Id. at 237. Both parties argued 

that their view was clearly mandated by the statute. Id. at 238. 

After a careful analysis, the court concluded that Congress 

had “failed to express clearly its intent about the FDA’s role,” 

id., but that the FDA’s construction of the statute was 

“permissible.” Id. at 241. 

Yet in reaching that conclusion the court noted specific 

provisions and elements of the statutory scheme favoring the 

plaintiff’s position. For example, it noted that §§ 355(d)(6) 

and (e)(4) specifically authorize FDA disapproval, or 

withdrawal of approval, of an NDA application if the NDA 

applicant failed to fulfill its patent-listing obligations. Id. at 

238. Moreover, it generally found “plausible” the plaintiff’s 

argument that there must be a mechanism for enforcing those 

obligations, so as to protect the third-party patent holder’s 

Hatch-Waxman rights. Id. at 242. It found “some force,” 

furthermore, in the plaintiff’s conclusion that since private 

enforcement was unavailable, the FDA had to fill the 

enforcement gap. Id. at 243. Against these elements, among 

other things, were the FDA’s claim of severe resource 

constraints and indications that in practice patent holders had 

not been much jeopardized.

Two propositions flow from aaiPharma. First, the FDA’s 

ministerial role in the Orange Book listing process is not 

mandated by the statute. Second, third-party patent holders 

have rights under Hatch-Waxman which are currently at the 

mercy of the NDA holder and which the FDA could vindicate 

by taking a more active role in the listing process. It seems 

quite likely, then, that had the FDA adopted the plaintiff’s 

position and sought to protect third-party patent holders, the 

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aaiPharma court would have viewed that construction of the 

statute as reasonable too. 

These considerations apply at least as strongly to the 

present case, which concerns a dispute over a delisting rather 

than a dispute over a failure to list. The statute has even less 

to say about it; as the FDA has pointed out, the statute is 

“silent with regard to the withdrawal of patent information 

previously submitted for listing in the Orange Book.” 

Ranbaxy Labs. Ltd. v. Leavitt, 469 F.3d 120, 124 (D.C. Cir. 

2006). And the policy of protecting third-party patent holders 

applies just as strongly. 

The Federal Circuit adopted the aaiPharma approach in 

Apotex, Inc. v. Thompson, 347 F.3d 1335 (Fed. Cir. 2003). 

There, the plaintiff wanted the FDA to delist certain patents 

which it contended did not claim the relevant drug. Id. at 

1347. Citing aaiPharma, the court held that “[w]e agree with 

the Fourth Circuit that the statute does not speak clearly to this 

issue.” Id. at 1348. Ultimately, as in aaiPharma, the court 

concluded that the FDA’s approach was reasonable. Id. at 

1349. 

This circuit’s cases are consistent with aaiPharma and 

Apotex. They take the FDA’s choice of a ministerial approach 

as a given, without implying that the choice was mandated by 

the statute. Purepac Pharm. Co. v. Thompson, 354 F.3d 877, 

883 (D.C. Cir. 2004) (noting that the FDA “leaves to the 

courts” the issue of what patents actually cover); Am. 

Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1080 (D.C. Cir. 

2001) (explaining that “[t]he 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”). 

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Thus, to read the majority opinion as implying that the 

statute locks the FDA into a ministerial role would be 

inappropriate. Such a reading would prevent the FDA from 

taking a more active role in the listing process, thereby better 

protecting third parties’ rights, and finds no support in the 

cases cited by the majority opinion, Maj. Op. at 7. The statute 

and the cases do, however, support the panel opinion’s view 

that the FDA’s decision to adopt a ministerial role in the 

listing process represents simply a permissible “commonsense policy choice.” Id. 

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